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Lopinavir/r vs efavirenz/FTC/TDF for HIV maintenance therapy: results of the ANRS 140 DREAM trial
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Background: Simplification of treatment maintenance strategies by sparing certain antiretroviral drug classes could decrease drug-toxicity and cost strategy. The primary objective of the trial was to assess the efficacy of a lopinavir/r (LPV/r) monotherapy in comparison to a single-tablet regimen containing efavirenz, FTC and tenofovir (cART) over two years in virologically controlled patients.
Methods: Randomized, multicenter, non-inferiority (margin set at -10%) trial. Adults were randomized if they had stable antiretroviral treatment, HIV-1 RNA < 50 cp/mL over the previous 12 months, and no prior documented treatment failure. The primary endpoint was the proportion of patients without treatment failure at W96, which defined as: HIV-1 RNA ≥50 cp/mL at W96, confirmed at W98, or treatment modification before W96, or new AIDS defining illnesses or death. Secondary endpoints were: proportion of success at W96 after intensification (in LPV/r group if failure), HIV resistance, self-reported treatment adherence and neurocognitive evaluation (Bref, Verbal Fluency, Weschler, cognitive dysfunctions).
Results: 195 patients were included, 70% male, median age 44 years. Follow-up and/or trial treatment was stopped early in 61 patients (31%). The primary endpoint was reached in 64% patients in the LPV/r group and 71% in the cART group in intent-to-treat [difference, -6.8%, lower limit of 95% two-sided confidence interval (CI) for difference, -19.9%]. When antiretroviral treatment intensification was taken into account, 73% of patients in the LPV/r and 71% in the cART groups met the primary endpoint (difference, 2.3%, lower limit of 95% two-sided CI for difference, -10.2%). Three patients developed PI mutations in the LPV/r (2 patients: I54V, V82A and 1 patient: I54V) and 2 developed NNRTI or/and NRTI mutations (1 patient: K103N, M184V and 1 patient: K103N) in the cART groups. One patient died (suicide) in LPV/r group at W12. No unexpected serious clinical event was reported. Treatment adherence tended to be lower in the LPV/r group. Neurocognitive evaluation did not differ between the two strategies.
Conclusions: It cannot be concluded at non-inferiority of LPV/r monotherapy versus single-tablet cART when treatment intensification is not taken into account. No deleterious impacts in terms of resistance, clinical events and neurocognitive function were reported at two years.
Methods: Randomized, multicenter, non-inferiority (margin set at -10%) trial. Adults were randomized if they had stable antiretroviral treatment, HIV-1 RNA < 50 cp/mL over the previous 12 months, and no prior documented treatment failure. The primary endpoint was the proportion of patients without treatment failure at W96, which defined as: HIV-1 RNA ≥50 cp/mL at W96, confirmed at W98, or treatment modification before W96, or new AIDS defining illnesses or death. Secondary endpoints were: proportion of success at W96 after intensification (in LPV/r group if failure), HIV resistance, self-reported treatment adherence and neurocognitive evaluation (Bref, Verbal Fluency, Weschler, cognitive dysfunctions).
Results: 195 patients were included, 70% male, median age 44 years. Follow-up and/or trial treatment was stopped early in 61 patients (31%). The primary endpoint was reached in 64% patients in the LPV/r group and 71% in the cART group in intent-to-treat [difference, -6.8%, lower limit of 95% two-sided confidence interval (CI) for difference, -19.9%]. When antiretroviral treatment intensification was taken into account, 73% of patients in the LPV/r and 71% in the cART groups met the primary endpoint (difference, 2.3%, lower limit of 95% two-sided CI for difference, -10.2%). Three patients developed PI mutations in the LPV/r (2 patients: I54V, V82A and 1 patient: I54V) and 2 developed NNRTI or/and NRTI mutations (1 patient: K103N, M184V and 1 patient: K103N) in the cART groups. One patient died (suicide) in LPV/r group at W12. No unexpected serious clinical event was reported. Treatment adherence tended to be lower in the LPV/r group. Neurocognitive evaluation did not differ between the two strategies.
Conclusions: It cannot be concluded at non-inferiority of LPV/r monotherapy versus single-tablet cART when treatment intensification is not taken into account. No deleterious impacts in terms of resistance, clinical events and neurocognitive function were reported at two years.