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| |  Raltegravir Maintains Suppression of HIV Virus in Treatment-Experienced Patients Up to 48 Weeks: Presented at CROI By Ed Susman BOSTON, MA -- February 6, 2007 -- Raltegravir, the first integrase inhibitor for treatment of HIV-infected patients, when added to an optimized background regimen, continued to show that it was superior to the background therapy alone in a 48-week evaluation. About 64% of patients receiving raltegravir achieved an undetectable viral load using the 50-copies/mL assay compared with 34% of patients receiving the optimized background therapy without raltegravir in a pooled analysis of 2 studies (P <.001). The 2 studies were the Blocking Integrase in Treatment Experienced Patients With a Novel Compound Against HIV: MeRcK 1 and 2 Protocol 018 and 019 (MK BENCHMRK-1 and -2). "Raltegravir 400 mg twice a day plus optimized background therapy has potent and superior antiretroviral and immunological efficacy when compared to placebo plus optimized background therapy, which is sustained through 48 weeks," said Roy Steigbigel, MD, Professor of Medicine, State University of New York Stony Brook Health Sciences Center, Stony Brook, New York. Dr. Steigbigel was principal investigator of BENCHMRK-2, which was conducted mainly in the Americas. Virtually similar data was found in BENCHMRK-1, conducted throughout the rest of the world. The 48-week results were both presented in poster sessions here on February 4 at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). In the phase 3 BENCHMRK-1 trial, 232 patients were randomly assigned to receive raltegravir and 119 patients were assigned to placebo plus the optimized therapy. In BENCHMRK-1, doctors assigned 234 patients to receive raltegravir and 118 received placebo. In the 48-week trial, 16 of the raltegravir patients (3.5%) in both trials developed a malignancy that translated to a 2.2/100 malignancy rate, compared with 4 patients on placebo who developed a malignancy (2.3%) in both trials, which translated to a 1.8/100 malignancy rate. "Raltegravir 400 mg twice a day plus optimized background therapy is generally well tolerated as compared to placebo in combination with optimized background therapy," Dr. Steigbigel said. Integrase is one of the three enzymes of HIV required for viral replication. Drugs to inhibit the other enzymes, protease and reverse transcriptase, have already been developed and are basic backbones of multidrug combinations. Funding for these studies was provided by Merck & Co. During development, raltegravir was known as MK-0518.
[Presentation title: 48-Week Results From BENCHMRK-1, a Phase III Study of Raltegravir in Patients Failing ART With Triple-class Resistant HIV-1. Abstract 788]
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