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Flisiak R, Rzymski P, Flisiak-Jackiewicz M, Brzdęk M, Zarębska-Michaluk D. Treatment of chronic hepatitis C infection: strategies to address poor therapy adherence. Expert Rev Anti Infect Ther 2025:1-9. [PMID: 40156354 DOI: 10.1080/14787210.2025.2486353] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2025] [Accepted: 03/20/2025] [Indexed: 04/01/2025]
Abstract
INTRODUCTION Non-adherence to any therapy may be related to skipping drug doses, discontinuation of therapy, or loss of follow-up. It leads to the ineffectiveness of treatment, which is associated with obvious individual health losses, significant social and financial costs, and, in the case of infectious diseases, epidemiological consequences resulting from the possibility of further spread of infection. AREAS COVERED This review article analyses the causes and effects of non-adherence to treatment in patients infected with the hepatitis C virus (HCV). It also presents strategies to reduce the risk of non-adherence, which can be implemented by simplifying the treatment process, improving the flow of information between the doctor and the patient, as well as improving patients' knowledge about hepatitis C infection, and facilitating the understanding of the risks associated with non-adherence. EXPERT OPINION Since the treatment of HCV infections is highly effective in almost all patients who complete medication, no new drugs are to be expected in the coming years. Therefore, the primary attention in the global elimination of HCV will be focused on screening programs, improving the availability of drugs, and reducing the risk of non-adherence.
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Affiliation(s)
- Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland
| | - Piotr Rzymski
- Department of Environmental Medicine, Poznan University of Medical Sciences, Poznań, Poland
| | - Marta Flisiak-Jackiewicz
- Department of Pediatrics, Gastroenterology, Hepatology, Nutrition and Allergology, Medical University of Bialystok, Bialystok, Poland
| | - Michał Brzdęk
- Collegium Medicum, Jan Kochanowski University, Kielce, Poland
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Hannigan A, Krishnan N, Singh K, Bytelaar S, Schmitz D, Bartlett S, Hall D, Barrios R, Montaner JSG, Harris M, Hull MW, Salters KA. Scaling up hepatitis C testing and linkage-to-care among people who use drugs: lessons learned from a pilot project implemented at a supervised consumption site. BMC Health Serv Res 2025; 25:243. [PMID: 39948586 PMCID: PMC11823232 DOI: 10.1186/s12913-025-12374-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Accepted: 02/04/2025] [Indexed: 02/17/2025] Open
Abstract
BACKGROUND Despite rolling out publicly-funded hepatitis C virus (HCV) treatment across the province of British Columbia (BC), Canada, 35% of people returning positive HCV RNA results in 2020 did not initiate treatment. The HCV epidemic in Canada continues to disproportionately impact people who use drugs and yet, this population has the lowest proportional uptake of HCV treatment. Evidence suggests linkages to healthcare after diagnosis is one of the key factors that impacts uptake of HCV treatment among this priority population. The Hep C Connect pilot project was implemented to characterize HCV testing outcomes and linkage-to-care rates within a low-barrier supervised consumption site (SCS) in Vancouver, BC. METHODS All clients (aged ≥ 19 years) attending the Hope to Health SCS in Vancouver, Canada were invited to participate in the pilot study between November 2021 and December 2022. Interviewer-led surveys were conducted and participants were offered same-day HCV point-of-care (POC) antibody (Ab) testing. Participants received a cash honorarium for sharing their time and experiences. Descriptive statistics are shared in order to describe the reach and impact of this pilot project. RESULTS The study enrolled 186 participants including 123(66.1%) men and 59(31.7%) women, with a median age of 42 (Q1,Q3- 34,49). Forty-seven (25.3%) participants stated that they use an SCS regularly and 123(66.1%) stated that they get new rigs every day. Notably, 64(34.4%) participants reported not having a primary care provider yet more than three-quarters of the participants (144, 77.4%) reported having been ever tested for HCV. All 186 participants agreed to HCV POC Ab testing with 59.7% returning a positive HCV POC Ab result. Despite good HCV POC Ab uptake and high rates of HCV knowledge, 49(44.1%) of the HCV Ab positive participants chose not to engage in confirmatory ribonucleic acid (RNA) testing. CONCLUSIONS The Hep C Connect pilot explored the gaps evident in the HCV cascade-of-care as it pertains to people who use drugs. Findings suggest that, despite high levels of HCV knowledge, the employment of blood draw RNA testing deterred people from engaging in confirmatory testing. Improving the HCV cascade-of-care will require alternative strategies that are more acceptable to this population.
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Affiliation(s)
- Alannah Hannigan
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
| | - Nandini Krishnan
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
| | - Kirti Singh
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
| | - Shannon Bytelaar
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
| | - Deb Schmitz
- BC Hepatitis Network, Vancouver, Canada
- British Columbia Centre for Disease Control, Vancouver, Canada
| | - Sofia Bartlett
- University of British Columbia, Vancouver, Canada
- British Columbia Centre for Disease Control, Vancouver, Canada
| | - David Hall
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
| | - Rolando Barrios
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
- University of British Columbia, Vancouver, Canada
| | - Julio S G Montaner
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
- University of British Columbia, Vancouver, Canada
| | - Marianne Harris
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
- University of British Columbia, Vancouver, Canada
| | - Mark W Hull
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
- University of British Columbia, Vancouver, Canada
| | - Kate A Salters
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada.
- University of British Columbia, Vancouver, Canada.
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Yang A, Swamy N, Giang J. Single-center retrospective review of standard versus minimal monitoring for hepatitis C direct-acting antiviral therapy. J Am Pharm Assoc (2003) 2025; 65:102265. [PMID: 39401696 DOI: 10.1016/j.japh.2024.102265] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2024] [Revised: 10/07/2024] [Accepted: 10/08/2024] [Indexed: 02/21/2025]
Abstract
BACKGROUND Highly effective direct-acting antiviral (DAA) therapies have transformed the landscape of hepatitis C virus (HCV) treatment. However, there continues to be limited data regarding the efficacy and safety of required in-person clinic visits (standard monitoring) versus completely telehealth clinic visits (minimal monitoring) during HCV therapy, which could delay practice adoption. OBJECTIVES This study aimed to assess the rates of undetectable HCV ribonucleic acid (RNA) in sustained viral load 12 weeks after therapy (SVR12) in standard versus minimal monitoring approaches during DAA. METHODS A 12-month, single-center retrospective cohort study was conducted in treatment-naïve HCV-infected adults who received DAA therapy between May 1, 2020, and April 30, 2021. The standard monitoring group had ≥1 in-person clinic visit with HCV RNA laboratory monitoring during DAA treatment. The minimal monitoring group had entirely telehealth visits without HCV RNA laboratory monitoring during treatment. Both groups received telephonic touchpoints throughout DAA treatment from a clinical pharmacist practitioner and a nurse care coordinator. The primary outcome was SVR12. RESULTS From May 2020 to April 2021, 133 patients with HCV met inclusion criteria and were treated with DAA (standard, n = 56; minimal, n = 77), with no differences in baseline demographics. Overall, total encounters during DAA treatment remained statistically significant in the standard than minimal monitoring group (standard, 2.1 ± 0.8, vs. minimal, 1.7 ± 0.9; P < .01). Although minimal monitoring had higher loss to follow-up rates (standard, 7.1%, vs. minimal, 18.2%; P = 0.06), the modified intention-to-treat analysis showed no differences in sustained virologic response (SVR) between standard and minimal monitoring approaches (standard, 98.1%, n = 51, vs. minimal, 95.3%, n = 60; P = 0.41). CONCLUSIONS This single-center retrospective cohort study demonstrated that minimal monitoring during HCV treatment was as effective in achieving SVR cure rates as standard monitoring. Eliminating required in-person clinic visits during DAA therapy alongside a collaborative approach may play a major role in overcoming barriers to HCV care in select patients.
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Parada Vázquez P, Pérez-Cachafeiro S, Castiñeira Domínguez B, González-Pérez JM, Mera Calviño JM, Souto-Rodríguez R, Falagán Cachafeiro Y, Pérez-Medrano I, Vázquez-Temprano N, Trigo M, Carrodeguas A, González-Sánchez JL, Durán-Parrondo C, Turnes J. Artificial intelligence-assisted identification and retrieval of chronic hepatitis C patients lost to follow-up in the health area of Pontevedra and O Salnés (Spain). GASTROENTEROLOGIA Y HEPATOLOGIA 2025; 48:502226. [PMID: 38950646 DOI: 10.1016/j.gastrohep.2024.502226] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Revised: 06/18/2024] [Accepted: 06/21/2024] [Indexed: 07/03/2024]
Abstract
OBJECTIVE Direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) infection offer an opportunity to eliminate the disease. This study aimed to identify and relink to care HCV patients previously lost to medical follow-up in the health area of Pontevedra and O Salnés (Spain) using an artificial intelligence-assisted system. PATIENTS AND METHODS Active retrospective search of previously diagnosed HCV cases recorded in the Galician Health Service proprietary health information exchange database using the Herramientas para la EXplotación de la INformación (HEXIN) application. RESULTS AND CONCLUSIONS Out of 99 lost patients identified, 64 (64.6%) were retrieved. Of these, 62 (96.88%) initiated DAA treatment and 54 patients (87.1%) achieved a sustained virological response. Mean time from HCV diagnosis was over 10 years. Main reasons for loss to follow-up were fear of possible adverse effects of treatment (30%) and mobility impediments (21%). Among the retrieved patients, almost one in three presented advanced liver fibrosis (F3) or cirrhosis (F4) at evaluation. In sum, HCV patients lost to follow-up can be retrieved by screening past laboratory records. This strategy promotes the achievement of HCV elimination goals.
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Affiliation(s)
- Pablo Parada Vázquez
- Servicio de Aparato Digestivo del Complejo Hospitalario Universitario de Pontevedra/Instituto de Investigación Sanitaria Galicia Sur, Pontevedra, Spain
| | - Santiago Pérez-Cachafeiro
- Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain; Admission Service, Complejo Hospitalario Universitario A Coruna, Coruna, Spain
| | - Belén Castiñeira Domínguez
- Servicio de Aparato Digestivo del Complejo Hospitalario Universitario de Pontevedra/Instituto de Investigación Sanitaria Galicia Sur, Pontevedra, Spain
| | - Juan Manuel González-Pérez
- Subdirección Xeral de Sistemas e Tecnoloxías de Información, Consellería de Sanidade, Xunta de Galicia, Spain
| | - José Manuel Mera Calviño
- Servicio de Aparato Digestivo del Complejo Hospitalario Universitario de Pontevedra/Instituto de Investigación Sanitaria Galicia Sur, Pontevedra, Spain
| | - Raquel Souto-Rodríguez
- Servicio de Aparato Digestivo del Complejo Hospitalario Universitario de Pontevedra/Instituto de Investigación Sanitaria Galicia Sur, Pontevedra, Spain
| | - Yolanda Falagán Cachafeiro
- Servicio de Aparato Digestivo del Complejo Hospitalario Universitario de Pontevedra/Instituto de Investigación Sanitaria Galicia Sur, Pontevedra, Spain
| | - Indhira Pérez-Medrano
- Servicio de Aparato Digestivo del Complejo Hospitalario Universitario de Pontevedra/Instituto de Investigación Sanitaria Galicia Sur, Pontevedra, Spain
| | - Nuria Vázquez-Temprano
- Unidad de Procesos Infecciosos, Complejo Hospitalario Universitario de Pontevedra, Spain
| | - Matilde Trigo
- Servicio de Microbiología, Complejo Hospitalario Universitario de Pontevedra, Spain
| | | | | | | | - Juan Turnes
- Servicio de Aparato Digestivo del Complejo Hospitalario Universitario de Pontevedra/Instituto de Investigación Sanitaria Galicia Sur, Pontevedra, Spain.
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Baptista-Leite R, Lopes H, Franco D, Clemens T, Brand H. Primary healthcare as a strategy for eliminating hepatitis C: the METRIC toolkit. Prim Health Care Res Dev 2024; 25:e61. [PMID: 39508085 PMCID: PMC11569853 DOI: 10.1017/s1463423624000355] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2023] [Revised: 02/29/2024] [Accepted: 07/08/2024] [Indexed: 11/08/2024] Open
Abstract
AIM This paper presents the development of the METRIC toolkit, aimed at enhancing primary healthcare interventions in the context of hepatitis C control, thus contributing to the World Health Organization's global strategy to achieve the elimination of the disease by 2030. BACKGROUND At the global level, most people living with hepatitis C are unaware of their condition. As such, the eradication of hepatitis C necessitates comprehensive strategies within primary healthcare settings, as it provides an opportunity to reach the general population, facilitates the identification of potential patients who may be unfamiliar with hepatitis C, and guides them toward adequate care. Herein, we propose the METRIC toolkit as a means to optimize the efficiency and efficacy of healthcare services dedicated to hepatitis C control. METHODS The development of the METRIC toolkit was guided by a thorough review of pertinent literature, focusing on primary healthcare interventions in hepatitis C control. Key components were identified, encompassing systematic problem identification, solution formulation, outcome evaluation, and feedback integration. FINDINGS The METRIC toolkit represents a valuable resource for strengthening primary healthcare interventions in hepatitis C control. By fostering a culture of continuous improvement and data-driven decision-making, this framework holds promise in advancing the global agenda towards hepatitis C elimination. However, its successful application requires careful consideration of contextual factors and ongoing adaptation to local needs and circumstances.
