Japan Approves First All-Oral, Ribavirin-Free Hep C Treatment, Daklinza (daclatasvir) and Sunvepra (asunaprevir)
Cinnamon Girl said
Jul 8, 2014
And well done BMS! Yes, Isiscat, I thought this was very interesting and it`s fascinating seeing which direction other countries are taking. Sounds like this is a very good move on the part of Japan bearing in mind their particular HCV population needs and with such a prevalence of Gen 1b.
Great to hear more people in need will be getting such a good all-oral treatment opportunity!
Isiscat2011 said
Jul 8, 2014
Good for Japan! By all reputable reports Japan does have an excellent health care system--universal for all citizens and affordable--and Japan also has a free market economy. Imagine that!
It will be interesting to see how countries fare in the battle against HCV in the long term. My guess is that the US will have spent the most money but been less effective and less efficient that other countries.
My best wishes to the Japanese people. Well done.
P.S. Yikes! Was that a crash I heard or just the sound of Gilead's stock falling?
Cinnamon Girl said
Jul 8, 2014
Monday, July 7, 2014. PRINCETON, N.J. Bristol-Myers Squibb Company announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra(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 Daklinza+Sunvepra 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 Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients."The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 (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 SVR24. Further, patients with compensated cirrhosis present at baseline had overall SVR24 .
And well done BMS! Yes, Isiscat, I thought this was very interesting and it`s fascinating seeing which direction other countries are taking. Sounds like this is a very good move on the part of Japan bearing in mind their particular HCV population needs and with such a prevalence of Gen 1b.
Great to hear more people in need will be getting such a good all-oral treatment opportunity!
Good for Japan! By all reputable reports Japan does have an excellent health care system--universal for all citizens and affordable--and Japan also has a free market economy. Imagine that!
It will be interesting to see how countries fare in the battle against HCV in the long term. My guess is that the US will have spent the most money but been less effective and less efficient that other countries.
My best wishes to the Japanese people. Well done.
P.S. Yikes! Was that a crash I heard or just the sound of Gilead's stock falling?
Monday, July 7, 2014. PRINCETON, N.J. Bristol-Myers Squibb Company announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra(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 Daklinza+Sunvepra 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 Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients."The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 (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 SVR24. Further, patients with compensated cirrhosis present at baseline had overall SVR24 .
Full press release...
http://news.bms.com/press-release/japan-approves-first-all-oral-interferon-and-ribavirin-free-hepatitis-c-treatment-dakl