Long-term effectiveness and safety of didanosine combined with lamivudine and efavirenz or nevirapine in antiretroviral-naive patients: a 9-year cohort study in Senegal Christian Laurent 1 , Jules Brice Tchatchueng Mbougua 1,2 , Nde `ye Fatou Ngom Gue `ye 3 , Jean-Franc ¸ois Etard 1 , Assane Diouf 4 , Roland Landman 5,6 , Nicolas Molinari 7,8 , Pierre-Marie Girard 5,6 , Papa Salif Sow 4,9 , Ibra Ndoye 10 and Eric Delaporte 1,11 for the ANRS 1215 / 1290 Study Group* 1 Institut de Recherche pour le De ´veloppement, University Montpellier 1, UMR 145, Montpellier, France 2 National Advanced School of Engineering, University Yaounde ´ 1, Yaounde ´, Cameroon 3 Ambulatory Care Unit, Fann University Teaching Hospital, Dakar, Senegal 4 Regional Research and Training Centre for HIV / AIDS, Fann University Teaching Hospital, Dakar, Senegal 5 Institut de Me ´decine et d’Epide ´miologie Applique ´e, Paris, France 6 Department of Infectious Diseases, Bichat-Claude Bernard Hospital, Paris, France 7 Department of Biostatistics, University Montpellier 1, Montpellier, France 8 Department of Biostatistics, University Hospital, Nı ˆmes, France 9 Department of Infectious Diseases, Fann University Teaching Hospital, Dakar, Senegal 10 National AIDS Program, Ministry of Health, Dakar, Senegal 11 Department of Infectious and Tropical Diseases, University Hospital, Montpellier, France Summary objective The use of didanosine (ddI) in first-line antiretroviral therapy has been recently promoted for resource-limited settings. We therefore compared the long-term effectiveness and safety of the regimen combining ddI, lamivudine, and efavirenz or nevirapine with that of the WHO-recommended regimen of zidovudine (ZDV), lamivudine, and efavirenz or nevirapine in antiretroviral-naı¨ve patients in Senegal. methods Observational cohort study of patients enrolled between January 2000 and April 2002 in the Senegalese antiretroviral drug access initiative. Multivariate analyses were performed to compare, between the ddI and ZDV groups, the proportion of patients with a viral load <500 copies / ml during follow-up; the increase in the CD4 cell count; survival; treatment changes and severe adverse events. results Of 151 patients, 71 received the ddI-based treatment and 80 received the ZDV-based treat- ment. Throughout follow-up, 80–95% of patients had a viral load below 500 copies / ml in both the ddI and ZDV groups (P = 0.5). The CD4 cell count increased after treatment initiation from 176 to 497 cells / mm 3 in the ddI group and from 176 to 567 cells / mm 3 in the ZDV group (P > 0.3). The rate of death tended to be higher in the ddI group (P = 0.06). ddI was less commonly discontinued than ZDV (P = 0.03). conclusion The combination of ddI, lamivudine, and efavirenz or nevirapine resulted in sustained viral suppression and immunological recovery. keywords Africa, HIV, antiretroviral therapy, didanosine, zidovudine Introduction First-line combination antiretroviral therapy (ART) rec- ommended by WHO in resource-limited countries consists of one non-nucleoside reverse transcriptase inhibitor (NNRTI; efavirenz or nevirapine) and two nucleoside reverse transcriptase inhibitors (NRTI). The preferred NRTI backbones are now zidovudine (ZDV) plus lamivudine or tenofovir plus either lamivudine or emtricitabine (World Health Organization, 2010). But the use of ZDV, although common, is hindered by frequent haematological disorders (especially severe anaemia) of various origins, including the HIV infection itself, other infectious diseases and malnu- trition (Colebunders et al. 2005; Moh et al. 2005). Ten- ofovir has only been adopted by few African programmes because of its high cost until recently and concerns about *See Appendix. Tropical Medicine and International Health doi:10.1111/j.1365-3156.2010.02690.x volume 16 no 2 pp 217–222 february 2011 ª 2010 Blackwell Publishing Ltd 217