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Gilead, Bristol Jump on Hepatitis C Drug Study

From Associated Press (April 19, 2012)

NEW YORK -- Two drug makers said Thursday that a combination of experimental oral treatments for hepatitis C cured almost all patients in a midstage clinical trial.

Gilead Sciences Inc. and Bristol-Myers Squibb Co. have been developing an all-oral drug regimen that could work faster than current treatments. Their drug cocktail also excludes interferon, which is a standard part of hepatitis C treatment but can cause months of flulike symptoms for patients.

The companies said a regimen that included Gilead’s drug GS-7977 and Bristol-Myers’ daclatasvir met its goals in a clinical study. They said all 88 patients in the trial had undetectable virus levels after four weeks of treatment. The study lasted 24 weeks, and almost all the patients had undetectable virus levels four weeks after treatment ended.

Hepatitis C is a virus that can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. The disease is spread through the blood, and that can happen through sharing intravenous drug needles or having sex with an infected person.

The study included 44 patients with hepatitis C genotype 1, and the companies said all of those patients had undetectable virus levels at the end of the study. So did 40 of the 44 patients with genotypes 2 and 3, which are less common and more easily treatable.

About two-thirds of the patients were also treated with ribavirin, another oral drug that is a standard part of treatment for hepatitis C.

Gilead Sciences also reported positive results from two other studies involving GS-7977, and its shares jumped $6.78, or 14.6 percent, to $53.48 in morning trading. Bristol-Myers Squibb stock rose 66 cents, or 2 percent, to $34.23.

Gilead and Bristol-Myers said the most common side effects in the trial were fatigue, headache, and nausea. The most severe side effects in the non-ribavirin treatment group included low phosphorous levels and high cholesterol.

Gilead, of Foster City, Calif., said a separate midstage study showed that a combination of GS-7977 and ribavirin may be effective at curing patients with genotype 1 hepatitis C who can’t be treated with interferon. That study lasted only 12 weeks, and the company said 22 of the 25 patients in the trial had undetectable virus levels a month after the study ended.

The company also said a combination of GS-7977, ribavirin and interferon cured 90 percent of patients in a separate 12-week trial.


Posted: April 2012