Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants

Antimicrobial Agents and Chemotherapy

Volumn 55, Issue 12, 2011, Pages 5914-5922

  Flynn, Patricia M ^a   Mirochnick, Mark ^b   Shapiro, David E ^c   Bardeguez, Arlene ^d   Rodman, John ^a   Robbins, Brian ^e   Huang, Sharon ^c   Fiscus, Susan A ^f   Van Rompay, Koen K A ^g   Rooney, James F ^h   Kearney, Brian ^h   Mofenson, Lynne M ⁱ   Watts, D Heather ⁱ   Jean Philippe, Patrick ^j   Heckman, Barbara ^k   Thorpe Jr , Edwin ^l   Cotter, Amanda ^m   Purswani, Murli ⁿ  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY   (United States)

^e UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^f UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h GILEAD SCIENCES   (United States)

ⁱ NATIONAL INSTITUTES OF HEALTH   (United States)

^j Henry Jackson Foundation   (United States)

^k FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^l UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^m UNIVERSITY OF MIAMI   (United States)

ⁿ BRONX LEBANON HOSPITAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

EMTRICITABINE; TENOFOVIR DISOPROXIL; ZIDOVUDINE;

ADULT; ANTIVIRAL RESISTANCE; AREA UNDER THE CURVE; ARTICLE; CESAREAN SECTION; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INFANT; LABOR ONSET; MATERNAL PLASMA; MAXIMUM PLASMA CONCENTRATION; PREGNANT WOMAN; PRIORITY JOURNAL; SIDE EFFECT; UMBILICAL CORD BLOOD; VAGINAL DELIVERY;

ADENINE; ADULT; ANTI-HIV AGENTS; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; INFANT; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; PHOSPHONIC ACIDS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; REVERSE TRANSCRIPTASE INHIBITORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 81555224248     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00544-11     Document Type: Article

References (41)

