Teratogenicity risk of antiretroviral therapy in pregnancy

Current HIV/AIDS Reports

Volumn 4, Issue 3, 2007, Pages 135-140

  Watts, D Heather ^a  

^a EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ANTIRETROVIRUS AGENT; DARUNAVIR; DELAVIRDINE; DIDANOSINE; EFAVIRENZ; ENFUVIRTIDE; LAMIVUDINE; LOPINAVIR; LOPINAVIR PLUS RITONAVIR; NELFINAVIR; NEVIRAPINE; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANENCEPHALUS; ANOPHTHALMIA; AUTOSOMAL DISORDER; BIRTH DEFECT; CLINICAL TRIAL; COHORT ANALYSIS; DANDY WALKER SYNDROME; DATA BASE; FACE MALFORMATION; FIRST TRIMESTER PREGNANCY; GESTATION PERIOD; HEART DISEASE; HEART VENTRICLE SEPTUM DEFECT; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPOSPADIAS; LACTIC ACIDOSIS; LIVER TOXICITY; MENINGOMYELOCELE; NEURAL TUBE DEFECT; NONHUMAN; PREGNANCY OUTCOME; PREVALENCE; PROSPECTIVE STUDY; REVIEW; RISK FACTOR; SECOND TRIMESTER PREGNANCY; TERATOGENICITY; THIRD TRIMESTER PREGNANCY; TRISOMY; VIRUS TRANSMISSION;

ABNORMALITIES, DRUG-INDUCED; ANIMALS; ANTI-RETROVIRAL AGENTS; DISEASE TRANSMISSION, VERTICAL; FEMALE; HIV INFECTIONS; HUMANS; INFANT, NEWBORN; PREGNANCY; RISK FACTORS; TERATOGENS;

EID: 34848869951     PISSN: 15483568     EISSN: 15483576     Source Type: Journal    
DOI: 10.1007/s11904-007-0020-y     Document Type: Review

References (19)

1. Connor EM, Sperling RS, Gelber R, et al.: Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment: Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med 1994, 331:1173-1180.
2. Cooper ER, Charurat M, Mofenson L, et al.: Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr 2002, 29:484-494.
3. Department of Health and Human Services: Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. October 10, 2006. http://aidsinfo.nih.gov/content-files/AdultandAdolescentGL.pdf. Accessed March 1, 2007.
4. Minkoff H, Ahdieh L, Watts DH, et al.: The relationship of pregnancy to the use of highly active antiretroviral therapy. Am J Obstet Gynecol 2001, 184:1221-1227.
5. Brent RL: Utilization of animal studies to determine the effects and human risks of environmental toxicants (drugs, chemicals, and physical agents). Pediatrics 2004, 113:984-995.
6. FDA Reviewer Guidance: Integration of study results to assess concerns about human reproductive and developmental toxicities. October 2001. http://www.fda.gov/OHRMS/DOCKETS/98fr/992079gd.pdf. Accessed March 1, 2007.
7. Public Health Service Task Force: Recommendations 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 - October 12, 2006. Safety and toxicity of individual antiretroviral agents in pregnancy. http://aidsinfo.nih.gov/contentfiles/Perinatal-GLSafetyTox_Sup. pdf. Accessed March 5, 2007. This document compiles all relevant data on safety of use of individual antiretroviral agents during pregnancy and is updated regularly, as new data become available or new drugs are approved by FDA.
8. The Antiretroviral Pregnancy Registry: Interim report. 1/1/89-7/31/06; issued December 2006. http://www.apregistry.com/forms/apr_report_706.pdf. Accessed May 4, 2007. Twice yearly report summarizes data on defects in cases reported to APR by drug and trimester of exposure, comparing first trimester to later exposure. Also includes data from clinical trials, retrospective cases, review of the literature, and detailed methods sections.
9. Nightingale SL: From the Food and Drug Administration. JAMA 1998, 280:1472.
10. Tilson HT, Doi PA, Covington DL, et al.: The Antiretrovirals in Pregnancy Registry: a fifteenth anniversary celebration. Obstet Gynecol Surv 2007, 62:137-148.
11. Covington DL, Tilson H, Elder J, Doi P: Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the Antiretroviral Pregnancy Registry. Pharmacoepidemiol Drug Safety 2004, 13:537-545.
12. European Collaborative Study: Exposure to antiretroviral therapy in utero or early life: the health of uninfected children born to HIV-infected women. J Acquir Immune Defic Syndr 2003, 32:380-387.
13. Townsend CL, Tookey PA, Cortina-Borja M, Peckham CS: Antiretroviral therapy and congenital abnormalities in infants born to HIV-1-infected women in the United Kingdom and Ireland, 1990-2003. J Acquir Immune Defic Syndr 2006, 42:91-94.
14. Watts DH, Li D, Handelsman E, et al.: Assessment of birth defects according to maternal therapy among infants in WITS. J Acquir Immune Defic Syndr 2007, 44:299-305.
15. Newschaffer CJ, Cocroft J, Anderson CE, et al.: Prenatal zidovudine use and congenital anomalies in a Medicaid population. J Acquir Immune Defic Syndr 2000, 24:249-256.
16. Jungmann EM, Mercey D, DeRuiter A, et al.: Is first trimester exposure to the combination of antiretroviral therapy and folate antagonists a risk factor for congenital abnormalities? Sex Transm Inf 2001, 77:441-443.
17. Richardson MP, Osrin D, Donaghy S, et al.: Spinal malformations in the fetuses of HIV infected women receiving combination antiretroviral therapy and cotrimoxazole. Eur J Obstetric Gynecol Reprod Biol 2000, 93:215-217.
18. Public Health Service Task Force: Recommendations 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 October 12, 2006. http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf. Accessed March 1, 2007. Comprehensive guidelines for management of pregnant women with HIV infection for both prevention of MTCT of HIV and HIV disease. Includes extensive review of the literature, clinical scenarios, and discussion of intrapartum and postpartum management.
19. Chersich MF, Urban MF, Venter FWD, et al.: Efavirenz use during pregnancy and for women of child-bearing potential. AIDS Research Ther 2006, 3:11-17.