Ciaffi L. auteur aut IRD Koulla-Shiro S. auteur aut IRD Sawadogo A. auteur aut IRD le Moing V. auteur aut IRD Eymard-Duvernay Sabrina auteur aut IRD Izard Suzanne auteur aut IRD Kouanfack C. auteur aut IRD Gueye N. F. N. auteur aut IRD Aghokeng Fobang Avelin auteur aut IRD Reynes J. auteur aut IRD Calmy A. auteur aut IRD Delaporte Eric auteur aut IRD text journalArticle eng text/pdf born digital access Objective: WHO recommends ritonavir-boosted protease inhibitor with two nucleoside reverse transcriptase inhibitors in HIV-infected patients failing non-nucleoside reverse transcriptase inhibitor-based first-line treatment. Here, we aimed to provide more evidence for the choice of nucleoside reverse transcriptase inhibitor and boosted protease inhibitor. Design: ANRS 12169 is a 48-week, randomized, open-label, non-inferiority trial in three African cities, comparing efficacy and safety of three second-line regimens. Methods: Patients failing non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy with confirmed plasma HIV-1 viral load above 1000copies/ml were randomly assigned to tenofovir/emtricitabine + lopinavir/ritonavir (control group as per WHO recommendations), abacavir + didanosine + lopinavir/ritonavir (ABC/ddI group) or tenofovir/emtricitabine + darunavir/ritonavir (DRV group) regimens. The primary endpoint was the proportion of patients with plasma vral load below 50copies/ml at week 48 in the modified intention-to-treat population. Non-inferiority was pre-specified with a 15% margin. Results: Of the 454 randomized patients, 451 were included in the analysis. Globally, 294 (65.2%) and 375 (83.2%) patients had viral load below 50 and 200copies/ml, respectively, at week 48. The primary endpoint was achieved in 105 (69.1%) control group patients versus 92 (63.4%) in the ABC/ddI (difference 5.6%, 95% confidence interval -5.1 to 16.4) and 97 (63.0%) in the DRV (difference 6.1%, 95% confidence interval -4.5 to 16.7) groups (non-inferiority not shown). Overall, less number of patients with baseline viral load at least 100000copies/ml (n=122) had a viral load below 50copies/ml at week 48 (37.7 versus 75.4%; P<0.001). Conclusions: The three second-line regimens obtained similar and satisfactory virologic control and confirmed the WHO recommendation (TDF/FTC/LPVr) as a valid option. However, the suboptimal response for patients with high viral load warrants research for improved strategies. specialized Africa HIV randomized clinical trial second-line antiretroviral therapy CAMEROUN SENEGAL BURKINA FASO 052 050 29 12 1473-1481 2015 0269-9370 https://www.documentation.ird.fr/hor/fdi:010065440 10.1097/qad.0000000000000709 0269-9370 [F B010065440] https://www.documentation.ird.fr/hor/fdi:010065440 https://www.documentation.ird.fr/intranet/publi/2015/12/010065440.pdf Accès réservé (Intranet de l'IRD) IRD - Base Horizon / Pleins textes 2016-01-14 2025-03-19 fdi:010065440 fre