BACKGROUND: This study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants. METHODS: HIV-exposed, uninfected infants (age 9-15 months) enrolled in Surveillance Monitoring for Antiretroviral Therapy Toxicities, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class) and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates. RESULTS: As of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black and 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (9% of protease inhibitor-containing regimens also included non-nucleoside reverse transcriptase inhibitors), 5% to regimens containing non-nucleoside reverse transcriptase inhibitors (without protease inhibitor) and 14% to regimens containing only nucleoside reverse transcriptase inhibitors. Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (P = 0.01). CONCLUSIONS: These results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.
BACKGROUND: This study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants. METHODS:HIV-exposed, uninfected infants (age 9-15 months) enrolled in Surveillance Monitoring for Antiretroviral Therapy Toxicities, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class) and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates. RESULTS: As of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black and 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (9% of protease inhibitor-containing regimens also included non-nucleoside reverse transcriptase inhibitors), 5% to regimens containing non-nucleoside reverse transcriptase inhibitors (without protease inhibitor) and 14% to regimens containing only nucleoside reverse transcriptase inhibitors. Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (P = 0.01). CONCLUSIONS: These results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.
Authors: Ariane Alimenti; John C Forbes; Tim F Oberlander; Deborah M Money; Ruth E Grunau; Michael P Papsdorf; Evelyn Maan; Lesley J Cole; David R Burdge Journal: Pediatrics Date: 2006-08-28 Impact factor: 7.124
Authors: S Blanche; M Tardieu; P Rustin; A Slama; B Barret; G Firtion; N Ciraru-Vigneron; C Lacroix; C Rouzioux; L Mandelbrot; I Desguerre; A Rötig; M J Mayaux; J F Delfraissy Journal: Lancet Date: 1999-09-25 Impact factor: 79.321
Authors: M Culnane; M Fowler; S S Lee; G McSherry; M Brady; K O'Donnell; L Mofenson; S L Gortmaker; D E Shapiro; G Scott; E Jimenez; E C Moore; C Diaz; P M Flynn; B Cunningham; J Oleske Journal: JAMA Date: 1999-01-13 Impact factor: 56.272
Authors: Sarah K Himes; Yanling Huo; George K Siberry; Paige L Williams; Mabel L Rice; Patricia A Sirois; Toni Frederick; Rohan Hazra; Marilyn A Huestis Journal: J Acquir Immune Defic Syndr Date: 2015-06-01 Impact factor: 3.731
Authors: Mabel L Rice; Jonathan S Russell; Toni Frederick; Murli Purswani; Paige L Williams; George K Siberry; Sean M Redmond; Howard J Hoffman; Tzy-Jyun Yao Journal: Pediatr Infect Dis J Date: 2018-07 Impact factor: 2.129
Authors: Ellen C Caniglia; Kunjal Patel; Yanling Huo; Paige L Williams; Suad Kapetanovic; Kenneth C Rich; Patricia A Sirois; Denise L Jacobson; Sonia Hernandez-Diaz; Miguel A Hernán; George R Seage Journal: AIDS Date: 2016-05-15 Impact factor: 4.177
Authors: Katherine Tassiopoulos; Yanling Huo; Joseph Braun; Paige L Williams; Renee Smith; Ann Aschengrau; Sharon Nichols; Rohan Hazra; William A Meyer; Katherine Knapp; Nagamah S Deygoo; George R Seage Iii Journal: AIDS Res Hum Retroviruses Date: 2017-03-21 Impact factor: 2.205
Authors: Itziar Familiar; Shalean M Collins; Alla Sikorskii; Horacio Ruisenor-Escudero; Barnabas Natamba; Paul Bangirana; Elizabeth M Widen; Daniel Achidri; Harriet Achola; Daniel Onen; Michael Boivin; Sera L Young Journal: J Acquir Immune Defic Syndr Date: 2018-03-01 Impact factor: 3.731
Authors: Sumona Chaudhury; Gloria K Mayondi; Paige L Williams; Jean Leidner; Roger Shapiro; Modiegi Diseko; Gbolahan Ajibola; Penny Holding; Vicki Tepper; Joseph Makhema; Chipo Petlo; George R Seage; Shahin Lockman; Betsy Kammerer Journal: AIDS Date: 2018-06-01 Impact factor: 4.177
Authors: Nandita Sugandhi; Jessica Rodrigues; Maria Kim; Saeed Ahmed; Anouk Amzel; Mike Tolle; Eric J Dziuban; Scott E Kellerman; Emilia Rivadeneira Journal: AIDS Date: 2013-11 Impact factor: 4.177
Authors: Stephen J Kerr; Thanyawee Puthanakit; Ung Vibol; Linda Aurpibul; Sophan Vonthanak; Pope Kosalaraksa; Suparat Kanjanavanit; Rawiwan Hansudewechakul; Jurai Wongsawat; Wicharn Luesomboon; Kattiya Ratanadilok; Wasana Prasitsuebsai; Kanchana Pruksakaew; Jasper van der Lugt; Robert Paul; Jintanat Ananworanich; Victor Valcour Journal: AIDS Care Date: 2014-05-30