title: Zidovudine/lamivudine/abacavir plus tenofovir in HIV-infected naive patients: a 96-week prospective one-arm pilot study.
abstract: We evaluated a single-class quadruple nucleoside/nucleotide regimen in a 96-week prospective one-arm pilot study in adult HIV-infected naive patients with CD4 >100 cells/microl. Standard zidovudine/lamivudine/abacavir and tenofovir doses were given. Virologic efficacy was evaluated by intent-to-treat (ITT), switch = failure and on-treatment (OT) analyses. A total of 54 patients were included (median CD4 count 254 cells/microl, VL 79,706 copies/ml). A median drop in VL of 2 log at 14 days and >3 log since week 12 was observed. A total of 34/54 (63%) patients (ITT) and 34/39 (87%) patients (OT) had VL <50 copies/ml at 96 weeks. Four (7%) patients switched therapy due to adverse events, 5 (9%) had virologic failure, and 1 died. Similar efficacy results were observed irrespective of baseline VL (> or <5 log) or CD4 cells (> or <250/microl). A median CD4 gain of +223 cells/microl was achieved. K65R + 41L + 219Q were detected in one patient at virologic failure. Only two patients presented fat loss on clinical evaluation. A decrease in total cholesterol (p = 0.007) and LDLc (p = 0.016) was observed. Our data suggest that zidovudine/lamivudine/abacavir plus tenofovir is a simple, effective, and well-tolerated NNRTI/PI-sparing regimen, even for patients with high viral loads. Larger trials comparing this option with standard initial antiretroviral regimens should be conducted.
authors.affiliation: Infectious Disease and Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain. eferrer@csub.scs.es
authors.forename: Elena
authors.initials: E
authors.lastname: Ferrer
authors.forename: Jose Maria
authors.initials: JM
authors.lastname: Gatell
authors.forename: Pochita
authors.initials: P
authors.lastname: Sanchez
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Teresa
authors.initials: T
authors.lastname: Puig
authors.forename: Jordi
authors.initials: J
authors.lastname: Niubo
authors.forename: Cristina
authors.initials: C
authors.lastname: Cortes
authors.forename: Sergio
authors.initials: S
authors.lastname: Veloso
authors.forename: Enric
authors.initials: E
authors.lastname: Pedrol
authors.forename: Agathe
authors.initials: A
authors.lastname: Leon
authors.forename: Mar
authors.initials: M
authors.lastname: Gutierrez
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015224:Dideoxynucleosides / Q000627:therapeutic use*; D023381:Endpoint Determination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D010865:Pilot Projects; D011446:Prospective Studies; D013030:Spain; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use*; D000099227:Abacavir
chemical_list: D000225:Adenine; D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D019259:Lamivudine; D063065:Organophosphonates; D000068698:Tenofovir; D015215:Zidovudine; D000099227:Abacavir