Suvaporn AnugulruengkittPiyarat SuntarattiwongPradthana OunchanumUssanee SrirompotongWatsamon JantarabenjakulJiratchaya SophonphanSunti PunnahitanonChitsanu PancharoenTim R. CresseyKulkanya ChokephaibulkitThanyawee PuthanakitHarvard T.H. Chan School of Public HealthChulalongkorn UniversityUniversity of LiverpoolThe HIV Netherlands Australia Thailand Research CollaborationKhon Kaen Regional HospitalFaculty of Medicine, Siriraj Hospital, Mahidol UniversityQueen Sirikit National Institute of Child HealthChiang Mai UniversityFaculty of MedicineChiangrai Prachanukroh Hospital2020-01-272020-01-272019-10-01The Pediatric infectious disease journal. Vol.38, No.10 (2019), 1045-1050153209872-s2.0-85072791175https://repository.li.mahidol.ac.th/handle/20.500.14594/51401BACKGROUND: Combination antiretroviral drug regimens are increasingly preferred for neonatal postexposure prophylaxis (PEP) among HIV-exposed infants with high-risk of transmission. We evaluated the adverse events associated with the use of zidovudine (ZDV)/lamivudine (3TC)/nevirapine (NVP) for neonatal PEP during the first 6 weeks of life. METHODS: A prospective cohort of non-breast-fed HIV-exposed infants was conducted at 5 clinical sites in Thailand. Study population included 100 high-risk HIV-exposed infants (maternal HIV RNA > 50 copies/mL prior to delivery or received antiretroviral therapy less than 12 weeks) and 100 low-risk HIV-exposed neonates. High-risk infants received ZDV/3TC/NVP for 6 weeks whereas low-risk HIV-exposed neonates received a 4-week regimen of ZDV. Complete blood count, aspartate transaminase and alanine transaminase were assessed at birth, 1, 2 and 4 months of life. RESULTS: From October 2015 to November 2017, 200 infants were enrolled, of which 18.5% had low birth weight < 2500 g. The proportion of infants with anemia grade 2 or higher at 1 and 2 months of life between ZDV/3TC/NVP and ZDV prophylaxis was 48.5% vs 32.3% (P=0.02); nevertheless, severe anemia (grade 3) was not significantly different; 9.2% vs 10.2% (P=0.81), respectively. At 1 month old, infants on ZDV/3TC/NVP prophylaxis had significantly higher grade 2 anemia versus infants on ZDV alone (33.0% vs 13.4%; P=0.001); however, no difference was observed at 2 months old. No differences in neutropenia or hepatotoxicity between infant prophylactic regimens were observed. CONCLUSIONS: Triple antiretroviral neonatal PEP with ZDV/3TC/NVP for 6 weeks in high-risk HIV-exposed infants did not significantly increase the risk of short-term toxicity compared with ZDV-monotherapy prophylaxis.Mahidol UniversityMedicineArticleSCOPUS10.1097/INF.0000000000002426