CROI 2012: Telaprevir sustained high response rates in treatment-naive HIV patients

Posted on InfectiousDiseaseNews.com March 6, 2012

SEATTLE — Significantly higher response rates were observed with telaprevir combined with peginterferon alfa and ribavirin compared with placebo for the treatment of chronic hepatitis C virus genotype-1 infection in treatment-naive HIV patients.

Douglas T. Dieterich, MD, professor of medicine in the division of hepatology at Mount Sinai School of Medicine in New York, presented findings from a 24-week interim analysis of patients assigned telaprevir (Incivek, Vertex Pharmaceuticals).

“The numbers are impressive — 74% for treatment arm vs. 45% in the control arm,” Dieterich said during a press conference today. “This is a huge leap forward in treatment for HCV and HIV patients.”

Patients were grouped into the following treatment regimens:

• Part A: Patients received no concurrent antiretroviral therapy.
• Part B: Patients were on ART and also an efavirenz-based regimen or on an atazanavir plus ritonavir-based regimen.

Of the 62 patients included in the study, 44 reached week 24 of treatment and are, therefore, included in the current analysis. The mean age of the patients was 46 years; 88% male, and 27% black. Subtype 1a was confirmed in 68% and cirrhosis in 3.3%.

Although CD4 cell count percentage remained unchanged by week 24, absolute CD4 cell counts decreased overall.

At week 24, undetectable HCV RNA levels occurred in 86% of patients assigned treatment and no ART vs. 33% among those assigned placebo; in 75% of patients assigned to treatment who were also on an ART plus efavirenz-based regimen vs. 50% of those assigned placebo; and in 67% of patients assigned to treatment who were also on ART plus atazanavir/ritonavir-based regimen vs. 75% of those assigned placebo.

One patient in the efavirenz-based regimen group and one patient in the atazanavir/ritonavir group achieved HCV RNA breakthrough on telaprevir, according to the researchers.

Compared with placebo, 10% or more of patients assigned to treatment groups experienced vomiting, abdominal pain, nausea, dizziness, depression and pruritus. Both bilirubinemia and hyperbilirubinemia were more common among patients in the atazanavir/ritonavir group.

For more information:

• Dieterich D. #46. Presented at: 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle.

Disclosures: The researchers report no relevant financial disclosures.

Perspective

There is a lot of exciting work on hepatitis being presented at CROI. This is the first time that we will have data on cure rates in HIV/HCV coinfected persons treated with new protease inhibitors; a few first-ever in man releases of data.

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