Monotherapy with boosted PIs as an ART simplification strategy in clinical practice

Abstract

Abstract Background Data on the efficacy of simplifying therapy using darunavir/ritonavir and lopinavir/ritonavir monotherapy in clinical practice remain limited. Methods A retrospective single-centre study including patients initiating darunavir/ritonavir or lopinavir/ritonavir monotherapy with a plasma HIV-1 viral load (pVL) <50 copies/mL and at least one subsequent follow-up visit. The primary endpoint was the percentage of patients remaining free of virological failure (VF; defined as a confirmed pVL >50 copies/mL or as any change in the regimen after a single determination with a pVL >50 copies/mL) during the follow-up. We also evaluated the percentage of patients remaining free of treatment failure (TF; defined as VF or the early discontinuation of monotherapy for any reason) and compared the effectiveness of the two regimens. Effectiveness was evaluated using cumulative survival analysis (at Weeks 48 and 96). Factors associated with VF and TF were analysed using Cox regression. Results A total of 522 patients were included (309 receiving lopinavir/ritonavir and 213 receiving darunavir/ritonavir). The median follow-up was 64.3 (30.5–143.0) weeks. The percentage of patients free of VF and TF was 94% (95% CI 91%–96%) and 79% (95% CI 75%–82%) at 48 weeks, respectively, and 86% (95% CI 81%–89%) and 62% (95% CI 57%–67%) at 96 weeks, respectively. The risk of VF was similar for the two regimens (HR = 1.0, 95% CI 0.6–1.8; P = 0.962). Lopinavir/ritonavir monotherapy was associated with a 1.5-fold greater risk of TF (95% CI 1.1–2.1; P = 0.012) and a 2.3-fold greater risk of discontinuation of therapy due to adverse events (95% CI 1.3–3.9; P = 0.003). Conclusions The virological efficacy of darunavir/ritonavir and lopinavir/ritonavir monotherapy is high in clinical practice. Treatment discontinuation due to safety issues is more frequent with lopinavir/ritonavir.