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Affiliation(s)
- Ricardo Baptista-Leite
- NOVA Center for Global Health – NOVA Information Management School (NOVA IMS), Universidade Nova de Lisboa, Lisbon, Portugal
- Department of International Health, Care and Public Health Research Institute – CAPHRI, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
| | - Henrique Lopes
- NOVA Center for Global Health – NOVA Information Management School (NOVA IMS), Universidade Nova de Lisboa, Lisbon, Portugal
| | - Diogo Franco
- NOVA Center for Global Health – NOVA Information Management School (NOVA IMS), Universidade Nova de Lisboa, Lisbon, Portugal
| | - Timo Clemens
- Department of International Health, Care and Public Health Research Institute – CAPHRI, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
| | - Helmut Brand
- Department of International Health, Care and Public Health Research Institute – CAPHRI, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
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Whittaker R, Midgard H, Dalgard O, Kløvstad H. Treatment uptake among notified cases of hepatitis C virus infection in Norway, 1990 to 2022: a registry-based study to monitor progress towards elimination. Euro Surveill 2024; 29:2400180. [PMID: 39544147 PMCID: PMC11565653 DOI: 10.2807/1560-7917.es.2024.29.46.2400180] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2024] [Accepted: 07/15/2024] [Indexed: 11/17/2024] Open
Abstract
BackgroundHepatitis C virus (HCV) infection is targeted for elimination as a public health threat by 2030. The World Health Organization goal for treatment uptake is ≥ 80% among cases diagnosed with an active HCV infection (RNA- or core antigen-positive), maintained for 2 years.AimTo calculate treatment uptake, time from diagnosis to treatment start and complete treatment dispensation among notified cases of HCV infection in Norway.MethodWe linked national data on notified cases diagnosed from 1990-2022 to dispensed prescriptions for HCV treatment from January 2004-February 2023 and data on residence status at the end of 2022. We described treatment uptake by demographic and epidemiological characteristics. We calculated the median number of months from diagnosis to treatment start by year. For direct-acting antiviral treatment periods, complete dispensation was based on the treatment and number of defined daily doses.ResultsAmong 12,178 notified cases that had an active infection at diagnosis and were still resident, 10,091 (83%) had received treatment. Uptake among resident cases was > 80% in 2021 and 2022. The median number of months from diagnosis to treatment decreased over time to 3 (interquartile range: 1-5) among cases diagnosed in 2021 and 2022. From 2015-22, 89-93% of direct-acting antiviral treatment periods annually had complete treatment dispensed.ConclusionNorway has achieved the elimination goal for treatment uptake among notified cases diagnosed with an active HCV infection. This highlights the benefit of a strategy that includes unrestricted, simplified and integrated treatment options.
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Affiliation(s)
- Robert Whittaker
- Department of Infection Control and Vaccines, Norwegian Institute of Public Health, Oslo, Norway
| | - Håvard Midgard
- Department of Gastroenterology, Oslo University Hospital, Oslo, Norway
| | - Olav Dalgard
- Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway
- Institute of Clinical Medicine, University of Oslo, Oslo, Norway
| | - Hilde Kløvstad
- Department of Infection Control and Vaccines, Norwegian Institute of Public Health, Oslo, Norway
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Wegener M, Sims K, Brooks R, Nichols L, Sideleau R, McKay S, Villanueva M. Understanding Users' Engagement in a Provider-Created Mobile App for Training to Advance Hepatitis C Care: Knowledge Assessment Survey Study. JMIR Form Res 2024; 8:e52729. [PMID: 39486023 PMCID: PMC11568402 DOI: 10.2196/52729] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2023] [Revised: 08/02/2024] [Accepted: 09/16/2024] [Indexed: 11/03/2024] Open
Abstract
BACKGROUND The World Health Organization and the Centers for Disease Control and Prevention have set ambitious hepatitis C virus (HCV) elimination targets for 2030. Current estimates show that the United States is not on pace to meet elimination targets due to multiple patient, clinic, institutional, and societal level barriers that contribute to HCV testing and treatment gaps. Among these barriers are unawareness of testing and treatment needs, misinformation concerning adverse treatment reactions, need for substance use sobriety, and treatment efficacy. Strategies to improve viral hepatitis education are needed. OBJECTIVE We aim to provide a high-quality HCV educational app for patients and health care workers, particularly nonprescriber staff. The app was vetted by health care providers and designed to guide users through the HCV testing and treatment stages in a self-exploratory way to promote engagement and knowledge retention. The app is comprised of five learning modules: (1) Testing for Hep C (hepatitis C), (2) Tests for Hep C Positive Patients, (3) Treatments Available to You, (4) What to Expect During Treatment, and (5) What to Expect After Treatment. METHODS An HCV knowledge assessment survey was administered to providers and patients at the Yale School of Medicine and 11 Connecticut HIV clinics as part of a grant-funded activity. The survey findings and pilot testing feedback guided the app's design and content development. Data on app usage from November 2019 to November 2022 were analyzed, focusing on user demographics, engagement metrics, and module usage patterns. RESULTS There were 561 app users; 216 (38.5%) accessed the training modules of which 151 (69.9%) used the app for up to 60 minutes. Of them, 65 (30.1%) users used it for >60 minutes with a median time spent of 5 (IQR 2-8) minutes; the median time between initial accession and last use was 39 (IQR 18-60) days. Users accessed one or more modules and followed a nonsequential pattern of use: module 1: 163 (75.4%) users; module 4: 82 (38%); module 5: 67 (31%); module 3: 49 (22.7%); module 2: 41 (19%). CONCLUSIONS This app, created in an academic setting, is one of a few available in English and Spanish that provides content-vetted HCV education for patients and health care supportive staff. It offers the convenience of on-demand education, allowing users to access crucial information about HCV management and treatment in a self-directed fashion that acknowledges and promotes variable preferences in learning approaches. While app uptake was relatively limited, we propose that future efforts should focus on combined promotion efforts with marketing strategies experts aligned with academic experts. Incorporating ongoing user feedback and integrating personalized reminders and quizzes, will further enhance engagement, supporting the broader public health HCV elimination goals.
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Affiliation(s)
- Maximilian Wegener
- Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States
| | - Katarzyna Sims
- Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States
| | - Ralph Brooks
- Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States
| | - Lisa Nichols
- Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States
| | - Robert Sideleau
- Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States
| | - Sharen McKay
- Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States
| | - Merceditas Villanueva
- Department of Internal Medicine, Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States
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Zarębska-Michaluk D, Brzdęk M, Tronina O, Janocha-Litwin J, Sitko M, Piekarska A, Klapaczyński J, Parfieniuk-Kowerda A, Sobala-Szczygieł B, Tudrujek-Zdunek M, Laurans Ł, Flisiak R. Loss to follow-up of patients after antiviral treatment as an additional barrier to HCV elimination. BMC Med 2024; 22:486. [PMID: 39444018 PMCID: PMC11515622 DOI: 10.1186/s12916-024-03699-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/03/2024] [Accepted: 10/10/2024] [Indexed: 10/25/2024] Open
Abstract
BACKGROUND Eliminating hepatitis C virus (HCV) infections is a goal set by the World Health Organization. This has become possible with the introduction of highly effective and safe direct-acting antivirals (DAA) but limitations remain due to undiagnosed HCV infections and loss of patients from the cascade of care at various stages, including those lost to follow-up (LTFU) before the assessment of the effectiveness of the therapy. The aim of our study was to determine the extent of this loss and to establish the characteristics of patients experiencing it. METHODS Patients with chronic HCV infection from the Polish retrospective multicenter EpiTer-2 database who were treated with DAA therapies between 2015 and 2023 were included in the study. RESULTS In the study population of 18,968 patients, 106 had died by the end of the 12-week post-treatment follow-up period, and 509 patients did not report for evaluation of therapy effectiveness while alive and were considered LTFU. Among patients with available assessment of sustained virological response (SVR), the effectiveness of therapy was 97.5%. A significantly higher percentage of men (p<0.0001) and a lower median age (p=0.0001) were documented in LTFU compared to the group with available SVR assessment. In LTFU patients, comorbidities such as alcohol (p<0.0001) and drug addiction (p=0.0005), depression (p=0.0449) or other mental disorders (p<0.0001), and co-infection with human immunodeficiency virus (HIV) (p<0.0001) were significantly more common as compared to those with SVR assessment. They were also significantly more often infected with genotype (GT) 3, less likely to be treatment-experienced and more likely to discontinue DAA therapy. CONCLUSIONS In a real-world population of nearly 19,000 HCV-infected patients, we documented a 2.7% loss to follow-up rate. Independent predictors of this phenomenon were male gender, GT3 infection, HIV co-infection, alcohol addiction, mental illnesses, lack of prior antiviral treatment and discontinuation of DAA therapy.
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Affiliation(s)
- Dorota Zarębska-Michaluk
- Department of Infectious Diseases and Allergology, Jan Kochanowski University, Kielce, 25-317, Poland
| | - Michał Brzdęk
- Collegium Medicum, Jan Kochanowski University, aleja IX Wieków Kielc 19A, Kielce, 25-317, Poland.
| | - Olga Tronina
- Department of Transplantology, Immunology, Nephrology and Internal Diseases, Medical University of Warsaw, Warsaw, Mazowieckie, 02-006, Poland
| | - Justyna Janocha-Litwin
- Department of Infectious Diseases and Hepatology, Wrocław Medical University, Wrocław, 50-367, Poland
| | - Marek Sitko
- Department of Infectious and Tropical Diseases, Jagiellonian University, Kraków, 31-088, Poland
| | - Anna Piekarska
- Department of Infectious Diseases and Hepatology, Medical University of Łódź, Łódź, 90-419, Poland
| | - Jakub Klapaczyński
- Department of Internal Medicine and Hepatology, The National Institute of Medicine of the Ministry of Interior and Administration, Warszawa, 02-507, Poland
| | - Anna Parfieniuk-Kowerda
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, 15-089, Poland
| | - Barbara Sobala-Szczygieł
- Department of Infectious Diseases and Hepatology, Medical University of Silesia in Katowice, Katowice, 40-635, Poland
| | | | - Łukasz Laurans
- Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, 70-204, Poland
- Multidisciplinary Regional Hospital in Gorzów Wielkopolski, Gorzów Wielkopolski, 66-400, Poland
| | - Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, 15-089, Poland
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Milošević I, Filipović A, Beronja B, Mitrović N, Ružić M, Simić J, Knežević N, Pete M, Todorović N, Nikolić N. Optimizing Hepatitis C Treatment Monitoring: Is Sustained Virologic Response at 4 Weeks Becoming the New Standard? Microorganisms 2024; 12:2050. [PMID: 39458359 PMCID: PMC11509943 DOI: 10.3390/microorganisms12102050] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2024] [Revised: 10/05/2024] [Accepted: 10/08/2024] [Indexed: 10/28/2024] Open
Abstract
This study, conducted at two university-based infectious disease clinics, included 216 patients with chronic hepatitis C. The primary objective was to assess the positive and negative predictive values, sensitivity, and specificity of achieving a sustained virological response (SVR) at 4 weeks compared to 12 weeks post-therapy. The results demonstrated a maximum sensitivity of 100% for achieving SVR at 12 weeks after reaching SVR at 4 weeks for all analyzed genotypes, except for genotype 1b treated with EBR/GZR therapy, where the specificity was 75%. Additionally, younger age and less advanced liver fibrosis were identified as independent predictors of achieving a sustained virological response at both 4 and 12 weeks. The significant normalization of various biochemical parameters was observed after treatment, indicating an overall improvement in liver function. This study suggests that shortening the monitoring period to 4 weeks might be effective for younger patients without significant fibrosis, potentially reducing loss to follow-up, which is a critical issue in HCV treatment. These findings align with the "test and treat" approach. Further research is needed to confirm these findings and incorporate them into official guidelines, which could simplify and enhance the effectiveness of HCV treatment protocols, aiding global efforts to eliminate HCV as a public health issue by 2030.
