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JAC Advance Access originally published online on November 6, 2008
Journal of Antimicrobial Chemotherapy 2009 63(1):189-196; doi:10.1093/jac/dkn450
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Original research

Effectiveness and safety of didanosine, lamivudine and efavirenz versus zidovudine, lamivudine and efavirenz for the initial treatment of HIV-infected patients from the Spanish VACH cohort

Manuel Crespo1, Esteban Ribera1,*, Ignacio Suárez-Lozano2, Pere Domingo3, Enric Pedrol4, José López-Aldeguer5, Agustín Muñoz6, Consuelo Viladés7, Trinitario Sánchez8, Pompeyo Viciana9, Ramón Teira10, María Luisa García-Alcalde11, Antonio Vergara12, Fernándo Lozano13, María José Galindo14, Jaime Cosin15, Bernardino Roca16, Alberto Terrón17, Paloma Geijo18, Francesc Vidal7, Myriam Garrido19 on behalf of the VACH Cohort Study Group

1 Hospital Universitari Vall d’Hebron, Barcelona, Spain 2 Hospital Infanta Elena, Huelva, Spain 3 Hospital de la Santa Creu i de Sant Pau, Barcelona, Spain 4 Hospital General de Granollers, Barcelona, Spain 5 Hospital la Fe, Valencia, Spain 6 Hospital Infanta Cristina, Badajoz, Spain 7 Hospital Joan XXIII, Universitat Rovira I Virgili, Tarragona, Spain 8 Hospital Virgen del Rosell, Cartagena, Murcia, Spain 9 Hospital Virgen del Rocío, Sevilla, Spain 10 Hospital de Basurto, Bilbao, Spain 11 Hospital de Cabueñes, Asturias, Spain 12 Hospital Clínico de Puerto Real, Cadiz, Spain 13 Hospital de Valme, Sevilla, Spain 14 Hospital Clínico, Valencia, Spain 15 Hospital Gregorio Marañon, Madrid, Spain 16 Hospital General de Castellón, Castellón de la Plana, Spain 17 Hospital SAS, Jerez de la Frontera, Cadiz, Spain 18 Hospital Virgen de la Luz, Cuenca, Spain 19 Data Management VACH Group, Huelva, Spain

Received 14 August 2008; returned 12 September 2008; revised 23 September 2008; accepted 2 October 2008

* Correspondence address. Infectious Diseases Division, Hospital Universitari Vall d’Hebron, Paseo Vall d’Hebron 119-129, 08035 Barcelona, Spain. Tel: +34-934894497; E-mail: eribera{at}vhebron.net

Background: Preliminary data suggest that a once-daily combination of lamivudine, didanosine and efavirenz is an effective alternative regimen for antiretroviral-naive HIV-1-infected patients. However, data from randomized trials comparing this combination versus standard first-line regimens are not available yet. In an observational study, we analyse the efficacy and tolerability of didanosine plus lamivudine and efavirenz versus zidovudine plus lamivudine and efavirenz in a cohort of therapy naive patients.

Methods: We performed an observational study on prospectively collected data from patients participating in a multicentre Spanish treatment-naive cohort (VACH cohort). Efficacy was assessed comparing time to therapeutic failure and CD4 cell recovery. Safety was analysed comparing the proportion of patients who discontinued therapy for toxicity or any other reason.

Results: Overall, 219 patients treated with once-daily didanosine/lamivudine/efavirenz and 409 patients receiving twice-daily zidovudine/lamivudine (Combivir®) plus efavirenz were evaluated. By intent-to treat analysis (non-completers and therapeutic change = failure), time to treatment failure was similar in both groups of treatment: 40.0 months (95% CI 23.3–56.8 months) among patients on didanosine/lamivudine/efavirenz and 33.3 months (95% CI 25.6–41.1 months) in patients treated with zidovudine/lamivudine/efavirenz (P = 0.253). The risk of failure due to treatment change was almost double among patients treated with zidovudine/lamivudine/efavirenz compared with those who received didanosine/lamivudine/efavirenz.

Conclusions: Our data suggest that didanosine/lamivudine/efavirenz is a combination with an efficacy comparable to zidovudine/lamivudine/efavirenz as first-line therapy for HIV infection. The risk of treatment change was significantly higher among patients treated with zidovudine/lamivudine/efavirenz than in those starting therapy with didanosine/lamivudine/efavirenz.

Keywords: nucleoside reverse transcriptase inhibitors , naive patients , observational cohort study , once-a-day regimen


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