FDA Expands Epclusa® Indication for HCV/HIV Co-infection

The FDA has approved an expanded indication for Epclusa to include the use of this once-daily single tablet regimen in patients co-infected with chronic hepatitis C virus and HIV.

Gilead announced that the Food and Drug Administration (FDA) has approved an expanded indication for Epclusa (sofosbuvir/velpatasvir) to include the use of this once-daily single tablet regimen in patients co-infected with chronic hepatitis C virus (HCV) and HIV.

The supplemental New Drug Application (sNDA) approval was based on data from the Phase 3 open-label, ASTRAL-5 study (n=106) that evaluated treatment with Epclusa for 12 weeks in patients with genotype 1–4 HCV infection who were co-infected with HIV and on stable antiretroviral therapy. Nearly all patients (95%) achieved the primary endpoint of SVR12, defined as undetectable viral load 12 weeks after treatment completion. No patient had HIV-1 rebound during treatment and CD4+ counts remained stable throughout.

The safety of Epclusa in HCV/HIV co-infected patients was similar to the profile seen in HCV mono-infected patients. Fatigue and headache were the most frequent adverse effects, occurring in at least 10% of patients. 

To reflect the new expanded indication, the Epclusa labeling has been updated with the recommended dosage for patients co-infected with HCV/HIV. The adverse reactions section has also been updated to include safety data from ASTRAL-5 in addition to post-marketing experience.

Epclusa is already indicated to treat HCV genotype 1–6 in adults without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin. 

The product is available as 400mg/100mg strength tablets in 28-count bottles. 

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  1. US FDA approves expanded labeling for Epclusa® (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis c in patients co-infected with HIV [press release]. Foster City, Calif: Gilead. Published onlined August 1, 2017. Accessed September 1, 2017.

This article originally appeared on MPR