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Affiliation(s)
- Ivana Milošević
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Ana Filipović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Branko Beronja
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Nikola Mitrović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Maja Ružić
- Faculty of Medicine, Clinic for Infectious Diseases, University Clinical Centre of Vojvodina, University of Novi Sad, 21000 Novi Sad, Serbia; (M.R.); (M.P.)
| | - Jelena Simić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Nataša Knežević
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Maria Pete
- Faculty of Medicine, Clinic for Infectious Diseases, University Clinical Centre of Vojvodina, University of Novi Sad, 21000 Novi Sad, Serbia; (M.R.); (M.P.)
| | - Nevena Todorović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Nataša Nikolić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
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10
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Dinh DA, Tan Y, Saeed S. Disengagement from Care Among People Co-Infected with HIV and HCV: A Scoping Review. AIDS Behav 2024; 28:3381-3403. [PMID: 38992228 DOI: 10.1007/s10461-024-04436-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/27/2024] [Indexed: 07/13/2024]
Abstract
Disengagement from care among people with HIV (PWH) and hepatitis C (HCV) increases the risks of adverse health outcomes and poses significant barriers to achieving global HIV and HCV elimination goals. In accordance with the Joanna Briggs Institute framework, a scoping review was conducted to synthesize and highlight existing gaps in the literature on (dis)engagement in care among PWH and HCV. We searched for original studies on (dis)engagement in care among PWH and HCV in high-income countries using eight electronic databases from inception to May 2023. Our search yielded 4462 non-duplicated records, which were scoped to 27 studies. Definitions of (dis)engagement in care were diverse, with considerable heterogeneity in how retention was operationalized and temporally measured. Studies identified predictors of (dis)engagement to be related to drug and substance use (n = 5 articles), clinical factors (n = 5), social and welfare (n = 4), and demographic characteristics (n = 2). When engagement in care was treated as an exposure, it was associated with HCV treatment initiation (n = 3), achieving sustained virological response (n = 2), and maintaining HIV viral suppression (n = 1). Interventions to improve care engagement among PWH and HCV were limited to five studies using cash incentives (n = 1) and individual case management (n = 4). (Dis)engagement in care is a dynamic process influenced by shifting priorities that may 'tip the balance' towards or away from regularly interacting with healthcare professionals. However, inconsistent definitions render cross-study comparisons and meta-analyses virtually impossible. Further research needs to establish a standardized definition to identify patients at high risk of disengagement and develop interventions that leverage the nested HIV/HCV care cascades to retain and recover patients lost from care.
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Affiliation(s)
- Duy A Dinh
- Faculty of Health Sciences, Queen's University, Kingston, ON, Canada
| | - Yvonne Tan
- Department of Medicine, Queen's University, Kingston, ON, Canada
| | - Sahar Saeed
- Department of Public Health Sciences, Queen's University, 203 Carruthers Hall 62 Fifth Field Company Lane, Kingston, ON, K7L 3N6, Canada.
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11
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Tramonti Fantozzi MP, Ceccarelli L, Petri D, De Vita E, Agostini A, Colombatto P, Stasi C, Rossetti B, Brunetto M, Surace L, Salvati A, Calì A, Tacconi D, Bianco C, Redi D, Fabbiani M, Panza F, Luchi S, Modica S, Moneta S, Iacopini S, Nencioni C, Chigiotti S, Ottaviano G, Zignego AL, Blanc P, Pierotti P, Mariabelli E, Berni R, Silvestri C, Tavoschi L. Hepatitis C epidemiology and treatment outcomes in Italy: Impact of the DAA era and the COVID-19 pandemic. J Viral Hepat 2024; 31:623-632. [PMID: 39072924 DOI: 10.1111/jvh.13983] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Revised: 06/18/2024] [Accepted: 07/16/2024] [Indexed: 07/30/2024]
Abstract
HCV infection poses a global health threat, with significant morbidity and mortality. This study examines HCV trends in a large Italian region from 2015 to 2022, considering demographic changes, evolving clinical profiles, treatment regimens and outcomes, including the impact of the COVID-19 pandemic. This multicentre retrospective study analysed demographics, clinical histories and risk factors in 6882 HCV patients. The study spanned before and after the direct-acting antiviral (DAA) era, and the COVID-19 period, focusing on treatment outcomes (SVR12, non-SVR12 and patients lost to follow-up). Statistical methods included ANOVA, multinomial logistic regression, Kruskal-Wallis test and chi-square analysis, and were conducted adhering to the intention-to-treat (ITT) principle. The cohort, mainly Italian males (average age 58.88), showed Genotype 1 dominance (56.6%) and a high SVR12 rate (97.5%). The pandemic increased follow-up losses, yet SVR12 rates remained stable, influenced by factors like age, gender, cirrhosis and comorbidities. Despite COVID-19 challenges, the region sustained high SVR12 rates in HCV care, emphasising the importance of sustained efforts in HCV care. Continuous screening and targeted interventions in high-risk populations are crucial for achieving WHO elimination targets. The study highlights the resilience of HCV care during the pandemic and provides insights for future public health strategies.
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Affiliation(s)
| | - Luca Ceccarelli
- Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
- Sant'Anna School of Advanced Studies, Pisa, Italy
| | - Davide Petri
- Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
| | - Erica De Vita
- Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
| | - Antonello Agostini
- Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
| | | | - Cristina Stasi
- CRIA-MASVE Center for Research and Innovation, Careggi University Hospital, Florence, Italy
| | | | - Maurizia Brunetto
- Hepatology Unit, Pisa University Hospital, Pisa, Italy
- Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Lidia Surace
- Hepatology Unit, Pisa University Hospital, Pisa, Italy
| | | | - Alessia Calì
- Hepatology Unit, Pisa University Hospital, Pisa, Italy
| | - Danilo Tacconi
- Division of Infectious Diseases, Arezzo Hospital, Arezzo, Italy
| | - Claudia Bianco
- Division of Infectious Diseases, Arezzo Hospital, Arezzo, Italy
| | - David Redi
- Division of Infectious Diseases, Arezzo Hospital, Arezzo, Italy
| | | | - Francesca Panza
- Infectious and Tropical Diseases Unit, Siena University Hospital, Siena, Italy
| | - Sauro Luchi
- Division of Infectious Diseases and Hepatology, San Luca Hospital, AUSL Toscana Nord Ovest, Lucca, Italy
| | - Sara Modica
- Division of Infectious Diseases and Hepatology, San Luca Hospital, AUSL Toscana Nord Ovest, Lucca, Italy
| | - Sara Moneta
- Division of Infectious Diseases and Hepatology, San Luca Hospital, AUSL Toscana Nord Ovest, Lucca, Italy
| | - Sarah Iacopini
- Division of Infectious Diseases and Hepatology, San Luca Hospital, AUSL Toscana Nord Ovest, Lucca, Italy
| | | | | | | | - Anna Linda Zignego
- Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
| | - Pierluigi Blanc
- Division of Infectious Diseases 1-2, AUSL Toscana Centro, Florence, Italy
| | - Piera Pierotti
- Division of Infectious Diseases 1-2, AUSL Toscana Centro, Florence, Italy
| | - Elisa Mariabelli
- Division of Infectious Diseases 1-2, AUSL Toscana Centro, Florence, Italy
| | - Roberto Berni
- Epidemiology Unit, Tuscany Regional Health Agency, Florence, Italy
| | | | - Lara Tavoschi
- Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
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12
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Rzymski P, Brzdęk M, Dobrowolska K, Poniedziałek B, Murawska-Ochab A, Zarębska-Michaluk D, Flisiak R. Like a Rolling Stone? A Review on Spontaneous Clearance of Hepatitis C Virus Infection. Viruses 2024; 16:1386. [PMID: 39339862 PMCID: PMC11435954 DOI: 10.3390/v16091386] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Revised: 08/23/2024] [Accepted: 08/29/2024] [Indexed: 09/30/2024] Open
Abstract
Elimination of hepatitis C virus (HCV) without the need for medical intervention, known as spontaneous clearance (SC), occurs at a significantly lower rate than in the case of hepatitis B virus infection and only in selected individuals, such as reportedly in Keith Richards, a guitarist of The Rolling Stones. The present paper provides an updated narrative review of the research devoted to the phenomenon in order to identify and discuss the demographic, lifestyle-related, clinical, viral genotype-related, and host genetic factors underpinning the SC occurrence. The body of evidence indicates that the likelihood of SC is decreased in older individuals, men, Black people, HIV-coinfected subjects, and intravenous drug and alcohol users. In turn, HBV coinfection and specific polymorphism of the genes encoding interferon lambda 3 (particularly at rs8099917) and interferon lambda 4 (particularly at rs12979860) and HLA genes increase the odds of SC. Numerous other host-specific genetic factors could be implicated in SC, but the evidence is limited only to certain ethnic groups and often does not account for confounding variables. SC of HCV infection is a complex process arising from a combination of various factors, though a genetic component may play a leading role in some cases. Understanding factors influencing the likelihood of this phenomenon justifies better surveillance of high-risk groups, decreasing health inequities in particular ethnic groups, and may guide the development of a prophylactic vaccine, which at present is not available, or novel therapeutic strategies. Further research is needed to elucidate the exact mechanisms underlying SC and to explore potential interventions that could enhance this natural antiviral response.
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Affiliation(s)
- Piotr Rzymski
- Department of Environmental Medicine, Poznań University of Medical Sciences, 60-806 Poznań, Poland
| | - Michał Brzdęk
- Collegium Medicum, Jan Kochanowski University, 25-317 Kielce, Poland
| | | | - Barbara Poniedziałek
- Department of Environmental Medicine, Poznań University of Medical Sciences, 60-806 Poznań, Poland
| | | | - Dorota Zarębska-Michaluk
- Department of Infectious Diseases and Allergology, Jan Kochanowski University, 25-317 Kielce, Poland
| | - Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540 Białystok, Poland
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13
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Roder C, Cosgrave C, Mackie K, McNamara B, Doyle JS, Wade AJ. Missed Opportunities: A Retrospective Study of Hepatitis C Testing in Hospital Inpatients. Viruses 2024; 16:979. [PMID: 38932269 PMCID: PMC11209528 DOI: 10.3390/v16060979] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2024] [Revised: 06/08/2024] [Accepted: 06/13/2024] [Indexed: 06/28/2024] Open
Abstract
Increasing testing is key to achieving hepatitis C elimination. This retrospective study aimed to assess the testing cascade of patients at a regional hospital in Victoria, Australia, who inject drugs or are living with hepatitis C, to identify missed opportunities for hepatitis C care. Adult hospital inpatients and emergency department (ED) attendees from 2018 to 2021 with indications for intravenous drug use (IDU) or hepatitis C on their discharge or ED summary were included. Data sources: hospital admissions, pathology, hospital pharmacy, and outpatients. We assessed progression through the testing cascade and performed logistic regression analysis for predictors of hepatitis C care, including testing and treatment. Of 79,923 adults admitted, 1345 (1.7%) had IDU-coded separations and 628 (0.8%) had hepatitis C-coded separations (N = 1892). Hepatitis C virus (HCV) status at the end of the study was unknown for 1569 (82.9%). ED admissions were associated with increased odds of not providing hepatitis C care (odds ratio 3.29, 95% confidence interval 2.42-4.48). More than 2% of inpatients at our hospital have an indication for testing, however, most are not being tested despite their hospital contact. As we work toward HCV elimination in our region, we need to incorporate testing and linkage strategies within hospital departments with a higher prevalence of people at risk of infection.
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Affiliation(s)
- Christine Roder
- Barwon South West Public Health Unit, Barwon Health, Geelong 3220, Australia;
- Centre for Innovation in Infectious Disease and Immunology Research (CIIDIR), Institute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Deakin University, Geelong 3220, Australia
| | - Carl Cosgrave
- Gastroenterology Department, Barwon Health, Geelong 3220, Australia;
| | - Kathryn Mackie
- Pharmacy Department, Barwon Health, Geelong 3220, Australia;
- Pharmacy Department, Alfred Health, Melbourne 3004, Australia
| | - Bridgette McNamara
- Barwon South West Public Health Unit, Barwon Health, Geelong 3220, Australia;
- Centre for Innovation in Infectious Disease and Immunology Research (CIIDIR), Institute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Deakin University, Geelong 3220, Australia
- Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne 3010, Australia
| | - Joseph S. Doyle
- Disease Elimination Program, Burnet Institute, Melbourne 3004, Australia;
- Department of Infectious Disease, Alfred Health, Melbourne 3004, Australia
| | - Amanda J. Wade
- Barwon South West Public Health Unit, Barwon Health, Geelong 3220, Australia;
- Centre for Innovation in Infectious Disease and Immunology Research (CIIDIR), Institute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Deakin University, Geelong 3220, Australia
- Disease Elimination Program, Burnet Institute, Melbourne 3004, Australia;
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14
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Kapadia SN, Jordan AE, Eckhardt BJ, Perlman DC. The Urgent Need to Implement Point-of-Care RNA Testing for Hepatitis C Virus to Support Elimination. Clin Infect Dis 2024; 78:1235-1239. [PMID: 37633653 PMCID: PMC11093654 DOI: 10.1093/cid/ciad503] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/30/2023] [Revised: 07/27/2023] [Accepted: 08/22/2023] [Indexed: 08/28/2023] Open
Abstract
Hepatitis C virus (HCV) elimination is an important global public health goal. However, the United States is not on track to meet the World Health Organization's 2030 targets for HCV elimination. Recently, the White House proposed an HCV elimination plan that includes point-of-care (POC) HCV RNA testing, which is currently in use in many countries but is not approved in the United States. POC HCV RNA testing is crucial for implementing community-based testing and for enabling test-and-treat programs, assessing cure, and monitoring for reinfection. Here, we review the status of POC HCV RNA testing in the United States, discuss factors that are needed for successful implementation, and issue specific public health and policy recommendations that would allow for the use of POC HCV RNA testing to support HCV elimination.
