%0 Journal Article
%9 ACL : Articles dans des revues avec comité de lecture répertoriées par l'AERES
%A Ciaffi, L.
%A Koulla-Shiro, S.
%A Sawadogo, A.
%A le Moing, V.
%A Eymard-Duvernay, Sabrina
%A Izard, Suzanne
%A Kouanfack, C.
%A Gueye, N. F. N.
%A Aghokeng Fobang, Avelin
%A Reynes, J.
%A Calmy, A.
%A Delaporte, Eric
%T Efficacy and safety of three second-line antiretroviral regimens in HIV-infected patients in Africa
%D 2015
%L fdi:010065440
%G ENG
%J Aids
%@ 0269-9370
%K Africa ; HIV ; randomized clinical trial ; second-line antiretroviral therapy
%K CAMEROUN ; SENEGAL ; BURKINA FASO
%M ISI:000364394700001
%N 12
%P 1473-1481
%R 10.1097/qad.0000000000000709
%U https://www.documentation.ird.fr/hor/fdi:010065440
%> https://www.documentation.ird.fr/intranet/publi/2015/12/010065440.pdf
%V 29
%W Horizon (IRD)
%X 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.
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