EU Regulators OK Two Hepatitis C Drugs, One for All Genotypes

Disclosures

May 27, 2016

European Union (EU) regulators today recommended approval of two more drugs for hepatitis C virus (HCV) that achieve high cure rates in 12 weeks without requiring concomitant use of interferon, known for its harsh adverse events.

One of the drugs is sofosbuvir/velpatasvir (Epclusa, Gilead Sciences). It targets all six HCV genotypes, which could make it a one-size-fits-all treatment suitable for primary care. The manufacturer has applied for approval in the United States. Sofosbuvir is the active ingredient in Solvadi (Gilead Sciences) and the chemical partner of ledipasvir in Harvoni (Gilead Sciences).

The other drug is elbasvir/grazoprevir (Zepatier, Merck), approved by the US Food and Drug Administration in January. It targets genotypes 1 and 4 of HCV.

Both sofosbuvir/velpatasvir and elbasvir/grazoprevir treat HCV by blocking certain proteins needed for viral replication, according to a news release from the European Medicines Agency (EMA). Elbasvir/grazoprevir works against proteins NS3/4A and NS5A while sofosbuvir/velpatasvir works against NS5A and NS5B.

EMA's Committee for Medicinal Products for Human Use (CHMP) determined that sofosbuvir/velpatasvir was effective and safe based on clinical trials involving more than 2000 patients, some of whom were also treated with ribavirin. More than 90% of patients across all genotypes were considered cured at 12 weeks because there was no detectable virus in their blood, or what is called sustained virologic response (SVR). However, SVR for patients with genotype 3 was slightly lower, at around 90%.

For elbasvir/grazoprevir, the CHMP looked at another set of clinical trials with 2000 patients. The drug achieved SVR in more than 90% of them and proved effective even in patients with chronic kidney disease, who have a poor prognosis.

Headache, fatigue, and nausea were the most common adverse events for both HCV drugs.

The EMA recommendation to approve the drugs now goes to the European Commission, the EU's executive branch, for a final decision. More information on today's EMA action is available on the agency's website.

Follow Robert Lowes on Twitter @ LowesRobert

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