Gilead 'Universal' Hepatitis C Combination Receives FDA Approval


US FDA approval made Gilead Sciences’ Epclusa, the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with all genotypes of chronic hepatitis C virus (HCV) infection.

Gilead SciencesEpclusa (sofosbuvir 400 mg/velpatasvir 100 mg) is the first all-oral treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

The US Food and Drug Administration (FDA) has given Epclusa a Priority Review and a Breakthrough Therapy  designation.

In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 clinical studies, 1,035 patients with genotype 1-6 chronic HCV infection, without cirrhosis or with compensated cirrhosis received 12 weeks of Epclusa. Among them 98% patients achieved SVR12.

The ASTRAL-4 study randomized 267 patients with genotype 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B), to receive 12 weeks of Epclusa with or without RBV or 24 weeks of Epclusa.

Patients receiving Epclusa with RBV for 12 weeks achieved high SVR12 rate compared to those receiving Epclusa for 12 or 24 weeks.

In the patients studied, headache and fatigue were the commonly observed side effects. In the patients under the ASTRAL-4 group, fatigue, anemia, nausea, headache, insomnia and diarrhea were the most common side effects.

Approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens.As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.”John Milligan, Ph.D., President and Chief Executive Officer of Gilead.

Earlier, we have told you regarding the tough competition among the major competitors like Merck, Abbvie and Bristol-Myers Squibb in the Chronic HCV infection domain and once again it seems Gilead is taking the lead.

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