A combination of sofosbuvir and velpatasvir effectively treated all six hepatitis C virus genotypes in treatment-naive patients without cirrhosis, according to Dr. Gregory T. Everson and his associates.
The study was separated into two parts. In Part A, 154 patients with HCV genotypes 1-6 received 400 mg sofosbuvir and either 25 mg velpatasvir or 100 mg velpatasvir. After 12 weeks of treatment, sustained viral response (SVR12) rates were 96% with 25 mg velpatasvir and 100% with 100 mg velpatasvir with genotype 1, 93% for both groups with genotype 3, and 96% with 25 mg velpatasvir and 95% with 100 mg velpatasvir with genotypes 2,4,5, and 6.
Dr. Gregory T. Everson
In part B, 223 patients with HCV genotypes 1 and 2 received 400 mg sofosbuvir and either 25 mg velpatasvir with ribavirin, 100 mg velpatasvir with ribavirin, 25 mg velpatasvir without ribavirin, or 100 mg velpatasvir without ribavirin. For genotype 1, SVR12 rates were 87% in the 25-mg velpatasvir group, 83% in the 25-mg velpatasvir plus ribavirin group, 90% in the 100-mg velpatasvir group, and 81% in the 100-mg velpatasvir plus ribavirin group. For genotype 2, SVR12 rates were 77% in the 25-mg velpatasvir group, 88% in the 25-mg velpatasvir plus ribavirin group, 88% in the 100-mg velpatasvir group, and 88% in the 100-mg velpatasvir plus ribavirin group.
Adverse events were experienced by 69% of study participants. Common events were fatigue, headache, and nausea, occurring in 21%, 20%, and 12%, respectively. Velpatasvir dosage size did not change adverse event occurrence, but patients on regimens containing ribavirin did experience more fatigue, insomnia, and rash. Only one discontinuation due to adverse events was reported.
“A single regimen with pangenotypic efficacy could obviate the need for HCV genotyping before initiation of treatment. The high efficacy demonstrated with coadministration of sofosbuvir and velpatasvir, 100 mg, for 12 weeks across all HCV genotypes evaluated in this study supports the development of a single, uniform pangenotypic regimen with these DAAs [direct-acting anti-virals],” the investigators noted.
Find the study in Annals of Internal Medicine (doi: 10.7326/M15-1000).
*CORRECTION, 11/10/2015: In an earlier version of this article, the drug name sofosbuvir was misspelled.