title: Dual therapy with etravirine plus raltegravir for virologically suppressed HIV-infected patients: a pilot study.
abstract: BACKGROUND
  Clinical use of protease inhibitors (PIs) and nucleoside reverse transcriptase inhibitors (NRTIs) may be hampered by toxicity, interactions or resistance issues. Simple and effective antiretroviral regimens avoiding both drug classes may be needed for selected patients.
  
  
  METHODS
  This was a prospective cohort study. Virologically suppressed patients on PI or NRTI regimens, with problems of tolerability, safety concerns due to comorbidities or risk of drug interactions for both PIs and NRTIs, were given the opportunity to switch their regimen to etravirine plus raltegravir. Patients were required not to have prior virological failure to raltegravir and if there was prior non-nucleoside reverse transcriptase inhibitor (NNRTI) virological failure, only patients in whom efficacy of etravirine could be anticipated through the Stanford Drug Resistance Database were included. Follow-up was scheduled for at least 48 weeks, unless the patient was lost to follow-up or discontinued therapy.
  
  
  RESULTS
  Twenty-five patients were included. Their median age was 54 years; they had a median of 16 years on antiretroviral therapy and a median of nine previous regimens; 21 (84%) patients had previous virological failure; and 15 (60%) patients had a genotypic test that showed three or more NRTI mutations in 9 (36%), four or more PI mutations in 11 (44%) and at least one NNRTI mutation in 8 (32%) patients. At 48 weeks efficacy was 84% (95% CI 65.3%-93.6%) by intent-to-treat analysis and 91.3% (95% CI 73.2%-97.6%) by per-protocol analysis. One (4%) patient died, two (8%) discontinued due to intolerance and one (4%) experienced virological failure. The CD4/CD8 ratio and plasma lipids improved.
  
  
  CONCLUSIONS
  Dual therapy with etravirine plus raltegravir was well tolerated and maintained durable viral suppression in selected virologically suppressed patients for whom both PI and NRTI therapy was challenging.
authors.affiliation: Infectious Diseases Unit, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain.
authors.forename: Polyana
authors.initials: P
authors.lastname: Monteiro
authors.forename: Iñaki
authors.initials: I
authors.lastname: Perez
authors.forename: Montserrat
authors.initials: M
authors.lastname: Laguno
authors.forename: Maria
authors.initials: M
authors.lastname: Martínez-Rebollar
authors.forename: Ana
authors.initials: A
authors.lastname: González-Cordon
authors.forename: Montserrat
authors.initials: M
authors.lastname: Lonca
authors.forename: Josep
authors.initials: J
authors.lastname: Mallolas
authors.forename: Jose L
authors.initials: JL
authors.lastname: Blanco
authors.forename: Jose M
authors.initials: JM
authors.lastname: Gatell
authors.forename: Esteban
authors.initials: E
authors.lastname: Martínez
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D010865:Pilot Projects; D011446:Prospective Studies; D011724:Pyridazines / Q000008:administration & dosage* / Q000009:adverse effects; D011743:Pyrimidines; D011760:Pyrrolidinones / Q000008:administration & dosage* / Q000009:adverse effects; D000068898:Raltegravir Potassium; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; D011760:Pyrrolidinones; C451734:etravirine; D000068898:Raltegravir Potassium
keywords: PI/NRTI sparing regimen; antiretroviral therapy efficacy; dual antiretroviral therapy