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Effectiveness and Safety of Abacavir, Lamivudine, and Zidovudine in Antiretroviral Therapy-Naive HIV-Infected Patients: Results From a Large Multicenter Observational Cohort

Berenguer, Juan MD*; Pérez-Elías, María Jesús MD; Bellón, José María MA*; Knobel, Hernando MD; Rivas-González, Pablo MD§; Gatell, José María MD; Miguélez, Máximo MD; Hernández-Quero, José MD#; Flores, Juan MD**; Soriano, Vicente MD††; Santos, Ignacio MD‡‡; Podzamczer, Daniel§§; Sala, Monserrat MD∥∥; Camba, Manuel MD, PhD¶¶; Resino, Salvador PhD*the Spanish Abacavir, Lamivudine, and Zidovudine Cohort Study Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: February 1st, 2006 - Volume 41 - Issue 2 - p 154-159
doi: 10.1097/01.qai.0000194231.08207.8a
Clinical Science

Objective: To analyze the safety and effectiveness of abacavir, lamivudine, and zidovudine (ABC/3TC/ZDV) in antiretroviral therapy (ART)-naive HIV-infected patients.

Design: Retrospective observational cohort study.

Methods: We analyzed all consecutive ART-naive HIV-infected patients who initiated ABC/3TC/ZDV in 71 centers throughout Spain and had a clinical visit and laboratory data at least 16 weeks after initiating this regimen. We assessed safety, mortality, new AIDS-defining conditions (ADCs) and treatment failure, the latter defined by any of the following: (1) reduction in plasma HIV-1 viral load (pVL) <1 log during the first 12 weeks of ART, unless it was less than the lower limit of quantification (LOQ); (2) failure to achieve a pVL <LOQ after 24 weeks of ART; and (3) rebound to 2 consecutive pVLs ≥LOQ after achieving a pVL <LOQ.

Results: A total of 730 patients were included, median patient age was 37 years, prior ADCs occurred in 20%, median pVL was 4.76 log, and median CD4 count was 255 cells/mm3; 109 (14.9%) patients had <100 CD4 cells/mm3. After a median follow-up of 50.5 weeks (interquartile ratio: 28-78), 104 (14.25%) patients discontinued therapy because of adverse events and 36 (4.93%) had a suspected hypersensitivity reaction to ABC. The frequency of treatment failure according to an intention-to-treat (ITT) analysis of observed data was 14.4%. In a more rigorous approach considering losses to follow-up and interruptions or switches of therapy as failures, however, the frequency of treatment failure was 22.92%. Factors independently associated with treatment failure by observed data ITT analysis were adherence <90% (hazard ratio [HR] = 4.248, 95% confidence interval [CI]: 2.640 to 6.833), methadone use (HR = 2.116, 95% CI: 1.180 to 3.797), baseline pVL (HR = 1.651, 95% CI: 1.190 to 2.292 per log), and prior ADC (HR = 1.639, 95% CI: 1.009 to 2.662).

Conclusion: The triple-nucleoside regimen of ABC/3TC/ZDV is a reasonable option for ART-naive patients with a pVL <100,000 copies/mL in whom, for any reason, preferred regimens are not advisable, even in patients with a baseline CD4 cell count <100 cells/mm3.

From the *Infectious Diseases and HIV Unit, Hospital Gregorio Marañón, Madrid, Spain; †Infectious Diseases Service, Hospital Ramón y Cajal, Madrid, Spain; ‡Department of Internal Medicine-Infectious Diseases, Hospital del Mar, Barcelona, Spain; §Infectious Diseases Division, Fundación Jiménez Díaz, Madrid, Spain; ∥Infectious Diseases Service, Hospital Clinic Universitari de Barcelona, Barcelona, Spain; ¶Infectious Diseases Unit, Hospital Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain; #Infectious Diseases Unit, San Cecilio University Hospital, Granada, Spain; **Infectious Diseases Unit, Hospital Arnau de Vilanova, Alicante, Spain; ††Infectious Diseases Service, Hospital Carlos III, Madrid, Spain; ‡‡Infectious Disease Unit, Hospital de la Princesa, Madrid, Spain; §§Infectious Disease Service, Hospital Universitari de Bellvitge, Barcelona, Spain; ∥∥Infectious Diseases Service, Consorci Hospitalari Parc Tauli, Sabadell, Spain; and ¶¶Internal Medicine Service, Clinica Povisa, Vigo, Spain.

Received for publication March 8, 2005; accepted October 21, 2005.

Study funded by an unrestricted grant from GlaxoSmithKline.

Reprints: Juan Berenguer, Unidad de Enfermedades Infecciosas/VIH, Hospital Gregorio Marañón (Planta 4100), Doctor Esquerdo 46, 28007 Madrid, Spain (e-mail: juaberber@terra.es).

© 2006 Lippincott Williams & Wilkins, Inc.