Published online Dec 6, 2022. doi: 10.12998/wjcc.v10.i34.12566
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
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.
Data on the clinical efficacy of generic DAA agents for chronic HCV infection treatment is rare in Bahrain.
This study evaluated the effectiveness and safety of generic compared to brand DAA agents for chronic HCV infection treatment.
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.
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.
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.
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.