Abstract LBPS7/6
Dual Therapy with Lopinavir/Ritonavir (LPV/r) and Lamivudine (3TC) is Non-inferior to Standard Triple Drug Therapy in Naïve HIV-1 Infected Subjects: 48-week Results of the GARDEL Study Print
P. Cahn1, The GARDEL Study Group
1Fundacion Huesped, Clinical Research, Buenos Aires, Argentina
Objectives: To compare the efficacy and safety of a dual therapy (DT) combination of LPV/r 400/100 mg BID+3TC 150 mg BID to a triple therapy (TT) with LPV/r 400/100 mg BID + 3TC or FTC and a third investigator-selected NRTI in fixed-dose combination.
Methods: Randomized, controlled, open-label, international study in HIV-1 infected, ARV-naïve adults. Eligible participants had no IAS-USA defined NRTI or PI resistance at baseline (the latter defined as > 1 major or > 2 minor LPV/r mutations). Primary endpoint was virologic response rate, defined as the proportion of patients with HIV-1 RNA< 50 copies/mL in an ITT-exposed analysis at 48 weeks (FDA-snapshot algorithm)
Results: Baseline characteristics among 416 dosed participants were similar between arms. At week 48, 88.3% of subjects receiving DT and 83.7% of subjects receiving TT were responders (p= 0.171, difference +4.6% [CI95%:-2.2% to +11.8%]). Patients with baseline VL>100,000 copies/mL showed similar results (85.8 vs. 84.8% respectively, p = 0.785). Virological failure was similarly distributed between arms (n=22):10 in DT, 12 in TT,(p=0.72). Mean CD4+ increases were similar between arms (DT=227 cells/mm3, TT=217 cells/mm3, p=0.625). A total of 153 Grade 2-3 clinical adverse events were reported:65 in DT,88 in TT (p=0.007). Only one SAE was reported as possibly related to study drugs (DT). A non-significant trend of more frequent treatment discontinuations by week 48 in the TT arm was observed:DT=16[4.5%], TT=27[13.4%],(p= 0.07; CI95%:-12.2% to +0.5%). Toxicity/tolerability-related discontinuations (n=11) were more frequent in the TT arm (DT=1[0.4%], TT=10[4.9%, p=0.01; CI95%:-8,1%to + 0,9%%])
Conclusion: Our results demonstrate that DT with LPV/r+3TC was non-inferior to triple therapy after 48 weeks of treatment, regardless of baseline viral load. The DT regimen tended to have better safety and tolerability. These results suggest that a dual LPV/r+3TC regimen warrants further clinical research and consideration as a potential therapeutic option for ARV naïve subjects.

Assigned speakers:
Md; PhD Pedro Cahn , Fundacion Huesped , Buenos Aires , Argentina

Assigned in sessions:
18.10.2013, 10:30-12:30, Parallel Session, PS7, Antiretroviral Therapy II, Bozar (Plenary Hall)