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First All-Oral Interferon- and Ribavirin-Free HCV Therapy Approved in Japan
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Bristol-Myers Squibb announced in July that the Japanese Ministry of Health, Labor and Welfare approved daclatasvir, a potent, pan-genotypic NS5A replication complex inhibitor, and asunaprevir, an NS3/4A protease inhibitor, for patients with hepatitis C virus.
The Daklinza and Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment option for patients with HCV genotype 1 infection, including those with compensated cirrhosis, according to a press release.
“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 investigator Kazuaki Chayama, MD, PhD, from Hiroshima University, Japan, stated in the release. “The approval of the Daklinza and Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients.”
Of the 1.2 million people living with HCV in Japan, approximately 70% have genotype 1b. A significant number of patients with HCV in Japan are aged older than 65 years, leading to more disease-related complications and a decreased likelihood of tolerating interferon-based therapies, according to the release.
The indications for the new regimen are for the improvement of viremia in either of the following patients with chronic HCV genotype 1, or chronic HCV genotype 1 with compensated cirrhosis: patients who are ineligible or intolerant to interferon-based therapy and patients who have failed to respond to interferon-based therapy, according to the release.
The approval was supported by results from a phase 3 study that demonstrated 24 weeks of treatment achieved overall sustained virologic response in 84.7% of HCV patients with genotype 1b in Japan. Among patients aged 65 years and older who were interferon-ineligible or intolerant, 91.9% achieved SVR at 24 weeks. Patients with compensated cirrhosis at baseline had overall SVR rates at 24 weeks of 90.9%, according to the release.