FLAMINGO: Dolutegravir vs. Darunavir for Initial Treatment of HIV
Rajesh T. Gandhi, MD
In a randomized trial comparing dolutegravir with ritonavir-boosted darunavir, a higher proportion of patients in the dolutegravir group achieved viral suppression.
In previous phase III trials conducted among treatment-naive HIV-infected patients, dolutegravir-based therapy was found to be noninferior to raltegravir-containing combinations and superior to an efavirenz-based regimen. Now, in an open-label, manufacturer-sponsored, phase IIIb study called FLAMINGO, dolutegravir has been compared with a first-line protease inhibitor, ritonavir-boosted darunavir.
Treatment-naive HIV-infected patients were randomized to receive either dolutegravir or boosted darunavir, each combined with investigator-selected nucleoside reverse transcriptase inhibitors (67% received tenofovir/FTC, 33% abacavir/3TC). Most of the 484 patients included in the analysis were male (85%); the median baseline CD4 count was ~400 cells/mm3.
At week 48, 90% of those in the dolutegravir group and 83% of those in the boosted-darunavir group had viral loads <50 copies/mL. In a prespecified secondary analysis, dolutegravir was found to be superior to boosted darunavir, largely because of fewer drug discontinuations, as well as a higher virologic response rate in those with pretreatment viral loads >100,000 copies/mL (93% vs. 70%, by FDA Snapshot analysis). Only two patients in each treatment arm had confirmed virologic failure; no treatment-emergent resistance mutations were detected. Serum creatinine increased more in the dolutegravir group than in the boosted-darunavir group, but the increase was small, and no patient discontinued the study because of renal events. This effect was attributed to a dolutegravir-induced decrease in the tubular secretion of creatinine.
Citation(s):
Clotet B et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet 2014 Apr 1; [e-pub ahead of print].
Pozniak AL and Arribas JR.FLAMINGO: How much rosier can antiretroviral therapy get? Lancet 2014 Apr 1; [e-pub ahead of print].
