title: Dual Raltegravir-Etravirine Combination as Maintenance Regimen in Virologically Suppressed HIV-1-Infected Patients.
abstract: 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.
authors.affiliation: 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Leonardo
authors.initials: L
authors.lastname: Calza
authors.affiliation: 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Eleonora
authors.initials: E
authors.lastname: Magistrelli
authors.affiliation: 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Colangeli
authors.affiliation: 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Roberto
authors.initials: R
authors.lastname: Manfredi
authors.affiliation: 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Marco
authors.initials: M
authors.lastname: Borderi
authors.affiliation: 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Nicolo'
authors.initials: N
authors.lastname: Rossi
authors.affiliation: 2 Centralized Laboratory, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Matteo
authors.initials: M
authors.lastname: Conti
authors.affiliation: 2 Centralized Laboratory, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Rita
authors.initials: R
authors.lastname: Mancini
authors.affiliation: 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, "Alma Mater Studiorum" University of Bologna , S. Orsola-Malpighi Hospital, Bologna, Italy .
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Viale
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D011446:Prospective Studies; D011724:Pyridazines / Q000008:administration & dosage*; D011743:Pyrimidines; D000068898:Raltegravir Potassium / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; C451734:etravirine; D000068898:Raltegravir Potassium
keywords: dual therapy; etravirine; raltegravir; switch; toxicity