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Affiliation(s)
- Shashi N Kapadia
- Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA
| | - Ashly E Jordan
- Center for Drug Use and HIV/HCV Research, New York, New York, USA
| | - Benjamin J Eckhardt
- Division of Infectious Diseases, New York University School of Medicine, New York, New York, USA
| | - David C Perlman
- Center for Drug Use and HIV/HCV Research, New York, New York, USA
- Division of Infectious Diseases, Icahn School of Medicine at Mt Sinai, New York, New York, USA
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15
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Saeed S, Thomas T, Dinh DA, Moodie E, Cox J, Cooper C, Gill J, Martel-Laferriere V, Panagiotoglou D, Walmsley S, Wong A, Klein MB. Frequent Disengagement and Subsequent Mortality Among People With HIV and Hepatitis C in Canada: A Prospective Cohort Study. Open Forum Infect Dis 2024; 11:ofae239. [PMID: 38798898 PMCID: PMC11127478 DOI: 10.1093/ofid/ofae239] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2023] [Accepted: 04/23/2024] [Indexed: 05/29/2024] Open
Abstract
Background The cascade of care, commonly used to assess HIV and hepatitis C (HCV) health service delivery, has limitations in capturing the complexity of individuals' engagement patterns. This study examines the dynamic nature of engagement and mortality trajectories among people with HIV and HCV. Methods We used data from the Canadian HIV-HCV Co-Infection Cohort, which prospectively follows 2098 participants from 18 centers biannually. Markov multistate models were used to evaluate sociodemographic and clinical factors associated with transitioning between the following states: (1) lost-to-follow-up (LTFU), defined as no visit for 18 months; (2) reengaged (reentry into cohort after being LTFU); (3) withdrawn from the study (ie, moved); (4) death; otherwise remained (5) engaged-in-care. Results A total of 1809 participants met the eligibility criteria and contributed 12 591 person-years from 2003 to 2022. LTFU was common, with 46% experiencing at least 1 episode, of whom only 57% reengaged. One in 5 (n = 383) participants died during the study. Participants who transitioned to LTFU were twice as likely to die as those who were consistently engaged. Factors associated with transitioning to LTFU included detectable HCV RNA (adjusted hazards ratio [aHR], 1.37; 95% confidence interval [CI], 1.13-1.67), evidence of HCV treatment but no sustained virologic response result (aHR, 1.99; 95% CI, 1.56-2.53), and recent incarceration (aHR, 1.94; 95% CI, 1.58-2.40). Being Indigenous was a significant predictor of death across all engagement trajectories. Interpretation Disengagement from clinical care was common and resulted in higher death rates. People LTFU were more likely to require HCV treatment highlighting a priority population for elimination strategies.
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Affiliation(s)
- Sahar Saeed
- Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada
| | - Tyler Thomas
- Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada
| | - Duy A Dinh
- Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada
| | - Erica Moodie
- School of Population and Global Health, McGill University, Montreal, Quebec, Canada
| | - Joseph Cox
- School of Population and Global Health, McGill University, Montreal, Quebec, Canada
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Curtis Cooper
- Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - John Gill
- Department of Medicine, Centre de recherche du Centre hospitalier de l'Université Montréal, Montreal, Quebec, Canada
| | - Valerie Martel-Laferriere
- Department of Medicine, Centre de recherche du Centre hospitalier de l'Université Montréal, Montreal, Quebec, Canada
| | | | - Sharon Walmsley
- Department of Medicine, University Health Network, Toronto, Ontario, Canada
| | - Alexander Wong
- Department of Medicine, Regina Qu’Appelle Health Region, Regina, Saskatchewan, Canada
| | - Marina B Klein
- Department of Medicine, Division of Infectious Diseases/Chronic Viral Illness Service, McGill University Health Center, Quebec, Canada
- Canadian HIV Trials Network, Vancouver, British Columbia, Canada
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16
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van Dijk M, Boyd A, Brakenhoff SM, Isfordink CJ, van Zoest RA, Verhagen MD, de Knegt RJ, Drenth JPH, van der Valk M. Socio-economic factors associated with loss to follow-up among individuals with HCV: A Dutch nationwide cross-sectional study. Liver Int 2024; 44:52-60. [PMID: 37718515 DOI: 10.1111/liv.15729] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2022] [Revised: 07/28/2023] [Accepted: 08/29/2023] [Indexed: 09/19/2023]
Abstract
BACKGROUND AND AIMS The path to hepatitis C virus (HCV) elimination is complicated by individuals who become lost to follow-up (LTFU) during care, particularly before receiving effective HCV treatment. We aimed to determine factors contributing to LTFU and whether LTFU is associated with mortality. METHODS In this secondary analysis, we constructed a database including individuals with HCV who were either LTFU (data from the nationwide HCV retrieval project, CELINE) or treated with directly acting antivirals (DAA) (data from Statistics Netherlands) between 2012 and 2019. This database was linked to mortality data from Statistics Netherlands. Determinants associated with being LTFU versus DAA-treated were assessed using logistic regression, and mortality rates were compared between groups using exponential survival models. These analyses were additionally stratified on calendar periods: 2012-2014, 2015-2017 and 2018-2019. RESULTS About 254 individuals, LTFU and 5547 DAA-treated were included. Being institutionalized (OR = 5.02, 95% confidence interval (CI) = 3.29-7.65), household income below the social minimum (OR = 1.96, 95% CI = 1.25-3.06), receiving benefits (OR = 1.74, 95% CI = 1.20-2.52) and psychiatric comorbidity (OR = 1.51, 95% CI = 1.09-2.10) were associated with LTFU. Mortality rates were significantly higher in individuals LTFU compared to those DAA-treated (2.99 vs. 1.15/100 person-years (PY), p < .0001), while in those DAA-treated, mortality rates slowly increased between 2012-2014 (.22/100PY) and 2018-2019 (2.25/100PY). CONCLUSION In the Netherlands, individuals who are incarcerated/institutionalized, with low household income, or with psychiatric comorbidities are prone to being LTFU, which is associated with higher mortality. HCV care needs to be adapted for these vulnerable individuals.
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Affiliation(s)
- Marleen van Dijk
- Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, the Netherlands
| | - Anders Boyd
- Department of Infectious Diseases, Amsterdam University Medical Centre, University of Amsterdam and Amsterdam Institute for Infection and Immunity, Amsterdam, the Netherlands
- Stichting HIV Monitoring, Amsterdam, the Netherlands
- Department of Infectious Diseases, Research and Prevention, Public Health Service of Amsterdam, Amsterdam, the Netherlands
| | - Sylvia M Brakenhoff
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands
| | - Cas J Isfordink
- Department of Infectious Diseases, Amsterdam University Medical Centre, University of Amsterdam and Amsterdam Institute for Infection and Immunity, Amsterdam, the Netherlands
- Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, the Netherlands
| | - Rosan A van Zoest
- Amsterdam Institute for Global Health and Development, Amsterdam, the Netherlands
| | - Mark D Verhagen
- Amsterdam Health & Technology Institute, Amsterdam, the Netherlands
| | - Robert J de Knegt
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands
| | - Joost P H Drenth
- Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, the Netherlands
| | - Marc van der Valk
- Department of Infectious Diseases, Amsterdam University Medical Centre, University of Amsterdam and Amsterdam Institute for Infection and Immunity, Amsterdam, the Netherlands
- Stichting HIV Monitoring, Amsterdam, the Netherlands
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17
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Ghebremeskel GG, Berhe Solomon M, Achila OO, Mengistu ST, Asmelash RF, Berhane Mesfin A, Hamida ME. Real-world treatment outcome of direct-acting antivirals and patient survival rates in chronic hepatitis C virus infection in Eritrea. Sci Rep 2023; 13:20792. [PMID: 38012181 PMCID: PMC10682448 DOI: 10.1038/s41598-023-47258-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2022] [Accepted: 11/10/2023] [Indexed: 11/29/2023] Open
Abstract
Reliable real-world data on direct acting anti-retroviral (DAA) uptake and treatment outcomes are lacking for patients with hepatitis C virus (HCV) in sub-Saharan Africa. This study provides data on HCV DAA-based treatment outcomes, mortality, loss-to-follow up, and associated factors among patients in Eritrea. A multicenter retrospective observational cohort study was conducted in two tertiary hospitals in Asmara, Eritrea. A structured checklist was used to collect data from patient's cards. Descriptive and inferential statistics used included means (± Standard deviation (SD), medians (Interquartile range (IQR), chi-squire (χ2), Kaplan-Meier estimates, and multivariate Cox proportional hazard models. A total of 238 patients with median age of 59 years (IQR 50-69 years) were enrolled in the study. Out of the 227 patients initiated on treatment, 125 patients had viral load measurements at 12 weeks after end of treatment (EOT) whereas 102 patients had no viral load measurements at 12 weeks EOT. Among the patients with HCV RNA data post-EOT 12, 116 (92.8%) had sustained viral response (SVR). The prevalence of death and loss-to-follow up (LTFU) were (7.5%, 95% CI 1.7-4.1) and 67 (28.1%, 95% CI 22.3-33.9) translating into an incidence of 1.1 (95% CI 0.8-1.5) per 10,000 person days. Independent predictors of LTFU included the enrollment year (2020: aHR = 2.2, 95% CI 1-4.7; p value = 0.04); Hospital (Hospital B: aHR = 2.2, 95% CI 1-4.7; p value = 0.03) and the FIB-4 score (FIB-Score < 1.45: aHR = 3.7, 95% CI 1.2-11.5; p value = 0.02). The SVR rates achieved in this cohort were high. However, high LTFU and high mortality driven largely by late presentation and suboptimal population screening/case finding, were uncovered. These challenges can be addressed by test-and-treat programs that simultaneously prioritize programmatic screening, decentralization of care, and better patient tracking in the HCV care cascade.
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Affiliation(s)
| | | | - Oliver Okoth Achila
- Unit of Clinical Laboratory Science, Orotta College of Medicine and Health Sciences (OCMHS), Asmara, Eritrea
| | | | | | - Araia Berhane Mesfin
- National Communicable Disease Control Division, Ministry of Health, Asmara, Eritrea
| | - Mohammed Elfatih Hamida
- Department of Medical Microbiology, Orotta College of Medicine and Health Sciences (OCMHS), Asmara, Eritrea
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18
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Tsai WC, Chiang HC, Chiu YC, Chien SC, Cheng PN, Chiu HC. Chronic Hepatitis C Virus Infection: An Ongoing Challenge in Screening and Treatment. Life (Basel) 2023; 13:1964. [PMID: 37895346 PMCID: PMC10608250 DOI: 10.3390/life13101964] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2023] [Revised: 09/22/2023] [Accepted: 09/23/2023] [Indexed: 10/29/2023] Open
Abstract
With the advent of direct-acting antiviral agents (DAA) in the recent few years, hepatitis C virus (HCV) infection has become a curable infectious disease. Successful clearance of HCV could lead to improvement of both hepatic and extrahepatic outcomes, such as complications of cirrhosis, hepatocellular carcinoma, cardiovascular diseases, and incident diabetes. However, challenges persist in reaching the HCV elimination goals of the World Health Organization by 2030. Among these challenges are identifying those already infected or undiagnosed subjects, re-linking to the care of known but untreated HCV-infected subjects, and developing strategies to enhance treatment rates and compliance in specific or high-risk populations. In addition, issues of post-DAA viral clearance, including avoiding or preventing reinfection in high-risk populations and surveillance of hepatocellular carcinoma, are important to consolidate the treatment's short- and long-term efficacies. In the current DAA era, treatment is the most effective prevention strategy not only in its excellent efficacy and safety but also in preventing HCV spread. All of the surveillance or measures should center on DAA treatment in clinical practice.
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Affiliation(s)
| | | | | | | | - Pin-Nan Cheng
- Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan; (W.-C.T.); (H.-C.C.); (Y.-C.C.); (S.-C.C.)
| | - Hung-Chih Chiu
- Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704, Taiwan; (W.-C.T.); (H.-C.C.); (Y.-C.C.); (S.-C.C.)
