title: Maraviroc/raltegravir simplification strategy following 6 months of quadruple therapy with tenofovir/emtricitabine/maraviroc/raltegravir in treatment-naive HIV patients.
abstract: We assessed the virological efficacy of a 6 month maraviroc/raltegravir simplification strategy following 6 months of quadruple therapy combining tenofovir disoproxil fumarate/emtricitabine with maraviroc/raltegravir.
  
  
  
  HIV-1-infected naive patients were enrolled in an open label, single-arm, Phase 2 trial. All patients received maraviroc 300 mg twice daily, raltegravir 400 mg twice daily and tenofovir/emtricitabine for 24 weeks. Patients with stable HIV-RNA <50 copies/mL stopped tenofovir/emtricitabine at week (W) 24 and pursued maraviroc/raltegravir until W48. The primary endpoint was the virological response defined by HIV-RNA <50 copies/mL at W48.
  
  
  
  Thirty-three patients were analysed. Patients were mostly male (94%), Caucasians (91%), MSM (82%); their median age was 42 years. At baseline, median CD4 cell count was 453 cells/mm3and HIV-RNA was 4.3 log copies/mL. All patients had CCR5-tropic viruses by genotropism and phenotropism assays. All but one patient had an HIV-RNA < 50 copies/mL at W24 and entered the simplification phase. Virological success was maintained at W48 in 88% (90% CI 79%-97%) of patients. N155H mutation was detected at failure in one patient. No tropism switch was observed. Raltegravir and maraviroc plasma exposure were satisfactory in 92% and 79% of 41 samples from 21 patients. Five severe adverse events (SAEs) were observed up to W48; none was related to the study drugs. Four patients presented grade 3 AEs; none was related to the study. No grade 4 AE was observed. No patient died.
  
  
  
  Maraviroc/raltegravir maintenance therapy following a 6 month induction phase with maraviroc/raltegravir/tenofovir/emtricitabine was well tolerated and maintained virological efficacy in these carefully selected patients.
authors.affiliation: Centre for Clinical Research, Department of Hepatology, Croix-Rousse Hospital, Hospices Civils de Lyon, Lyon, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Pradat
authors.affiliation: Department of Infectious Diseases, Hôpital de l'Archet, Nice, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Durant
authors.affiliation: Centre for Clinical Research, Department of Hepatology, Croix-Rousse Hospital, Hospices Civils de Lyon, Lyon, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Brochier
authors.affiliation: Department of Virology, Croix-Rousse Hospital, Hospices Civils de Lyon, Lyon, France.
authors.forename: Mary-Anne
authors.initials: MA
authors.lastname: Trabaud
authors.affiliation: Department of Virology, Hôpital de l'Archet, Nice, France.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Cottalorda-Dufayard
authors.affiliation: INSERM U1043, Toulouse, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Izopet
authors.affiliation: Department of Infectious Diseases, Nantes University Hospital, Nantes, France.
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.affiliation: Department of Infectious Diseases, Hôpital Nord, Saint Etienne, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Lucht
authors.affiliation: Department of Pharmacology, Hôpital E. Herriot, Hospices Civils de Lyon, Lyon, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Gagnieu
authors.affiliation: Department of Infectious Diseases, Saint-Louis Hospital, Paris, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Gatey
authors.affiliation: Department of Infectious Diseases, CHU Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Jacomet
authors.affiliation: Department of Internal Medicine, Centre Hospitalier de Cannes, Cannes, France.
authors.forename: Matteo
authors.initials: M
authors.lastname: Vassallo
authors.affiliation: Department of Infectious Diseases, Hôpital de l'Archet, Nice, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Dellamonica
authors.affiliation: Department of Infectious Diseases and Tropical Medicine, Croix-Rousse Hospital, Hospices Civils de Lyon, Lyon, France laurent.cotte@chu-lyon.fr.
authors.forename: Laurent
authors.initials: L
authors.lastname: Cotte
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D003510:Cyclohexanes / Q000008:administration & dosage* / Q000009:adverse effects; D000068679:Emtricitabine / Q000008:administration & dosage; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D060046:Maintenance Chemotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D000068898:Raltegravir Potassium / Q000008:administration & dosage* / Q000009:adverse effects; D000068698:Tenofovir / Q000008:administration & dosage; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D014230:Triazoles; D000068898:Raltegravir Potassium; D000068698:Tenofovir; D000068679:Emtricitabine; D000077592:Maraviroc