FDA to Review Combo Drug Considered a Salvage Therapy for HCV Patients
Gilead Sciences announced the submission of a New Drug Application (NDA) for a once-daily single tablet regimen containing sofosbuvir 400mg, velpatasvir 100mg, and voxilaprevir 100mg (SOF/VEL/VOX) for the treatment of patients with direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV) infection.
The NDA submission includes data to support the SOF/VEL/VOX regimen for 12 weeks in DAA-experienced patients with genotype 1–6 HCV infection without cirrhosis or with compensated cirrhosis. Two Phase 3 studies (POLARIS-1 and POLARIS-4) evaluated 12 weeks of the fixed-dose combination in DAA-experienced patients, including those who failed prior treatment with an NS5A-containing regimen. A total of 445 patients were treated with SOF/VEL/VOX of which 430 (97%) patients met the primary efficacy endpoint of SVR12.
Data from two other studies, POLARIS-2 and POLARIS-3, which evaluated DAA-naive HCV-infected patients (n=611) taking SOF/VEL/VOX for 8 weeks, were also included in the NDA submission.
Among patients who received SOF/VEL/VOX, the most common adverse events reported were headache, fatigue, diarrhea, and nausea.
The investigational fixed-dose combination of SOF/VEL/VOX was granted Breakthrough Therapy designation by the Food and Drug Administration (FDA) for the treatment of chronic genotype 1 HCV patients who previously failed an NS5A inhibitor-containing regimen.
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