Drug & Device Development

Roche hepatitis C drug appears safe in combination

Last Updated: 2010-10-18 19:55:02 -0400 (Reuters Health)

By Tan Ee Lyn

HONG KONG (Reuters) - Two experimental drugs -- one of them belonging to Switzerland's Roche -- appear to be safe and well-tolerated by hepatitis C patients when used in combination, a new report shows.

The search for new treatments for hepatitis C has gained urgency because the present cocktail -- interferon and ribavirin -- has serious side effects and a growing number of people do not respond to interferon anymore.

In a paper published online October 15th in The Lancet, researchers in Australia, New Zealand and the United States said patients who were given the two experimental drugs -- danoprevir and Roche's RG7128 -- appeared to tolerate the combination well.

A total of 88 patients in Australia and New Zealand participated in the 13-day phase 1 trial, of whom 14 were given placebo.

The rest were divided into seven groups and given both drugs in different dosages.

Patients who were given the highest doses -- 1,000 mg of RG7128 and 900 mg of danoprevir twice daily -- showed huge reductions in viral loads by day 13.

"Our study was to combine two different drugs with two different mechanisms of action; they target different parts of the virus," said professor Edward Gane of Auckland City Hospital and Auckland District Health Board in New Zealand.

"We wanted to see if we can prevent emergence of resistance and suppress the virus and this is certainly what was shown. There were no cases of resistance in this study."

Viral loads for several of the patients given the highest doses became undetectable, they said in the paper.

Gane said neither drug should be used for monotherapy. "When you use these drugs by themselves, even though they are very well tolerated and have very little side effect, the virus rapidly mutates and becomes resistant to them," he said.

The patients complained of headache, lethargy, rash, gastrointestinal disorders and nausea but they were mild to moderate, the researchers said.

SOURCE: http://link.reuters.com/mak98p

Lancet 2010.