FDA OKs Epclusa, First Drug for All Major Forms of HCV


June 28, 2016

The US Food and Drug Administration (FDA) has approved the combination drug of sofosbuvir and velpatasvir (Epclusa, Gilead Sciences) for adults with chronic hepatitis C virus (HCV) infection, the first one to treat all six major genotypes of the infection, the agency announced today.

The new drug's broad coverage could make it a one-size-fits-all therapy suitable for primary care. Gilead Sciences President and CEO John Gilliland said in a news release that sofosbuvir/velpatasvir could eliminate the need for genotype testing, "which can be a barrier to treatment in certain resource-constrained settings."

"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

Sofosbuvir won FDA clearance in 2013, while velpatasvir is a new drug. The combination drug, a fixed-dose tablet, is indicated for patients with chronic HCV infection whether or not they have cirrhosis. However, patients with moderate to severe cirrhosis should use the new drug together with ribavirin.

Sofosbuvir/velpatasvir treats HCV genotypes 1 through 6, with genotype 1 accounting for 75% of cases in the United States.

Like many HCV drugs of recent vintage, sofosbuvir/velpatasvir does not require concomitant use of interferon, known for its harsh adverse effects. And more important, it is another HCV drug that achieves a cure rate topping 90% with just a 12-week regimen.

Last month the European Medicines Agency recommended approval of sofosbuvir/velpatasvir in the European Union.

The wholesale price of the new drug is $74,760 for a 12-week regimen, Gilead Sciences spokesperson Cara Miller told Medscape Medical News. That price is considerably less than the company's wholesale prices of $84,000 and $94,500 for Sovaldi and Harvoni, respectively, its other HCV drugs containing sofosbuvir.

"Gilead believes the pricing of Epclusa will facilitate access for the US population with the greatest unmet medical need — patients with genotypes 2 and 3 who previously required more complex and costly multitablet regimens," Miller said in an email. "For genotype 3 patients in particular, the cost of Epclusa will be half the cost of the most commonly used regimen (sofosbuvir plus daclatasvir)."

Avoid Prescribing Alongside Amiodarone

The FDA evaluated four clinical trials to establish that sofosbuvir/velpatasvir is safe and effective. In three trials involving 1558 patients with HCV who had no cirrhosis or only mild cirrhosis, 95% to 99% of patients taking the new drug had no detectable virus in their bloodstream after 12 weeks of treatment. In the fourth trial, 87 patients with HCV and moderate to severe cirrhosis received sofosbuvir/velpatasvir along with ribavirin, and there was no detectable virus in the bloodstream in 94%.

Headache and fatigue were the most common adverse events observed in the clinical trials.

The drug's label warns against administering sofosbuvir/velpatasvir with amiodarone because reports of symptomatic bradycardia and pacemaker interventions have surfaced for patients who have used sofosbuvir with the antiarrhythmic agent. The label also warns against using sofosbuvir/velpatasvir with certain other drugs that may reduce its bloodstream amount and efficacy.

More information about the new HCV drug is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert


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