Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Dec 6, 2022; 10(34): 12566-12577
Published online Dec 6, 2022. doi: 10.12998/wjcc.v10.i34.12566
Effectiveness and safety of generic and brand direct acting antivirals for treatment of chronic hepatitis C
Maheeba Abdulla, Aysha Mohamed Al Ghareeb, Hamed Ali Hasan Yusuf Husain, Nafeesa Mohammed, Jehad Al Qamish
Maheeba Abdulla, Department of Internal Medicine, Salmaniya Medical Complex, Arabian Gulf University, Manama 2904, Bahrain
Aysha Mohamed Al Ghareeb, Hamed Ali Hasan Yusuf Husain, Nafeesa Mohammed, Department of Internal Medicine, Salmaniya Medical Complex, Manama 2904, Bahrain
Jehad Al Qamish, Internal Medicine Department, Ibn AlNafees Hospital, Manama 3302, Bahrain
Author contributions: Abdulla M, Al Ghareeb AM, Husain HAHY, Mohammed N, and Al Qamish J contributed equally to this work; Abdulla M and Al Qamish J designed the research study; Abdulla M, Al Ghareeb AM, Husain HAHY, Mohammed N, and Al Qamish J performed the research; Husain HAHY, Al Ghareeb AM, and Mohammed N contributed new reagents and analytic tools; Abdulla M, Husain HAHY, and Mohammed N analyzed the data and wrote the manuscript; all authors have read and approved the final manuscript.
Institutional review board statement: The study was approved by the Secondary Health Care Research Sub Committee, Ministry of Health, Kingdom of Bahrain (Reference number 22G45-40-01925).
Conflict-of-interest statement: The authors declare that they have no conflict of interest to disclose.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at amaheeba@gmail.com.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Maheeba Abdulla, MD, Doctor, Department of Internal Medicine, Salmaniya Medical Complex, Arabian Gulf University, Rd No. 2904, Manama 2904, Bahrain. amaheeba@gmail.com
Received: July 13, 2022
Peer-review started: July 13, 2022
First decision: August 6, 2022
Revised: September 28, 2022
Accepted: November 8, 2022
Article in press: November 8, 2022
Published online: December 6, 2022
Processing time: 141 Days and 20.7 Hours
Abstract
BACKGROUND

Direct acting antivirals (DAAs) are a very effective treatment for hepatitis C virus (HCV). However, brand DAAs are expensive. The licensing of cheaper generic DAAs may address this issue, but there is a lack of clinical studies comparing the efficacy of generic vs brand DAA formulations.

AIM

To compare the efficacy and safety of generic against brand DAAs for chronic hepatitis C treatment in Bahrain.

METHODS

This was a retrospective observational study involving 289 patients with chronic HCV infection during 2016 to 2018. There were 149 patients who were treated with brand DAAs, while 140 patients were treated with generic DAAs. Commonly used DAAs were Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir ± Ribavirin, and Sofosbuvir/Daclatasvir ± Ribavirin. SVR at 12 wk post treatment was the main outcome variable.

RESULTS

Overall, 87 patients (30.1%) had cirrhosis and 68.2% had genotype 1 HCV infection. At 12 wk post treatment, SVR was achieved by 271 (93.8%) of the patients. In patients who were treated with generic medications, 134 (95.7%) achieved SVR at 12 wk post treatment, compared to 137 (91.9%) among those treated with brand medications (P = 0.19). Having cirrhosis [odds ratio (OR): 9.41, 95% confidence interval (CI): 2.47–35.84] and having HCV genotype 3 (OR: 3.56, 95%CI: 1.03–12.38) were significant independent predictors of not achieving SVR. Alanine transaminase, gamma-glutamyl transpeptidase, and total bilirubin levels decreased significantly following therapy with both generic and brand DAAs.

CONCLUSION

Generic and brand DAAs demonstrate comparable effectiveness in the treatment of chronic hepatitis C patients. Both are safe and equally effective in improving biochemical markers of hepatic inflammation.

Keywords: Hepatitis C virus; Direct acting antivirals; Generic; Brand; Sofosbuvir; Ombitasvir; Ledipasvir; Daclatasvir; Paritaprevir; Ritonavir; Dasabuvir; Ribavirin; Sustained virologic response

Core Tip: The World Health Organization aims to eliminate hepatitis C virus (HCV) infection by 2030. Its guidelines recommend treatment for all individuals diagnosed with HCV infection for > 12 years. Management of HCV infection in low- and middle-income countries is hampered by high costs of medication. This is the first study to compare efficacy and safety of generic compared to original brand direct acting antivirals (DAAs) for hepatitis C treatment in Bahrain, where the prevalence of HCV infection is estimated to be 1.7% (1.39-2.21%). Overall, our study adds to the literature on the similarity in effectiveness in patients receiving both brand and generic formulations of DAAs for chronic hepatitis C.