Week 96 efficacy of lopinavir/ritonavir monotherapy in virologically suppressed patients with HIV: a randomized non-inferiority trial (ANRS 140 DREAM)

Abstract

Lopinavir/r monotherapy cannot be considered non-inferior to EFV/FTC/TDF. PI resistance rarely emerged in the lopinavir/r arm and did not undermine future PI options. Two years of lopinavir/r monotherapy had no deleterious clinical impact when compared with EFV/FTC/TDF.

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“…Lopinavir/ritonavir (Kaletra, Aluvia) is a protease inhibitor used in combined therapy for human immunodeficiency virous (HIV) [74] . Lopinavir inhibits cleavage of the gag-pol protein, whilst ritonavir inhibits cleavage of the gag-pol protein precursor and lopinavir metabolism to increase the concentration of lopinavir [75] .…”

Cost-Effectiveness Analysis of Lopinavir/Ritonavir Monotherapy Versus Standard Combination Antiretroviral Therapy in HIV-1 Infected Patients with Viral Suppression in France (ANRS 140 DREAM)

“…First, the study period of 2 years is relatively short, so the cost-effectiveness of the monotherapy strategy may have been overestimated. Indeed, given that patients with VL rebound are switched to cART without loss of future PI/r options [11], the two strategies are expected to have similar long-term health benefits. However, as outlined previously, we cannot completely exclude the risk of lower long-term health benefits due to long-term consequences of residual viral replication [35].…”

“…The ANRS 140 DREAM trial was conducted in France to compare the effectiveness of PI/r monotherapy using lopinavir/ritonavir (LPV/r) with fixed-dose cART comprising two NRTIs and one NNRTI (efavirenz/emtricitabine/tenofovir [EFV/FTC/TDF]) in patients with HIV-1 who were virally suppressed [11]. LPV/r was chosen because of its good tolerance profile and high genetic barriers, and EFV/FTC/TDF was chosen because the two NRTIs have favourable tolerance profiles and are combined with EFV in a single pill [12–14].…”

“…LPV/r was chosen because of its good tolerance profile and high genetic barriers, and EFV/FTC/TDF was chosen because the two NRTIs have favourable tolerance profiles and are combined with EFV in a single pill [12–14]. Using the proportion of patients without treatment failure at week 96 as a primary endpoint (with failure defined as a VL ≥ 50 copies/mL, treatment discontinuation including re-intensification in the LPV/r arm, or a new AIDS-defining illness or death), the trial failed to demonstrated the non-inferiority of PI/r monotherapy (difference between arms − 6.8%; 95% confidence interval [CI] − 19.9 to 6.2) [11]. When re-intensification in the LPV/r arm was not considered to represent failure, the proportions of participants without treatment failure were similar in the two arms (difference between arms − 0.7%; 95% CI − 13.5 to 12.0).…”

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“…Lopinavir and ritonavir (Kaletra/Aluvia) is the first-line drug for the clinical treatment of AIDS. 26,27 Developed by Abbott, marketed in 2005, mainly combined with viral protease to inhibit protease function. Lopinavir-ritonavir is a compound tablet consisting of lopinavir and ritonavir.…”