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Nevirapine Concentrations During the First Month of Life and Maternal Efavirenz Washout in High-Risk HIV-Exposed Infants Receiving Triple Antiretroviral Prophylaxis

Anugulruengkitt, Suvaporn, MD*,†; Cressey, Tim R., PhD‡,§,¶; Suntarattiwong, Piyarat, MD; Ounchanum, Pradthana, MD**; Srirompotong, Ussanee, MD††; Jantarabenjakul, Watsamon, MD*,†; Sophonphan, Jiratchaya, MSc‡‡; Tawon, Yardpiroon, BSc; Punnahitanon, Sunti, MD*; Pancharoen, Chitsanu, MD*,†; Chokephaibulkit, Kulkanya, MD§§; Puthanakit, Thanyawee, MD*,† on Behalf of CIPHER_AEPEP Study Team

The Pediatric Infectious Disease Journal: February 2019 - Volume 38 - Issue 2 - p 152–156
doi: 10.1097/INF.0000000000002195
HIV Reports
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Background: Triple-drug infant antiretroviral prophylaxis containing nevirapine (NVP) is increasingly used to prevent HIV transmission among neonates at high risk of HIV infection. Our aim was to describe NVP concentration from birth through the first month of life.

Methods: High-risk HIV-exposed neonates were enrolled in a prospective cohort in Thailand. High-risk neonates defined as maternal HIV RNA >50 copies/mL before delivery or mother received antiretroviral treatment for <12 weeks before delivery. Neonates received zidovudine (4 mg/kg) and lamivudine (2 mg/kg) twice daily, plus NVP (4 mg/kg) once daily (no lead-in) from birth to 6 weeks of life. Infant plasma samples were collected at 1, 2, 14 or 2, 7, 28 days of life. NVP trough concentrations (C24) were estimated using a population pharmacokinetic model and target C24 was ≥0.1 mg/L. “Washout” efavirenz (EFV) concentrations were assessed in infants whose mother received EFV-based antiretroviral treatment.

Results: A total of 48 infants were included: 25 (52%) were male and 12 (25%) were preterm (gestational age 34–37 weeks). Median (interquartile range) predicted NVP C24 were 1.34 mg/L (1.13–1.84), 2.24 (2.00–2.59), 2.78 (2.61–3.12), 2.20 (1.86–2.44) and 0.81 (0.58–0.98) on days 1, 2, 7, 14 and 28 of life, respectively. NVP C24 was not significantly different between term and preterm infants. All infants maintained NVP C24 ≥0.1 mg/L. EFV via placental transfer remained detectable in infants up to 7 days of life.

Conclusions: NVP 4 mg/kg daily from birth provided adequate prophylactic concentrations during the first month of life in high-risk HIV-exposed neonates.

From the *Department of Pediatrics

Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Program for HIV Prevention and Treatment, Department of Medical Technology, Faculty of Associated Medical Sciences (PHPT/IRD), Chiang Mai University, Chiang Mai, Thailand

§Harvard T.H. Chan School of Public Health, Boston, Massachusetts

Department of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom

Department of Pediatrics, Faculty of Medicine, Queen Sirikit National Institute of Child Health, Bangkok, Thailand

**Department of Pediatrics, Chiang Rai Prachanukroh Hospital, Chiang Rai, Thailand

††Department of Pediatrics, Khon Kaen Hospital, Khon Kaen, Thailand

‡‡The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), the Thai Red Cross AIDS Research Centre, Bangkok, Thailand

§§Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Accepted for publication August 23, 2018.

Members of the CIPHER_AEPEP Study Team are given in the Acknowledgments.

The study was funded by a CIPHER grant from the International AIDS Society and the 100th Anniversary Chulalongkorn University Fund for Doctoral Scholarship.

The authors have no conflicts of interest to disclose.

Address for correspondence: Suvaporn Anugulruengkitt, MD, Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand. E-mail: suvaporn.a@chula.ac.th.

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