Efficacy and safety of nucleoside-sparing regimen based on raltegravir and ritonavir-boosted darunavir in HIV-1-infected treatment-experienced patients

J Med Virol. 2017 Dec;89(12):2122-2129. doi: 10.1002/jmv.24826. Epub 2017 Aug 31.

Abstract

Aim: To assess the efficacy and tolerability of dual therapy containing raltegravir (RAL) and ritonavir boosted darunavir (DRV/r) in HIV-1-infected treatment-experienced patients.

Method: Retrospective analysis of 81 HIV-1-infected treatment-experienced patients (56 male and 25 female, 5 Polish centers) who switched to RAL/DRV/r.

Results: The main reasons for the introduction of dual therapy were renal dysfunction (16/81 patients-19.8%) and virologic failure on previous regimens (15/81 patients-18.5%). At 48 weeks the treatment was continued in 58/81 (71.6% of patients). In three patients the therapy was discontinued because of virologic failure. However, no mutations to DRV or integrase inhibitors (InI) were detected. At 48 weeks of treatment CD4+ lymphocyte count increased statistically significantly (median 121 cells/μL) P < 0.005. The main reasons for the discontinuation of therapy were treatment simplification (11/23-47.8% patients), adverse events (7/23 patients 30.4%), virologic failure (3/23 patients 13.0%). All patients who switched to RAL/DRV/r therapy because of prior renal impairment were maintained on the treatment for 48 weeks. In this group, before the introduction of dual therapy eGFR (estimated glomerular filtration rate) <60 mL/min/1.72 m2 was reported in nine patients and after 48 weeks in four patients (56.3% vs 25%) (P > 0.05). We found a statistically significant decrease in the prevalence of proteinuria or eGFR <60 mL/min/1.72 m2 (93.8% vs 37.5%; P = 0.004 before and after the introduction of dual therapy, respectively).

Conclusions: Dual therapy was effective and safe for the vast majority of antiretroviral-experienced subjects. Such therapy can be recommended especially for patients with renal impairment or NRTIs intolerance.

Keywords: ARV; DRV/r; HIV; RAL; dual therapy; kidney; lipids.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects*
  • Anti-HIV Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Darunavir / administration & dosage
  • Darunavir / adverse effects
  • Darunavir / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV Protease Inhibitors / administration & dosage
  • HIV Protease Inhibitors / adverse effects
  • HIV Protease Inhibitors / therapeutic use*
  • HIV-1 / drug effects
  • Humans
  • Kidney / drug effects
  • Male
  • Middle Aged
  • Proteinuria / etiology
  • RNA, Viral
  • Raltegravir Potassium / administration & dosage
  • Raltegravir Potassium / adverse effects
  • Raltegravir Potassium / therapeutic use*
  • Retrospective Studies
  • Viral Load / drug effects

Substances

  • Anti-HIV Agents
  • HIV Protease Inhibitors
  • RNA, Viral
  • Raltegravir Potassium
  • Darunavir