The Japanese Ministry of Health, Labor and Welfare has approved Bristol-Myers Squibb’s Daklinza (daclatasvir) and Sunvepra (asunaprevir) to treat those with genotype 1 of hepatitis C virus (HCV), or those with genotype 1 who have compensated cirrhosis. The 24-week, all-oral, interferon- and ribavirin-free regimen and is indicated for those who are interferon-ineligible or intolerant or who have failed a previous interferon-based hep C therapy.

“Japan has a unique hepatitis C patient population, many of whom are older and have been unable to take, or respond to, traditional therapies, so we have a real sense of urgency to treat these patients now,” lead study investigator Kazuaki Chayama, MD, PhD, of Hiroshima University in Japan, said in a release. “The approval of the Daklinza plus Sunvepra dual regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients.”

Out of an estimated 1.2 million people living with the virus in Japan, about 70 percent have genotype 1b. A Phase III study submitted with the application for approval found that 24 weeks of Daklinza and Sunvepra led to a sustained virologic response 24 weeks after completing treatment (SVR24, considered a cure) among 84.7 percent of Japanese study participants with genotype 1b. Those with compensated cirrhosis at the beginning of the trial had an SVR24 rate of 90.9 percent. Participants 65 years or older who were either interferon-ineligible or intolerant had a 91.9 percent cure rate.

“The approval of Daklinza plus Sunvepra in Japan reflects our strategic focus on developing a treatment option that meets the needs of the Japanese HCV patient population,” Lamberto Andreotti, chief executive officer of BMS, said in a release. “This milestone underscores the company’s commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan and globally.”

To read the BMS press release, click here.