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Title: Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm<sup>3</sup>
Authors: Judith S. Currier
Paula Britto
Risa M. Hoffman
Sean Brummel
Gaerolwe Masheto
Esau Joao
Breno Santos
Linda Aurpibul
Marcelo Losso
Marie F. Pierre
Adriana Weinberg
Devasena Gnanashanmugam
Nahida Chakhtoura
Karin Klingman
Renee Browning
Anne Coletti
Lynne Mofenson
David Shapiro
Jose Pilotto
Manuela Bullo
Silvina Ivalo
Anthony Ogwu
Tebogo Kakhu
Aida Asmelash
Ayotunde Omoz-Oarhe
Cristina Hofer
Elizabeth MacHado
Jacqueline Menezes
Leon Claude Sidi
Jorge Pinto
Flavia Ferreira
Geraldo Duarte
Conrado Milani Coutinho
Rosa Dea Sperhacke
Silvia Mariani Costamilan
Luis Eduardo Fernandes
Luiz Felipe Mpreira
Regis Kreitchmann
Debora Fernandes Coelho
Marineide Goncalves De Melo
Rita De Cassia Alves Lira
Linda Aristhomene
Jerry Bonhomme
Rosa Infante
Fanny Rosas
Esmelda Montalban
Jessica Rios
Julkanya Chokephaibulkit
Thanomsak Anekthananon
Jullapong Achalapong
Pacharee Kantipong
Guttiga Halue
Wirawan Rasri
Prapap Yuthavisuthi
Malee Techapornroong
Sinart Prommas
Prapaisri Layangool
Chureeratana Bowonwatanuwong
Nantasak Chotivanich
Fuanglada Tongprasert
Patcharaphan Sugandhavesa
Vanessa Cajahuaringa
Renee Weinman
Sara Mattiucci
Princy Kumar
Joseph Timpone
Chivon McMullen-Jackson
Shelley Buschur
Keywords: Agricultural and Biological Sciences
Biochemistry, Genetics and Molecular Biology
Issue Date: 1-May-2017
Abstract: Background Health benefits of postpartum antiretroviral therapy (ART) for human immunodeficiency virus (HIV) positive women with high CD4+ T-counts have not been assessed in randomized trials. Methods Asymptomatic, HIV-positive, non-breastfeeding women with pre-ART CD4+ T-cell counts ≥ 400 cells/mm3started on ART during pregnancy were randomized up to 42 days after delivery to continue or discontinue ART. Lopinavir/ritonavir plus tenofovir/emtricitabine was the preferred ART regimen. The sample size was selected to provide 88% power to detect a 50% reduction from an annualized primary event rate of 2.07%. A post-hoc analysis evaluated HIV/AIDS-related and World Health Organization (WHO) Stage 2 and 3 events. All analyses were intent to treat. Results 1652 women from 52 sites in Argentina, Botswana, Brazil, China, Haiti, Peru, Thailand and the US were enrolled (1/2010-11/2014). Median age was 28 years and major racial categories were Black African (28%), Asian (25%) White (15%). Median entry CD4 count was 696 cells/mm3(IQR 575±869), median ART exposure prior to delivery was 19 weeks (IQR 13± 24) and 94% had entry HIV-1 RNA < 1000 copies/ml. After a median follow-up of 2.3 years, the primary composite endpoint rate was significantly lower than expected, and not significantly different between arms (continue arm 0.21 /100 person years(py); discontinue 0.31/ 100 py, Hazard ratio (HR) 0.68, 95% CI: 0.19, 2.40). WHO Stage 2 and 3 events were significantly reduced with continued ART (2.08/100 py vs. 4.36/100 py in the discontinue arm; HR 0.48, 95%CI: 0.33, 0.70). Toxicity rates did not differ significantly between arms. Among women randomized to continue ART, 189/827 (23%) had virologic failure; of the 155 with resistance testing, 103 (66%) failed without resistance to their current regimen, suggesting non-adherence. Conclusions Overall, serious clinical events were rare among young HIV-positive post-partum women with high CD4 cell counts. Continued ART was safe and was associated with a halving of the rate of WHO 2/3 conditions. Virologic failure rates were high, underscoring the urgent need to improve adherence in this population. Trial registration NCT00955968.
ISSN: 19326203
Appears in Collections:CMUL: Journal Articles

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