FDA Approves Gilead’s Epclusa Combo Pill for All Hepatitis C Genotypes

On June 28 the U.S. Food and Drug Administration (FDA) approved Gilead Sciences Epclusa, a new once-daily combination pill containing sofosbuvir and velpatasvir, for the treatment of adults with hepatitis C virus (HCV) genotypes 1 through 6 — the first approved oral pangenotypic regimen. While it is more effective against more types of HCV, Epclusa will cost less than most earlier interferon-free direct-acting antiviral regimens.

Epclusa contains 400 mg of the nucleotide HCV polymerase inhibitor sofosbuvir (marketed separately as Sovaldi) and 100 mg of the novel NS5A inhibitor velpatasvir.

Unlike the currently available Harvoni (sofosbuvir/ledipasvir) combination, which is indicated for HCV genotypes 1, 4, and the little-studied 5 and 6, Epclusa is active against all genotypes. Genotype 1 — the predominant type in the U.S. and Europe — now has several good treatment options available. Other genotypes are more common elsewhere, including genotype 3 in India, genotype 4 in the Middle East and North Africa, genotype 5 in South Africa, and genotype 6 in parts of Asia. Pangenotypic regimens are especially welcome in low- and middle-income countries that have high burdens of hepatitis C, as they can be used without prior genotypic testing.

Epclusa is a complete single-tablet regimen that can be used without ribavirin for all HCV genotypes. It was approved for previously untreated and treatment-experienced adult chronic hepatitis C patients with or without cirrhosis. However, people with decompensated cirrhosis (Child-Pugh B or C) should add ribavirin. Treatment duration is 12 weeks for all patients. Epclusa should not be used with certain other medications (including amiodarone, rifampin, St. John’s wort, and carbamazepine) due to the risk of drug-drug interactions that could cause side effects or reduce drug concentrations.

Epclusa is approved to treat people with HIV and HCV coinfection. However, it should not be used with some antiretrovirals — including efavirenz and tipranavir — and people taking tenofovir should have their kidney function monitored regularly.

Gilead set the list price of Epclusa at $74,760 — lower than the retail cost of its earlier Sovaldi ($84,000) and Harvoni ($94,500), not to mention a combination of Sovaldi plus Bristol-Myers Squibb’s $63,000 daclatasvir (Daklinza). The only regimen with a lower list price is Merck’s grazoprevir/elbasvir (Zepatier), at $54,600, which is only indicated for genotypes 1 and 4.

To assist eligible patients in the U.S., Gilead has added Epclusa to its patient assistance and co-pay programs (www.MySupportPath.com).

Published on Wednesday, 29 June 2016 00:00
Written by Liz Highleyman


FDA. FDA approves Epclusa for treatment of chronic Hepatitis C virus infection. Press release. June 28, 2016.

Gilead Sciences. U.S. Food and Drug Administration Approves Gilead’s Epclusa (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C. Press release. June 28, 2016.