Safety Profile of New Pan-Genomic HCV Drug Similar to Current Treatments

Epclusa has been approved as the first pan-genomic treatment for the hepatitis C virus (HCV). After reviewing the evidence for Epclusa and other HCV treatments already on the market, Advera Health has determined that Gilead Sciences’ Epclusa has a similar safety profile as Sovaldi, Harvoni, Daklinza, and Viekira Pak.

The FDA approved Epclusa (sofosbuvir/velpatasvir) for the treatment of adult patients with chronic HCV both with and without cirrhosis. It is also approved as a part of a combination treatment with ribavirin for patients with moderate to severe cirrhosis. Epclusa is a combination tablet that contains 400 mg sofosbuvir and 100 mg velpatasvir, and is the first approved drug treatment for all 6 major genotypes (strains) of HCV. This new pan-genomic treatment has the potential to greatly simplify clinical decision-making and reduce the need for pretreatment genomic testing prior to therapy. Epclusa is a product of Gilead Sciences.

Advera found that Epclusa seems to have a slightly higher or similar sustained viral response after 12 weeks for genotypes 1-4 as the other treatments. Notably, Epclusa shows a high cure rate (80% to 95% in trials) for HCV genotype 3, which is the most challenging to treat.

The FDA based its approval of Epclusa on three 12-week safety and efficacy studies in 1588 patients without cirrhosis or with mild cirrhosis. The studies showed that 95% to 99% of patients who received Epclusa had no virus detected in their blood 12 weeks after finishing treatment, which the FDA states suggests the patients’ infections had been cured. The safety and efficacy of Epclusa was also analyzed in a study of 267 patients with moderate to severe cirrhosis, of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detectable in their blood 12 weeks after finishing treatment.

The most common adverse effects associated with Epclusa in clinical trials include headache, fatigue, and nausea. Epclusa’s labeling has a warning about serious slowing of the heart rate and cases requiring implantation of a pacemaker that have been reported when certain other drugs are dosed at the same time. However, the rate of serious adverse events, the rate of discontinuation of the drug, and overall rates of adverse events in the clinical trials are comparable to placebo and the available medications already in use for HCV.

Sovaldi, Harvoni, Daklinza, and Viekira Pak all do not have any boxed warnings, and Advera expects that Epclusa will likely not have any either considering its safety profile.

“Though our analysis of the clinical trial data support the possibility of this drug to be a safe genome-wide anti-HCV drug, close post-marketing surveillance after its approval will help us to identify further safety issues,” Advera reported.