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Babigumira JB, Karichu JK, Clark S, Cheng MM, Garrison LP, Maniecki MB, Hamid SS. Assessing the potential cost-effectiveness of centralised versus point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison. BMJ Open 2023; 13:e066770. [PMID: 37142306 PMCID: PMC10163545 DOI: 10.1136/bmjopen-2022-066770] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/06/2023] Open
Abstract
OBJECTIVES Pakistan has a hepatitis C virus (HCV) infection prevalence of 6%-9% and aims to achieve World Health Organisation (WHO) targets for elimination of HCV by the year 2030. We aim to evaluate the potential cost-effectiveness of a reference laboratory-based (centralised laboratory testing; CEN) confirmatory testing approach versus a molecular near-patient point-of-care (POC) confirmatory approach to screen the general population for HCV in Pakistan. STUDY DESIGN We used a decision tree-analytic model from a governmental (formal healthcare sector) perspective. STUDY SETTING Individuals were assumed to be initially screened with an anti-HCV test at home, followed by POC nucleic acid test (NAT) at nearby district hospitals or followed by NAT at centralised laboratories. PARTICIPANTS We included the general testing population for chronic HCV in Pakistan. INTERVENTION Screening with an anti-HCV antibody test (Anti-HCV) followed by either POC NAT (Anti-HCV-POC), or reference laboratory NAT (Anti-HCV-CEN), was compared, using data from published literature and the Pakistan Ministry of Health. MEASURES Outcome measures included: number of HCV infections identified per year, percentage of individuals correctly classified, total costs, average costs per individual tested, and cost-effectiveness (assessed as cost per additional HCV infection identified). Sensitivity analysis was also performed. RESULTS At a national level (25 million annual screening tests), the Anti-HCV-CEN strategy would identify 142 406 more HCV infections in 1 year and increase correct classification of individuals by 0.57% compared with the Anti-HCV-POC strategy. The total annual cost of HCV testing was reduced using the Anti-HCV-CEN strategy by US$7.68 million (US$0.31/person). Thus, incrementally, the Anti-HCV-CEN strategy costs less and identifies more HCV infections than Anti-HCV-POC. The incremental difference in HCV infections identified was most sensitive to the probability of loss to follow-up (for POC confirmatory NAT). CONCLUSIONS Anti-HCV-CEN would provide the best value for money when scaling up HCV testing in Pakistan.
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Affiliation(s)
- Joseph B Babigumira
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore
| | | | - Samantha Clark
- The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington Seattle Campus, Seattle, Washington, USA
| | - Mindy M Cheng
- Roche Molecular Systems Inc, Pleasanton, California, USA
| | - Louis P Garrison
- The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington Seattle Campus, Seattle, Washington, USA
- VeriTech Corporation, Mercer Island, Washington, USA
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Baliashvili D, Blumberg HM, Gandhi NR, Averhoff F, Benkeser D, Shadaker S, Gvinjilia L, Turdziladze A, Tukvadze N, Chincharauli M, Butsashvili M, Sharvadze L, Tsertsvadze T, Zarkua J, Kempker RR. Hepatitis C care cascade among patients with and without tuberculosis: Nationwide observational cohort study in the country of Georgia, 2015-2020. PLoS Med 2023; 20:e1004121. [PMID: 37141386 PMCID: PMC10194957 DOI: 10.1371/journal.pmed.1004121] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2022] [Revised: 05/18/2023] [Accepted: 04/13/2023] [Indexed: 05/06/2023] Open
Abstract
BACKGROUND The Eastern European country of Georgia initiated a nationwide hepatitis C virus (HCV) elimination program in 2015 to address a high burden of infection. Screening for HCV infection through antibody testing was integrated into multiple existing programs, including the National Tuberculosis Program (NTP). We sought to compare the hepatitis C care cascade among patients with and without tuberculosis (TB) diagnosis in Georgia between 2015 and 2019 and to identify factors associated with loss to follow-up (LTFU) in hepatitis C care among patients with TB. METHODS AND FINDINGS Using national ID numbers, we merged databases of the HCV elimination program, NTP, and national death registry from January 1, 2015 to September 30, 2020. The study population included 11,985 adults (aged ≥18 years) diagnosed with active TB from January 1, 2015 through December 31, 2019, and 1,849,820 adults tested for HCV antibodies between January 1, 2015 and September 30, 2020, who were not diagnosed with TB during that time. We estimated the proportion of patients with and without TB who were LTFU at each step of the HCV care cascade and explored temporal changes. Among 11,985 patients with active TB, 9,065 (76%) patients without prior hepatitis C treatment were tested for HCV antibodies, of which 1,665 (18%) had a positive result; LTFU from hepatitis C care was common, with 316 of 1,557 (20%) patients with a positive antibody test not undergoing viremia testing and 443 of 1,025 (43%) patients with viremia not starting treatment for hepatitis C. Overall, among persons with confirmed viremic HCV infection, due to LTFU at various stages of the care cascade only 28% of patients with TB had a documented cure from HCV infection, compared to 55% among patients without TB. LTFU after positive antibody testing substantially decreased in the last 3 years, from 32% among patients diagnosed with TB in 2017 to 12% among those diagnosed in 2019. After a positive HCV antibody test, patients without TB had viremia testing sooner than patients with TB (hazards ratio [HR] = 1.46, 95% confidence intervals [CI] [1.39, 1.54], p < 0.001). After a positive viremia test, patients without TB started hepatitis C treatment sooner than patients with TB (HR = 2.05, 95% CI [1.87, 2.25], p < 0.001). In the risk factor analysis adjusted for age, sex, and case definition (new versus previously treated), multidrug-resistant (MDR) TB was associated with an increased risk of LTFU after a positive HCV antibody test (adjusted risk ratio [aRR] = 1.41, 95% CI [1.12, 1.76], p = 0.003). The main limitation of this study was that due to the reliance on existing electronic databases, we were unable to account for the impact of all confounding factors in some of the analyses. CONCLUSIONS LTFU from hepatitis C care after a positive antibody or viremia test was high and more common among patients with TB than in those without TB. Better integration of TB and hepatitis C care systems can potentially reduce LTFU and improve patient outcomes both in Georgia and other countries that are initiating or scaling up their nationwide hepatitis C control efforts and striving to provide personalized TB treatment.
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Affiliation(s)
- Davit Baliashvili
- Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
| | - Henry M. Blumberg
- Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Department of Global Health, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
| | - Neel R. Gandhi
- Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Department of Global Health, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
| | - Francisco Averhoff
- Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
| | - David Benkeser
- Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
| | - Shaun Shadaker
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
| | - Lia Gvinjilia
- Eastern Europe and Central Asia Regional Office, Centers for Disease Control and Prevention, Tbilisi, Georgia
| | | | - Nestani Tukvadze
- National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia
| | | | | | - Lali Sharvadze
- Clinic “Hepa”, Tbilisi, Georgia
- The University of Georgia, Tbilisi, Georgia
| | - Tengiz Tsertsvadze
- Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia
| | | | - Russell R. Kempker
- Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
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Dröse S, Hansen JF, Røge BT, Øvrehus ALH, Christensen PB. Retrieval of patients with hepatitis C who were lost to follow-up in Southern Denmark. Infect Dis (Lond) 2023; 55:361-369. [PMID: 36930953 DOI: 10.1080/23744235.2023.2189298] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/19/2023] Open
Abstract
BACKGROUND The goal of the C-Free-South project is to eliminate hepatitis C (HCV) in the Region of Southern Denmark (1.2 million inhabitants). One target group consists of people with HCV who had received care but were lost to follow-up. The study aim was to evaluate program efficacy in locating these patients and getting them into care. METHODS Patients were contacted if they were HCV-RNA positive and age 18+ years, registered in the clinical hepatitis database as of November 1, 2019, and had no scheduled HCV-related appointment. They were contacted at 2-month intervals by phone or letter. For patients who did not respond, we asked their general practitioner to refer them, if possible. RESULTS We identified 69 (7%) patients in the database who were listed as untreated and not being followed up. We successfully contacted 54 (78%), and the remaining 15 (22%) did not respond to our contacts. To date, 45 (65%) had initiated treatment, one (1%) had rejected treatment, and eight (12%) did not show up to their appointments. Among those receiving treatment, 20 (44%) responded after the first contact, 18 (40%) after the second contact, and 7 (16%) after informing the general practitioner. CONCLUSION An intensified and persistent effort made it possible to reach most HCV patients lost to follow-up. All new contact attempts increased the possibility that patients would receive treatment. Nevertheless, 22% of HCV patients lost to follow-up did not respond to repeated contact attempts.
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Affiliation(s)
- Sandra Dröse
- Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.,Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
| | | | | | - Anne Lindebo Holm Øvrehus
- Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.,Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
| | - Peer Brehm Christensen
- Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.,Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
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Pediatric Hepatitis C Quality Improvement Project Improves Healthcare Access. J Pediatr Gastroenterol Nutr 2023; 76:371-378. [PMID: 36728827 DOI: 10.1097/mpg.0000000000003690] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
OBJECTIVES Incidence of hepatitis C virus (HCV) infection is increasing in women of reproductive age, leading to increased prevalence of HCV infection in children via vertical transmission. This quality improvement (QI) project aimed to increase referrals to and appointments scheduled with a specialty pediatric gastroenterology HCV clinic and the number of eligible children with HCV who completed treatment. METHODS From July 2020 to August 2021, the QI team designed a project using the Model for Improvement and completed Plan Do Study Act cycles to test change ideas to improve HCV awareness and education for medical providers and families; standardize the referral process; track patients; increase clinic capacity; and connect families with community resource care coordination. Referrals to the pediatric HCV clinic, appointments scheduled, no shows, and treatment follow-up were tracked during the project period and a comparison timeframe from July 2019 to June 2020. RESULTS There were improvements in several measures during the project period versus the comparison timeframe, with 80 versus 48 referrals received (66% increase), 115 versus 59 scheduled clinic visits (95% increase), and 7 versus 5 treatment completers (40% increase), along with a small (7%) decline in the proportion of scheduled clinic visits that were no shows. CONCLUSION Application of QI methodology increased medical provider and caregiver awareness and engagement in accessing HCV healthcare available for at-risk children. More QI efforts should be accelerated to identify best practices amidst a nationwide HCV epidemic.
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Hepatitis C Virus Micro-Elimination Plan in Southern Italy: The "HCV ICEberg" Project. Pathogens 2023; 12:pathogens12020195. [PMID: 36839474 PMCID: PMC9967587 DOI: 10.3390/pathogens12020195] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/31/2022] [Revised: 01/21/2023] [Accepted: 01/24/2023] [Indexed: 01/31/2023] Open
Abstract
This study evaluates the feasibility of a local action program for HCV micro-elimination in highly endemic areas. Retrospective analysis: administrative and laboratory data (Local Health Unit, southern Italy) were integrated to quantize the anti-HCV-positive subjects not RNA tested and untreated HCV-infected subjects (2018-2022). Prospective analysis: all subjects admitted to a division of the LHU largest hospital (2021-2022) were tested for HCV, with linkage of active-infected patients to care. Overall, 49287 subjects were HCV-Ab tested: 1071 (2.2%) resulted positive without information for an HCV RNA test and 230 (0.5%) had an active infection not yet cured. Among 856 admitted subjects, 54 (6.3%) were HCV-Ab+ and 27 (3.0%) HCV RNA+. Of HCV-infected patients, 22.2% had advanced liver disease, highlighting the need for earlier diagnosis; 27.7% were unaware of HCV infection; and 20.4% were previously aware but never referred to a clinical center. Of these, 26% died and 74% received treatment. Our study emphasizes the value of an active HCV hospital case-finding program to enhance diagnosis in patients with several comorbidities and to easily link them to care. Our data strongly suggest extending this program to all hospital wards/access as a standard of care, particularly in highly endemic areas, to help HCV disease control and take steps in achieving the elimination goals.
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Mendizabal M, Thompson M, Gonzalez-Ballerga E, Anders M, Castro-Narro GE, Pessoa MG, Cheinquer H, Mezzano G, Palazzo A, Ridruejo E, Descalzi V, Velarde-Ruiz Velasco JA, Marciano S, Muñoz L, Schinoni MI, Poniachik J, Perazzo R, Cerda E, Fuster F, Varon A, Ruiz García S, Soza A, Cabrera C, Gomez-Aldana AJ, Beltrán FDM, Gerona S, Cocozzella D, Bessone F, Hernández N, Alonso C, Ferreiro M, Antinucci F, Torre A, Moutinho BD, Coelho Borges S, Gomez F, Murga MD, Piñero F, Sotera GF, Ocampo JA, Cortés Mollinedo VA, Simian D, Silva MO. Implementation of a re-linkage to care strategy in patients with chronic hepatitis C who were lost to follow-up in Latin America. J Viral Hepat 2023; 30:56-63. [PMID: 36197907 DOI: 10.1111/jvh.13758] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2022] [Revised: 09/25/2022] [Accepted: 10/02/2022] [Indexed: 12/09/2022]
Abstract
To achieve WHO's goal of eliminating hepatitis C virus (HCV), innovative strategies must be designed to diagnose and treat more patients. Therefore, we aimed to describe an implementation strategy to identify patients with HCV who were lost to follow-up (LTFU) and offer them re-linkage to HCV care. We conducted an implementation study utilizing a strategy to contact patients with HCV who were not under regular follow-up in 13 countries from Latin America. Patients with HCV were identified by the international classification of diseases (ICD-9/10) or equivalent. Medical records were then reviewed to confirm the diagnosis of chronic HCV infection defined by anti-HCV+ and detectable HCV-RNA. Identified patients who were not under follow-up by a liver specialist were contacted by telephone or email, and offered a medical reevaluation. A total of 10,364 patients were classified to have HCV. After reviewing their medical charts, 1349 (13%) had undetectable HCV-RNA or were wrongly coded. Overall, 9015 (86.9%) individuals were identified with chronic HCV infection. A total of 5096 (56.5%) patients were under routine HCV care and 3919 (43.5%) had been LTFU. We were able to contact 1617 (41.3%) of the 3919 patients who were LTFU at the primary medical institution, of which 427 (26.4%) were cured at a different institutions or were dead. Of the remaining patients, 906 (76.1%) were candidates for retrieval. In our cohort, about one out of four patients with chronic HCV who were LTFU were candidates to receive treatment. This strategy has the potential to be effective, accessible and significantly impacts on the HCV care cascade.
