AbbVie Gets Japanese approval for Hepatitis C Drug

Japanese regulators have approved AbbVie’s drug called Viekirax to treat patients with genotype 1 chronic hepatitis C, including those with compensated cirrhosis, the most common type of hepatitis in that country, according to a statement from the company.

Viekirax is a once daily drug that is taken for 12 weeks and does not require interferon or ribavirin, AbbVie said in the statement. The drug is an all-oral, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir.

Hepatitis C is a bloodborne virus that if left untreated can cause serious liver damage. Genotype 1 is the most common strain of hepatitis C virus (HCV) in Japan, where it is estimated that up to 2 million people are living with the virus, according to the AbbVie statement.

“We are pleased to provide VIEKIRAX as a new treatment that offers a high probability of virologic cure for GT1b (genotype 1) HCV patients and are working to support access to our treatment in Japan,” said Michael Severino, MD, AbbVie’s executive vice president of research and development and chief scientific officer. "We are also prioritizing disease education and awareness by collaborating with stakeholders to identify and address the diverse challenges across Japan, such as supporting screening and diagnosis initiatives, and providing accurate information to the medical community about treatment options.”

AbbVie said approval of Viekirax was based on results from its phase 3 clinical trial dubbed GIFT-1. Among study subjects given Viekirax, an overall 95% of patients who had never been treated for HCV and 94% of treatment-experienced GT1B HCV infected patients achieved sustained virologic response rate (SVR) at 12 weeks after treatment, the company said.

The primary endpoint was achieved with a 95% SVR rate at 12 weeks after treatment in a subgroup of patients who had not previously been treated for GT1b chronic hepatitis C infection, according to AbbVie. Study participants were adult Japanese patients without cirrhosis who were eligible for therapy with interferon and had a high viral load, the release states. A secondary endpoint in GT1b HCV patients with compensated cirrhosis achieved 91%, the release states.

There were three patients out of 362 patients from all treatment arms who experienced on-treatment virologic failure, eight patients relapsed after treatment was completed and three patients stopped taking the drug due to adverse events, AbbVie said. The most common adverse events were nasopharyngitis, headache, peripheral edema, nausea, pyrexia and decreased platelet count.

The Viekirax drug regimen has already been approved in the United States under the brand Viekira Pak. Regulatory approvals have also been granted in Canada and, more recently, by the European Commission under the brand name Viekirax + Exviera.