Thursday, November 17, 2016

Adding Voxilaprevir to Sofosbuvir/Velpatasvir Effective for HCV Genotype 3: Presented at AASLD

Adding Voxilaprevir to Sofosbuvir/Velpatasvir Effective for HCV Genotype 3: Presented at AASLD
By Frances Morin

BOSTON -- November 17, 2016 -- Adding voxilaprevir to the combination tablet containing sofosbuvir and velpatasvir (Epclusa) for 8 weeks shows similar efficacy to sofosbuvir/velpatasvir alone for 12 weeks in the treatment of patients with hepatitis C virus (HCV) genotype 3 and cirrhosis.

“The results show that sofosbuvir/velpatasvir and voxilaprevir for 8 weeks and sofosbuvir/velpatasvir for 12 weeks each provide simple, safe, and effective treatment regimens for patients with HCV genotype 3 and cirrhosis,” said Graham R. Foster, MD, Royal London Hospital, London, United Kingdom, at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

In efforts to treat HCV with direct acting antivirals, genotype 3 infection has become notably difficult to cure, particularly in patients with cirrhosis.

For the phase 3 POLARIS-3 trial, the researchers investigated the addition of voxilaprevir 100 mg/day to sofosbuvir/velpatasvir 400 mg/100 mg/day for 8 weeks compared with sofosbuvir/velpatasvir 400 mg/100 mg/day alone for 12 weeks in 219 patients with genotype 3 HCV infection and cirrhosis.

The results showed that 96% of patients in each group achieved a sustained virologic response for at least 12 weeks after treatment (SVR12).

In the voxilaprevir group, there were 2 relapses, 1 patient withdrew consent, and there was 1 death. In the sofosbuvir/velpatasvir group, there was 1 on-treatment failure, 1 relapse, 1 discontinuation due to an adverse event (AE), and 1 lost to follow-up.

In looking at patients according to prior treatment, 96% of treatment-naïve patients in the voxilaprevir group (72/75) achieved SVR12 compared with 99% of the sofosbuvir/velpatasvir group (76/77). Among those who received prior treatment, 97% and 91% achieved SVR 12, respectively.

The most common AEs (>10% of patients) were fatigue and headache. Rates of nausea and diarrhoea were higher in the voxilaprevir group (21% and 15%, respectively), compared with the sofosbuvir/velpatasvir group (9% and 5%).

According to the researchers, baseline NS5A resistance-associated substitutions, including Y93H, did not impact treatment outcomes for either group.

Funding for this study was provided by Gilead Sciences.

[Presentation title: A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/ Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients With Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study]

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