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Affiliation(s)
- Manuel Mendizabal
- Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina
| | - Marcos Thompson
- Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina
| | - Esteban Gonzalez-Ballerga
- Sección Hepatología, Hospital de Clínicas "José de San Martín", Universidad de Buenos Aires, Buenos Aires, Argentina
| | - Margarita Anders
- Unidad de Hepatología y Trasplante Hepático, Hospital Alemán, Buenos Aires, Argentina
| | - Graciela E Castro-Narro
- Departamento de Gastroenterología, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán", Ciudad de Mexico, Mexico
| | - Mario G Pessoa
- Divisão de Gastroenterologia e Hepatologia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | - Hugo Cheinquer
- Departamento de Gastroenterología y Hepatología, Universidad Federal do Rio Grande do Sul e do Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
| | - Gabriel Mezzano
- Sección de Gastroenterología, Hospital El Salvador, Santiago, Chile
| | - Ana Palazzo
- Servicio de Gastroenterología, Sección de Hepatología, Hospital Padilla, Tucumán, Argentina
| | - Ezequiel Ridruejo
- Sección Hepatología, Departamento de Medicina, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno "CEMIC", Buenos Aires, Argentina
| | - Valeria Descalzi
- Unidad de Hígado y Trasplante Hepático, Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina
| | | | - Sebastian Marciano
- Sección Hepatología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
| | - Linda Muñoz
- Hospital Universitario "Dr. José E. González", Monterrey, Mexico
| | - Maria I Schinoni
- Núcleo de Hepatología, Hospital Universitario Prof. Edgard Santos, Universidad Federal de Bahia, Salvador, Brazil
| | - Jaime Poniachik
- Sección de Gastroenterología, Departamento de Medicina, Hospital Clínico de la Universidad de Chile, Santiago, Chile
| | - Rosalía Perazzo
- Unidad de Gastroenterología, Hospital Miguel Perez Carreño, Caracas, Venezuela
| | - Eira Cerda
- Hospital Central Militar, Escuela Militar de Graduados de Sanidad, Ciudad de México, Mexico
| | - Francisco Fuster
- Unidad de Hepatología, Hospital Gustavo Fricke, Viña del Mar, Chile
| | - Adriana Varon
- Fundación Cardioinfantil, Instituto de Cardiología, Bogotá, Colombia
| | | | - Alejandro Soza
- Departamento de Gastroenterología, Pontificia Universidad Católica de Chile, Santiago, Chile
| | - Cecilia Cabrera
- Unidad de Gastroenterología, Hospital Nacional Daniel A. Carrión, Callao, Peru
| | - Andres J Gomez-Aldana
- Unidad de Gastroenterología y Trasplante Fundación Santa Fe de Bogotá, Bogotá, Colombia
| | | | - Solange Gerona
- Unidad de Hígado, Hospital de Fuerzas Armadas, Montevideo, Uruguay
| | | | - Fernando Bessone
- Departamento de Gastroenterología, Facultad de Medicina, Hospital Provincial del Centenario, University of Rosario School of Medicine, Rosario, Argentina
| | - Nelia Hernández
- Clínica de Gastroenterología, Hospital de Clínicas, Facultad de Medicina, UdelaR, Montevideo, Uruguay
| | - Cristina Alonso
- Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina
| | - Melina Ferreiro
- Sección Hepatología, Hospital de Clínicas "José de San Martín", Universidad de Buenos Aires, Buenos Aires, Argentina
| | - Florencia Antinucci
- Unidad de Hepatología y Trasplante Hepático, Hospital Alemán, Buenos Aires, Argentina
| | - Aldo Torre
- Departamento de Gastroenterología, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán", Ciudad de Mexico, Mexico
| | - Bruna D Moutinho
- Divisão de Gastroenterologia e Hepatologia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | | | - Fernando Gomez
- Sección de Gastroenterología, Hospital El Salvador, Santiago, Chile
| | - Maria Dolores Murga
- Servicio de Gastroenterología, Sección de Hepatología, Hospital Padilla, Tucumán, Argentina
| | - Federico Piñero
- Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina
| | - Gisela F Sotera
- Sección Hepatología, Hospital de Clínicas "José de San Martín", Universidad de Buenos Aires, Buenos Aires, Argentina
| | - Jhonier A Ocampo
- Unidad de Hepatología y Trasplante Hepático, Hospital Alemán, Buenos Aires, Argentina
| | - Valeria A Cortés Mollinedo
- Departamento de Gastroenterología, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán", Ciudad de Mexico, Mexico
| | - Daniela Simian
- Sección de Gastroenterología, Departamento de Medicina, Hospital Clínico de la Universidad de Chile, Santiago, Chile
| | - Marcelo O Silva
- Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina
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Kuwano A, Yada M, Kurosaka K, Tanaka K, Masumoto A, Motomura K. Risk factors for loss to follow-up after the start of direct-acting antiviral treatment for hepatitis C virus infection. JGH Open 2022; 7:98-104. [PMID: 36852151 PMCID: PMC9958342 DOI: 10.1002/jgh3.12855] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2022] [Revised: 11/01/2022] [Accepted: 12/12/2022] [Indexed: 01/01/2023]
Abstract
Background and Aim Direct-acting antivirals (DAAs) have recently been developed to treat hepatitis C virus (HCV) infection. Additionally, interferon-free DAA treatment has improved liver function and reduced the risk of hepatocellular carcinoma (HCC) following HCV eradication. Previous studies on HCV have focused mainly on the treatment rate and the risk of developing HCC, and less attention has been given to loss to follow-up (LTFU) after DAA treatment. Therefore, the present study aimed to identify the definitive risk factors for LTFU after the start of DAA treatment. Methods Between September 2017 and March 2022, 296 patients receiving glecaprevir and pibrentasvir for HCV infection were enrolled in this study. The incidence of LTFU following DAA treatment and the risk factors contributing to LTFU were identified using the patients' clinical characteristics. Results In the present study, 75 patients (25.3%) interrupted their follow-up visits. Multivariate logistic analysis revealed a history of injection drug use (hazard ratio [HR], 1.81; P = 0.017), treatment duration (8 weeks) (HR, 3.51; P = 0.0033), and age <70 years (HR, 1.9; P = 0.0422) as independent factors associated with LTFU after the start of DAA treatment. Conclusion Young patients and those with injection drug use are likely to discontinue their follow-up visits after the start of DAA treatment for HCV infection. Therefore, these patients require strict supervision.
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Boeke CE, Adesigbin C, Adisa O, Agwuocha C, Akanmu MM, Anartati A, Aung KS, Azania A, Bello Nabe R, Budiman A, Chan Y, Chawla U, Fatchanuraliyah, Fernandes O, Grover GS, Naing TS, Ngo D, Ramers CB, Regan S, Sindhwani S, Tandy G, Tint K, Nguyen KV, Witschi M, McClure C. Patient outcomes in public sector hepatitis C treatment programmes: a retrospective cohort analysis across five low- and middle-income countries. BMJ Open 2022; 12:e062745. [PMID: 36576192 PMCID: PMC9723848 DOI: 10.1136/bmjopen-2022-062745] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
OBJECTIVES Given limited data on factors associated with hepatitis C virus (HCV) treatment discontinuation and failure in low- and middle-income countries, we aimed to describe patient populations treated for HCV in five countries and identify patient groups that may need additional support. DESIGN Retrospective cohort analysis using routinely collected data. SETTING Public sector HCV treatment programmes in India (Punjab), Indonesia, Myanmar, Nigeria (Nasarawa) and Vietnam. PARTICIPANTS 104 957 patients who initiated treatment in 2016-2022 (89% from Punjab). PRIMARY OUTCOMES Treatment completion and cure. RESULTS Patient characteristics and factors associated with outcomes varied across countries and facilities. Across all patients, median age was 40 years (IQR: 29-52), 30.6% were female, 7.0% reported a history of injecting drugs, 18.2% were cirrhotic and 4.9% were coinfected with HIV. 79.8% were prescribed sofosbuvir+daclastasvir. Of patients with adequate follow-up, 90.6% (89,551) completed treatment. 77.5% (69,426) of those who completed treatment also completed sustained virological testing at 12 weeks (SVR12), and of those, 92.6% (64 305) were cured. In multivariable-adjusted models, in most countries, significantly lower treatment completion was observed among patients on 24-week regimens (vs 12-week regimens) and those initiated in later years of the programme. In several countries, males, younger patients <20 years and certain groups of cirrhotic patients were less likely to complete treatment or be cured. In Punjab, treatment completion was also lower in those with a family history of HCV and people who inject drugs (PWID); in other countries, outcomes were comparable for PWID. CONCLUSION High proportions of patients completed treatment and were cured across patient groups and countries. SVR12 follow-up could be strengthened. Males, younger people and those with decompensated cirrhosis on longer regimens may require additional support to complete treatment and achieve cure. Adequate programme financing, minimal user fees and implementation of evidence-based policies will be critical to close gaps.
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Affiliation(s)
| | - Clement Adesigbin
- National AIDS/STIs Control Programme, Federal Ministry of Health, Abuja, FCT, Nigeria
| | | | | | | | | | - Khin Sanda Aung
- National Hepatitis Control Program, Department of Public Health, Ministry of Health, Naypyidaw, Myanmar
| | - Amy Azania
- Clinton Health Access Initiative, Boston, Massachusetts, USA
| | | | - Arief Budiman
- Clinton Health Access Initiative, Jakarta, Indonesia
| | - Yuhui Chan
- Clinton Health Access Initiative, Boston, Massachusetts, USA
| | | | - Fatchanuraliyah
- Directorate of Communicable Disease Prevention and Control, Ministry of Health of the Republic of Indonesia, Jakarta, Indonesia
| | - Oriel Fernandes
- Clinton Health Access Initiative, Boston, Massachusetts, USA
| | - Gagandeep Singh Grover
- State Viral Hepatitis Management Unit, Department of Health and Family Welfare, Government of Punjab, Chandigarh, Punjab, India
| | | | - Dang Ngo
- Clinton Health Access Initiative, Hanoi, Viet Nam
| | | | - Sean Regan
- Clinton Health Access Initiative, Boston, Massachusetts, USA
| | | | - Gertrudis Tandy
- Directorate of Communicable Disease Prevention and Control, Ministry of Health of the Republic of Indonesia, Jakarta, Indonesia
| | - Khin Tint
- Clinton Health Access Initiative, Yangon, Myanmar
| | | | | | - Craig McClure
- Clinton Health Access Initiative, Boston, Massachusetts, USA
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Von den Hoff DW, Berden FAC, Drenth JPH, Schellekens AFA. Implementation of a decentralized hepatitis C care pathway for people who use drugs in Dutch addiction care. Study protocol for the Hepatitis C: chain of addiction care (CAC) project. Addict Sci Clin Pract 2022; 17:67. [PMID: 36451175 PMCID: PMC9710026 DOI: 10.1186/s13722-022-00350-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2022] [Accepted: 11/16/2022] [Indexed: 12/05/2022] Open
Abstract
BACKGROUND People who use drugs (PWUD) are at high risk for hepatitis C virus (HCV) infection and its complications. Given the high prevalence rate of HCV in PWUD, the World Health Organization (WHO) emphasizes PWUD as a target population for HCV elimination. The introduction of pangenotypic direct acting antivirals (DAAs) greatly simplifies HCV treatment, which encourages integration of HCV treatment in primary care. Facilitating low threshold HCV care for PWUD by implementing decentralized models is crucial for HCV elimination. AIMS With this study we aim to (1) eliminate 90% of identified HCV infections in Dutch addiction care, using a decentralized PWUD-HCV care model, and (2) identify facilitators and barriers for successful implementation of the model using interviews. METHODS We will perform a multicenter mixed-method study on HCV treatment in addiction care. In a prospective observational study we will examine HCV-related outcomes in PWUD receiving HCV treatment as part of addiction care. The primary outcome is viral elimination, defined as percentage of identified HCV positive patients cured with DAAs. In parallel, we will perform a qualitative study to explore facilitators and barriers for implementation of fully decentralized HCV-PWUD care. We will interview addiction care professionals and board members about their experience with HCV-care as part of addiction care. DISCUSSION This study will show effectiveness of integration of HCV care within addiction care, and provide insight in facilitators and barriers to implement integrated HCV-addiction care. The results will provide recommendations for implementation and maintenance of the decentralized HCV pathway, which can facilitate scaling-up to contribute to reaching WHO HCV elimination goals. Trial registration NCT05401136.
