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In-utero exposure to tenofovir disoproxil fumarate pre-exposure prophylaxis and growth metrics in HIV unexposed breastfed infants in South Africa: a post hoc analysis of the CAP 016 PrEP in pregnancy RCT.
Naidoo, Megeshinee; Naidoo, Kimesh L; Lombard, Carl; Desmond, Alicia C; Clark, Richard; Rooney, James F; Gray, Glenda; Moodley, Dhayendre.
Afiliación
  • Naidoo M; Centre for the Program of AIDS Research in South Africa (CAPRISA), Durban, South Africa.
  • Naidoo KL; Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.
  • Lombard C; Biostatistics Unit, South African Medical Research Council, Tygerberg, South Africa.
  • Desmond AC; Division of Epidemiology and Biostatistics, Department of Global Health, University of Stellenbosch, Tygerberg, South Africa.
  • Clark R; Centre for the Program of AIDS Research in South Africa (CAPRISA), Durban, South Africa.
  • Rooney JF; Gilead Sciences Inc, Foster City, CA, United States.
  • Gray G; Gilead Sciences Inc, Foster City, CA, United States.
  • Moodley D; South African Medical Research Council, Cape Town, South Africa.
Front Pediatr ; 12: 1447173, 2024.
Article en En | MEDLINE | ID: mdl-39184858
ABSTRACT

Objective:

We evaluated growth metrics in HIV unexposed African breastfed infants in the first 18 months of life in association with in-utero exposure to Tenofovir Diphosphate Fumarate (TDF) containing pre-exposure prophylaxis (PrEP).

Design:

We conducted a secondary data analysis of a TDF-PrEP randomized control trial (CAP016 RCT). Pregnant women without HIV were randomized to initiating TDF-PrEP in pregnancy (Immediate-PrEP-IP) or deferred initiation of TDF-PrEP at cessation of breastfeeding (Deferred-PrEP-DP).

Methods:

Infant weight (W), length (L), and head circumference (HC) were measured at birth and 6, 26, 50, and 74 weeks of age. Stored dried blood spot samples from pregnant women randomized to the IP arm were used to measure tenofovir-diphosphate (TFV-DP) levels. Age-stratified mean weight-for-age (WAZ), length-for-age (LAZ), weight-for-length (WLZ), and head circumference-for-age (HCAZ) Z-scores were compared between infants exposed to varying TFV-DP concentrations and infants in the DP arm.

Results:

A total of 455 mother-infant pairs were included in the secondary analysis, 228 in the IP arm and 227 in the DP arm. WAZ, LAZ, WLZ, and HCAZ scores were comparable between infants in the Deferred-PrEP arm and Immediate-PrEP arm. In a mixed-effects linear regression model adjusting for maternal age, body mass index, socioeconomic and newborn characteristics, in-utero exposure to varying TFV-DP levels was not associated with WAZ (ß = -0.52), LAZ (ß = -0.46), WLZ (ß = -0.43) and HCAZ (ß = -0.11) scores over time.

Conclusion:

There was no evidence of an association between growth metrics in the first 18 months of life and in-utero exposure to TFV-DP among breastfed HIV unexposed infants.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Front Pediatr Año: 2024 Tipo del documento: Article País de afiliación: Sudáfrica Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Front Pediatr Año: 2024 Tipo del documento: Article País de afiliación: Sudáfrica Pais de publicación: Suiza