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European Commission Approves Epclusa for all HCV Genotypes

The European Commission approved Gilead Science’s marketing authorization application for Epclusa for the treatment of all chronic hepatitis C genotypes, according to a press release from the manufacturer.

Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) is an investigational, pangenotypic, once-daily tablet containing 400 mg sofosbuvir and 100 mg velpatasvir. It has been approved as treatment for 12 weeks for use in patients without cirrhosis or with compensated cirrhosis and in combination with ribavirin for patients with decompensated cirrhosis.

The authorization allows for the marketing of sofosbuvir/velpatasvir in all 28 countries of the European Union and comes after The European Committee for Medicinal Products for Human Use granted a positive opinion on the regimen in May after an accelerated review procedure.

“Built on the foundation of sofosbuvir, [sofosbuvir/velpatasvir] offers a highly effective and tolerable choice which is protease inhibitor-free and ribavirin-free for the majority of patients. For the first time we have a once-daily, single-tablet treatment option which works across all genotypes, including genotype 3, which is often the least responsive to treatment,” Stefan Zeuzem, MD, chief of the department of medicine at J.W. Goethe University Hospital, Frankfurt, Germany, said in the release. “This approval marks a significant advance in the treatment of HCV and is an important step in our efforts to achieve elimination of the disease throughout Europe.”

The drug was looked upon favorably by the committee based on data from multiple phase 3 studies — ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4.

In the first three studies, researchers treated 1,035 patients with HCV with or without compensated cirrhosis with sofosbuvir/velpatasvir for 12 weeks, and 98% achieved sustained virologic response 12 weeks’ post-treatment. In the ASTRAL-4 study, the researchers randomly assigned 267 patients with HCV and decompensated cirrhosis 12 weeks of sofosbuvir/velpatasvir with or without ribavirin or 24 weeks of sofosbuvir/velpatasvir. In those who also received ribavirin, 94% achieved SVR12. This rate was higher compared with those who received sofosbuvir/velpatasvir alone for 12 weeks (83%) or 24 weeks (86%). The most common adverse events in the ASTRAL studies were headache, fatigue and nausea. These were comparable in incidence to the placebo group included in ASTRAL-1.

“The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected,” John Milligan, PhD, president and CEO of Gilead Sciences, said in the release. “The European approval of [sofosbuvir/velpatasvir] reflects our continued focus to bring a cure to all infected patients across the region, and we look forward to working with physicians, health care providers and governments to make it available as quickly as possible.”

The FDA approved Epclusa for the treatment of all HCV genotypes in June.

Disclosures: Zeuzem reports consulting for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen and Merck; giving sponsored lectures for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen and Merck; and being an investigator for Merck. Milligan is employed by Gilead Sciences.

The European Commission approved Gilead Science’s marketing authorization application for Epclusa for the treatment of all chronic hepatitis C genotypes, according to a press release from the manufacturer.

Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) is an investigational, pangenotypic, once-daily tablet containing 400 mg sofosbuvir and 100 mg velpatasvir. It has been approved as treatment for 12 weeks for use in patients without cirrhosis or with compensated cirrhosis and in combination with ribavirin for patients with decompensated cirrhosis.

The authorization allows for the marketing of sofosbuvir/velpatasvir in all 28 countries of the European Union and comes after The European Committee for Medicinal Products for Human Use granted a positive opinion on the regimen in May after an accelerated review procedure.

“Built on the foundation of sofosbuvir, [sofosbuvir/velpatasvir] offers a highly effective and tolerable choice which is protease inhibitor-free and ribavirin-free for the majority of patients. For the first time we have a once-daily, single-tablet treatment option which works across all genotypes, including genotype 3, which is often the least responsive to treatment,” Stefan Zeuzem, MD, chief of the department of medicine at J.W. Goethe University Hospital, Frankfurt, Germany, said in the release. “This approval marks a significant advance in the treatment of HCV and is an important step in our efforts to achieve elimination of the disease throughout Europe.”

The drug was looked upon favorably by the committee based on data from multiple phase 3 studies — ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4.

In the first three studies, researchers treated 1,035 patients with HCV with or without compensated cirrhosis with sofosbuvir/velpatasvir for 12 weeks, and 98% achieved sustained virologic response 12 weeks’ post-treatment. In the ASTRAL-4 study, the researchers randomly assigned 267 patients with HCV and decompensated cirrhosis 12 weeks of sofosbuvir/velpatasvir with or without ribavirin or 24 weeks of sofosbuvir/velpatasvir. In those who also received ribavirin, 94% achieved SVR12. This rate was higher compared with those who received sofosbuvir/velpatasvir alone for 12 weeks (83%) or 24 weeks (86%). The most common adverse events in the ASTRAL studies were headache, fatigue and nausea. These were comparable in incidence to the placebo group included in ASTRAL-1.

“The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected,” John Milligan, PhD, president and CEO of Gilead Sciences, said in the release. “The European approval of [sofosbuvir/velpatasvir] reflects our continued focus to bring a cure to all infected patients across the region, and we look forward to working with physicians, health care providers and governments to make it available as quickly as possible.”

The FDA approved Epclusa for the treatment of all HCV genotypes in June.

Disclosures: Zeuzem reports consulting for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen and Merck; giving sponsored lectures for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen and Merck; and being an investigator for Merck. Milligan is employed by Gilead Sciences.