FDA Approves HCV Drug Combo for All Genotypes

The FDA approved a combination tablet of sofosbuvir and velpatasvir (Epclusa) for treating chronic hepatitis C virus (HCV) infection, the agency announced.

The drug is unique in that it is the first to treat all six of the HCV genotypes, for patients with and without cirrhosis, the agency said. For patients with moderate to severe cirrhosis, the approved indication calls for co-treatment with ribavirin.

Epclusa was the third HCV combination drug to be approved by the FDA, following the approvals of Harvoni (ledipasvir and sofosbuvir) and Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets, which are co-packaged with dasabuvir tablets).

Compared with drug combinations that were previously approved to cure HCV, Epclusa provides a "management and treatment option for a wider scope of patients," explained Edward Cox, MD, of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a statement.

Results of three phase III clinical trials, enrolling a total of 1,558 patients either without cirrhosis or with mild cirrhosis, showed that 95% to 99% of patients who took the drug had sustained undetectable virus after 12 weeks.

In addition, 87 out of 267 participants with moderate to severe cirrhosis in a separate clinical trial were administered Epclusa in conjunction with ribavirin. Ninety-four-percent of these 87 participants were free of HCV after 12 weeks.

Decreased heart rate and the need for pacemaker interventions have previously been reported among patients receiving sofosbuvir and amiodarone, in addition to another HCV antiviral drug. Therefore, it is not recommended for patients to take Epclusa concomitantly with amiodarone.

Headache and fatigue were other general side effects reported.

Gilead Sciences is responsible for manufacturing and marketing Epclusa. TheStreet.com reported Gilead planned a base cost of $74,760 for a 12-week treatment course -- about 20% less than it has charged for Harvoni.

Let's block ads! (Why?)

FDA Approves HCV Drug Combo for All Genotypes