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To the Editor: Pregnancy is not an indication for discontinuing or delaying combined antiretroviral therapy (CART) in women with human immunodeficiency virus (HIV) infection, but concerns remain about potential adverse effects for the infant.^1-2 Prior small case series have suggested an increased risk for hemangioma.^3-4 We assessed the risk of hemangioma and other congenital malformations in a somewhat larger cohort of infants exposed to CART in utero, as well as in a comparison cohort.

Methods
We assessed the outcomes of all pregnancies in HIV-positive women (69 cases with 2 twins) receiving CART who delivered between 1997 and 2002 at the Catholic University of the Sacred Heart, Rome. Data were compared with a control group of 284 cases selected among HIV-negative women who contacted our Teratology Information Service for counseling about drugs that are not known or suspected to be teratogenic. We assessed infants for the presence of any congenital anomalies, including cavernous hemangioma, nevus flammeus, and hemangiomas greater than 5 cm in diameter. The data were collected by pediatricians or by telephone interview, between 30 days and 12 months after delivery. All the patients provided informed consent at first contact with our institution (HIV-positive patients provided written consent; control patients provided oral consent). Our study was approved by the ethics committees of the Catholic University of the Sacred Heart, Rome. Data were analyzed using the Fisher exact test.

Results
In the HIV-positive group, 71 infants were delivered and 1 of them was infected following vertical transmission (1.4%): 62 were exposed to nucleoside reverse transcriptase inhibitors and protease inhibitor, while 9 were exposed both to nucleoside reverse transcriptase inhibitors and to nonnucleoside reverse transcriptase inhibitors. We observed 4 cases (5.6%) of congenital anomalies (1 [1.4%] with myelomeningocele and 3 [4.2%] with hemangiomas). All 3 cases of hemangiomas were exposed to the same therapy with zidovudine, lamivudine, and nelfinavir, and none of these infants was infected.

In the control group the prevalence of congenital anomalies was 1.7% (1 congenital club foot, 1 cardiac defect associated to deafness and cataract, 1 skeletal dysplasia, 1 bilateral anophthalmia with cleft lip, and 1 large hemangioma of the arm). This overall prevalence was not statistically different than the group receiving CART (P = .09).

Comment
Hemangioma is a dysplastic disorder that can compromise organ function depending on site and dimension. Moreover, it could have cosmetic effects. We found a higher prevalence of hemangiomas among infants with prenatal exposure to CART, although the small numbers preclude robust statistical comparisons. We note, however, that all 3 infants with hemangiomas were exposed to the same regimen.

Marco De Santis, MD; Anna Franca Cavaliere, MD; Alessandro Caruso, MD
Telefono Rosso—Teratology Information Service
Department of Obstetrics and Gynaecology

Paola Villa, MD
Department of Obstetrics and Gynaecology

Enrica Tamburrini, MD; Roberto Cauda, MD
Department of Infectious Disease

Carlo Fundaro, MD; Orazio Genovese, MD
Department of Pediatrics
Catholic University of the Sacred Heart
Rome, Italy

1. Minkoff H. Human immunodeficiency virus infection in pregnancy. Obstet Gynecol. 2003;101:797-810. PUBMED 2. US Department of Health and Human Services. Recommendation for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. Available at: http://www.aidsinfo.nih.gov. Accessibility verified December 19, 2003. 3. Lorenzi P, Spicher VM, Laubereau B, et al, Swiss HIV Cohort Study, the Swiss Collaborative HIV and Pregnancy Study, and the Swiss Neonatal HIV Study. Antiretroviral therapies in pregnancy: maternal, fetal and neonatal effects. AIDS. 1998;12:F241-F247. FULL TEXT | WEB OF SCIENCE | PUBMED 4. Simon T, Funke AM, Hero B, Reiser-Hartwig S, Fuhrmann U. Efficiency and side effects of antiretroviral treatment of HIV infected pregnant women [in German]. Zentralbl Gynakol. 2002;124:413-417. PUBMED

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291:305.

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Combined Antiretroviral Therapy During Pregnancy and Risk of Congenital Malformations
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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Combined Antiretroviral Therapy During Pregnancy and Risk of Congenital Malformations
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JAMA 2004;291:1961-1962.
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