Decay of human immunodeficiency virus (HIV) RNA in seminal plasma and rectal fluid in treatment-naïve adults starting antiretroviral therapy with dolutegravir plus lamivudine or bictegravir/emtricitabine/tenofovir alafenamide.

Abstract

Decay of HIV in seminal plasma (SP) and rectal fluid (RF) has not yet been described for the antiretroviral combination of dolutegravir(DTG) + lamivudine(3TC). Randomized multicenter pilot trial. Antiretroviral-naive males were randomized (2:1) to DTG + 3TC or bictegravir(BIC)/emtricitabine(FTC)/tenofovir alafenamide(TAF). HIV-1 RNA was measured in blood plasma (BP), SP, and RF at baseline, days 3, 7, 14, 28, and weeks 12 and 24. Of 25 individuals enrolled, 24 completed the study (DTG + 3TC n = 16, BIC/FTC/TAF n = 8). No significant differences were observed between groups for median decline in HIV-1 RNA from baseline at each time point or median time to achieve HIV-1 RNA <20 copies/mL in BP, SP, and RF.HIV-1 RNA decay patterns were compared in individuals receiving DTG + 3TC. Despite significantly higher percentages for changes from baseline in BP, median times to HIV-1 RNA suppression were shorter in SP (7 days [0; 8.75]) and in RF (10.5 days [3; 17.5]) than in BP (28 days [14; 84]) (p < 0.001). Comparable HIV-1 RNA decay in BP, SP, and RF was observed between DTG + 3TC and BIC/F/TAF. As shown with triple-drug integrase inhibitor-based regimens, rapid HIV-1 RNA suppression in SP and RF is achieved with DTG + 3TC, despite decay patterns differing from those of BP.