Scientific article
Open access

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

Published inAIDS, vol. 29, no. 12, p. 1473-1481
Publication date2015-07-31

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 1000 copies/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 50 copies/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 200 copies/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 100 000 copies/ml (n = 122) had a viral load below 50 copies/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.

  • Adult
  • Africa
  • Anti-Retroviral Agents / adverse effects
  • Anti-Retroviral Agents / therapeutic use
  • Antiretroviral Therapy, Highly Active / adverse effects
  • Antiretroviral Therapy, Highly Active / methods
  • Cities
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • HIV Infections / drug therapy
  • HIV-1 / isolation & purification
  • Humans
  • Male
  • Middle Aged
  • Plasma / virology
  • Treatment Outcome
  • Viral Load
Research group
Citation (ISO format)
CIAFFI, Laura et al. Efficacy and safety of three second-line antiretroviral regimens in HIV-infected patients in Africa. In: AIDS, 2015, vol. 29, n° 12, p. 1473–1481. doi: 10.1097/QAD.0000000000000709
Main files (1)
Article (Published version)
ISSN of the journal0269-9370

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