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| |  Simplification of ART Possible by Substituting Raltegravir for Protease Inhibitors: Presented at AIDS 2010 By Evelyn Harvey VIENNA -- July 20, 2010 -- The complexity of antiretroviral regimens, pill burden, and occurrence of adverse events are all barriers to long-term treatment adherence. Protease inhibitors (PIs) in particular can affect lipid profiles. The Once-Daily Isentress (ODIS) trial showed that regimen simplification using once or twice-daily raltegravir instead of a PI is safe and effective, in people with HIV without resistance to other components of their drug regimen. Eugenia Vispo, MD, Hospital Carlos III, Madrid, Spain, presented the findings on July 19 here at the 18th International AIDS Conference. Raltegravir's long intracellular half-life may make it suitable for once-daily dosing, making it attractive for regimen simplification. Previous trials have shown its efficacy when used twice daily. The ODIS trial included 222 adult patients with HIV who were on a PI-containing regimen and had maintained a viral load <50 copies/mL for at least 24 weeks. None were previously treated with integrase-inhibitors. Patients were randomised in a 2:1 ratio to receive raltegravir 800 mg QD (n = 149) or raltegravir 400 mg BID (n = 73). After 12 weeks, patients in the twice-daily group who had an undetectable viral load were then randomised to switch to raltegravir 800 mg QD or to remain on the twice-daily regimen. The most frequently replaced PIs were atazanavir (48%), lopinavir (28%), and fosamprenavir (13%). Up to 69% of patients received raltegravir along with tenofovir-emtricitabine, and 31% with abacavir-lamivudine. The primary endpoint was maintenance of virological control at 24 weeks. In all, 13 (5.9%) patients experienced virological failure -- 12 (6.4%) in the once-daily arm and 1 (2.9%) in the twice-daily group (P = .18). Strikingly, the virological failure rate was 16.2% (12/74) in patients with prior nucleoside reverse transcriptase inhibitor (NRTI) resistance, but only 0.7% (1/148) in the non-resistant population (P < .001). Concerning secondary endpoints, total cholesterol, low-density lipoprotein, and high-density lipoprotein levels decreased at 24 weeks after raltegravir substitution. The ODIS study was interrupted due to the observed increase in virological failure in participants with background NRTI resistance. Multivariate analysis confirmed this as the only significant risk factor for virological failure. "As a simplification strategy, where there is no prior NRTI resistance, we think that raltegravir substitution for PIs is a good strategy," said Dr. Vispo. "However, it would not be as good for monotherapy." [Presentation title: Simplification From Protease Inhibitors to Once or Twice Daily Raltegravir: The ODIS Trial. Abstract MOAB0102]
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