Bristol-Myers Squibb Co has filed an all-oral combination in Japan for hepatitis C, seeking "the world’s first interferon- and ribavirin-free treatment regimen" for the disease.
The submission with Japan's Pharmaceutical and Medical Devices Agency is for daclatasvir, a NS5A inhibitor and the protease inhibitor asunaprevir. It is based on results from a Phase III study demonstrating that the combo achieved an overall sustained virologic response 24 weeks after the end of treatment of 84.7% in Japanese patients.
The patients had chronic HCV genotype 1b who were either interferon-ineligible or intolerant or non-responders to interferon-based therapies; the latter group had an SVR rate of 80.5%. Patients aged 65 and over had SVR24 rates of 91.9% and the full data set will be presented at the American Association for the Study of Liver Diseases meeting in Washington DC on November 5.
B-MS noted that globally, there are 170 million people who are infected with HCV and of the 1.2 million people living with the disease in Japan, about 70% have genotype 1b, "which has one of the lowest response rates to current treatments". Brian Daniels, head of global development and medical affairs, said the all-oral regimen of DCV plus ASV "represents the potential for a significant advance" in Japan, particularly when considering that patients there chronically infected with HCV "are often older than in other countries and predominantly infected with genotype 1b, both factors which impact response to therapy".