SAN FRANCISCO — A fixed-dose combination of Sovaldi and velpatasvir yielded 99% SVR12 across a number of genotypes, according to a presentation at the Late Breakers session of The Liver Meeting 2015.
“Although there has been phenomenal progress in HCV therapy over the last few years, interferon-free regimens are not pangenotypic and, therefore, most regimens need to be selected for specific patient groups,” Jordan J. Feld, MD, of the Toronto Western Hospital Liver Centre, said in his presentation.
Feld presented phase 3 data for the daily fixed-dose combination of 400 mg of Sovaldi (sofosbuvir, Gilead Sciences) and100 mg of velpatasvir (Gilead Sciences) for 12 weeks in a cohort of patients with HCV genotypes 1, 2, 4, 5 and 6.
The researchers randomly assigned 740 patients to treatment or placebo in a 5:1 ratio. The study had a double-blind design. There were 624 patients in the active therapy group and 116 patients in the placebo group. “We used a broad inclusion criteria,” Feld said. All patients with genotype 5 disease received active therapy.
Eligible participants were accrued at 81 sites in North America, Europe and Hong Kong.
The primary endpoint was a pre-specified efficacy goal of 85% for the treatment group. The researchers also evaluated safety, tolerability, resistance and additional efficacy outcomes, according to Feld.
The overall SVR12 rate in the sofosbuvir/velpatasvir group was 99% (95% CI, 97.9%-99.6%). The study met the primary efficacy endpoint (P < .001).
SVR12 rates were 99% for genotype 1, 100% for genotypes 2, 4 and 6, and 97% for genotype 5. Treatment regimens were completed by 622 patients in the active therapy arm and 113 patients in the placebo arm.
The SVR12 rate was 99% in patients with and without cirrhosis. Similarly, treatment-naive and treatment-experienced patients both reached a 99% SVR12 rate.
Feld reported that 257 patients had baseline NS5A resistance-associated variants (RAVs). The SVR12 rate among these patients was 99%.
Three percent of patients in the treatment arm experienced a grade 3 or 4 adverse event. Headache, fatigue, nasopharyngitis and nausea were the most frequently reported adverse events.
There was one discontinuation due to an adverse event in the active therapy arm, and one patient in this arm was lost to follow-up.
One relapse occurred in a patient with genotype 1a disease, and one occurred in a patient with genotype 1b disease.
“There were no recurrent adverse events,” Feld said.
Laboratory abnormalities were reported 7% of patients in the active treatment arm 12% of those in the placebo arm.
“In summary, sofosbuvir/velpatasvir provides a simple, safe and highly effective regimen for patients with HCV genotype 1, 2, 4, 5 and 6 infection,” Feld said. – by Rob Volansky
Feld JJ, et al. Abstract LB-2. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.
Disclosures: Feld reports associations with a number of device and pharmaceutical companies. Please see the full study for a list of all other authors’ relevant financial disclosures.