Article: Efficacy of sofosbuvir and velpatasvir, with and without ribavirin, in patients with HCV genotype 3 infection and cirrhosis—R. Esteban, et. al.
Source: Gastroenterology https://doi.org/10.1053/j.gastro.2018.06.042
Study Aims and Results: The aim of the study was to examine the effect of ribavirin on NS5A resistance-associated substitutions (RASs). This was a phase 3 clinical trial of 204 patients with chronic hepatitis C virus infection (HCV). All participants had genotype 3 with cirrhosis, and were treated with Epclusa (sofosbuvir plus velpatasvir) with and without ribavirin for 12 weeks. RASs are treatment-related substitutions that can prevent a NS5a drug—in this case, velpatasvir—from working. The primary endpoint of the study was virologic cure 12 weeks after treatment.
The overall cure rate was 91% in the people who did not receive ribavirin and 96% in the people who did receive ribavirin. But, when they analyzed the results of the people who had previously received treatment and who did and didn’t have RASs, the cure rates were different—84% (with RASs) vs. 96% (w/o RASs). In another analysis that looked at the same baseline characteristics but who received ribavirin, having RASs did not statistically affect the results —99% (with RASs) vs. 96% (w/o RASs).
Conclusions: Epclusa produced high cure rates in people with a difficult to treat population—HCV genotype 3, cirrhosis, prior treatment failures and some who had NS5A RASs
Editorial Comments: HCV genotype 3 is the most difficult to treat among the HCV population. Cirrhosis, prior treatment failure, and RASs further complicate treatment. The addition of ribavirin didn’t add much benefit to treatment in this study. The people who didn’t receive ribavirin and failed treatment may need to be re-treated with another treatment regimen. Additional studies are needed to find out what direct-acting antiviral (DAA) therapy is needed to re-treat people who don’t respond to Epclusa.Share This Page