Incivek: Additional Phase II data

Additional data from 60 evaluable HCV patients co-infected with HIV-1 from both parts of a 2-part, double-blind, international Phase II trial showed that 74% of patients receiving oral Incivek plus standard of care (SOC; peginterferon alfa-2a and ribavirin) achieved an SVR defined as undetectable HCV RNA levels 12 weeks after the end of treatment (SVR12), a secondary endpoint, vs. 45% for placebo plus SOC. Part A of the trial is evaluating Incivek in patients not currently being treated with antiretroviral therapy for HIV infection, while Part B is evaluating Incivek in patients receiving Atripla efavirenz/tenofovir/emtricitabine or a Reyataz atazanavir-based regimen for HIV. In Part A, the SVR12 rate was 71% for patients receiving Incivek plus SOC vs. 33% for placebo plus SOC. In Part B, Incivek plus SOC led to SVR12 rates of 69% and 80% for the Atripla and Reyataz-based regimens, respectively, vs. 50% for placebo plus SOC.

Additionally, Vertex reported updated RVR and extended rapid viral response (eRVR) data, where eRVR is defined as undetectable HCV RNA levels at weeks 4 and 12. Specifically, 68% and 61% of patients receiving Incivek plus SOC in both parts of the trial achieved an RVR and an eRVR, respectively, vs. 0% and 0% for placebo plus SOC. Incivek was well tolerated in combination with Atripla and Reyataz, and no patients experienced HIV breakthrough. Patients received placebo or 750 or 1,125 mg Incivek every 8 hours plus SOC for 12 weeks, followed by SOC alone for 36 weeks. All patients were naïve to HCV therapy. Data were presented at the Retroviruses and Opportunistic Infections meeting in Seattle. ...