Bourlière M, et al. - In this open-label, deferred treatment substudy, researchers evaluated the effectiveness and safety of sofosbuvir-velpatasvir-voxilaprevir in subjects from the deferred treatment group of POLARIS-1, who were initially assigned to masked placebo treatment. In patients with chronic hepatitis C virus (HCV) infection who had previous treatment failure with NS5A inhibitor-containing regimens, the single-tablet regimen of sofosbuvir-velpatasvir-voxilaprevir for 12 weeks was safe, well tolerated, and highly effective. For patients with limited retreatment options, this salvage regimen represents an important advance.

Methods

• This investigation was performed at 73 clinical sites (hospitals and clinics) in the US, France, Canada, the UK, Germany, Australia, and New Zealand.
• Eligibility criteria included patients who received placebo in the primary study and who did not have a new clinically significant illness at the post-treatment week 4 assessment.
• Participants received a combination tablet of sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg) once daily for 12 weeks.
• Achievement of sustained virologic response (defined as HCV RNA concentration below the lower limit of quantification) 12 weeks after the end of treatment (SVR12) was the primary efficacy outcome.
• The proportion of patients who discontinued treatment due to adverse events was the primary safety outcome.

Results

• According to the findings, 152 subjects were potentially eligible for participation in the open-label substudy, of whom 147 were enlisted from March 30, 2016 to October 12, 2016.
• It was observed that all 147 patients completed treatment, and 143 (97%; 95% CI 93–99) achieved SVR12.
• It was noted that four (3%) subjects had virologic relapse; all had HCV genotype 1a infection and one also had compensated cirrhosis.
• Fatigue (31 [21%]), headache (29 [20%]), diarrhea (28 [19%]), and nausea (21 [14%]) were the most common adverse events.
• No deaths, treatment discontinuations, or treatment-related serious adverse events occurred in this analysis.