Annals of Tropical Medicine and Public Health
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Year : 2012  |  Volume : 5  |  Issue : 4  |  Page : 344-348

Approaches to effectively documenting prior single dose nevirapine exposure among women in Africa

1 Deputy Director, Clinical HIV Research Unit (CHRU), University of the Witwatersrand, Johannesburg, South Africa
2 Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, M.A., USA
3 Clinical Director, University of North Carolina Project, Lilongwe, Malawi
4 Division of Infectious Diseases, University of Pittsburgh Medical Centre, P.A, USA
5 Deputy Director, HIV Care and Research, Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya
6 Virologist, Johns Hopkins University School of Medicine, Baltimore, MD, USA
7 CRS Leader, Soweto ACTG CRS, Perinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa
8 University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe
9 Botswana-Harvard AIDS Institute, Gaborone, Botswana
10 Associate Professor and Site P.I., University of Alabama at Birmingham/CIDRZ, Lusaka, Zambia
11 Department of Medicine, Moi University School of Medicine, Eldoret, Kenya
12 Study Coordinator, Joint Clinical Research Centre, Kampala, Uganda
13 University of KwaZulu Natal, South Africa
14 Clinical Trials Specialist, Social and Scientific Systems Inc, Silver Spring, MD, USA
15 ACTG International Site Liaison, Social and Scientific Systems Inc, Silver Spring, MD, USA
16 Professor of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
17 Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA, USA
18 Executive Director, Perinatal HIV Research Unit (PHRU) and Associate Professor, Department of Obstetrics and Gynaecology, University of the Witwatersrand, Johannesburg, South Africa
19 JCRC Kampala, Uganda
20 Data Manager, Frontier Science and Technology Research Foundation, Amherst, NY 14226, USA
21 Assistant Professor in Medicine, Brigham and Women's Hospital and Harvard School of Public Health, Boston USA; and Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana

Correspondence Address:
Francesca M Conradie
Deputy Director, Clinical HIV Research Unit (CHRU), Helen Joseph Hospital, Perth Road, Westdene, Johannesburg
South Africa
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/1755-6783.102051

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Background: Single dose nevirapine (sdNVP) is widely used in resource-limited settings for the prevention of mother to child transmission of HIV, but can result in NVP resistance that negatively impacts the subsequent efficacy of maternal antiretroviral therapy (ART). It is important to determine prior sdNVP exposure status to help guide treatment decisions, but systematic data on approaches to documenting previous sdNVP ingestion are lacking. Aim: With the growing body of evidence of the effects of sdNVP exposure on subsequent choices of ART, we aim to highlight some of the practical challenges that exist in documenting prior sdNVP exposure or lack thereof. Materials and Methods: ACTG A5208 Optimized Combination Therapy after Nevirapine Exposure (OCTANE) is a randomized treatment trial of protease inhibitor vs. NVP-based ART that enrolled 745 HIV-infected women in 7 African countries. Documentation of previous exposure to sdNVP (or lack thereof) was collected prospectively and intensively, as were locally-available sources of such data. Results: All 243 women who were exposed to sdNVP recalled having taken sdNVP; written documentation of sdNVP exposure was found for 73% and an additional 20% identified having ingested a NVP tablet when the tablet was shown to them. Among 502 women not exposed to sdNVP, only 10 (2%) had written documentation of lack of sdNVP exposure. NVP resistance was detected in 33 (13.8%) of sdNVP-exposed and 1 of non-exposed women. Conclusion: Maternal self-report of prior sdNVP exposure was corroborated by supporting evidence in the majority of women participating in the trial.

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