Doravirine Plus Integrase Strand Transfer Inhibitors as a 2-Drug Treatment-Switch Strategy in People Living with HIV: The Real-Life DORINI Multicentric Cohort Study

J Acquir Immune Defic Syndr. 2023 Nov 1;94(3):235-243. doi: 10.1097/QAI.0000000000003248.

Abstract

Background: Few data are available about the efficacy, durability, and tolerability of doravirine (DOR) + integrase strand inhibitors (INI) as a switching strategy among antiretroviral therapy (ART)-experienced people living with HIV (PLWH).

Setting: Retrospective, multicenter cohort study investigating the durability, efficacy, and tolerability of 2 off-label drug associations of DOR + INI among ART-experienced PLWH.

Methods: The study included PLWH who switched to DOR combined with either raltegravir (RAL) or dolutegravir (DTG) between June 1, 2020, and December 31, 2021, with at least 1 follow-up (FU) visit. Virologic, biometric, and metabolic parameters were evaluated at baseline (T0) and at 1-3 (T1), 6 (T2), and 12 (T3) months. Univariate and multivariate survival analyses assessed the 28-week probability of persistence on the regimens. Patient satisfaction was measured using the HIV Treatment Satisfaction Questionnaire.

Results: Ninety-five PLWH were included, 52 in DOR + RAL and 43 in DOR + DTG. Six treatment discontinuations were reported during a mean of 37 (±17) weeks of FU (incidence of 2.7 × 1000 person-weeks FU). Only 2 were the result of virological failure without resistance mutations. DOR + DTG demonstrated significantly higher 28-week persistence than DOR + RAL (HR 1.90, 95% CI: 1.24-2.90, log-rank: P = 0.003). Weight, waist circumference, and fasting lipids reduced considerably at T3 vs T0. Overall, high satisfaction with the new treatment was reported, particularly in the DOR + RAL (68 (64-72)/72), compared with the DOR + DTG group (58 (50-65)/72, P < 0.001).

Conclusions: Our experience revealed few treatment discontinuations, improved metabolic parameters, and high patient satisfaction among ART-experienced PLWH switching to DOR combined with INI, irrespective of the specific INI used.

Publication types

  • Multicenter Study

MeSH terms

  • Anti-HIV Agents* / therapeutic use
  • Cohort Studies
  • HIV Infections* / drug therapy
  • HIV Integrase Inhibitors* / pharmacology
  • HIV Integrase Inhibitors* / therapeutic use
  • Heterocyclic Compounds, 3-Ring / therapeutic use
  • Humans
  • Integrases
  • Off-Label Use
  • Pyridones / therapeutic use
  • Raltegravir Potassium / therapeutic use
  • Retrospective Studies

Substances

  • HIV Integrase Inhibitors
  • doravirine
  • Raltegravir Potassium
  • Anti-HIV Agents
  • Pyridones
  • Heterocyclic Compounds, 3-Ring
  • Integrases