Combination therapy containing @entity486 plus XXXX has superior short-term antiretroviral efficacy: a randomized trial.

@entity1 @entity2353 @entity5190 @entity485 @entity645 @entity486
OBJECTIVES: To compare the efficacy and safety of @entity5190 800 mg three times a day, @entity486 600 mg twice a day, and a combination of @entity486 400 mg twice a day and @entity485 400 mg twice a day, when administered with two @entity2353 analogues. DESIGN: A randomized, open-labelled, controlled trial. Two hundred and eighty-four @entity1 started randomized treatment. The primary end-point was the proportion of @entity1 with @entity645 RNA of 200 copies/ml or less (Roche Amplicor) and @entity645 RNA of 20 copies/ml or less (Roche ultradirect assay) at 6 months. Analysis was performed as intent-to-treat, and missing values were accounted for as failures. RESULTS: As of 1 May 1998, 269 @entity1 should have completed 24 weeks of treatment. The proportion of @entity1 with @entity645 RNA of 200 copies/ml or less was 71% ( @entity5190 ), 67% ( @entity486 ), and 82% ( @entity486 + @entity485 ), P = 0.07. In antiretroviral drug-naive @entity1 (n = 119), the corresponding figures were 63, 57, and 89% (P < 0.01), whereas among drug-experienced @entity1 (n = 165) 77, 74, and 77% had @entity645 RNA of 200 copies/ml or less (P = 0.90). The same pattern was observed in the ultradirect analysis. All three regimens were generally safe, but significantly more @entity1 in the @entity486 group (37%) stopped treatment because of adverse drug reactions compared with the @entity5190 group (8%) and the @entity486 plus @entity485 group (16%) (P < 0.001). CONCLUSIONS: Treatment with @entity485 plus @entity486 in combination with two @entity2353 analogues is generally safe, and has superior short-term antiviral efficacy compared with @entity5190 and @entity486 also combined with two @entity2353 analogues in antiretroviral drug-naive @entity1 . Further follow-up is needed to determine the durability of the viral response.
