Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in africa: A randomized trial

Lockman, S and Hughes, M and Sawe, F and Zheng, Y and McIntyre, J and Chipato, T and Asmelash, A and Rassool, M and Kimaiyo, S and Shaffer, D and Hosseinipour, M and Mohapi, L and Ssali, F and Chibowa, M and Amod, F and Halvas, E and Hogg, E and Alston-Smith, B and Smith, L and Schooley, R and Mellors, J and Currier, J (2012) Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in africa: A randomized trial. PLoS Medicine, 9 (6). 15 - ?. ISSN 1549-1277

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Abstract

Background: Nevirapine (NVP) is widely used in antiretroviral treatment (ART) of HIV-1 globally. The primary objective of the AA5208/OCTANE trial was to compare the efficacy of NVP-based versus lopinavir/ritonavir (LPV/r)-based initial ART. Methods and Findings: In seven African countries (Botswana, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe), 500 antiretroviral-naïve HIV-infected women with CD4<200 cells/mm3 were enrolled into a two-arm randomized trial to initiate open-label ART with tenofovir (TDF)/emtricitabine (FTC) once/day plus either NVP (n = 249) or LPV/r (n = 251) twice/day, and followed for ≥48 weeks. The primary endpoint was time from randomization to death or confirmed virologic failure ([VF]) (plasma HIV RNA<1 log10 below baseline 12 weeks after treatment initiation, or ≥400 copies/ml at or after 24 weeks), with comparison between treatments based on hazard ratios (HRs) in intention-to-treat analysis. Equivalence of randomized treatments was defined as finding the 95% CI for HR for virological failure or death in the range 0.5 to 2.0. Baseline characteristics were (median): age = 34 years, CD4 = 121 cells/mm3, HIV RNA = 5.2 log10copies/ml. Median follow-up = 118 weeks; 29 (6%) women were lost to follow-up. 42 women (37 VFs, five deaths; 17%) in the NVP and 50 (43 VFs, seven deaths; 20%) in the LPV/r arm reached the primary endpoint (HR 0.85, 95% CI 0.56-1.29). During initial assigned treatment, 14% and 16% of women receiving NVP and LPV/r experienced grade 3/4 signs/symptoms and 26% and 22% experienced grade 3/4 laboratory abnormalities. However, 35 (14%) women discontinued NVP because of adverse events, most in the first 8 weeks, versus none for LPV/r (p<0.001). VF, death, or permanent treatment discontinuation occurred in 80 (32%) of NVP and 54 (22%) of LPV/r arms (HR = 1.7, 95% CI 1.2-2.4), with the difference primarily due to more treatment discontinuation in the NVP arm. 13 (45%) of 29 women tested in the NVP versus six (15%) of 40 in the LPV/r arm had any drug resistance mutation at time of VF. Conclusions: Initial ART with NVP+TDF/FTC demonstrated equivalent virologic efficacy but higher rates of treatment discontinuation and new drug resistance compared with LPV/r+TDF/FTC in antiretroviral-naïve women with CD4<200 cells/mm3. Trial registration: ClinicalTrials.gov NCT00089505. © 2012 Lockman et al.

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Details

Item Type:	Article
Status:	Published
Creators/Authors:	Creators Email Pitt Username ORCID Lockman, S Hughes, M Sawe, F Zheng, Y McIntyre, J Chipato, T Asmelash, A Rassool, M Kimaiyo, S Shaffer, D Hosseinipour, M Mohapi, L Ssali, F Chibowa, M Amod, F Halvas, E ekh2@pitt.edu EKH2 Hogg, E Alston-Smith, B Smith, L Schooley, R Mellors, J jwm1@pitt.edu JWM1 Currier, J
Contributors:	Contribution Contributors Name Email Pitt Username ORCID Editor Deeks, Steven G. UNSPECIFIED UNSPECIFIED UNSPECIFIED
Date:	1 January 2012
Date Type:	Publication
Journal or Publication Title:	PLoS Medicine
Volume:	9
Number:	6
Page Range:	15 - ?
DOI or Unique Handle:	10.1371/journal.pmed.1001236
Refereed:	Yes
ISSN:	1549-1277
PubMed Central ID:	PMC3373629
PubMed ID:	22719231
Date Deposited:	11 Jul 2012 18:10
Last Modified:	19 Jun 2021 10:55
URI:	http://d-scholarship.pitt.edu/id/eprint/12709

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