Bristol-Myers Squibb Company
(NYSE:BMY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved
(daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (
(asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The
Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.
“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,” said a lead study investigator Kazuaki Chayama of Hiroshima University in Japan. “The approval of the
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. Further, a significant number of patients with HCV in Japan are over the age of 65, leading to more disease-related complications and a decreased likelihood of tolerating interferon-based therapies, the historical standard of care for treating HCV.
“The approval of
in Japan reflects our strategic focus on developing a treatment option that meets the needs of the Japanese HCV patient population,” said
, chief executive officer, Bristol-Myers Squibb. “This milestone underscores the company’s commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe
-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally.”
The Daklinza+ Sunvepra Dual Regimen
The indications for
in Japan are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: (1) patients who are ineligible or intolerant to interferon-based therapy, and (2) patients who have failed to respond to interferon-based therapy.
The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of
achieved overall SVR
(sustained virologic response 24 weeks after the end of treatment; a functional cure) among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years of age or older who were either interferon-ineligible or intolerant, 91.9% achieved SVR
Further, patients with compensated cirrhosis present at baseline had overall SVR
rates of 90.9%.
The regimen used in the Phase III study resulted in low rates of discontinuation (5%) due to adverse events (AEs). In addition, the rate of serious adverse events (SAEs) was low (5.9%) and few SAEs were experienced by more than one patient. Nasopharyngitis was the most common AE in the study (30.2%).