Evidence of Severe Liver Toxicity Causes GlaxoSmithKline to End Phase III Trial of AIDS Drug, Aplaviroc

Ono Pharmaceutical (Ono) has announced that GlaxoSmithKline (GSK) has cancelled its Phase III trials of the antiretroviral drug aplaviroc because it caused liver toxicity in one of the study participants. Ono licensed the drug to GSK.

After evaluating data from its Phase IIb and Phase III studies, GSK reported in a company statement that it plans to instruct all people involved in the trial to stop taking the medication.

GSK had already suspended a trial of the drug last month when two HIV-positive patients reported liver problems. The participants were two of 250 HIV-positive volunteers in the international trial who had just been diagnosed and who had not received any prior treatment for HIV.  GSK is not currently planning to continue trials of aplaviroc.

For more information see the Kaiser Daily Health Policy Report at http://www.kaisernetwork.org/dailyreports/health.policy

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