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| |  Raltegravir Maintains Efficacy Versus Efavirenz After 144 Weeks: Presented at IAS By Ed Susman CAPE TOWN, South Africa-- July 20, 2009 -- Antiretroviral therapy based on treatment with the first HIV anti-integrase maintains its effectiveness against similar combination therapy with the non-nucleoside reverse transcriptase efavirenz, one of the recognised standard treatments for HIV infection, after 144 weeks, researchers said here. In addition, treatment with raltegravir appeared to be better tolerated than efavirenz-based therapy, reported Bach-Yen Nguyen, MD, Merck Research Laboratories, Infectious Diseases & Vaccines Clinical, West Point, Pennsylvania, at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. “At 144 weeks, raltegravir had sustained antiretroviral effect similar to 96-week data and similar to efavirenz,” she said at her July 20 poster presentation. Both groups of patients in the study were also receiving tenofovir and lamivudine, which both impact the viral nucleoside reverse transcriptase functions. At 144 weeks, 78% of the 160 previously treatment-naïve patients taking the raltegravir-based treatment maintained viral suppression at a level that was undetectable using the 50 copies/mL assay, Dr. Nguyen said. About 76% of the 38 patients on efavirenz had maintained undetectable viral loads after about 3 years on medication. “We are encouraged that these data demonstrate the efficacy and tolerability profile of raltegravir with less effect on lipid levels for up to 144 weeks,” said Martin Markowitz, MD, Aaron Diamond AIDS Research Center, New York, New York, and one of the study’s researchers. “It is important for patients at any stage of HIV to have treatment options that are effective and have a demonstrated tolerability profile in order to help them manage their disease.” On July 8, 2009, raltegravir was approved by the US Food and Drug Administration for use in treatment-naïve adult patients in combination with other antiretroviral medicines for the treatment of HIV-1 infection. The use of raltegravir in treatment-naïve patients is investigational in other countries throughout the world. These 144-week findings are from an ongoing multicentre, dose-ranging, double-blind, randomised trial of previously untreated HIV-infected adult patients. In this study, 198 treatment-naïve, HIV-infected patients received either raltegravir administered orally twice daily in combination with tenofovir and lamivudine or efavirenz 600 mg dosed orally once daily in combination with the same agents. During the first 48 weeks of the study, patients were randomised to 1 of 4 dose regimens. After 48 weeks, all groups receiving raltegravir received 400 mg dosed twice daily. Patients on both treatment regimens experienced increases in CD4 cell counts. At 144 weeks of treatment, the mean increase from baseline in CD4 cell count was 252 cells/mm3 for patients receiving the regimen containing raltegravir and 233 cells/mm3 for patients receiving the regimen containing efavirenz. Both treatment regimens were generally well tolerated, with cumulative rates of drug-related clinical adverse experiences less frequent in the regimen containing raltegravir. About 54% of the raltegravir patients had adverse side effects compared with 76% of the efavirenz patients. Malignancy rates were about equal. Raltegravir had less effect on total or low-density lipoprotein cholesterol or triglycerides. Funding for the study was provided by Merck Sharp & Dohme. [Presentation title: Sustained Antiretroviral Efficacy of Raltegravir as Part of Combination ART in Treatment-Naïve HIV-1 Infected Patients: 144-Week Data. Abstract MOPEB030]
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