Hard Time: Hepatitis C in Arizona's State Prisons.: Treatment Works: Telaprevir drug trials.

Surviving Hepatitis C in AZ Jails, State Prisons, and Federal Detention Centers.

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Sunday, August 15, 2010

Treatment Works: Telaprevir drug trials.

Vertex: telaprevir could shorten hep C treatment

Associated Press
Updated: Aug 12, 2010 10:59 AM

CAMBRIDGE, Mass. (AP) - Vertex Pharmaceuticals Inc. said Tuesday that a study showed some patients who take its hepatitis C drug candidate telaprevir may be able to complete their treatment sooner.

Vertex said patients who responded quickly to treatment with telaprevir had better results after 24 weeks of therapy than after 48 weeks. The company said that shows a 24-week regimen including telaprevir can be an effective treatment for the disease.

Vertex highlighted results for patients who responded well to telaprevir, as they had undetectable levels of the hepatitis C virus after 4 weeks and 12 weeks of treatment. Treatment in the study included 12 weeks of telaprevir in combination with two older drugs, pegylated interferon and ribavirin. That was followed by additional treatment with pegylated interferon and ribavirin alone.

The patients who had undetectable virus levels after 4 weeks and 12 weeks were treated with pegylated interferon and ribavirin for either 12 more weeks or 36 more weeks. Of the patients who were treated for an additional 12 weeks - making 24 weeks of therapy in total - Vertex said 92 percent had undetectable levels of the hepatitis C virus. It said 88 percent of the patients who received 48 weeks of treatment had undetectable virus levels.

Patients' virus levels were measured 24 weeks after the end of their treatment.

The clinical trial was called ILLUMINATE. Patients who did not have a quick response to telaprevir were given pegylated interferon and ribavirin alone for 48 weeks.

The company plans to file for Food and Drug Administration approval of telaprevir in the fourth quarter. The drug is seen as a potential billion-seller for Vertex.

The most common side effects of telaprevir treatment were fatigue, itching, nausea, anemia, rash, and headache. Vertex said most of those side effects were mild or moderate.

In morning trading, Vertex shares fell 75 cents, or 2 percent, to $36.25.

(This version CORRECTS details on the design of the trial.)