RCT: Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from SPRING-2 study

Source: Lancet Area: News The Lancet has featured the results of the SPRING-2 phase III study evaluating a new once-daily HIV integrase inhibitor dolutegravir, in comparison with raltegravir as initial treatment for adults with HIV-1.   The 96-week, double-blind, active-controlled, non-inferiority study involved 822 patients aged ?18 years with HIV-1 infection and HIV-1 RNA concentrations of 1000 copies per mL or greater, who were randomised to receive dolutegravir 50 mg once daily (n=411) or raltegravir 400 mg twice daily (n=411). The primary endpoint was the proportion of participants with HIV-1 RNA less than 50 copies per mL at 48 weeks, with a 10% non-inferiority margin. Main secondary endpoints were changes from baseline in CD4 cell counts, incidence and severity of adverse events, changes in laboratory parameters, and genotypic or phenotypic evidence of resistance.   The following results were reported:   . At 48 weeks, 361 (88%) patients in the dolutegravir group ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news