Hepatitis C Drug Gets European Approval

The European Commission has approved a drug called Zepatier to treat chronic hepatitis C with or without the use of ribavirin in patients with genotype 1 or 4 of the virus, according to a Merck & Co announcement.

Zepatier is already approved in the US and Canada for treatment of hepatitis C, a bloodborne virus that if left unchecked can cause serious liver damage over time. Millions of people worldwide are believed to be infected with the virus including an estimated 15 million people who live in Europe, notes a news release from Merck & Co (MSD), the maker of Zepatier.

“The approval of Zepatier in the European Union, following approvals in the United States and Canada earlier this year, is an important step in offering a new and effective treatment for millions of people infected with hepatitis C virus genotype 1 or 4,” Roger Perlmutter MD, president of Merck Research Laboratories, a US division of Merck & Co (MSD) said in the release. “Zepatier is the most recent advance from MSD in our more than 30-year effort to combat the effects of hepatitis C virus infection, and hence, to reduce the burden of this disease around the world.”

The European Commission’s granting of a marketing authorization for Zepatier allows Merck to sell the drug in 28 countries that are European Union members and also in Iceland, Liechtenstein and Norway, members of the European Economic Area, according to the release. The company expects to launch the drug beginning in late 2016 or early 2017.

Zepatier was approved as a once daily, fixed dose combination tablet recommended for most patients as a 12- week course to treat chronic hepatitis C in patients with genotypes 1 and 4. It is a combination of the drugs elbasvir and grazoprevir, which targets the proteins NS3/4A and NS5A.

Clinical trials leading to Zepatier’s approval included thousands of patients worldwide with chronic hepatitis C infection, according to the company release. The trial was designed to encompass treatment challenges of patients with compensated cirrhosis and those who had unsuccessful treatment that involved the use of peginterferon and ribavirin.

The overall sustained virologic response after 12 weeks of Zepatier, a marker for a cure, was achieved in 96% of patients with genotype 1b strain of the virus. In patients infected with genotype 4 of the virus, 94% were cured after 12 weeks of Zepatier treatment, according to the release.

Headache and fatigue were common side effects for patients who were treated for Zepatier for 12 weeks, states the release. Other common adverse reactions included decreased appetite, insomnia, anxiety depression, dizziness, nausea, diarrhea, constipation, abdominal pain, dry mouth, vomiting, pruritus, alopecia, arthralgia, myalgia asthenia, and irritability.

Hepatic laboratory testing should be done before therapy with Zepatier begins, states the release. In certain patients, a 16-week course that includes ribavirin may be considered and additional hepatitis testing should be conducted at the 12th week of treatment.