Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials

Team, Six Week Extended-Dose Nevirapine Study; Bedri, A; Gudetta, Berhanu; Isehak, Abdulhamid; Kumbi, Solomon; Lulseged, Sileshi; Mengistu, Yohannes; Bhore, Arvind V.; Bhosale, Ramesh; Varadhrajan, Venkat; Gupte, Nikhil; Sastry, Jayagowri; Suryavanshi, Nishi; Tripathy, Srikanth; Mmiro, Francis; Mubiru, Michael; Onyango, Carolyne; Taylor, Adrian; Musoke, Philippa; Nakabiito, Clemensia; Abashawl, Aida; Adamu, Rahel; Antelman, Gretchen; Bollinger, Robert C.; Bright, Patricia; Chaudhary, Mohammad A.; Coberly, Jacqueline S.; Guay, Laura; Fowler, Mary Glenn; Gupta, Amita; Hassen, Elham; Jackson, J. Brooks; Moulton, Lawrence H.; Nayak, Uma; Omer, Saad B.; Propper, Lidia; Ram, Malathi; Rexroad, Vivian; Ruff, Andrea; Shankar, Anita; Zwerski, Sheryl

doi:10.1016/s0140-6736(08)61114-9

Cited by 231 publications

(76 citation statements)

References 23 publications

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“…The Six Week Extended-Dose Nevirapine (SWEN) study team reported data from three separate, but coordinated, randomized clinical trials conducted in Uganda, Ethiopia, and India to assess whether daily NVP given to breastfed infants through 6 weeks of age could decrease risk of HIV transmission from breastfeeding [34]. HIV-infected women and their infants received the standard HIVNET 012 single-dose NVP regimen [11] only or the standard HIVNET 012 single-dose NVP regimen plus extended-dose NVP daily to the infants from 8 to 42 days of age.…”

Section: Overview Of Select Important Studies Of Arv Prophylaxis To Rmentioning

confidence: 99%

Prevention of mother-to-child transmission of HIV Type 1: the role of neonatal and infant prophylaxis

Hurst

Appelgren

Kourtis³

2015

Expert Review of Anti-infective Therapy

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Summary The prevention of mother-to-child transmission (PMTCT) of HIV is one of the great public health successes of the past 20 years. Much concerted research efforts and dedicated work have led to the achievement of very low rates of PMTCT of HIV in settings that can implement optimal prophylaxis. Though several implementation challenges remain, global elimination of pediatric HIV infection seems now more than ever to be an attainable goal. Often overlooked, the role of prophylaxis of the newborn is nevertheless a very important component of PMTCT. In this paper, we focus on the role of neonatal and infant prophylaxis, discuss mechanisms of protection, and present the clinical trial-generated evidence that led to the current recommendations for preventing infections in breastfed and nonbreastfed infants. PMTCT of HIV should not end at birth; a continuum of care extending postpartum and postnatally is required to minimize the risk of new pediatric HIV infections.

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Section: Overview Of Select Important Studies Of Arv Prophylaxis To Rmentioning

confidence: 99%

Prevention of mother-to-child transmission of HIV Type 1: the role of neonatal and infant prophylaxis

Hurst

Appelgren

Kourtis³

2015

Expert Review of Anti-infective Therapy

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“…This is especially concerning since up to 40% of mother-to-child transmission to infants occurs during breastfeeding [3]. The results of several large randomized trials and observational studies have demonstrated substantially reduced transmission by either providing pre-exposure prophylaxis to the uninfected breastfeeding baby with antiretrovirals (ARVs), or by providing combination ARV therapy (ART) to the breastfeeding mother [1,2, 4-14]. With these interventions, the World Health Organization (WHO) has proposed to decrease MTCT to 5% and ensure 90% of breastfeeding infant-mother pairs receive antiretroviral therapy or prophylaxis by 2015.…”

Section: Introductionmentioning

confidence: 99%

Antiretroviral Pharmacokinetics in Mothers and Breastfeeding Infants from 6 to 24 Weeks Post-Partum: Results of the Ban Study

Corbett

Kayira²,

White³

et al. 2013

Antiviral Therapy

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Background An intensive, prospective, open-label pharmacokinetic (PK) study in a subset of HIV-infected mothers and their uninfected infants enrolled in the Breastfeeding, Antiretroviral, and Nutrition study was performed to describe drug exposure and antiviral response. Methods Women using Combivir®[zidovudine (ZDV)+ lamivudine (3TC)]+Aluvia®[lopinavir/ritonavir(LPV/RTV)] were enrolled. Breast milk (BM) and mother and infant plasma (MP, IP) samples were obtained over 6hrs after observed dosing at 6, 12, or 24wks post-partum for drug concentrations and HIV RNA. Results 30 mother/infant pairs (10 each at 6, 12,and 24wks post-partum) were enrolled. Relative to MP, BM concentrations of ZDV and 3TC were 35% and 21% higher, while LPV and RTV were 80% lower. Only 3TC was detected in IP with concentrations 96% and 98% lower than MP and BM, respectively. Concentrations in all matrices were similar at 6-24wks. The majority (98.3%) of BM concentrations were >HIVwt IC50, with one having detectable virus. There was no association between PK parameters and MP or BM HIV RNA. Conclusions ZDV and 3TC concentrated in BM while LPV and RTV did not, possibly due to protein binding and drug transporter affinity. Undetectable to low ARV concentrations in IP suggests prevention of transmission while breast feeding may be due to ARV effects on systemic or BM HIV RNA in the mother. Low IP 3TC exposure may predispose an infected infant to HIV resistance, necessitating testing and treating infants early.

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“…Institutional review boards from Johns Hopkins University and the Byramjee Jeejeebhoy Government Medical College Ethics Committee approved the SWEN study methods, which are described elsewhere. 13 …”

Section: Methodsmentioning

confidence: 99%

“…Due to concerns that prophylactic nevirapine might partially suppress viral load, 5000 copies/mL was used to define a positive HIV RNA PCR study (instead of 10,000 copies/mL) based on a modification of the Pediatric AIDS Clinical Trials Group definition for infant HIV diagnosis. 13 …”

Section: Methodsmentioning

confidence: 99%

Maternal Syphilis: An Independent Risk Factor for Mother to Infant Human Immunodeficiency Virus Transmission

et al. 2017

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Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials

Cited by 231 publications

References 23 publications

Prevention of mother-to-child transmission of HIV Type 1: the role of neonatal and infant prophylaxis

Prevention of mother-to-child transmission of HIV Type 1: the role of neonatal and infant prophylaxis

Antiretroviral Pharmacokinetics in Mothers and Breastfeeding Infants from 6 to 24 Weeks Post-Partum: Results of the Ban Study

Maternal Syphilis: An Independent Risk Factor for Mother to Infant Human Immunodeficiency Virus Transmission

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