Observational Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Sep 27, 2018; 10(9): 622-628
Published online Sep 27, 2018. doi: 10.4254/wjh.v10.i9.622
Chronic hepatitis B virus monoinfection at a university hospital in Zambia
Michael J Vinikoor, Edford Sinkala, Annie Kanunga, Mutinta Muchimba, Bright Nsokolo, Roma Chilengi, Gilles Wandeler, Joseph Mulenga, Tina Chisenga, Debika Bhattacharya, Michael S Saag, Graham Foster, Michael W Fried, Paul Kelly
Michael J Vinikoor, Edford Sinkala, Annie Kanunga, Mutinta Muchimba, Bright Nsokolo, Paul Kelly, Tropical Gastroenterology and Nutrition Group, School of Medicine, University of Zambia, Lusaka 50110, Zambia
Michael J Vinikoor, Roma Chilengi, Centre for Infectious Disease Research in Zambia, Lusaka 34681, Zambia
Michael J Vinikoor, Michael S Saag, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, United States
Gilles Wandeler, Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern 3012, Switzerland
Gilles Wandeler, Institute of Social and Preventive Medicine, University of Bern, Bern 3012, Switzerland
Joseph Mulenga, Zambia National Blood Transfusion Service, Private Bag RW1X Ridgeway, Lusaka 50110, Zambia
Tina Chisenga, Zambian Ministry of Health, Ndeke House, Lusaka 30205, Zambia
Debika Bhattacharya, Department of Medicine, University of California at Los Angeles, Los Angeles, CA 90035, United States
Graham Foster, Paul Kelly, Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London E1 2AT, United Kingdom
Michael W Fried, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, United States
Author contributions: Vinikoor MJ, Sinkala E and Kelly P conceived the study; Vinikoor MJ, Sinkala E, Kanunga A and Muchimba M managed study implementation; Vinikoor MJ wrote the first draft of the manuscript; all authors provided critical review of the analysis, read and approved the final manuscript.
Supported by School of Medicine at University of Alabama at Birmingham; Fogarty International Center, No. K01TW009998; National Institute of Allergy and Infectious Diseases, U.S. National Institutes of Health, No. U01AI069924; and Swiss National Science Foundation (to Wandeler G), No. PZ0093_154730.
Institutional review board statement: The study was reviewed and approved by the Biomedical Research Ethics Committee at University of Zambia (Lusaka, Zambia) and the Institutional Review Board at University of Alabama at Birmingham (Birmingham, AL, United States).
Informed consent statement: All participants provided written informed consent prior to study enrollment.
Conflict-of-interest statement: There are no conflicts of interest to report.
Data sharing statement: No additional data are available.
STROBE statement: The STROBE Statement has been adopted.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Michael J Vinikoor, MD, Assistant Professor, Department of Medicine, University of Alabama at Birmingham, BBRB 256, 845 19th Street South, Birmingham, AL 35294, United States. mjv3@uab.edu
Telephone: +1-260-972921285
Received: April 26, 2018
Peer-review started: April 26, 2018
First decision: May 9, 2018
Revised: May 23, 2018
Accepted: July 9, 2018
Article in press: July 10, 2018
Published online: September 27, 2018
Processing time: 154 Days and 14.4 Hours
Abstract
AIM

To characterize antiviral therapy eligibility among hepatitis B virus (HBV)-infected adults at a university hospital in Zambia.

METHODS

Hepatitis B surface antigen-positive adults (n = 160) who were HIV-negative and referred to the hospital after a routine or clinically-driven HBV test were enrolled. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), platelet count, hepatitis B e-antigen, and HBV DNA were measured. Liver fibrosis/cirrhosis was assessed by physical examination, AST-to-platelet ratio index, and transient elastography. In antiviral therapy-naïve individuals, we described HBV stages and antiviral therapy eligibility per World Health Organization (WHO) and by HBV test (routine vs clinical). Elevated ALT was > 19 in women and > 30 U/L in men. Among treatment-experienced individuals, we described medication side effects, adherence, and viral suppression.

RESULTS

The median age was 33 years, 71.9% were men, and 30.9% were diagnosed with HBV through a clinically-driven test with the remainder identified via routine testing (at the blood bank, community events, etc.). Among 120 treatment-naïve individuals, 2.5% were categorized as immune tolerant, 11.7% were immune active, 35.6% were inactive carriers, and 46.7% had an indeterminate phenotype. Per WHO guidelines, 13 (10.8%) were eligible for immediate antiviral therapy. The odds of eligibility were eight times higher for those diagnosed at clinical vs routine settings (adjusted odds ratio, 8.33; 95%CI: 2.26-29.41). Among 40 treatment-experienced HBV patients, virtually all took tenofovir, and a history of mild side effects was reported in 20%. Though reported adherence was good, 12 of 29 (41.4%) had HBV DNA > 20 IU/mL.

CONCLUSION

Approximately one in ten HBV-monoinfected Zambians were eligible for antivirals. Many had indeterminate phenotype and needed clinical follow-up.

Keywords: Hepatitis B virus; Liver fibrosis; Treatment; Tenofovir; Africa

Core tip: Data to inform the scale-up of hepatitis B testing and treatment in Africa are badly lacking. Among 120 recently diagnosed hepatitis B surface antigen-positive and HIV negative adults in Zambia, Southern Africa, 10% met the WHO’s criteria for immediate antiviral therapy and an additional 40% had an “indeterminate” hepatitis B virus (HBV) phenotype with either elevated alanine aminotransferase or HBV DNA > 2000 IU/mL. Among 40 additional patients who were antiviral therapy-experienced (primarily with tenofovir), tolerability and adherence were good; however, nearly half had incomplete HBV DNA suppression. Effective approaches to retain antiviral-ineligible HBV patients in care will be important in Zambia.