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Title: Maraviroc Shows Efficacy Over 48 Weeks in Drug-Resistant Patients With R5 HIV
URL: http://www.pslgroup.com/dg/22E02E.htm
Doctor's Guide
October 2, 2008

NEW YORK -- October 2, 2008 -- Maraviroc is effective over 48 weeks for drug-resistant patients with R5 HIV-1, according to a study in the October 2 issue of the New England Journal of Medicine (NEJM).

"It is now possible to expect that a majority of treatment-experienced patients who experience failure on their current HIV drugs will regain control of their HIV infection with maraviroc combined with other newer antiretroviral drugs. This is an important step forward," said principal investigator Roy Gulick, MD, Cornell HIV Clinical Trials Unit, Weill Cornell Medical College, and NewYork-Presbyterian Hospital, New York, New York.

"Suppressing virus levels and increasing immune system T-cells with HIV treatment regimens help HIV-infected people live longer, healthier lives."

Results of the 2 phase 3 multicentre Maraviroc Plus Optimized Therapy in Viremic Antiretroviral Treatment Experienced Patients (MOTIVATE) studies found that the drug, taken with an optimised standard HIV drug regimen, resulted in significantly greater suppression of the virus at 48 weeks, with concurrent increases in immune system T-cell counts, when compared with placebo.

The double-blind study followed 1,049 patients with advanced HIV and resistance to 3 antiretroviral drug classes. Patients were randomised to receive maraviroc once or twice daily or placebo. Safety and efficacy were assessed at 48 weeks.

More patients receiving maraviroc once or twice daily versus placebo achieved HIV-1 RNA <50 copies/mL (43%-46% vs 17%). CD4 counts increased more with maraviroc once or twice daily versus placebo (+116-124 vs +61 cells/mcL). Frequencies of side effects and toxicities were similar across groups.

A subgroup analyses of the MOTIVATE trials is also published in the October 2 edition of NEJM. "Findings from the subgroup analyses show that maraviroc plus standard antiretroviral regimen provides consistent clinical benefit over placebo plus optimised background therapy for all subgroups analysed," said lead author of the subgroup analyses Gerd Fätkenheuer, MD, Universitätsklinik Köln, Köln, Germany.

"Results highlight that maraviroc provides a valuable additional treatment option for a wide spectrum of treatment-experienced patients with R5 HIV-virus infection."


SOURCE: NewYork-Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College

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