Nucleoside reverse transcriptase inhibitor (NRTI)- and
protease inhibitor (PI)-sparing antiretroviral regimens may be useful in selected human immune deficiency virus (HIV)-infected patients with resistance or intolerance to these drug classes. This was an observational prospective study of patients on suppressive antiretroviral
therapy containing two NRTIs plus one
ritonavir-boosted PI who switched to a dual regimen containing
raltegravir plus
etravirine. Patients were required not to have prior virological failure to
raltegravir and to have efficacy of
etravirine shown through the genotypic resistance assay in case of prior non-
nucleoside reverse transcriptase inhibitor (NNRTI) virological failure. As a whole, 38 patients were enrolled. The mean duration of current regimen was 4.3 years, and the reason for simplification was toxicity in 29 patients and resistance to NRTIs in 9 patients. After switching, the percentage of patients with HIV
RNA <20 copies/ml at week 48 was 81.6% in the intent-to-treat-exposed analysis. The switch led to a significant reduction in the mean serum
triglyceride levels (-81.2 mg/dl), in the mean total
cholesterol levels (-44.3 mg/dl), and in the prevalence of tubular
proteinuria (-30.2%), with a significant increase in the mean phosphoremia (+0.52 mg/dl) and in both mean lumbar and femoral neck bone mineral density (+6.5% and +4.7%, respectively). Two patients (5.2%) had virological failure due to suboptimal adherence, and five subjects (13.1%) discontinued treatment due to adverse events. In our study, simplification to the dual-
therapy raltegravir plus
etravirine was associated with a good efficacy and tolerability, in addition to a favorable effect on kidney, bone, and serum
lipids.