Patients with hepatitis C genotype 3 with compensated cirrhosis achieved a sustained virologic response rate higher than 90% after treatment with Epclusa with or without ribavirin, according to results of a recently published phase 3 study.
According to Rafael Esteban, MD, from the Hospital Universitario Val d'Hebron in Spain, and colleagues, these results were consistent with previous studies. Additionally, response rates were numerically higher in patients treated with ribavirin, largely due to the impact of baseline NS5A resistance-associated substitutions (RASs).
The researchers randomly assigned 204 patients to receive Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) with ribavirin (n = 103) or without ribavirin (n = 101) for 12 weeks. At follow-up, SVR rates were 96% (95% CI, 90.4-98.9) for the ribavirin group and 91% (95% CI, 83.8-95.8) for the group without ribavirin.
Treatment-experienced patients had a numerically higher SVR rate compared with treatment-naive patients (96% vs. 89%) and no difference in rate regardless of treatment with or without ribavirin (96%).
Among patients with baseline NS5A RASs, 21 of 22 patients from the ribavirin group (95%) and 16 of 19 patients treated without ribavirin (84%) achieved SVR.
Overall, sofosbuvir/velpatasvir was well-tolerated regardless of ribavirin. Two patients discontinued treatment due to unrelated adverse events and four patients experienced serious adverse events unrelated to treatment.
“The impact of the results of this study on clinical practice for this patient population are likely to be influenced by the cost and availability of resistance testing, treatment with ribavirin, as well as potential retreatment of virologic failures with salvage,” the researchers wrote. “The simplicity of a single tablet regimen given once daily for a uniform duration to patients irrespective of genotype or fibrosis stage is supported by these data, and particularly appropriate given the small percentage of patients with virologic relapse can be successfully retreated with sofosbuvir/velpatasvir/voxilaprevir.” – by Talitha Bennett
Disclosure: Esteban reports advisory or speaker roles with AbbVie, Gilead and Merck. Please see the full study for the other authors’ relevant financial disclosures.