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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Single-dose tenofovir and emtricitabine for reduction of viral resistance to non-nucleoside reverse transcriptase inhibitor drugs in women given intrapartum nevirapine for perinatal HIV prevention: an open-label randomised trial
Lancet, Volume 370, No. 9600, Year 2007
Notification
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Description
Background: Intrapartum and neonatal single-dose nevirapine are essential components of perinatal HIV prevention in resource-constrained settings, but can induce resistance to other non-nucleoside reverse transcriptase inhibitor drugs. We aimed to investigate whether this complication would be reduced with a single peripartum intervention of tenofovir and emtricitabine. Methods: We randomly assigned 400 HIV-infected pregnant women who sought care at two public-sector primary health facilities in Lusaka, Zambia. One was excluded, 200 were assigned to receive a single oral dose of 300 mg tenofovir disoproxil fumarate with 200 mg emtricitabine under direct observation, and 199 to receive no study drug. Short-course zidovudine and intrapartum nevirapine were offered to all HIV-infected women, according to the local standard of care. Women who met national criteria for antiretroviral therapy were referred for care and not enrolled. Our primary study outcome was resistance to non-nucleoside reverse transcriptase inhibitors at 6 weeks after delivery. We used standard population sequencing to determine HIV genotypes. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00204308. Findings: Of the 200 women who were randomly assigned to the intervention, 14 were lost to follow-up or withdrew from the study, two did not take study drug according to protocol, and one specimen was lost; 23 of 199 controls were lost to follow-up or withdrew from the study, and three specimens were lost. Women given the intervention were 53% less likely than controls to have a mutation that conferred resistance to non-nucleoside reverse transcriptase inhibitors at 6 weeks after delivery (20/173 [12%] vs 41/166 [25%]; risk ratio [RR] 0·47, 95% CI 0·29-0·76). We noted postpartum anaemia, the most common serious adverse event in mothers, in four women in each group. 20 of 198 (10%) infants in the intervention group and 23 of 199 (12%) controls had a serious adverse event, mostly due to septicaemia (n=22) or pneumonia (n=8); these events did not differ between groups, and none were judged to be caused by the study intervention. Interpretation: A single dose of tenofovir and emtricitabine at delivery reduced resistance to non-nucleoside reverse transcriptase inhibitors at 6 weeks after delivery by half; therefore this treatment should be considered as an adjuvant to intrapartum nevirapine. © 2007 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Chi, Benjamin H.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
United States, Birmingham
The University of Alabama at Birmingham
Sinkala, Moses M.
United States, Birmingham
The University of Alabama at Birmingham
Zambia, Lusaka
Catholic Medical Mission Board
Mbewe, Felistas M.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Cantrell, Ronald A.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
United States, Birmingham
The University of Alabama at Birmingham
Kruse, Gina Rae
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Chintu, Namwinga T.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Aldrovandi, Grace M.
United States, Los Angeles
Keck School of Medicine of Usc
Stringer, Elizabeth Mc Phillips
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
United States, Birmingham
The University of Alabama at Birmingham
Kankasa, Chipepo
Zambia, Lusaka
University Teaching Hospital Lusaka
Safrit, Jeffrey T.
United States, Washington, D.c.
Elizabeth Glaser Pediatric Aids Foundation
Stringer, Jeffrey S.A.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
United States, Birmingham
The University of Alabama at Birmingham
Statistics
Citations: 115
Authors: 11
Affiliations: 6
Identifiers
Doi:
10.1016/S0140-6736(07)61605-5
ISSN:
01406736
Research Areas
Cancer
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cross Sectional Study
Cohort Study
Study Locations
Zambia
Participants Gender
Female