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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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Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
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, Eekh2@pitt.eduEKH2
Hogg, E
Alston-Smith, B
Smith, L
Schooley, R
Mellors, Jjwm1@pitt.eduJWM1
Currier, J
Contributors:
ContributionContributors NameEmailPitt UsernameORCID
EditorDeeks, Steven G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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: 29 Jan 2019 15:55
URI: http://d-scholarship.pitt.edu/id/eprint/12709

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