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Phase 2 Trial Shows Telaprevir Lowers Hepatitis C Viral Levels In People With HIV And Hepatitis C (CROI 2011)

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Published: Mar 4, 2011 2:26 pm
Phase 2 Trial Shows Telaprevir Lowers Hepatitis C Viral Levels In People With HIV And Hepatitis C (CROI 2011)

Interim results from a Phase 2 trial showed that the investigational drug telaprevir lowers hepatitis C viral levels in people infected with both HIV and hepatitis C. Results also showed that telaprevir is well tolerated and safe to use, causing mild side effects such as nausea and fever.

The interim results were presented at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) on Wednesday.

“Research in hepatitis C has shown that people who respond early to treatment have a higher likelihood of achieving a viral cure. These interim results are encouraging because they showed a high proportion of people in the study had a rapid viral response to telaprevir,” said Dr. Robert Kauffman, senior vice president and chief medical officer of Vertex Pharmaceuticals, the maker of telaprevir, in a press release.

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). Without treatment, HCV can lead to liver damage and scarring, liver cancer, and ultimately liver failure.

Some people who are infected with HCV can spontaneously clear the virus themselves; the rest need treatment with antiviral drugs. The cure rate of current HCV antivirals is about 50 percent.

In the United States, approximately 30 percent of people with HIV have HCV. People with HIV are less likely to clear HCV than uninfected individuals, and HCV treatment is less effective in people with HIV (see related AIDS Beacon news).

Telaprevir is a HCV protease inhibitor that is being developed by Vertex Pharmaceuticals for the treatment of hepatitis C infection. Like HIV protease inhibitors, it works by inhibiting HCV replication in the body.

In this Phase 2 trial, researchers are assessing the efficacy, safety, and tolerability of telaprevir in 60 HIV-HCV co-infected patients.

The study is split into two parts. Part A includes HIV-HCV co-infected patients who are not taking antiretroviral therapy. Part B includes HIV-HCV co-infected patients taking either an Atripla (efavirenz/emtricitabine/tenofovir) or Reyataz (atazanavir)-based regimen for HIV treatment.

In addition, patients in each part are split into two groups. One group will receive telaprevir for 12 weeks in combination with two other HCV drugs, ribavirin (Copegus) and Pegasys (pegylated interferon alfa-2a). The other group will receive a placebo, ribavirin, and Pegasys for 12 weeks. Both groups will then receive an additional 36 weeks of treatment with ribavirin plus Pegasys.

Preliminary results indicate that 70 percent of HIV-HCV patients receiving telaprevir-based therapy had undetectable HCV levels after four weeks, compared to 5 percent of patients receiving the placebo plus ribavirin and Pegasys.

In addition, 68 percent of participants who received telaprevir for 12 weeks had undetectable HCV levels, compared to 14 percent of participants receiving ribavirin plus Pegasys alone. Not all participants had reached 12 weeks of treatment by the time of the analysis.

Participants who received telaprevir had stable HIV viral loads (amount of HIV in the blood) and CD4 (white blood cell) counts.

The most common side effects in both the telaprevir-treated and placebo groups were fatigue, nausea, headache, itching, dizziness, fever, weight loss, vomiting, diarrhea, and chills.

Itching, nausea, dizziness, fever, weight loss, and vomiting occurred more frequently in the telaprevir-treated groups. Rates of side effects were similar to those observed in clinical trials with HIV-negative patients.

The Phase 2 trial is ongoing and will assess the drug’s ability to cure HCV in HIV-HCV co-infected patients. For HCV, cure is defined as undetectable HCV levels six months after completing treatment. The trial will also continue to evaluate the safety and tolerability of telaprevir in people co-infected with HIV and HCV.

Vertex plans to initiate a Phase 3 trial in HIV-positive adults with hepatitis C by the end of this year.

For more information, please see the press release from Vertex Pharmaceuticals or the abstract at the CROI 2011 website.

Photo by Tom Varco on Wikipedia – some rights reserved.
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