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| |  Maraviroc Has Durable Treatment Effect at 96 Weeks in Treatment-Naïve HIV Patients: Presented at IAS By Charlene Laino CAPE TOWN, South Africa --- July 21, 2009 --- Treatment-naïve patients with HIV taking maraviroc experienced comparable virologic suppression to undetectable levels and significantly greater increases in CD4 T-cell count through 96 weeks, compared with patients taking efavirenz, according to follow-up data from the Reanalysis of the MERIT Study With the Enhanced Trofile Assay (MERIT-ES). Both drugs were given in combination with zidovudine/lamivudine, researchers reported here at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. "Durable HIV treatments are critical as they better ensure that patients remain on therapy, which can delay disease progression and help patients live considerably longer," said Michael Saag, MD, Center for AIDS Research, University of Alabama, Birmingham, Alabama. "These results further support maraviroc's durability and safety profile and, therefore, offer the potential to enhance currently available treatment options for treatment-naïve HIV patients," he said on July 21. The Maraviroc Versus Efavirenz Regimens as Initial Therapy (MERIT) study is a randomised, double-blind trial designed to compare the safety and efficacy of maraviroc 300 mg BID with efavirenz 600 mg QD, both administered with a fixed-dose combination of zidovudine and lamivudine, in treatment-naïve patients. The enhanced sensitivity test used in MERIT-ES was not available at the time of the MERIT study. The new analysis shows that at 96 weeks, 58.5% of the 311 patients taking maraviroc achieved an undetectable viral load <50 copies/mL, compared with 62.4% of the 303 patients taking efavirenz. The point difference was -3.9 and the lower bound of the confidence interval was -11.5, making maraviroc noninferior, Dr. Saag said. In addition, at 96 weeks, a similar number of patients taking maraviroc and efavirenz remained on therapy (66.9% and 66.0%, respectively), he said. For patients from the MERIT-ES population with higher viral loads at screening (>100,000 copies/mL), a similar number of patients taking maraviroc maintained undetectable viral load compared with those taking efavirenz (56.0% and 56.7%, respectively). Additionally, at week 96 the increase in CD4 T-cell count was significantly greater with maraviroc than with efavirenz. The median change from baseline was 212 cells/mm3 and 171 cells/mm3, respectively, a difference of 41 cells/mm3 (95% confidence interval, 17-65). At 96 weeks, similar to 48 weeks, the most common adverse events reported by patients taking maraviroc were nausea, headache, fatigue, and dizziness. For patients taking efavirenz, nausea, headache, diarrhoea, dizziness, vomiting, and abnormal dreams were the most commonly reported adverse events. Funding for this study was provided by Pfizer. [Presentation title: The MERIT Study of Maraviroc in Antiretroviral-Naive Patients With R5 HIV-1: 96-Week Results. Abstract TUAB103]
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