@article{fdi:010065440, title = {{E}fficacy and safety of three second-line antiretroviral regimens in {HIV}-infected patients in {A}frica}, author = {{C}iaffi, {L}. and {K}oulla-{S}hiro, {S}. and {S}awadogo, {A}. and le {M}oing, {V}. and {E}ymard-{D}uvernay, {S}abrina and {I}zard, {S}uzanne and {K}ouanfack, {C}. and {G}ueye, {N}. {F}. {N}. and {A}ghokeng {F}obang, {A}velin and {R}eynes, {J}. and {C}almy, {A}. and {D}elaporte, {E}ric}, editor = {}, language = {{ENG}}, abstract = {{O}bjective: {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. {H}ere, we aimed to provide more evidence for the choice of nucleoside reverse transcriptase inhibitor and boosted protease inhibitor. {D}esign: {ANRS} 12169 is a 48-week, randomized, open-label, non-inferiority trial in three {A}frican cities, comparing efficacy and safety of three second-line regimens. {M}ethods: {P}atients 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}/dd{I} group) or tenofovir/emtricitabine + darunavir/ritonavir ({DRV} group) regimens. {T}he primary endpoint was the proportion of patients with plasma vral load below 50copies/ml at week 48 in the modified intention-to-treat population. {N}on-inferiority was pre-specified with a 15% margin. {R}esults: {O}f the 454 randomized patients, 451 were included in the analysis. {G}lobally, 294 (65.2%) and 375 (83.2%) patients had viral load below 50 and 200copies/ml, respectively, at week 48. {T}he primary endpoint was achieved in 105 (69.1%) control group patients versus 92 (63.4%) in the {ABC}/dd{I} (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). {O}verall, 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). {C}onclusions: {T}he three second-line regimens obtained similar and satisfactory virologic control and confirmed the {WHO} recommendation ({TDF}/{FTC}/{LPV}r) as a valid option. {H}owever, the suboptimal response for patients with high viral load warrants research for improved strategies.}, keywords = {{A}frica ; {HIV} ; randomized clinical trial ; second-line antiretroviral therapy ; {CAMEROUN} ; {SENEGAL} ; {BURKINA} {FASO}}, booktitle = {}, journal = {{A}ids}, volume = {29}, numero = {12}, pages = {1473--1481}, ISSN = {0269-9370}, year = {2015}, DOI = {10.1097/qad.0000000000000709}, URL = {https://www.documentation.ird.fr/hor/fdi:010065440}, }