Efficacy and safety of three second-line antiretroviral regimens in HIV-infected patients in Africa.

摘要: OBJECTIVE: WHO recommends ritonavir-boosted protease inhibitor with two nucleoside reverse transcriptase inhibitors in HIV-infected patients failing non-nucleoside inhibitor-based first-line treatment. Here we aimed to provide more evidence for the choice of and boosted inhibitor. DESIGN: ANRS 12169 is a 48-week randomized open-label non-inferiority trial three African cities comparing efficacy safety second-line regimens. METHODS: Patients antiretroviral therapy confirmed plasma HIV-1 viral load above 1000 copies/ml were randomly assigned tenofovir/emtricitabine + lopinavir/ritonavir (control group as per recommendations) abacavir didanosine (ABC/ddI group) or darunavir/ritonavir (DRV The primary endpoint was proportion vral below 50 at week 48 modified intention-to-treat population. Non-inferiority pre-specified 15% margin. RESULTS: Of 454 451 included analysis. Globally 294 (65.2%) 375 (83.2%) had 200 respectively 48. achieved 105 (69.1%) control versus 92 (63.4%) ABC/ddI (difference 5.6% 95% confidence interval -5.1 16.4) 97 (63.0%) DRV 6.1% -4.5 16.7) groups (non-inferiority not shown). Overall less number baseline least 100 000 (n = 122) (37.7 75.4%; P < 0.001). CONCLUSIONS: regimens obtained similar satisfactory virologic recommendation (TDF/FTC/LPVr) valid option. However suboptimal response high warrants research improved strategies.