Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women: A Prospective Short-Term Study of Antiretroviral Excretion in Breast Milk and Infant Absorption

1. UNAIDS. The Gap Report 2014. http://www.unaids.org/sites/default/files/media_asset/UNAIDS_Gap_report_en.pdf. Accessed December 21, 2015.

2. Drake AL, Wagner A, Richardson B, John-Stewart G. Incident HIV during Pregnancy and Postpartum and Risk of Mother-to-Child HIV Transmission: A Systematic Review and Meta-Analysis. PLoS Med. 2014;11(2):e1001608. doi: 10.1371/journal.pmed.1001608 24586123

3. Gray RH, Li X, Kigozi G, Serwadda D, Brahmbhatt H, Wabwire-Mangen F, et al. Increased risk of incident HIV during pregnancy in Rakai, Uganda: a prospective study. Lancet. 2005;366(9492):1182–8. 16198767

4. Moodley D, Esterhuizen T, Reddy L, Moodley P, Singh B, Ngaleka L, et al. Incident HIV infection in pregnant and lactating women and its effect on mother-to-child transmission in South Africa. J Infect Dis. 2011;203(9):1231–4. doi: 10.1093/infdis/jir017 21398393

5. Mugo NR, Heffron R, Donnell D, Wald A, Were EO, Rees H, et al. Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1-serodiscordant couples. AIDS. 2011;25(15):1887–95. doi: 10.1097/QAD.0b013e32834a9338 21785321

6. Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000;342(13):921–9. 10738050

7. Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, et al. Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1–Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda. PLoS Med. 2016;13(8):e1002099. doi: 10.1371/journal.pmed.1002099 27552090

8. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women. N Engl J Med. 2012;367(5):399–410. doi: 10.1056/NEJMoa1108524 22784037

9. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. N Engl J Med. 2010;363(27):2587–99. doi: 10.1056/NEJMoa1011205 21091279

10. McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53–60. doi: 10.1016/S0140-6736(15)00056-2 26364263

11. Molina J-M, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, et al. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015;373(23):2237–46. doi: 10.1056/NEJMoa1506273 26624850

12. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana. N Engl J Med. 2012;367(5):423–34. doi: 10.1056/NEJMoa1110711 22784038

13. South Africa Medicines Control Council. 2015. http://www.mccza.com/documents/2e4b3a5310.11_Media_release_ARV_FDC_PrEP_Nov15_v1.pdf. Accessed December 20, 2015.

14. Gilead Statement on the Approval of PrEP in Kenya, December 2015. https://xa.yimg.com/kq/groups/17854090/2023799735/name/kenya_prep_approval_statement_—_final.pdf. Accessed March 08, 2016.

15. Centers for Disease Control and Prevention. Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United States: A Clinical Practice Guideline. May 2014. http://www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf. Accessed September 27, 2015.

16. Food and Drug Administration.Truvada approved to reduce the risk of sexually transmitted HIV in people who are not infected with the virus. 2012. http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM311828.pdf. Accessed September 12, 2015.

17. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0 November, 2014. Available from: http://rsc.tech-res.com/Document/safetyandpharmacovigilance/DAIDS_AE_Grading_Table_v2_NOV2014.pdf. Accessed September 02, 2016.

18. US Department of Health and Human Services, FDA, CDER, CVM. Rockville, MD. Guidance for the Industry: Bioanalytical Method Validation. 2001. http://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf. Accessed January 20, 2016.

19. Begg EJ. Determinants of drug transfer into human milk. In: Drugs and Human Lactation (Second Edition). Bennett PN, Ed. Amsterdam: Elsevier Science BV; 1996. p.47–58.

20. Ito S, Lee A. Drug excretion into breast milk—Overview. Adv Drug Deliv Rev. 2003;55(5):617–27. 12706545

21. Ito S, Koren G. A novel index for expressing exposure of the infant to drugs in breast milk. Br J Clin Pharmacol. 1994;38(2):99–102. 7981020

22. Hirt D, Urien S, Rey E, Arrivé E, Ekouévi DK, Coffié P, et al. Population Pharmacokinetics of Emtricitabine in Human Immunodeficiency Virus Type 1-Infected Pregnant Women and Their Neonates. Antimicrob Agents Chemother. 2009;53(3):1067–73. doi: 10.1128/AAC.00860-08 19104016

23. Mirochnick M, Thomas T, Capparelli E, Zeh C, Holland D, Masaba R, et al. Antiretroviral concentrations in breast-feeding infants of mothers receiving highly active antiretroviral therapy. Antimicrob Agents Chemother. 2009;53(3):1170–6. doi: 10.1128/AAC.01117-08 19114673

24. Wang LH, Wiznia AA, Rathore MH, Chittick GE, Bakshi SS, Emmanuel PJ, et al. Pharmacokinetics and Safety of Single Oral Doses of Emtricitabine in Human Immunodeficiency Virus-Infected Children. Antimicrob Agents Chemother. 2004;48(1):183–91. 14693538

25. Mirochnick M, Taha T, Kreitchmann R, Nielsen-Saines K, Kumwenda N, Joao E, et al. Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life. J Acquir Immune Defic Syndr. 2014;65(1):33–41. doi: 10.1097/QAI.0b013e3182a921eb 23979002

26. Benaboud S, Pruvost A, Coffie PA, Ekouevi DK, Urien S, Arrive E, et al. Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d'Ivoire, in the ANRS 12109 TEmAA Study, Step 2. Antimicrob Agents Chemother. 2011;55(3):1315–7. doi: 10.1128/AAC.00514-10 21173182

27. Ito S. Drug Therapy for Breast-Feeding Women. N Engl J Med. 2000;343(2):118–26. 10891521

28. Van Rompay KK, Hamilton M, Kearney B, Bischofberger N. Pharmacokinetics of tenofovir in breast milk of lactating rhesus macaques. Antimicrob Agents Chemother. 2005;49(5):2093–4. 15855535

29. Waitt CJ, Garner P, Bonnett LJ, Khoo SH, Else LJ. Is infant exposure to antiretroviral drugs during breastfeeding quantitatively important? A systematic review and meta-analysis of pharmacokinetic studies. J Antimicrob Chemother. 2015;70(7):1928–41. doi: 10.1093/jac/dkv080 25858354