Retrospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Oct 28, 2017; 9(30): 1190-1196
Published online Oct 28, 2017. doi: 10.4254/wjh.v9.i30.1190
Safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in hepatitis C virus/human immunodeficiency virus co-infected patients
Xiaoping He, Lynne Hopkins, George Everett, Willie M Carter, Cynthia SchroppDyce, Khalid Abusaada, Vincent Hsu
Xiaoping He, George Everett, Khalid Abusaada, Vincent Hsu, the Internal Medicine Residency Program of Florida Hospital, Orlando, FL 32804, United States
Lynne Hopkins, Willie M Carter, Cynthia SchroppDyce, Sunshine Care Center, Florida Department of Health in Orange County, Orlando, FL 32804, United States
Author contributions: He X contributed to protocol design and development, data collection and analysis, and writing of the first draft of the manuscript; Hopkins L contributed to protocol design and development, and writing of the manuscript; Carter WM and SchroppDyce C contributed to protocol development; Everett G, Abusaada K and Hsu V contributed to critical manuscript revision.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the Sunshine Care Center, Florida Department of Health in Orange County.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment.
Conflict-of-interest statement: The authors have no financial relationships to disclose.
Data sharing statement: No additional data are available.
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: Xiaoping He, MD, PhD, the Internal Medicine Residency Program of Florida Hospital, 2501 North Orange Ave, Suite 235, Orlando, FL 32804, United States. xiaoping.he.md@flhosp.org
Telephone: +1-407-3037270 Fax: +1-407-3032553
Received: April 6, 2017
Peer-review started: April 10, 2017
First decision: May 19, 2017
Revised: July 14, 2017
Accepted: September 3, 2017
Article in press: September 4, 2017
Published online: October 28, 2017
Processing time: 203 Days and 12.4 Hours
Abstract
AIM

To evaluate the safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in patients with hepatitis C virus (HCV)/human immunodeficiency virus (HIV) co-infection in an urban HIV clinic.

METHODS

A retrospective cohort study of 40 subjects co-infected with HIV-1 and HCV treated with the fixed-dose combination of ledipasvir and sofosbuvir for 12 wk from 2014 to 2016. All patients included were receiving antiretroviral therapy (ART) with HIV RNA values of 100 copies/mL or fewer regardless of baseline HCV RNA level. The primary end point was a sustained virologic response of HCV at 12 wk (SVR12) after the end of therapy.

RESULTS

Of the 40 patients enrolled, 55% were black, 22.5% had been previously treated for HCV, and 25% had cirrhosis. The patients were on a wide range of ART. Overall, 39 patients (97.5%) had a SVR 12 after the end of therapy, including rates of 97.1% in patients with HCV genotype 1a and 100% in those with HCV genotype 1b. One patient with HCV genotype 3a was included and achieved SVR12. Rates of SVR12 were similar regardless of previous treatment or the presence of compensated cirrhosis. Only 1 patient experienced relapse at week 12 following treatment and deep sequencing didn’t reveal any resistance associated mutation in the NS5A or NS5B region. Interestingly, 7 (17.5%) patients who were adherent to ART experienced HIV viral breakthrough which resolved after continuing the same ART regimen. Two (5%) patients experienced HIV-1 virologic rebound due to noncompliance with HIV therapy, which resolved after resuming the same ART regimen. No severe adverse events were observed and no patient discontinued treatment because of adverse events. The most common adverse events included headache (12.5%), fatigue (10%), and diarrhea (2.5%).

CONCLUSION

This retrospective study demonstrated the high rates of SVR12 of ledipasvir/sofosbuvir on HCV eradication in patients co-infected with HCV and HIV, regardless of HCV baseline levels, HCV treatment history or cirrhosis condition. The oral combination of ledipasvir/sofosbuvir represents a safe and well tolerated HCV treatment option that does not require modification for many of the common HIV ART. Occasional HIV virologic rebound occurred but later resolved without the need to change ART.

Keywords: Hepatitis C; Human immunodeficiency virus; Ledipasvir; Sofosbuvir

Core tip: This is a retrospective study to evaluate the safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in patients with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infection in an urban HIV clinic. It demonstrated the high rates of SVR12 of ledipasvir/sofosbuvir on HCV eradication in patients co-infected with HCV and HIV, regardless of HCV baseline levels, HCV treatment history or cirrhosis condition. The oral combination of ledipasvir/sofosbuvir represents a safe and well tolerated HCV treatment option that does not require modification for many of the common HIV antiretroviral therapy (ART). Occasional HIV virologic rebound occurred but later resolved without the need to change ART.