January 18, 2012, 6:08 PM EST
By Drew Armstrong and Robert Langreth
Jan. 18 (Bloomberg) -- Two experimental pills from Bristol- Myers Squibb Co. cleared the hepatitis C virus in 36 percent of patients who failed existing drugs, in a small study that may lead to a new oral-therapy approach against the liver disease.
The study released today is the first to suggest that difficult hepatitis C cases may be cured without using the injected drug interferon, said Anna Lok, the lead study author and director of hepatology at the University of Michigan in Ann Arbor. Interferon, a mainstay of existing treatment, causes unpleasant side effects including fatigue and flu-like symptoms.
Drug companies including Bristol-Myers, Merck & Co., Gilead Sciences Inc., and Vertex Pharmaceuticals Inc. are racing to come up with interferon-free treatment. The new results in 21 patients show that such a therapy will be possible, Lok said.
Oral treatments with fewer side effects would vastly increase the number of patients treated, according to an editorial in the New England Journal of Medicine, where the study was published.
“We are on the threshold of a treatment revolution that will greatly improve the effectiveness of HCV therapy,” wrote Raymond Chung, a gastroenternologist at Massachusetts General Hospital in Boston. He called it “a watershed moment in the annals of HCV therapy.”
The study compared Bristol-Myers’s two pills in combination with interferon to the pills alone in 21 hepatitis C patients who weren’t helped by existing therapy. It found that 4 of 11 patients had undetectable virus 24 weeks after treatment with Bristol’s experimental oral drugs daclatasvir and asunaprevir.
Adding injectable drugs, however, boosted the response rate. Results showed that 9 of 10 patients who got the two oral drugs plus interferon and a fourth drug, ribavirin, for 24 weeks had no detectable virus 24 weeks after stopping therapy.
“The combination of drugs we picked may not be the best, and we need to tweak it and find the best combination,” Lok said in a telephone interview from Ann Arbor.
Bristol-Myers, based in New York, sponsored the clinical trial.
--Editors: Angela Zimm, Andrew Pollack
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