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Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm3

หน่วยงาน มหาวิทยาลัยเชียงใหม่

รายละเอียด

ชื่อเรื่อง : Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm3
นักวิจัย : Currier J. , Britto P. , Hoffman R. , Brummel S. , Masheto G. , Joao E. , Santos B. , Aurpibul L. , Losso M. , Pierre M. , Weinberg A. , Gnanashanmugam D. , Chakhtoura N. , Klingman K. , Browning R. , Coletti A. , Mofenson L. , Shapiro D. , Pilotto J. , Bullo M. , Ivalo S. , Ogwu A. , Kakhu T. , Asmelash A. , Omoz-Oarhe A. , Hofer C. , MacHado E. , Menezes J. , Sidi L. , Pinto J. , Ferreira F. , Duarte G. , Coutinho C. , Sperhacke R. , Costamilan S. , Fernandes L. , Mpreira L. , Kreitchmann R. , Coelho D. , De Melo M. , De Cassia Alves Lira R. , Aristhomene L. , Bonhomme J. , Infante R. , Rosas F. , Montalban E. , Rios J. , Chokephaibulkit J. , Anekthananon T. , Achalapong J. , Kantipong P. , Halue G. , Rasri W. , Yuthavisuthi P. , Techapornroong M. , Prommas S. , Layangool P. , Bowonwatanuwong C. , Chotivanich N. , Tongprasert F. , Sugandhavesa P. , Cajahuaringa V. , Weinman R. , Mattiucci S. , Kumar P. , Timpone J. , McMullen-Jackson C. , Buschur S.
คำค้น : -
หน่วยงาน : มหาวิทยาลัยเชียงใหม่
ผู้ร่วมงาน : -
ปีพิมพ์ : 2560
อ้างอิง : 2-s2.0-85019102777 , 10.1371/journal.pone.0176009 , https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85019102777&origin=inward , http://cmuir.cmu.ac.th/jspui/handle/6653943832/40529
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ความเชี่ยวชาญ : -
ความสัมพันธ์ : -
ขอบเขตของเนื้อหา : -
บทคัดย่อ/คำอธิบาย :

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/mm 3 started 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/mm 3 (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 ad herence in this population. Trial registration ClinicalTrials.gov NCT00955968.

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