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Affiliation(s)
- Daan W Von den Hoff
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
| | - Floor A C Berden
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands
| | - Joost P H Drenth
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands
| | - Arnt F A Schellekens
- Department of Psychiatry, Cognition and Behaviour, Radboud University Medical Center, Netherlands and Nijmegen Institute for Scientist-Practitioners in Addiction and Donders Institute for Brain, Radboud University, Nijmegen, The Netherlands
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Awareness of HCV Status and Preferences for Testing and Treatment among People with Recent Injecting Drug Use at a Peer-Led Needle and Syringe Program: The TEMPO Pilot Study. Viruses 2022; 14:v14112463. [PMID: 36366561 PMCID: PMC9696805 DOI: 10.3390/v14112463] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2022] [Revised: 10/26/2022] [Accepted: 11/02/2022] [Indexed: 11/09/2022] Open
Abstract
BACKGROUND New technologies and therapies allow the possibility of a single-visit test and treat model for hepatitis C virus (HCV), addressing some of the barriers to care faced by people who inject drugs. METHODS The TEMPO Pilot Study was an interventional cohort study evaluating a single-visit test and treat intervention among people with recent injecting drug use at a one peer-led needle and syringe program (NSP) in Sydney, Australia between September 2019 and February 2021. This analysis evaluated awareness of HCV status and agreement of self-report with HCV RNA test results. The analysis also assessed acceptability of: modality of result delivery, modality of blood sampling, site of treatment, and duration of treatment. RESULTS Among 101 participants (median age 43; 31% female), 100 had a valid HCV RNA test result and 27% (27/100) were HCV RNA detectable. Overall, 65% (65/100) were aware of their status. Among people with a positive HCV RNA result, 48% (13/27) were aware of their status. People preferred same-day HCV test results (95%, 96/101), and preferred to receive results in person (69%, 70/101). Receiving treatment at an NSP was acceptable (100%, 101/101) and 78% (79/101) were willing to discuss their health with a peer NSP worker. CONCLUSION Half of people with current HCV infection were aware of their status. The high acceptability of simplified testing and treatment pathways delivered at NSPs indicates that this is an appropriate strategy to improve HCV awareness and treatment uptake in this population.
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Midgard H, Bjørnestad R, Egeland M, Dahl E, Finbråten A, Kielland KB, Blindheim M, Dalgard O. Peer support in small towns: A decentralized mobile Hepatitis C virus clinic for people who inject drugs. Liver Int 2022; 42:1268-1277. [PMID: 35362660 PMCID: PMC9543121 DOI: 10.1111/liv.15266] [Citation(s) in RCA: 19] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/19/2021] [Revised: 03/20/2022] [Accepted: 03/29/2022] [Indexed: 01/26/2023]
Abstract
BACKGROUND & AIMS New models of HCV care are needed to reach people who inject drugs (PWID). The primary aim was to evaluate HCV treatment uptake among HCV RNA positive individuals identified by point-of-care (POC) testing and liver disease assessment in a peer-driven decentralized mobile clinic. METHODS This prospective study included consecutive patients assessed in a mobile clinic visiting 32 small towns in Southern Norway from November 2019 to November 2020. The clinic was staffed by a bus driver and a social educator offering POC HCV RNA testing (GeneXpert®), liver disease staging (FibroScan® 402) and peer support. Viremic individuals were offered prompt pan-genotypic treatment prescribed by local hospital-employed specialists following a brief telephone assessment. RESULTS Among 296 tested individuals, 102 (34%) were HCV RNA positive (median age 51 years, 77% male, 24% advanced liver fibrosis/cirrhosis). All participants had a history of injecting drug use, 71% reported past 3 months injecting, and 37% received opioid agonist treatment. Treatment uptake within 6 months following enrolment was achieved in 88%. Treatment uptake was negatively associated with recent injecting (aHR 0.60; 95% CI 0.36-0.98), harmful alcohol consumption (aHR 0.44; 95% CI 0.20-0.99), and advanced liver fibrosis/cirrhosis (aHR 0.44; 95% CI 0.25-0.80). HCV RNA prevalence increased with age (OR 1.81 per 10-year increase; 95% 1.41-2.32), ranging from 3% among those <30 years to 55% among those ≥60 years. CONCLUSIONS A peer-driven mobile HCV clinic is an effective and feasible model of care that should be considered for broader implementation to reach PWID outside the urban centres.
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Affiliation(s)
- Håvard Midgard
- Department of Infectious DiseasesAkershus University HospitalLørenskogNorway,Department of GastroenterologyOslo University HospitalOsloNorway
| | | | | | | | | | - Knut B. Kielland
- Norwegian National Advisory Unit on Concurrent Substance Abuse and Mental Health DisordersInnlandet Hospital TrustBrumunddalNorway
| | | | - Olav Dalgard
- Department of Infectious DiseasesAkershus University HospitalLørenskogNorway,Institute of Clinical MedicineUniversity of OsloOsloNorway
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Kusejko K, Salazar-Vizcaya L, Shah C, Stöckle M, Béguelin C, Schmid P, Ongaro M, Darling K, Bernasconi E, Rauch A, Kouyos RD, Günthard HF, Böni J, Fehr JS, Braun DL. Sustained effect on hepatitis C elimination among men who have sex with men in the Swiss HIV Cohort Study: A systematic re-screening for hepatitis C RNA two years following a nation-wide elimination program. Clin Infect Dis 2022; 75:1723-1731. [PMID: 35404384 DOI: 10.1093/cid/ciac273] [Citation(s) in RCA: 17] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2021] [Indexed: 12/14/2022] Open
Abstract
INTRODUCTION The Swiss HCVree Trial (NCT02785666) was conducted in 2015-2017 with the goal of implementing a population-based systematic hepatitis C (HCV) micro-elimination program among men who have sex with men (MSM) living with HIV enrolled in the Swiss HIV Cohort Study (SHCS). The trial led to a 91% and 77% decline of HCV prevalence and incidence, respectively. The long-term effect of this HCV micro-elimination program is yet to be explored. METHODS All MSM enrolled in the SHCS were screened for HCV RNA using stored plasma samples obtained in 2019, termed "Swiss HCVree Post" screen. The incidence of HCV infection over time was assessed using additional information on HCV testing routinely collected in the SHCS. Characteristics of participants with replicating HCV infection were analyzed. RESULTS The point-prevalence of "Swiss HCVree Post" (N = 4641) was 0.6%, reflecting a decline of 48% compared to the end of the Swiss HCVree Trial where the prevalence was 1.2%. Further, the incidence of HCV among MSM in the SHCS declined from 0.31/100 person-years (py) (95%-confidence interval (CI) = [0.17,0.55]) in 2017 to 0.19/100 py (95%-CI = [0.09,0.39]) in 2019. CONCLUSION A systematic HCV RNA-based screening among MSM living with HIV conducted two years after the Swiss HCVree Trial revealed a sustained effect and further decline of the prevalence and incidence of replicating HCV infection. This indicates that the Swiss HCVree Trial was successful in curbing the HCV epidemic among MSM living with HIV in Switzerland.
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Affiliation(s)
- Katharina Kusejko
- Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.,Institute of Medical Virology, University of Zurich, Zurich, Switzerland
| | - Luisa Salazar-Vizcaya
- Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Cyril Shah
- Institute of Medical Virology, University of Zurich, Zurich, Switzerland
| | - Marcel Stöckle
- Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel, University Basel, Switzerland
| | - Charles Béguelin
- Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Patrick Schmid
- Division of Infectious Diseases, Cantonal Hospital St. Gallen, St. Gallen, Switzerland
| | - Marie Ongaro
- Division of Gastroenterology and Hepatology, University Hospitals and University of Geneva, Geneva, Switzerland
| | - Katherine Darling
- Service of Infectious Diseases, Lausanne University Hospital, Lausanne, Switzerland
| | - Enos Bernasconi
- Division of Infectious Diseases, Regional Hospital Lugano, Lugano, University of Geneva, Geneva, and University of Southern Switzerland, Lugano, Switzerland
| | - Andri Rauch
- Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Roger D Kouyos
- Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.,Institute of Medical Virology, University of Zurich, Zurich, Switzerland
| | - Huldrych F Günthard
- Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.,Institute of Medical Virology, University of Zurich, Zurich, Switzerland
| | - Jürg Böni
- Institute of Medical Virology, University of Zurich, Zurich, Switzerland
| | - Jan S Fehr
- Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.,Department Public Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
| | - Dominique L Braun
- Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.,Institute of Medical Virology, University of Zurich, Zurich, Switzerland
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Against All Odds? Addiction History Associated with Better Viral Hepatitis Care: A Dutch Nationwide Claims Data Study. J Clin Med 2022; 11:jcm11041146. [PMID: 35207419 PMCID: PMC8878485 DOI: 10.3390/jcm11041146] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/31/2021] [Revised: 02/15/2022] [Accepted: 02/18/2022] [Indexed: 02/01/2023] Open
Abstract
The elimination of viral hepatitis in target populations is crucial in reaching WHO viral hepatitis elimination goals. Several barriers for the treatment of viral hepatitis in people with addictive disorders have been identified, yet nationwide data on hepatitis healthcare utilization (HCU) in these patients are limited. We investigated whether a history of addictive disorder is associated with suboptimal hepatitis HCU, indicating failure to receive diagnostic care or treatment. We identified all newly referred viral hepatitis patients in the Netherlands between 2014 and 2019 by query of the Dutch national hospital claims database. Each patient’s first year of HBV or HCV care activities was collected and clustered in two categories, ‘optimal’ or ‘suboptimal’ hepatitis HCU. Optimal HCU includes antiviral therapy. We tested the association between addiction history and HCU, adjusted for sex, age, migrant status, and comorbidity. In secondary analyses, we explored additional factors affecting hepatitis HCU. We included 10,513 incident HBV and HCV patients, with 13% having an addiction history. Only 47% of all patients achieved optimal hepatitis HCU. Addiction history was associated with less suboptimal HCU (adjusted OR = 0.73, 95% CI = 0.64–0.82). Migration background was associated with suboptimal HCU (OR = 1.62, 95% CI = 1.50–1.76). This study shows that addiction history is associated with higher viral hepatitis HCU; thus, this population performs better compared to non-addicted patients. However, less than 50% of all patients received optimal hepatitis care. This study highlights the need to improve hepatitis HCU in all patients, with a focus on migrant populations. Linkage to care in the addicted patients is not studied here and may be a remaining obstacle to be studied and improved to reach WHO viral hepatitis elimination goals.
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32
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Cuesta-Sancho S, Márquez-Coello M, Illanes-Álvarez F, Márquez-Ruiz D, Arizcorreta A, Galán-Sánchez F, Montiel N, Rodriguez-Iglesias M, Girón-González JA. Hepatitis C: Problems to extinction and residual hepatic and extrahepatic lesions after sustained virological response. World J Hepatol 2022; 14:62-79. [PMID: 35126840 PMCID: PMC8790402 DOI: 10.4254/wjh.v14.i1.62] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/06/2021] [Revised: 08/02/2021] [Accepted: 12/10/2021] [Indexed: 02/06/2023] Open
Abstract
Loss of follow-up or reinfections hinder the expectations of hepatitis C eradication despite the existence of highly effective treatments. Moreover, the elimination of the infection does not imply the reversion of those chronic alterations derived from the previous infection by hepatitis C virus (HCV). This review analyzes the risk factors associated with loss to follow-up in diagnosis or treatment, and the possibility of reinfection. Likewise, it assesses the residual alterations induced by chronic HCV infection considering the liver alterations (inflammation, fibrosis, risk of decompensation, hepatocellular carcinoma, liver transplantation) and, on the other hand, the comorbidities and extrahepatic manifestations (cryoglobulinemia, non-Hodgkin lymphoma, peripheral insulin resistance, and lipid, bone and cognitive alterations). Peculiarities present in subjects coinfected with human immunodeficiency virus are analyzed in each section.
