FDA Approves Revisions to Epclusa Label to Include Co-Infection Clinical Trial Data

The FDA approved revisions to the Epclusa (sofosbuvir/velpatasvir) label yesterday to include information from adults co-infected with chronic hepatitis C virus (HCV) and HIV-1 based on ASTRAL-5 clinical trial data.

Epclusa was approved on June 27, 2016, as a single agent for the treatment of chronic HCV genotypes 1, 2, 3, 4, 5, or 6 in adults with or without compensated cirrhosis.

Major changes to the approved label fall into the following sections: dosage and administration, adverse reactions section, and clinical studies.

Epclusa’s recommended dose is a single oral tablet taken once daily with or without food. A tablet of Epclusa contains 400 mg of sofosbuvir and 100 mg of velpatasvir.

Dosage recommendations for patients with HCV and HIV-1 co-infection should follow the same dosage recommendations for individuals with only HCV.

A 12-week regimen with Epclusa is recommended for treatment-naïve and treatment-experienced patients without cirrhosis and with compensated cirrhosis. For treatment-naïve and treatment-experienced patients with decompensated cirrhosis, Epclusa plus ribavirin for 12 weeks is recommended.

Section 6 adverse reactions were updated to include safety findings from the open-label ASTRAL-5 trial, along with post-marketing experience.

ASTRAL-5 was designed to evaluate the 12-week Epclusa treatment regimen in 106 patients with HCV genotype 1-6 who were co-infected with HIV-1 and on stable antiretroviral therapy. The median age of participants was 57 years, 86% of whom were male.

The safety profile among the co-infected participants was similar to those observed in HCV mono-infected participants, with the most common adverse events fatigue and headache.

The skin and subcutaneous tissue disorders was updated to include skin rashes, sometimes with blisters, or angioedema-like swelling because of reports during post approval use of sofosbuvir.