Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study

AIDS Res Ther. 2023 Jan 3;20(1):1. doi: 10.1186/s12981-022-00499-4.

Abstract

Objectives: We assessed the virologic efficacy of switching to co-formulated elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (E/C/F/TDF) in patients with controlled HIV infection.

Methods: We conducted a retrospective multicenter observational cohort study including adult patients with controlled HIV-1 infection on any stable antiretroviral (ART) regimen, who switched to E/C/F/TDF. Success was measured by the proportion of patients with plasma viral load < 50 copies/ml at W48 using the FDA snapshot algorithm. We also assessed risk factors associated with virological failure (VF).

Results: 382 patients with HIV RNA < 50 copies/mL who switched to E/C/F/TDF were included in the study. Most patients (69.9%) were male, with median age 44 years (IQR 38-51), who had been on ART for a median of 7 years (IQR 4-13). Median CD4 count was 614/mm3 and 24.6% of the patients had a history of previous virological failure. The reasons for switching were simplification (67.0%) and tolerance issues (22.0%). At week 48, 314 (82.0% [95% CI 78.4-86.0]) patients had HIV RNA < 50 copies/mL, 13 (3.5% [95% CI 3.64-8.41]) experienced virological failure. Genotype at failure was available in 6/13 patients with detection of resistance-associated mutations to integrase inhibitors and NRTIs in 5/6 (83.3%) patients. We found no predictive factor associated with virological failure except for a borderline significance with the duration of viral suppression before the switch. Tolerability of E/C/F/TDF was good with 23/382 (6.0%) patients experiencing mild adverse reactions.

Conclusion: In our cohort, switching well-suppressed patients to E/C/F/TDF resulted in few virologic failures and was well tolerated. However, resistance to integrase inhibitors emerged in patients with virological failure.

Keywords: E/C/F/TDF; integrase resistance; switch; virologic efficacy.

Publication types

  • Observational Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents* / adverse effects
  • Cobicistat / adverse effects
  • Cobicistat / therapeutic use
  • Cohort Studies
  • Emtricitabine / adverse effects
  • Emtricitabine / therapeutic use
  • Female
  • HIV Infections* / drug therapy
  • Humans
  • Integrase Inhibitors / therapeutic use
  • Male
  • RNA
  • Tenofovir / adverse effects
  • Tenofovir / therapeutic use

Substances

  • Tenofovir
  • Emtricitabine
  • Cobicistat
  • elvitegravir
  • Anti-HIV Agents
  • Integrase Inhibitors
  • RNA