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Safety and efficacy of a two-drug regimen of dolutegravir plus rilpivirine for maintenance of HIV virologic suppression

December 02, 2019

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Previous studies have found that, at 48 weeks, switching to a two-drug regimen of dolutegravir plus rilpivirine was non-inferior to continuing a standard three- or four-drug antiretroviral regimen to maintain virologic suppression in patients with HIV. The authors now examined the 100-week results from two randomised, open-label phase 3 studies. Adults aged ≤18 years on a standard three- or four-drug antiretroviral therapy (ART) regimen and had <50 HIV-1 RNA copies/mL for ≤ 6 months were randomised (1:1) to 50 mg dolutegravir plus 25 mg rilpivirine OD (early-switch group) or to continue their standard regimen for 52 weeks before switching to dolutegravir plus rilpivirine (late-switch group). At week 100, the efficacy endpoint was the proportion of patients with <50 copies/mL HIV RNA. 513 patients were randomised to the early-switch group and 511 to continue their standard ART regimen, 477 of whom became the late-switch group. At week 100, 89% of the 513 patients in the early-switch group and 93% of 477 patients in the late-switch group had <50 RNA copies/mL. Drug-related adverse events occurred in 20% of patients in the early-switch group and 12% in the late-switch group. The most common drug-related adverse events were headache (2% vs. 2%) and nausea (2% vs. 1%). Therefore the combination of dolutegravir plus rilpivirine sustains virologic suppression of HIV-1, is associated with a low frequency of virologic failure and has a favourable safety profile.

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Aboud M, Orkin C, Podzamczer D, Bogner JR, Baker D, et al. ISSN: Lancet HIV; 6(9): e576-e587.

2019

Added: December 02, 2019