TY - JOUR
T1 - Evaluation for late effects of In Utero (IU) ZDV exposure among uninfected infants bom to HIV+ women enrolled in ACTG 076 & 219
AU - Culnane, M.
AU - Fowler, M. G.
AU - Lee, S.
AU - McSherry, G.
AU - Mofcnson, L.
AU - Gortmaker, S.
AU - Shapiro, D. E.
AU - O'Donneii, K.
AU - Cunningham, B. A.
AU - Oleske, J. M.
PY - 1997
Y1 - 1997
N2 - Background/Aim: ZDV is widely used in the US for preventing HIV mother-infant transmission (MIT). Late effects of IU ZDV exposure are unknown. IU ZDV exposed infants were evaluated for adverse effects 2yrs after the conclusion of 076. Methods: 66% of infants randomized to ZDV or PL intrapartum & 6wks post birth (076), were enrolled in ACTG 219, a cohort study providing follow-up for PACTG patients (pts) thru 21yrs. Data assessing growth, cognitive, immune status, & other organ system toxicity are collected every 6mo for HIV+ & HIV- infants <24mo of age & yearly thereafter (except cognitive testing). Baseline echocardiogram & fundoscopic exams were collected at 36mo. Results: Data were available on 230 seroreverters (121 ZDV exposed). Pts median age 3.4yrs (range 2.4-4.9). Mat & infant characteristics are similar to the original 076 pts No unexpected opthamology diagnosis (dx), cardiac dx, neoplasms or other organ system dx were reported. CD4 & CD8 measurements, growth, & cognitive data (see below) reveal no difference for ZDV vs. PL infants. Bayley Scores McCarthy Scores months mental motor GCI ZDV PL ZDV PL ZDV PL 18 (15-21) 97.2 93.5 99.0 97.4 NA NA 24 (21-30.5) 94.0 89.8 101.6 101.5 NA NA 36 (28.5-54) NA NA NA NA 87.6 87.6 Conclusion: 076/219 pts evaluation reveal no adverse effects for ZDV IU exposed infants followed as long as 4yrs. While data are reassuring, continued prospective evaluations of perinatally exposed infants (to ZDV & other antiviral or immunotherapy agents) are critical to assess long term safety of successful HIV MIT prevention strategies.
AB - Background/Aim: ZDV is widely used in the US for preventing HIV mother-infant transmission (MIT). Late effects of IU ZDV exposure are unknown. IU ZDV exposed infants were evaluated for adverse effects 2yrs after the conclusion of 076. Methods: 66% of infants randomized to ZDV or PL intrapartum & 6wks post birth (076), were enrolled in ACTG 219, a cohort study providing follow-up for PACTG patients (pts) thru 21yrs. Data assessing growth, cognitive, immune status, & other organ system toxicity are collected every 6mo for HIV+ & HIV- infants <24mo of age & yearly thereafter (except cognitive testing). Baseline echocardiogram & fundoscopic exams were collected at 36mo. Results: Data were available on 230 seroreverters (121 ZDV exposed). Pts median age 3.4yrs (range 2.4-4.9). Mat & infant characteristics are similar to the original 076 pts No unexpected opthamology diagnosis (dx), cardiac dx, neoplasms or other organ system dx were reported. CD4 & CD8 measurements, growth, & cognitive data (see below) reveal no difference for ZDV vs. PL infants. Bayley Scores McCarthy Scores months mental motor GCI ZDV PL ZDV PL ZDV PL 18 (15-21) 97.2 93.5 99.0 97.4 NA NA 24 (21-30.5) 94.0 89.8 101.6 101.5 NA NA 36 (28.5-54) NA NA NA NA 87.6 87.6 Conclusion: 076/219 pts evaluation reveal no adverse effects for ZDV IU exposed infants followed as long as 4yrs. While data are reassuring, continued prospective evaluations of perinatally exposed infants (to ZDV & other antiviral or immunotherapy agents) are critical to assess long term safety of successful HIV MIT prevention strategies.
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M3 - Article
AN - SCOPUS:0000827226
SN - 1058-4838
VL - 25
SP - 445
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 2
ER -