Keywords
Chronic Hepatitis C; Telaprevir; Boceprevir; Sustained virologic response; Direct acting anti-viral
Abstract
Telaprevir and Boceprevir were the first US Food and Drug Administration (FDA) approved NS3/4A protease inhibitors of Chronic Hepatitis C infection in 2011. Despite their discontinuation from the US market 3 years after their approval by the US FDA, both protease inhibitors left a great impact in the treatment approach of Chronic Hepatitis C. Both antiviral agents allowed a dramatic improvement in SVR rates compared to the old dual regimen of Pegylated interferon and ribavirin. However, there were associated significant adverse outcomes. Randomized clinical trials may have limited generalizability in terms of efficacy, safety, and tolerability of these drugs in everyday outpatient setting. Our prospective cohort study of 113 Chronic Hepatitis C patients, who were treated outside of a controlled trial, showed different efficacies and safety profiles compared to what was described in controlled trials of Telaprevir and Boceprevir. In addition, our analysis identified no significant predictors of end of treatment response or sustained virologic responses at weeks 12 and 24 following treatment completion. This does not correspond with data from recent studies. Research studies conducted outside of a controlled trial about new chronic hepatitis C therapies that have obtained FDA approval is important as newer antiviral agents are being reviewed by the FDA.
Citation
Mousa OY, Kim CH, Pham LE, Zela SA, Egwim CI and Ankoma-Sey V. Predictors of Sustained Virologic Response and Failure of First DAA Therapy in Chronic Hepatitis C Patients. SM J Hepat Res Treat. 2017; 3(1): 1014. https://dx.doi.org/10.36876/smjhrt.1014