China has moved closer to approval of the nation's first state-of-the-art treatment for hepatitis C, according to researchers who presented data from their initial trial at the Liver Meeting conference in San Francisco.
In many developing countries, the HCV treatment of choice is use of direct-acting antivirals, but China's millions of patients with the infection still rely on interferon-based treatments for standard therapy, according to HCPLive.
The Phase I trial tested Bristol-Myers Squibb's ($BMY) DAA drugs Daklinza (daclatasvir) and Sunpreva (asunaprevir). Researchers said the viral response rate for the drugs over a 12-week period ranged from 91% to 99%, HCPLive reported.
China's HCV Prevention and Treatment Guideline recommends daclatasvir for treatment, but the drug is not expected to qualify for approval until 2018, even as the country moves to clear a backlog of pending regulatory approvals numbering in the tens of thousands.
One participant on the conference panel cited an urgency for the treatment, noting that 15 percent of Mongolia's half-million people have the hep C virus, HCPLive said.
China's Ascletis Pharmaceuticals won approval in September to start a Phase II trial of danoprevir (ASC08) in Taiwan in combination with ASC16 (PPI-668) for an interferon-free HCV treatment that could also help put it in pole position in the Chinese market, where a separate clinical trial application rests with China FDA for review.
Separately, Gilead Sciences ($GILD) is in talks with China on pricing for Sovaldi as the country stands outside of an access program by the U.S. drugmaker that relies heavily on manufacturing and sales licensing to mostly India-based companies. Gilead does not yet have regulatory approval for the drug in China.
- here's the story from HCPLive