Vertex Pharmaceuticals Inc. (VRTX) recently reported positive interim data from a mid-stage study on Incivek (telaprevir) when dosed in combination with pegylated-interferon and ribavirin in people co-infected with genotype 1 hepatitis C virus (:HCV) and human immuno deficiency virus (:HIV). The results were presented at the Conference on Retroviruses and Opportunistic Infections.
The data demonstrated that after 12 weeks of treatment with the Incivek combination therapy, 74% of the patients experienced undetectable HCV, while 45% of the patients dosed only with pegylated-interferon and ribavirin had undetectable HCV. The study also showed that Incivek was well tolerated with HIV drugs – Gilead Sciences Inc.’s (GILD) Atripla and Bristol-Myers Squibb Co.’s (BMY) Reyataz.
The phase II study, which enrolled treatment-naïve HCV patients, comprises two parts – A and B. Part A of the study is evaluating patients who are not currently being treated with antiretroviral therapy for HIV infection. Part B is evaluating those who are currently on Atripla- or Reyataz-based regimen for HIV.
We note that Vertex Pharma is conducting this study in collaboration with Janssen, a subsidiary of Johnson & Johnson (JNJ), to evaluate the safety and tolerability of the Incivek combination therapy in patients co-infected with HCV and HIV.
The companies are presently enrolling patients for a phase III study of Incivek combination therapy in patients co-infected with HCV and HIV. This study will include treatment-naïve patients and patients who have relapsed after at least one prior course of therapy with pegylated-interferon and ribavirin alone.
Incivek is currently marketed in the US and Canada for the treatment of HCV. The drug is available as Incivo outside the US and the Far East, and as Telavic in Japan.
We currently have a Neutral recommendation on Vertex Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.
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