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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: A randomized controlled trial
JAMA, Volume 304, No. 10, Year 2010
Notification
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Description
Context: Protease inhibitor (PI)-based therapy is recommended for infants infected with human immunodeficiency virus (HIV) who were exposed to nevirapine for prevention of mother-to-child HIV transmission. However, there are limitations of continuing PI-based therapy indefinitely and reuse of nevirapine has many advantages. Objective: To test whether nevirapine-exposed infants who initially achieve viral suppression with PI-based therapy can maintain viral suppression when switched to nevirapine-based therapy. Design, Setting, and Patients: Randomized trial conducted between April 2005 and May 2009 at a hospital in Johannesburg, South Africa, among 195 children who achieved viral suppression less than 400 copies/mL for 3 or more months from a cohort of 323 nevirapine-exposed children who initiated PI-based therapy before 24 months of age. Interventions: Control group children continued to receive ritonavir-boosted lopinavir, stavudine, and lamivudine (n=99). Switch group children substituted nevirapine for ritonavir-boosted lopinavir (n=96). Main Outcome Measures: Children were followed up for 52 weeks after randomization. Plasma HIV-1 RNA of greater than 50 copies/mL was the primary end point. Confirmed viremia greater than 1000 copies/mL was used as a criterion to consider regimen changes for children in either group (safety end point). Results: Plasma viremia greater than 50 copies/mL occurred less frequently in the switch group (Kaplan-Meier probability, 0.438; 95% CI, 0.334-0.537) than in the control group (0.576; 95% CI, 0.470-0.668) (P=.02). Confirmed viremia greater than 1000 copies/mL occurred more frequently in the switch group (0.201; 95% CI, 0.125-0.289) than in the control group (0.022; 95% CI, 0.004-0.069) (P<.001). CD4 cell response was better in the switch group (median CD4 percentage at 52 weeks, 34.7) vs the control group (CD4 percentage, 31.3) (P=.004). Older age (relative hazard [RH], 1.71; 95% CI, 1.08-2.72) was associated with viremia greater than 50 copies/mL in the control group. Inadequate adherence (RH, 4.14; 95% CI, 1.18-14.57) and drug resistance (RH, 4.04; 95% CI, 1.40-11.65) before treatment were associated with confirmed viremia greater than 1000 copies/mL in the switch group. Conclusion: Among HIV-infected children previously exposed to nevirapine, switching to nevirapine-based therapy after achieving viral suppression with a ritonavirboosted lopinavir regimen resulted in lower rates of viremia greater than 50 copies/ mL than maintaining the primary ritonavir-boosted lopinavir regimen. Trial Registration: clinicaltrials.gov Identifier: NCT00117728. ©2010 American Medical Association. All rights reserved.
Authors & Co-Authors
Coovadia, Ashraf Hassen
South Africa, Johannesburg
Rahima Moosa Mother and Child Hospital
Abrams, Elaine J.
United States, New York
Columbia University
United States, New York
Mailman School of Public Health
Stehlau, Renate
South Africa, Johannesburg
Rahima Moosa Mother and Child Hospital
Meyers, Tammy M.M.
South Africa, Johannesburg
Chris Hani Baragwanath Hospital
Martens, Leigh
South Africa, Johannesburg
Rahima Moosa Mother and Child Hospital
Sherman, Gayle Gillian
South Africa, Johannesburg
University of the Witwatersrand
South Africa, Johannesburg
National Health Laboratory Service
Hunt, Gillian M.
South Africa, Johannesburg
National Institute for Communicable Diseases
Hu, Chihchi
United States, New York
Columbia University
Tsai, Wei Yann
United States, New York
Columbia University
Morris, Lynn
South Africa, Johannesburg
National Institute for Communicable Diseases
Kuhn, Louise
United States, New York
Mailman School of Public Health
United States, New York
Gertrude H. Sergievsky Center
Statistics
Citations: 86
Authors: 11
Affiliations: 8
Identifiers
Doi:
10.1001/jama.2010.1278
ISSN:
00987484
e-ISSN:
15383598
Research Areas
Environmental
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cohort Study
Study Approach
Quantitative
Study Locations
South Africa