Telaprevir/Vertex drug promising in hep C patients with HIV

Wed Mar 2, 2011 1:06pm EST

* RVR rate 70 pct with telaprevir combination therapy

* RVR rate 5 pct on standard hepatitis C drugs alone

* Vertex expects final cure rate data in 2012

By Bill Berkrot

NEW YORK, March 2 (Reuters) - Vertex Pharmaceuticals Inc's (VRTX.O) hepatitis C drug telaprevir helped eliminate the virus in 70 percent of patients who were also infected with HIV, according to interim analysis from a small midstage clinical trial, the company said.

Telaprevir is awaiting a U.S. approval decision after demonstrating an ability to greatly improve hepatitis cure rates when combined with current standard of care medicines compared with those drugs alone.

Patients in the co-infection study, which was presented at a medical meeting on Wednesday, had not yet received other treatment for hepatitis. Telaprevir was tested in one group of patients who were not receiving antiretroviral therapy for HIV and another group who were.

The interim analysis looked for a rapid viral response (RVR), meaning the hepatitis C virus was undetectable in the blood after four weeks of treatment.

At four weeks, 70 percent of those in the 60-patient study who received combination therapy with telaprevir had achieved RVR compared with 5 percent who received only the standard drugs of pegylated interferon and ribavirin, according to data presented at the Conference on Retroviruses and Opportunistic Infections in Boston.

Undetectable virus must be maintained for a far longer period of time in order to achieve sustained viral response (SVR), which is tantamount to a cure. But RVR can be an early indicator of eventual success rates.

SVR rates from the study are expected to be available next year, Vertex said.

In patients who were not also receiving HIV antiretroviral therapy, 71 percent of those treated with telaprevir achieved RVR compared with none on the standard drugs.

For co-infected patients taking Gilead Sciences Inc's(GILD.O) Atripla for HIV, 75 percent on telaprevir combination therapy hit RVR versus one patient, or 13 percent, in the control arm.

For HIV patients being treated by Bristol-Myers Squibb's (BMY.N) Reyataz, 64 percent on telaprevir hit RVR versus no one in the eight-patient control arm.

Vertex shares were up $1.12, or 2.4 percent, at $47.17 in afternoon trade on Nasdaq. (Reporting by Bill Berkrot, editing by Dave Zimmerman)
http://www.reuters.com/article/2011/03/02/vertex-idUSN0224123520110302