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

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 m 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 m (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.