Japan approves Viekirax for HCV

The Japanese Ministry of Health, Labour and Welfare has approved Viekirax for the treatment of chronic hepatitis C genotype 1 infection in adults, including those with compensated cirrhosis, according to a press release from the manufacturer.

The approval is supported by the phase 3 GIFT-I study, where 95% of treatment-naive patients and 94% of treatment-experienced patients achieved a sustained virologic response at 12 weeks after a fixed-dose combination regimen of Viekirax (paritaprevir/ritonavir/ombitasvir, AbbVie), according to the release.

“[The] approval represents an important step forward for the treatment of Japanese patients, a population with specific needs based on patient and viral characteristics,” Jean-Michel Pawlotsky, MD, PhD, professor of medicine at the University of Paris-Est, France, said in the release. “Viekirax is a valuable new addition to a number of treatments that are changing the face of hepatitis C, making it possible to achieve high virologic cure rates, even in patients whose disease has progressed to compensated liver cirrhosis.”

There are reportedly between 1.5 and 2 million people in Japan with HCV, according to the release. Genotype 1 is the most common HCV genotype in Japan with 60% to 70% of patients infected and, of those, about 95% are infected with genotype 1b.

“We are pleased to provide Viekirax as a new treatment that offers a high probability of virologic cure for [genotype 1b] HCV patients and are working to support access to our treatment in Japan,” Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie, said in the release. “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.”

Disclosures: Severino reports being employed by AbbVie. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Pawlotsky at the time of publication.