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First-line therapy with LPV/r vs NVP and 2 NRTIs in a developing country: W144 of a randomized trial


In resource-limited countries, NNRTI-based regimen may result in emergence of more HIV drug resistance because of a low genetic barrier. We compare the efficacy and tolerance of LPV/r and NVP-based regimens and 2 WHO nucleoside backbones in naive HIV infected patients (p.).

Materials and methods

Naive p. from 5 clinics in Lubumbashi (Congo-DRC) were randomized to receive LPV/r versus NVP combined with TDF/FTC or ZDV/3TC. VL and CD4 were performed at baseline (BL) and every 24 weeks (W). The primary endpoint was the % of p. with therapeutic failure defined as clinical and virologic failures (VL>1000 c/ml)(missing data=failure), assessed at W48 and 96. We present here the results of 144 W of follow-up.


425 Black African p. (72% female; median (md) age 38 years, md CD4 165/µL; md VL 5.2 log c/ml) were randomized (216 in LPV/r, 209 in NVP). BL characteristics were comparable. In the ITT analysis, previous results showed no difference between LPV/r and NVP treatment arms at W96 except a higher proportion of virologic failure (VF) in p. on NVP-based regimens. W144 ITT analysis showed a significant difference on endpoints between LPV/r (94/216) and NVP (111/209)(p=0.0479) and persistence of a significant difference in VF rate (20/216 vs 37/209 for LPV/r and NVP, respectively)(p= 0.015). BL genotypes showed NNRTI mutations (mt) in 3/31 NVP-failing p. and no PI mt in LPV/r-failing patients. At time of failure, NNRTI mt were seen in 23/26 NVP-failing p. and 0/13 primary PI mt in LPV/r failing patients. NRTI mt were seen in 19/26 p. in NVP arm (including K65R in 7p. and M184V in 18p.) vs 3/13p. in LPV/r arm (M184V in 3p.).

Md CD4 change from BL was significant higher in LPV/r arm (251 cells/µL [interquartile range (IQR) 153;384]) compared with NVP arm (174 cells/µL [IQR 102-330])(p= 0.0093). Percentage of p. with adherence >95% was similar (73.6 vs 74.4 for LPV/r vs NVP).


In a resource-limited setting after 144 weeks of follow-up NNRTI-NRTI first-line regimen is associated with more virologic failure, more drug resistance mutations and a lower immunologic response than a PI-based regimen.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

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Clumeck, N., Mwamba, C., Kabeya, K. et al. First-line therapy with LPV/r vs NVP and 2 NRTIs in a developing country: W144 of a randomized trial. BMC Infect Dis 14 (Suppl 2), O2 (2014).

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