Sustained Efficacy and Safety of Raltegravir After 5 Years of Combination Antiretroviral Therapy as Initial Treatment of HIV-1 Infection: Final Results of a Randomized, Controlled, Phase II Study (Protocol 004)

Department to de Enfermedades Infecciosas y Tropicales, Hospital Nacional Cayetano Heredia, Lima, Peru.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.56). 06/2012; 61(1):73-7. DOI: 10.1097/QAI.0b013e318263277e
Source: PubMed


Raltegravir as initial HIV therapy was examined in a double-blind study; 160 patients were randomized to raltegravir (400 mg bid after dose-ranging), 38 to efavirenz, both with tenofovir/lamivudine. At week 240, HIV-RNA remained <50 copies per milliliter in 68.8% (raltegravir) versus 63.2% (efavirenz), and CD4 increases were 302 versus 276 cells per microliter, respectively. Early HIV-RNA decline predicted later CD4 increases in both groups. Raltegravir resistance was observed in 3 of 10 raltegravir recipients with virologic failure. Few drug-related adverse events were reported after week 48. Raltegravir had minimal effect on laboratory values, including lipids. Raltegravir with tenofovir/lamivudine showed durable efficacy and good tolerability over 5 years.

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    • "This percentage dropped to only 80% by the end of 5 years. Viral load <50 copies/mL was a secondary end point, with 110 (69%) of the patients on RAL compared to 24 (63%) in the efavirenz group achieving this goal at 240 weeks.33,34 "
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