Lopinavir/ritonavir in pregnancy

Journal of Acquired Immune Deficiency Syndromes

Volumn 51, Issue 4, 2009, Pages 456-461

  Roberts, Susan Sinclair ^a,b   Martinez, Marisol ^c   Covington, Deborah L ^b   Rode, Richard A ^c   Pasley, Mary V ^c   Woodward, William C ^c  

^a UNIVERSITY OF NORTH CAROLINA WILMINGTON   (United States)

^b Kendle International Inc   (United States)

^c ABBOTT LABORATORIES   (United States)

Author keywords

Antiretroviral therapy; Birth defects; Epidemiology; Pregnancy; Protease inhibitor

Indexed keywords

LOPINAVIR PLUS RITONAVIR;

ADOLESCENT; ADULT; ARTICLE; BIRTH DEFECT; CONTROLLED STUDY; DRUG EXPOSURE; FEMALE; FIRST TRIMESTER PREGNANCY; HEALTH SURVEY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFANT; MAJOR CLINICAL STUDY; PREGNANCY OUTCOME; PREVALENCE; PRIORITY JOURNAL; RISK FACTOR; SECOND TRIMESTER PREGNANCY; THIRD TRIMESTER PREGNANCY;

ABNORMALITIES, DRUG-INDUCED; ACQUIRED IMMUNODEFICIENCY SYNDROME; ADULT; ANTI-HIV AGENTS; FEMALE; HUMANS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PYRIMIDINONES; REGISTRIES; RITONAVIR;

EID: 68049116981     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3181a2813f     Document Type: Article

References (24)

1. Watts DH. Management of human immunodeficiency virus infection in pregnancy. N Engl J Med. 2002;346:1879-1891. (Pubitemid 34603032)
2. Covington DL, Tilson H, Elder J, et al, and APR Steering Committee. Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the APR. Pharmacoepidemiol Drug Saf. 2004;13:537-545.
3. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report for 1 January 1989 Through 31 July 2007. Wilmington, NC: Registry Coordinating Center; 2007.
4. Perinatal HIV GuidelinesWorking Group. Public health service task force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. July 8, 2008 1-96 (Table 3, page 69-72). Available at: http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf. Accessed July 19, 2008.
5. Kaletra® (lopinavir/ritonavir) Prescribing Information. North Chicago, IL: Abbott Laboratories; 2007. Available at: http://www.rxabbott.com/ pdf/kaletratabpi.pdf. Accessed December 17, 2007.
6. Code of Federal Regulations: labeling, 21 C.F.R. Sect. 201.57 (1997). Available at: http://www.fda.gov/cder/pediatric/21cfr20157.htm. Accessed December 17, 2007.
7. Norvir® (ritonavir) Prescribing Information. North Chicago, IL: Abbott Laboratories; 2007. Available at: http://www.rxabbott.com/pdf/norpi2a. pdf#page=1. Accessed December 17, 2007.
8. Kotelchuck MC, Wise P. Epidemiology of prematurity and goals for prevention. In: Taeusch HW, Yogman MW, eds. Follow-Up Management of the High-Risk Infant. Boston, MA: Little, Brown & Co; 1987: 3-14.
9. Centers for Disease Control and Prevention. Metropolitan Atlanta Congenital Defects Program. Surveillance Procedure Manual and Guide to Computerized Anomaly Record. Atlanta, GA: US Department of Health and Human Services, Public Health Service; 1998.
10. US Food and Drug Administration. Guidance for industry: establishing pregnancy exposure registries, August 2002. Available at: http://www.fda.gov/ cber/gdlns/pregexp.htm. Accessed June 6, 2008.
11. Correa A, Cragan J, Kucik J, et al. Metropolitan Atlanta congenital defects program 40th anniversary edition surveillance report: reporting birth defects surveillance data 1968-2003. Birth Defects Research. (Part A) 2007;79:65-93.
12. Stevenson RE, Hall JG, Goodman RM, et al. Human Malformations and Related Anomalies, Volume 1. Oxford Monographs on Medical Genetics, no.27. New York, NY: Oxford University Press; 1993.
13. Collett D. Modelling Binary Data. London, United Kingdom: Chapman and Hall; 1991.
14. Fleiss JL, Levin B, Paik MC. Statistical Methods for Rates and Proportions. 3rd ed. New York, NY: Wiley Interscience; 2003.
15. Kleinbaum DG, Kupper LL, Morgenstern H. Epidemiologic Research: Principles and Quantitative Methods. New York, NY: Van Nostrand Reinhold Company; 1982.
16. 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.
17. Townsend CL, Tookey PA, Cortina-Borja M, et al. 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.
18. Watts DH, Danner L, Handelsman E, et al. Assessment of birth defects according to maternal therapy among infants in the Women and Infants Transmission Study. J Acquir Immune Defic Syndr. 2007:44:299-305. (Pubitemid 46328346)
19. Covington DL, Conner SD, Doi PA, et al. Risk of birth defects associated with nelfinavir exposure during pregnancy. Obstet Gynecol. 2004;103: 1181-1189. (Pubitemid 40458947)
20. Cotter AM, Garcia, AG, Duthely ML, et al. Is antiretroviral therapy during pregnancy associated with an increased risk of preterm delivery, low birth weight, or stillbirth? J Infect Dis. 2006:193:1195-1201.
21. Morris AB, Dobles AR, Cu-Vin S, et al. Protease inhibitor use in 233 pregnancies. J Acquir Immune Defic Syndr. 2005:40:30-33.
22. Schulte J, Dominguez K, Sukalac T, et al. Pediatric Spectrum of HIV Disease Consortium. Declines in low birth weight and preterm birth among infants who were born to HIV-infected women during an era of increased use of maternal antiretroviral drugs: pediatric spectrum of HIV disease, 1989-2004. Pediatrics. 2007;119:e900-e906. Available at: www.pediatrics.org/cgi/content/full/peds.2006- 1123v1. Accessed December 17, 2007.
23. Townsend CL, Cortina-Borja M, Peckham CS, et al. Antiretroviral therapy and premature delivery in diagnosed HIV-infected women in the United Kingdom and Ireland. AIDS. 2007;21:1019-1026. (Pubitemid 46684333)
24. Honein MA, Paulozzi LJ, Cragan JD, et al. Evaluation of selected characteristics of pregnancy drug registries. Teratology. 1999;60: 356-364.