Background: Based on the results of the GARDEL trial, we designed a proof of concept study to evaluate the antiviral efficacy, safety and tolerability of a dual therapy regimen with Dolutegravir (DTG) 50m mg QD plus Lamivudine (3TC) 300 mg QD as initial HAART among ARV-naïve patients. Week 48 analysis was presented at AIDS 2016 (90% (18/20) reached the primary end point of a pVL < 50 copies/mL. Week 96 results are reported here.
Methods: Pilot study including 20 HIV-infected ARV-naïve adults. Eligible participants had no IAS-USA defined NRTI resistance, HIV-1 RNA < 100.000 copies/mL at screening and negative HBsAg. Viral load (pVL) was measured at baseline, on days 2, 4, 7, 10, 14, 21, 28 and on weeks 6, 8, 12, and thereafter every 12 months up to 96 weeks. Primary endpoint was the proportion of patients with HIV-1 RNA< 50 copies/mL in an ITT-exposed analysis at 48 weeks and week 96(FDA-snapshot algorithm).
Results: Eighteen patients completed 48 weeks and were included in the extension phase. Fifteen patients completed week 96, 100% maintained plasma HIV-1 RNA below 50 copies/mL. Three patients are virologically suppressed at week 84. Their week 96 results will be reported at the conference. Mean CD4+ increase between baseline and week 96 was 271 cell/mm ³ , without change between 48 and 96 weeks. No new virologic failures, no new AIDS defining illnesses, or SAEs (related/possibly related to study drugs) were observed. No Treatment discontinuations were reported through the extension phase. Two grade 3 laboratory abnormalities were reported (high cholesterol, and proteinuria) but considered unrelated to study drug.
Conclusions: In this pilot study, dual therapy with DTG+3TC has demonstrated efficacy, safety, tolerability and durability through 96 weeks of treatment. This strategy is being explored in a large randomized trial.

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