1. Anderson, P. L., et al. 2011. Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection. J. Antimicrob. Chemother. 66(2):240-250.
2. Barditch-Crovo, P., et al. 2001. Phase I/II trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob. Agents Chemother. 45: 2733-2739. (Pubitemid 32906664)
3. Best, B. M., et al. 2008. High-dose lopinavir and standard-dose emtricitabine pharmacokinetics during pregnancy and postpartum, abstr. 629. Abstr. 15th Conf. Retrovir. Oppor. Infect., Boston, MA.
4. Blum, M. R., G. E. Chittick, J. A. Begley, and J. Zong. 2007. Steady-state pharmacokinetics of emtricitabine and tenofovir disoproxil fumarate administered alone and in combination in healthy volunteers. J. Clin. Pharmacol. 47:751-759. (Pubitemid 46800418)
5. Chi, B. H., et al. 2007. Single-dose tenofovir and emtricitabine for reduction of viral resistance to non-nucleoside reverse transcriptase inhibitor drugs in women given intrapartum nevirapine for perinatal HIV prevention: an open-label randomised trial. Lancet 370:1698-1705. (Pubitemid 350100773)
6. Connor, E. M., et al. 1994. 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. 331:1173-1180. (Pubitemid 24331334)
7. Durand-Gasselin, L., et al. 2009. Nucleotide analogue prodrug tenofovir disoproxil enhances lymphoid cell loading following oral administration in monkeys. Mol. Pharm. 6:1145-1151.
8. Eshleman, S. H., et al. 2006. Development of nevirapine resistance in infants is reduced by use of infant-only single-dose nevirapine plus zidovudine postexposure prophylaxis for the prevention of mother-to-child transmission of HIV-1. J. Infect. Dis. 193:479-481. (Pubitemid 43202737)
9. Eshleman, S. H., et al. 2001. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS 15:1951-1957. (Pubitemid 32980636)
10. Flys, T. S., et al. 2006. Quantitative analysis of HIV-1 variants with the K103N resistance mutation after single-dose nevirapine in women with HIV-1 subtypes A, C, and D. J. Acquir. Immune Defic. Syndr. 42:610-613. (Pubitemid 44162432)
11. Flys, T., et al. 2005. Sensitive drug-resistance assays reveal long-term persistence of HIV-1 variants with the K103N nevirapine (NVP) resistance mutation in some women and infants after the administration of single-dose NVP: HIVNET 012. J. Infect. Dis. 192:24-29. (Pubitemid 40863853)
12. Grant, R. M., et al. 2010. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N. Engl. J. Med. 363:2587-2599.
13. Guay, L. A., et al. 1999. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 354: 795-802. (Pubitemid 29415583)
14. Hirt, D., et al. 2009. ANRS 12109. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). Clin. Pharmacol. Ther. 85:182-189.
15. Hirt, D., et al. 2009. Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Antimicrob. Agents Chemother. 53:1067-1073.
16. Hirt, D., et al. 2011. Plasma and intracellular tenofovir pharmacokinetics in the neonate (ANRS 12109 Trial, step 2). Antimicrob. Agents Chemother. 55:2961-2967.
17. Johnson, J. A., et al. 2005. Emergence of drug-resistant HIV-1 after intrapartum administration of single-dose nevirapine is substantially underestimated. J. Infect. Dis. 192:16-23. (Pubitemid 40863852)
18. Johnson, J. A., et al. 2007. Simple PCR assays improve the sensitivity of HIV-1 subtype B drug resistance testing and allow linking of resistance mutations. PLoS One 2:e638.
19. Kearney, B. P., J. F. Flaherty, and J. Shah. 2004. Tenofovir disoproxil fumarate: clinical pharmacology and pharmacokinetics. Clin. Pharmacokinet. 43(9):595-612. (Pubitemid 38951802)
20. Mathias, A. A., et al. 2007. Bioequivalence of efavirenz/emtricitabine/ tenofovir disoproxil fumarate single tablet regimen. J. Acquir. Immune Defic. Syndr. 46:167-173. (Pubitemid 47482611)
21. McIntyre, J. A., et al. 2009. Efficacy of short-course AZT plus 3TC to reduce nevirapine resistance in the prevention of mother-to-child HIV transmission: a randomized clinical trial. PLoS Med. 6(10):e1000172.
22. Mirochnick, M., et al. 2003. Predose infant nevirapine concentration with the 2 dose intrapartum-neonatal nevirapine regimen: association with timing of maternal intrapartum nevirapine dose. J. Acquir. Immune Defic. Syndr. 33:153-156. (Pubitemid 36793148)
23. Mirochnick, M., et al. 2009. Pharmacokinetics of tenofovir disoproxil fumarate after administration to HIV-1-infected pregnant women and their newborns, abstr. 940. Abstr. 16th Conf. Retrovir. Oppor. Infect., Montreal, Canada.
24. Mirochnick, M., et al. 2010. Tenofovir disoproxil fumarate (TDF) pharmacokinetics (PK) with increased doses in HIV-1 infected pregnant women and their newborns (HPTN 057), abstr. 3. Abstr. 11th Int. Workshop Clin. Pharmacol. HIV Ther., Sorrento, Italy.
25. Mirochnick, M., et al. 2008. Nevirapine concentrations in newborns receiving an extended prophylactic regimen. J. Acquir. Immune Defic. Syndr. 47:334-337. (Pubitemid 351619419)
26. Nielsen-Saines, K., et al. 2011. Phase III randomized trial of the safety and efficacy of 3 neonatal ARV regimens for prevention of intrapartum HIV-1 transmission: NICHD HPTN 040/PACTG 1043, abstr. 124LB. Abstr. 18th Conf. Retrovir. Oppor. Infect., Boston, MA.
27. Palumbo, P., et al. 2010. Antiretroviral treatment for children with peripartum nevirapine exposure. N. Engl. J. Med. 363:1510-1520.
28. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. 14 September 2011, posting date. 2 November 2011, accession date. Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Department of Health and Human Services, NIH, Bethesda, MD. http://aidsinfo.nih.gov/ContentFiles /PerinatalGL.pdf.
29. Ramanathan, S., G. Shen, A. Cheng, and B. P. Kearney. 2007. Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137. J. Acquir. Immune Defic. Syndr. 45:274-279. (Pubitemid 47012373)
30. Sperling, R. S., et al. 1996. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N. Engl. J. Med. 335:1621-1629. (Pubitemid 26392726)
31. Stephan, C. 2008. Experience with tenofovir disoproxil fumarate for antiretroviral therapy. Expert Opin. Pharmacother. 9(7):1197-1209. (Pubitemid 351721756)
32. Tarantal, A. F., M. L. Marthas, J. P. Shaw, K. Cundy, and N. Bischofberger. 1999. Administration of 9-[2-(R)-(phosphonomethoxy)propyl]adenine (PMPA) to gravid and infant rhesus macaques (Macaca mulatta): safety and efficacy studies. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 20:323-333. (Pubitemid 29143025)
33. TEmAA ANRS 12109 Study Group. 2009. Tolerance and viral resistance after single-dose nevirapine with tenofovir and emtricitabine to prevent vertical transmission of HIV-1. AIDS 23:825-833.
34. TEmAA ANRS 12109 Study Group. 2010. Maternal and neonatal tenofovir and emtricitabine to prevent vertical transmission of HIV-1: tolerance and resistance. AIDS 24:2481-2488.
35. Van Rompay, K. K., et al. 1998. Two doses of PMPA protect newborn macaques against oral simian immunodeficiency virus infection. AIDS 12: F79-F83. (Pubitemid 28276961)
36. Van Rompay, K. K. A., et al. 2004. Biological effects of short-term or prolonged administration of 9-[2-(phosphonomethoxy)propyl]adenine (tenofovir) to newborn and infant rhesus macaques. Antimicrob. Agents Chemother. 48:1469-1487. (Pubitemid 38544348)
37. Van Rompay, K. K., et al. 2006. Evaluation of oral tenofovir disoproxil fumarate and topical tenofovir GS-7340 to protect infant macaques against repeated oral challenges with virulent simian immunodeficiency virus. J. Acquir. Immune Defic. Syndr. 43:6-14. (Pubitemid 44306481)
38. Van Rompay, K. K., et al. 1998. Administration of 9-[2-(phosphonomethoxy- ) propyl]adenine (PMPA) for prevention of perinatal simian immunodeficiency virus infection in rhesus macaques. AIDS Res. Hum. Retroviruses 14:761-773. (Pubitemid 28265737)
39. Van Rompay, K. K., et al. 2001. Two low doses of tenofovir protect newborn macaques against oral simian immunodeficiency virus infection. J. Infect. Dis. 184(4):429-438. (Pubitemid 32718506)
40. Van Rompay, K. K. A., et al. 2000. Prophylactic and therapeutic benefits of short-term 9-[2-(R)-(phosphonomethoxy)propyl]adenine (PMPA) administration to newborn macaques following oral inoculation with simian immunodeficiency virus with reduced susceptibility to PMPA. J. Virol. 74:1767-1774. (Pubitemid 30434034)
41. Wang, L. H., et al. 2004. Pharmacokinetics and safety of single oral doses of emtricitabine in human immunodeficiency virus-infected children. Antimicrob. Agents Chemother. 48:183-191. (Pubitemid 38040196)