The two-drug regimen of maraviroc + darunavir/ritonavir proved inferior to the three-drug regimen of tenofovir/emtricitabine + darunavir/ritonavir in antiretroviral-naive adults with HIV-1 infection, study authors reported in the journal AIDS.
Researchers conducted MODERN, a Phase 3 multicenter, double-blind, non-inferiority study (n=797) that evaluated the efficacy of once daily maraviroc + darunavir/ritonavir for the treatment ofantiretroviral-naive HIV-1 infected patients. Study patients had HIV-1 RNA >1000 copies/mL with no evidence of reduced susceptibility to study drugs.
At screening, they were randomized to undergo either genotypic or phenotypic tropism testing. Patients with CCR5-tropic HIV-1 were randomized to maraviroc 150mg daily or tenofovir/emtricitabine daily with darunavir/ritonavir daily for 96 weeks. The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at Week 48.
The Data Monitoring Committee recommended early study termination due to inferior efficacy exhibited in the maraviroc treatment arm. At Week 48, the amount of patients with HIV-1 RNA <50 copies/mL was 77.3% for the maraviroc arm vs. 86.8% for the tenofovir/emtricitabine arm (difference of -9.54%, 95% CI: -14.83%, -4.24%). In addition, more patients in the maraviroc arm discontinued therapy for lack of efficacy not associated with non-R5 tropism or resistance.
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