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| |  Raltegravir-Based Regimen an Effective Alternative to Efavirenz in Treatment-Naïve HIV Patients NEW YORK -- August 2, 2009 -- Use of raltegravir in combination with optimum background therapy, is a safe and effective alternative to conventional combination treatment using efavirenz in treatment-naïve patients with HIV, according to a study published online first and in an upcoming edition of The Lancet. It is already known from previous studies that use of raltegravir with optimum background therapy is effective and well tolerated in treatment-experienced patients with multidrug-resistant HIV, but the safety and efficacy in treatment-naïve patients has not been proven in larger studies. Jeffrey L. Lennox, MD, Emory University School of Medicine, Atlanta, Georgia, and colleagues, conducted an international, multicentre randomised controlled trial between September 2006 and June 2008. Patients had HIV-1, had viral RNA (vRNA) concentration >5,000 copies per mL of blood, and no baseline resistance to efavirenz, or to the background treatments tenofovir or emtricitabine. Patients were randomised to receive oral raltegravir 400 mg BID or oral efavirenz 600 QD, in combination with tenofovir and emtricitabine. The primary endpoint was achievement of a vRNA concentration of <50 copies per mL of blood at week 48. In order to be declared ‘non-inferior’ to the efavirenz regimen, the proportion of patients reaching the endpoint in the raltegravir group had to be within 12% of that of the efavirenz group. The final analysis included 281 patients given raltegravir and 282 given efavirenz. A total of 297 patients at baseline had a vRNA of >100,000 per mL, and 47% had CD4 counts of 200 cells/mL or less. The main analysis (with non-completion of treatment counted as failure) showed that 86% of the raltegravir group reached the primary endpoint, compared with 82% of the efavirenz group. Patients given raltegravir also reached the endpoint faster -- 50% of the raltegravir group achieved virological suppression by week 4 of treatment, compared with less than 20% of the efavirenz group. Treatment-related adverse events were also less common in patients given raltegravir (124/44%) than efavirenz (217/77%), although serious adverse events were similar (10%) in each group. The authors acknowledge that the need to take raltegravir twice daily, rather than once daily as with efavirenz, could have an effect on treatment adherence in clinical practice. “Our findings that raltegravir-based combination treatment is effective and generally well tolerated in treatment-naive patients, compared with efavirenz, are supported by follow-up data to week 96 in a phase 2 study of treatment-naive patients.” “Raltegravir is an important additional drug for initial treatment of HIV-1 infection, and should be regarded as an alternative to efavirenz as part of a first-line combination regimen with tenofovir and emtricitabine in treatment-naive patients.” SOURCE: The Lancet
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