Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial.
Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, Baril JG, Domingo P, Brennan C, Almond S, Min S; extended SPRING-2 Study Group.
Lancet Infect Dis. 2013 Nov;13(11):927-35
7 December 2013, by Pr François Raffi
SPRING-2 is a phase III, non-inferiority, double-blind randomized trial of 96 weeks duration. Naïve HIV-1 infected adults received either dolutegravir 50 mg once daily (n = 411) or raltegravir 400 mg twice daily (n = 411), both in combination with either tenofovir/emtricitabine or abacavir/lamivudine. By intention to treat using the snapshot algorithm, the proportion of patients with HIV-1 RNA < 50 copies/ml at week 96 was 81% in the dolutegravir group, compared with 76% in the raltegravir group (difference 4.5%, 95% CI -1.1% to 10.0%), confirming week 48 primary endpoint that dolutegravir was non-inferior to raltegravir. Overall, few patients (10 in each group, 2%) discontinued for adverse events. Rate and nature of adverse events, mostly of grade 1 were similar in both groups. Resistance emergence to integrase in protocol-defined virologic failures (2 consecutive plasma HIV-1 RNA > 50 c/ml at or after week 24) was seen in no patients in the dolutegravir group and 1 in the raltegravir group. Mean decrease in estimated creatinine clearance through 96 weeks was higher in the dolutegravir group (- 19.6 vs -9.3 ml/min).
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