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Affiliation(s)
- Sara Cuesta-Sancho
- Medicina Interna, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - Mercedes Márquez-Coello
- Medicina Interna, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - Francisco Illanes-Álvarez
- Medicina Interna, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - Denisse Márquez-Ruiz
- Medicina Interna, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - Ana Arizcorreta
- Medicina Interna, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - Fátima Galán-Sánchez
- Microbiología, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - Natalia Montiel
- Microbiología, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - Manuel Rodriguez-Iglesias
- Microbiología, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
| | - José-Antonio Girón-González
- Medicina Interna, Hospital Universitario Puerta del Mar, Facultad de Medicina, Universidad de Cádiz, Instituto para la Investigación e Innovación en Ciencias Biomédicas de Cádiz (INiBICA), Cádiz 11009, Spain
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Martel-Laferrière V, Brissette S, Wartelle-Bladou C, Juteau LC, Popa M, Goyer MÈ, Bruneau J. Impact of an Accelerated Pretreatment Evaluation on Linkage-to-Care for Hepatitis C-infected Persons Who Inject Drugs. Subst Abuse 2022; 16:11782218221119068. [PMID: 35990750 PMCID: PMC9382068 DOI: 10.1177/11782218221119068] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2022] [Accepted: 07/25/2022] [Indexed: 11/15/2022]
Abstract
Background: Historically, hepatitis C virus (HCV) pretreatment evaluation has required multiple visits, frequently resulting in loss to follow-up and a delayed initiation of treatment. New technologies can accelerate this process. We investigated the feasibility of a single-day evaluation program and its impact on evaluation completion, treatment eligibility awareness, and treatment initiation among people who inject drugs (PWIDs). Methods: HCV-infected PWID who were unaware if they were eligible for treatment were recruited in a prospective evaluation of an accelerated model of care between 2017 and 2019 and compared to a historical cohort. The patients underwent a medical evaluation, rapid HCV viral load testing, and transient elastography during a single visit, at the end of which they were informed whether they were eligible for treatment. A historical cohort of patients fulfilling the same inclusion criteria and evaluated with the usual standard of care spanning several visits who were examined at the addiction medicine clinic from 2014 to 2016 served as the comparison group. Results: The accelerated and historical cohorts included 99 and 76 patients, respectively. The cohorts did not differ significantly by age and gender, but more patients in the historical cohort were undergoing opioid agonist therapy, while more patients in the accelerated cohort injected drugs in the last month. An accelerated evaluation resulted in a higher rate of evaluation completion (100% vs 67.1%; P < .001). Among those eligible for treatment, the proportion of those initiating treatment was similar between the groups (51/64 (79.7%) vs. 26/37 (70.3%); P = .28). The delay in the initiation of treatment was shorter in the accelerated cohort than in the historical cohort (69 (IQR: 49-106) days vs. 219 (IQR: 141-416) days; P < .001). Conclusions: Accelerated evaluation enhanced the awareness of eligibility and reduced the time to initiation among eligible patients. Trial Registration: This study is registered on www.clinicaltrials.gov (NCT02755402).
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Affiliation(s)
- Valérie Martel-Laferrière
- Université de Montréal, Montreal, QC, Canada
- Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
- Centre de recherche du Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
| | - Suzanne Brissette
- Université de Montréal, Montreal, QC, Canada
- Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
- Centre de recherche du Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
| | - Claire Wartelle-Bladou
- Université de Montréal, Montreal, QC, Canada
- Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
- Centre de recherche du Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
| | - Louis-Christophe Juteau
- Université de Montréal, Montreal, QC, Canada
- Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
- Centre de recherche du Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
| | - Maria Popa
- Université de Montréal, Montreal, QC, Canada
| | - Marie-Ève Goyer
- Université de Montréal, Montreal, QC, Canada
- CIUSSS du Centre-Sud de Montréal, Montreal, QC, Canada
| | - Julie Bruneau
- Université de Montréal, Montreal, QC, Canada
- Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
- Centre de recherche du Centre hospitalier de l’Université de Montréal, Montreal, QC, Canada
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Von den Hoff DW, Berden FAC, Schellekens AFA. If the mountain won't come to Mohammed, then Mohammed must go to the mountain: Decentralisation of hepatitis C care for people who use drugs. United European Gastroenterol J 2021; 9:1101-1102. [PMID: 34687156 DOI: 10.1002/ueg2.12167] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/07/2022] Open
Affiliation(s)
- Daan W Von den Hoff
- Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, the Netherlands
| | - Floor A C Berden
- Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, the Netherlands
| | - Arnt F A Schellekens
- Department of Psychiatry, Radboud university medical centre, Nijmegen, The Netherlands.,Nijmegen Institute for Scientist-Practitioners in Addiction, Nijmegen, The Netherlands.,Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands
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35
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Seaman A, King CA, Kaser T, Geduldig A, Ronan W, Cook R, Chan B, Levander XA, Priest KC, Korthuis PT. A hepatitis C elimination model in healthcare for the homeless organization: A novel reflexive laboratory algorithm and equity assessment. THE INTERNATIONAL JOURNAL OF DRUG POLICY 2021; 96:103359. [PMID: 34325969 PMCID: PMC8720290 DOI: 10.1016/j.drugpo.2021.103359] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2021] [Revised: 06/16/2021] [Accepted: 06/18/2021] [Indexed: 12/13/2022]
Abstract
BACKGROUND Reaching World Health Organization hepatitis C (HCV) elimination targets requires diagnosis and treatment of people who use drugs (PWUD) with direct acting antivirals (DAAs). PWUD experience challenges engaging in HCV treatment, including needing multiple provider and laboratory appointments. Women, minoritized racial communities, and homeless individuals are less likely to complete treatment. METHODS We implemented a streamlined opt-out HCV screening and linkage-to-care program in two healthcare for the homeless clinics and a medically supported withdrawal center. Front-line staff initiated a single-order reflex laboratory bundle combining screening, confirmation, and pre-treatment laboratory evaluation from a single blood draw. Multinomial logistic regression models identified characteristics influencing movement through each stage of the HCV treatment cascade. Multiple logistic regression models identified patient characteristics associated with HCV care cascade progression and Cox proportional hazards models assessed time to initiation of DAAs. RESULTS Of 11,035 clients engaged in services between May 2017 and March 2020, 3,607 (32.7%) were screened. Of those screened, 1,020 (28.3%) were HCV PCR positive. Of those with detectable RNA, 712 (69.8%) initiated treatment and 670 (94.1%) completed treatment. Of those initiating treatment, 407 (57.2%) achieved SVR12. There were eight treatment failures and six reinfections. In the unadjusted model, the bundle intervention was associated with increased care cascade progression, and in the survival analysis, decreased time to initiation; these differences were attenuated in the adjusted model. Women were less likely to complete treatment and SVR12 labs than men. Homelessness increased likelihood of screening and diagnosis but was negatively associated with completing SVR12 labs. Presence of opioid and stimulant use disorder diagnoses predicted increased care cascade progression. CONCLUSIONS The laboratory bundle and referral pathways improved treatment initiation, time to initiation, and movement across the cascade. Despite overall population improvements, women and homeless individuals experienced important gaps across the HCV care cascade.
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Affiliation(s)
- A Seaman
- Department of Medicine, Section of Addiction Medicine, Oregon Health & Science University, Portland, Oregon, United States; Hepatitis C Elimination Program, Central City Concern, Portland, Oregon, United States.
| | - C A King
- Dept. of Biomedical Engineering, School of Medicine, Oregon Health & Science University, Portland, Oregon, United States
| | - T Kaser
- Hepatitis C Elimination Program, Central City Concern, Portland, Oregon, United States
| | - A Geduldig
- Hepatitis C Elimination Program, Central City Concern, Portland, Oregon, United States
| | - W Ronan
- Hepatitis C Elimination Program, Central City Concern, Portland, Oregon, United States
| | - R Cook
- Department of Medicine, Section of Addiction Medicine, Oregon Health & Science University, Portland, Oregon, United States
| | - B Chan
- Department of Medicine, Section of Addiction Medicine, Oregon Health & Science University, Portland, Oregon, United States; Hepatitis C Elimination Program, Central City Concern, Portland, Oregon, United States
| | - X A Levander
- Department of Medicine, Section of Addiction Medicine, Oregon Health & Science University, Portland, Oregon, United States
| | - K C Priest
- School of Medicine, MD/PhD Program, Oregon Health & Science University, Portland, Oregon, United States
| | - P T Korthuis
- Department of Medicine, Section of Addiction Medicine, Oregon Health & Science University, Portland, Oregon, United States
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Metsch LR, Feaster DJ, Gooden LK, Masson C, Perlman DC, Jain MK, Matheson T, Nelson CM, Jacobs P, Tross S, Haynes L, Lucas GM, Colasanti JA, Rodriguez A, Drainoni ML, Osorio G, Nijhawan AE, Jacobson JM, Sullivan M, Metzger D, Vergara-Rodriguez P, Lubelchek R, Duan R, Batycki JN, Matthews AG, Munoz F, Jelstrom E, Mandler R, Del Rio C. Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064). Open Forum Infect Dis 2021; 8:ofab334. [PMID: 34377726 PMCID: PMC8339611 DOI: 10.1093/ofid/ofab334] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2021] [Accepted: 06/24/2021] [Indexed: 12/13/2022] Open
Abstract
Background Direct-acting antivirals can cure hepatitis C virus (HCV). Persons with HCV/HIV and living with substance use are disadvantaged in benefiting from advances in HCV treatment. Methods In this randomized controlled trial, participants with HCV/HIV were randomized between February 2016 and January 2017 to either care facilitation or control. Twelve-month follow-up assessments were completed in January 2018. Care facilitation group participants received motivation and strengths-based case management addressing retrieval of HCV viral load results, engagement in HCV/HIV care, and medication adherence. Control group participants received referral to HCV evaluation and an offer of assistance in making care appointments. Primary outcome was number of steps achieved along a series of 8 clinical steps (eg, receiving HCV results, initiating treatment, sustained virologic response [SVR]) of the HCV/HIV care continuum over 12 months postrandomization. Results Three hundred eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% of participants were male and 72.6% were Black/African American. Median HIV-1 viral load was 27 209 copies/mL, with 69% having a detectable viral load. Mean number of steps completed was statistically significantly higher in the intervention group vs controls (2.44 vs 1.68 steps; χ 2 [1] = 7.36, P = .0067). Men in the intervention group completed a statistically significantly higher number of steps than controls. Eleven participants achieved SVR with no difference by treatment group. Conclusions The care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women. Study findings also highlight continued challenges to achieve individual-patient SVR and population-level HCV elimination. Clinical Trials Registration NCT02641158.
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Affiliation(s)
- Lisa R Metsch
- Department of Sociomedical Sciences, Columbia University, New York, New York, USA
| | - Daniel J Feaster
- Department of Public Health Sciences, University of Miami, Miami, Florida, USA
| | - Lauren K Gooden
- Department of Sociomedical Sciences, Columbia University, New York, New York, USA
| | - Carmen Masson
- Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, California, USA
| | - David C Perlman
- Division of Infectious Diseases, Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Mamta K Jain
- Division of Infectious Diseases, University of Texas Southwestern Medical Center and Parkland Health & Hospital System, Dallas, Texas, USA
| | - Tim Matheson
- Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, California, USA
| | - C Mindy Nelson
- Department of Public Health Sciences, University of Miami, Miami, Florida, USA
| | - Petra Jacobs
- Center for Clinical Trials Network, National Institute on Drug Abuse, Rockville, Maryland, USA
| | - Susan Tross
- Department of Psychiatry, Columbia University, New York, New York, USA
| | - Louise Haynes
- College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA
| | - Gregory M Lucas
- Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | | | - Allan Rodriguez
- Infectious Disease, University of Miami, Miami, Florida, USA
| | - Mari-Lynn Drainoni
- Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA
| | - Georgina Osorio
- Division of Infectious Diseases, Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Ank E Nijhawan
- Division of Infectious Diseases, University of Texas Southwestern Medical Center and Parkland Health & Hospital System, Dallas, Texas, USA
| | - Jeffrey M Jacobson
- Division of Infectious Diseases and HIV Medicine, Case Western Reserve University, Cleveland, Ohio, USA
| | - Meg Sullivan
- Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA
| | - David Metzger
- HIV/AIDS Prevention Research Division, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Pamela Vergara-Rodriguez
- Mental Health and Substance Abuse Division, John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois, USA
| | - Ronald Lubelchek
- Infectious Diseases, John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois, USA
| | - Rui Duan
- Department of Public Health Sciences, University of Miami, Miami, Florida, USA
| | - Jacob N Batycki
- Department of Public Health Sciences, University of Miami, Miami, Florida, USA
| | - Abigail G Matthews
- Data Statistical Center, The Emmes Company, LLC, Rockville, Maryland, USA
| | - Felipe Munoz
- Data Statistical Center, The Emmes Company, LLC, Rockville, Maryland, USA
| | - Eve Jelstrom
- Clinical Coordinating Center, The Emmes Company, LLC, Rockville, Maryland, USA
| | - Raul Mandler
- Clinical/Medical Branch, National Institute on Drug Abuse, Rockville, Maryland, USA
| | - Carlos Del Rio
- Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA
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