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news.Vertex Pharmaceuticals has announced interim results from an ongoing Phase 2 study designed to evaluate the safety and tolerability of Incivek (telaprevir) tablets in combination with pegylated-interferon and ribavirin in people who are co-infected with genotype 1 hepatitis C virus and human immunodeficiency virus (HIV).
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According to the study data, 74% (28 out of 38) of patients who were treated with Incivek combination therapy had undetectable hepatitis C virus (HCV RNA) 12 weeks after the end of all study treatment (SVR12) compared to 45% (10 out of 22) treated with pegylated-interferon and ribavirin alone.
With commonly used Atripla- and Reyataz-based HIV treatment regimens, Incivek was well tolerated.
Similar changes in CD4 counts were seen between the treatment groups, and no HIV viral load breakthroughs were observed in either treatment group during the study.
Fatigue, pruritis (itching), headache, nausea and rash were the most common adverse events in the Incivek arms of the study.
The study did not report any cases of severe rash, and there were no discontinuations due to rash.
Vertex senior vice president and chief medical officer Robert Kauffman said these new Incivek data are important as the company work toward its goal of helping cure more people with hepatitis C.
"We’re actively enrolling co-infected patients in a Phase 3 study and expect that data from this study will be included in a submission for a supplemental approval of INCIVEK," Kauffman said.
Under the two-part Phase 2 study, Part A involved with evaluating people who are not currently being treated with antiretroviral therapy (ART) for HIV infection, while Part B included evaluating those who are taking an Atripla- or Reyataz-based regimen for HIV.
This study enrolled patients who were new to hepatitis C treatment (treatment naïve).
According to the interim data, 68% (26 out of 38) of patients treated with Incivek combination therapy had a rapid viral response (RVR, undetectable hepatitis C virus at week 4 of treatment) compared to none of the patients who received pegylated-interferon and ribavirin alone.
The company concluded that the majority of adverse events in this study were mild or moderate.