title: Long-term efficacy and toxicity of abacavir/lamivudine/nevirapine compared to the most prescribed ARV regimens before 2013 in a French Nationwide Cohort Study.
abstract: Data on the long-term efficacy and safety of abacavir/lamivudine (ABC/3TC) and nevirapine (NVP) are scarce. This combination has the advantage of simplifying treatment and improving long-term tolerance. The aim of this study was to compare the rate of any discontinuation of antiretroviral (ARV) regimen because of virologic failure (VF), and/or adverse drug reaction (ADR) among patients receiving stable ARV regimens for at least 6 months.ABC/3TC/NVP was compared to ABC/3TC with either ritonavir-boosted darunavir (DRV/r) or ritonavir-boosted atazanavir (ATV/r), unboosted ATV, or tenofovir/emtricitabine (TDF/FTC) with either one of the following: ATV/r, unboosted ATV, DRV/r, efavirenz (EFV), or NVP, in the French prospective multicenter Dat'AIDS cohort.The study enrolled 16,511 patients treated with following ARV regimens: ABC/3TC/NVP (n = 1089), TDF/FTC/NVP (n = 1542), ABC/3TC/DRV/r (n = 1065), ABC/3TC/ATV/r (n = 1847), ABC/3TC/ATV (n = 563), TDF/FTC/ATV/r (n = 3519), TDF/FTC/DRV/r (n = 2767), TDF/FTC/ATV (n = 419), and TDF/FTC/EFV (n = 3700). Mean follow-up was 36 ± 24 months. Patients treated with ABC/3TC/NVP received this regimen as a switch regimen in 97% of cases. By multivariable analysis, the risk of treatment discontinuation due to VF was similar between ABC/3TC/NVP and other ARV regimens, except for TDF/FTC/ATV and ABC/3TC/ATV, which were associated with a higher risk of treatment interruption due to VF (hazard ratio [HR] 1.99; 95% confidence interval [CI] 1.29-3.06 and HR 2.19; 95% CI 1.51-3.18, respectively). Treatment discontinuation due to ADR was lowest with the ABC/3TC/NVP regimen. Other ARV regimens were associated with a 1.80- to 3.19-fold increase in the risk of treatment discontinuation due to ADR (P < 0.0001 for all comparisons).ABC/3TC/NVP as a simplification regimen is a long-term effective regimen with lower discontinuation due to long-term toxicity compared with other standard ARV regimens.
authors.affiliation: Department of Research and Innovation, Reims Teaching Hospitals, Robert Debré Hospital Faculty of Medicine, University of Reims Champagne-Ardenne, Reims Department of Infectious Diseases, University Hospital, Nantes Department of Infectious and Tropical Diseases, Martinique Teaching Hospitals, Fort-De-France Hospital, Fort-De-France, Martinique Aix-Marseille University, APHM Hôpital Sainte-Marguerite, Immuno-Hematology Clinic, Marseille, France Inserm U912 (SESSTIM), Marseille, France Hospices Civils de Lyon, Service des Maladies Infectieuses et Tropicales, INSERM U1052, Lyon Laboratoire de pharmacologie, Université de Nice-Sophia-Antipolis, Hôpital Pasteur, CHU de Nice, Nice Cedex 1 CHU de Toulouse, Service des Maladies Infectieuses et Tropicales, INSERM UMR1043, Université Toulouse III Paul Sabatier, Toulouse Centre Hospitalier Tourcoing, Service Universitaire de Maladies Infectieuses et du Voyageur, Tourcoing Le Trait d'Union, Centre de Soins de l'Infection par le VIH, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg Department of Internal Medicine, Infectious Diseases, and Clinical Immunology, Reims Teaching Hospitals, Robert Debré Hospital Faculté de médecine, EA-4684/SFR CAP-SANTE, Université de Reims Champagne-Ardenne, Reims, France.
authors.forename: Paul
authors.initials: P
authors.lastname: de Boissieu
authors.forename: Moustapha
authors.initials: M
authors.lastname: Dramé
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: André
authors.initials: A
authors.lastname: Cabie
authors.forename: Isabelle
authors.initials: I
authors.lastname: Poizot-Martin
authors.forename: Laurent
authors.initials: L
authors.lastname: Cotte
authors.forename: Rodolphe
authors.initials: R
authors.lastname: Garraffo
authors.forename: Pierre
authors.initials: P
authors.lastname: Delobel
authors.forename: Thomas
authors.initials: T
authors.lastname: Huleux
authors.forename: David
authors.initials: D
authors.lastname: Rey
authors.forename: Firouzé
authors.initials: F
authors.lastname: Bani-Sadr
mesh_terms: D000328:Adult; D015224:Dideoxynucleosides / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005602:France; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000627:therapeutic use; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D000099227:Abacavir
chemical_list: D015224:Dideoxynucleosides; D019259:Lamivudine; D019829:Nevirapine; D018894:Reverse Transcriptase Inhibitors; D000099227:Abacavir