Abdulla M, Al Ghareeb AM, Husain HAHY, Mohammed N, Al Qamish J. Effectiveness and safety of generic and brand direct acting antivirals for treatment of chronic hepatitis C. World J Clin Cases 2022; 10(34): 12566-12577 [PMID: 36579085 DOI: 10.12998/wjcc.v10.i34.12566]
Corresponding Author of This Article
Maheeba Abdulla, MD, Doctor, Department of Internal Medicine, Salmaniya Medical Complex, Arabian Gulf University, Rd No. 2904, Manama 2904, Bahrain. amaheeba@gmail.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Observational Study
Open-Access Policy of This Article
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/
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
ARTICLE HIGHLIGHTS
Research background
Direct acting antiviral (DAA) agents have revolutionized the treatment of hepatitis C virus (HCV) infection because they are highly effective. However, brand DAA agents are very expensive and unaffordable to many patients who need them. Generic versions of the DAA agents are being developed to address this challenge but research on whether their effectiveness is comparable to brand DAA agents are limited.
Research motivation
Data on the clinical efficacy of generic DAA agents for chronic HCV infection treatment is rare in Bahrain.
Research objectives
This study evaluated the effectiveness and safety of generic compared to brand DAA agents for chronic HCV infection treatment.
Research methods
In this observational study, 149 patients were enrolled and treated with brand DAA agents (brand group), and another 140 patients were enrolled and treated with generic versions of DAA agents (generic group) over a two-year period. The primary outcomes included sustained virologic response after 12 wk of treatment and its determinants.
Research results
In general, there was no significant differences in the treatment outcome of patients who received brand vs generic DAA agents in terms of their sustained virologic response after 12 wk of treatment. Both generic and brand DAAs showed marked improvement in liver function evidenced by a substantial reduction in serum alanine and aspartate aminotransferase levels and total bilirubin levels. Overall, patients who had cirrhosis and HCV genotype 3 were significantly less likely to achieve sustained virologic response after 12 wk of treatment.
Research conclusions
Generic DAA agents have similar clinical efficacy and safety levels compared to brand DAA agents in the treatment of chronic HCV infection. They also show similarity in their improvement of hepatic function in these patients.
Research perspectives
Further studies are needed to better evaluate the long-term efficacy and safety of generic direct acting antiviral (DAA) agents in previously treated hepatitis C virus (HCV) infected patients and in patients with cirrhosis and HCV genotype 3.
