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Vertex Pharmaceuticals Incorporated Message Board

  • jrus2010 jrus2010 Feb 10, 2012 1:13 PM Flag

    Incivek doesn't interfere with anti-HIV meds unlike Victrelis

    Merck's Victrelis has been found to have an adverse impact in patients on anti-HIV meds. VRTX had looked at this subpopulation and Incivek has no similiar untoward effect. This is a testament to the quality of science and clinical development at Vertex, even when compared to a company like Merck.

    From WSJ 2/9/12-

    WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration said Thursday the use of Merck & Co.'s (MRK) Hepatitis C drug Victrelis with certain types of HIV medicines may reduce effectiveness of both types of treatments.

    Victrelis was approved last year to treat Hepatitis C, a liver disease caused by infection with the hepatitis C virus, which is transmitted through contaminated blood. Although Victrelis wasn't approved for use in people who are infected with both HIV, another virus transmitted through contaminated blood, and Hepatitis C, many patients have both diseases.

    FDA's announcement was prompted by the results of a small study conducted by Merck that specifically looked at the concentrations, or blood levels, of Victrelis when used with three so-called ritonavir-boosted HIV drugs. Treatments for both Hepatitis C and HIV include several drugs meant to be administered together.

    The study looked at Victrelis when given with ritonavir, also sold under the brand name Norvir, and in combination with other HIV drugs Reyataz, Prezista or Kaletra. According to Merck, Victrelis "reduced mean trough concentrations" of the HIV drugs by a range of 43% to 59%. Administration with two regimens of HIV drugs also reduced the exposure of Victrelis, Merck said in a Monday letter to healthcare professionals, which was posted to FDA's website Thursday.

    "These drug interactions may be clinically significant for patients infected with both chronic [Hepatitis C] and HIV by potentially reducing the effectiveness of these medicines when coadministered," Merck said in the letter. The company said Victrelis shouldn't be used with ritonavir-boosted HIV therapies.

    Both Merck and the FDA said the new information would be included in an updated Victrelis drug label, which provides information and gives instructions to doctors about how to use products.

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