Safety of tenofovir during pregnancy for the mother and fetus: A systematic review

Clinical Infectious Diseases

Volumn 57, Issue 12, 2013, Pages 1773-1781

  Wang, Liming ^a   Kourtis, Athena P ^b   Ellington, Sascha ^b   Legardy Williams, Jennifer ^b   Bulterys, Marc ^a,c  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION   (United States)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

HIV; PMTCT; pregnancy; safety; TDF

Indexed keywords

ABACAVIR; CALCIUM; EMTRICITABINE; HEPATITIS B ANTIBODY; HEPATITIS B VACCINE; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; PARATHYROID HORMONE; RALTEGRAVIR; SOMATOMEDIN C; TELBIVUDINE; TENOFOVIR DISOPROXIL; ZIDOVUDINE;

ANEMIA; ANTIVIRAL THERAPY; BIRTH WEIGHT; BODY HEIGHT; BRAIN INJURY; CALCIUM URINE LEVEL; CHILD GROWTH; CLINICAL TRIAL (TOPIC); CONGENITAL MALFORMATION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; ENVIRONMENTAL EXPOSURE; FETUS; FETUS GROWTH; GASTROENTERITIS; HEPATITIS B; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HYPERBILIRUBINEMIA; INFECTION PREVENTION; LEUKOPENIA; MENINGITIS; MOTHER; NEPHROTOXICITY; NEUTROPENIA; NEWBORN OPHTHALMIA; NEWBORN SEPSIS; NONHUMAN; OBSERVATIONAL STUDY; PARATHYROID HORMONE BLOOD LEVEL; PNEUMONIA; PREGNANCY OUTCOME; PREGNANT WOMAN; PRENATAL DRUG EXPOSURE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PYELECTASIS; RETROSPECTIVE STUDY; REVIEW; RHESUS MONKEY; RISK ASSESSMENT; SEPTICEMIA; SHORT COURSE THERAPY; SIDE EFFECT; SINGLE DRUG DOSE; STREPTOCOCCUS PNEUMONIA; SYSTEMATIC REVIEW; TERATOGENESIS; TERATOGENICITY; TREATMENT DURATION; URINARY TRACT INFECTION; VIREMIA; VIRUS PNEUMONIA;

HIV; PMTCT; PREGNANCY; SAFETY; TDF;

ADENINE; ANIMALS; FEMALE; FETAL DEVELOPMENT; HIV INFECTIONS; HUMANS; INFANT, NEWBORN; ORGANOPHOSPHONATES; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS;

EID: 84890033623     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cit601     Document Type: Review

References (57)

1. Read JS. Prevention of mother-to-child transmission of HIV: Antiretroviral strategies. Clin Perinatol 2010; 37:765-76
2. Thomas TK, Masaba R, Borkowf CB, et al. Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding - The Kisumu Breastfeeding Study, Kenya: A clinical trial. PLoS Med 2011; 8:e1001015
3. Palombi L, Marazzi MC, Voetberg A, Magid NA. Treatment acceleration program and the experience of the DREAM program in prevention of mother-to-child transmission of HIV. AIDS 2007; 21(suppl 4): S65-71
4. Chasela CS, Hudgens MG, Jamieson DJ, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med 2010; 362:2271-81
5. World Health Organization. Programmatic update: Use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants - executive summary. Geneva, Switzerland: WHO, 2012.Available at: Http://whqlibdoc.who.int/hq/2012/WHO-HIV-2012.6-eng.pdf. Accessed 6 August 2013
6. Gallant JE, Staszewski S, Pozniak AL, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: A 3-year randomized trial. JAMA 2004; 292:191-201
7. Cassetti I, Madruga JV, Suleiman JM, et al. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naive HIV-1-infected patients. HIV Clin Trials 2007; 8:164-72
8. Nelson MR, Katlama C, Montaner JS, et al. The safety of tenofovir disoproxil fumarate for the treatment of HIV infection in adults: The first 4 years. AIDS 2007; 21:1273-81
9. Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012; 367:411-22
10. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012; 367:399-410
11. Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012; 367:423-34
12. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010; 329:1168-74
13. Marcellin P, Heathcote EJ, Buti M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008; 359:2442-55
14. Liaw YF, Sheen IS, Lee CM, et al. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology 2011; 53:62-72
15. Murray KF, Szenborn L, Wysocki J, et al. Randomized, placebocontrolled trial of tenofovir disoproxil fumarate in adolescents with chronic hepatitis B. Hepatology 2012; 56:2018-26
16. Kuhn L, Bulterys M. Does maternal use of tenofovir during pregnancy affect growth of HIV-exposed uninfected infants? AIDS 2012; 26:1167-9
17. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. 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. 2012. Available at: Http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf. Accessed 6 August 2013
18. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report for 1 January 1989 through 31 January 2013. Wilmington, NC: Registry Coordinating Center, 2013. Available at: Http://www.APRegistry.com. Accessed 6 August 2013
19. Tarantal AF, Castillo A, Ekert JE, Bischofberger N, Martin RB. Fetal and maternal outcome after administration of tenofovir to gravid rhesus monkeys (Macaca mulatta). J Acquir Immune Defic Syndr 2002; 29:207-20
20. Tarantal AF, Marthas ML, Shaw JP, Cundy K, Bischofberger N. 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 1999; 20:323-33
21. Van Rompay KK, Brignolo LL, Meyer DJ, et al. Biological effects of short-term or prolonged administration of 9-[2-(phosphonomethoxy) propyl]adenine (tenofovir) to newborn and infant rhesus macaques. Antimicrob Agents Chemother 2004; 48:1469-87
22. Chi BH, Sinkala M, Mbewe F, et al. 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 2007; 370:1698-705
23. Arrive E, Chaix ML, Nerrienet E, et al. Tolerance and viral resistance after single-dose nevirapine with tenofovir and emtricitabine to prevent vertical transmission of HIV-1. AIDS 2009; 23:825-33
24. Arrive E, Chaix ML, Nerrienet E, et al. Maternal and neonatal tenofovir and emtricitabine to prevent vertical transmission of HIV-1: Tolerance and resistance. AIDS 2010; 24:2481-8
25. Flynn PM, Mirochnick M, Shapiro DE, et al. Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants. Antimicrob Agents Chemother 2011; 55:5914-22
26. Nurutdinova D, Onen NF, Hayes E, Mondy K, Overton ET. Adverse effects of tenofovir use in HIV-infected pregnant women and their infants. Ann Pharmacother 2008; 42:1581-5
27. Colbers A, Hawkins D, Gingelmaier A, et al. The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1 infected pregnant women. AIDS 2013; 27:739-48
28. Gibb DM, Kizito H, Russell EC, et al. Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial. PLoS Med 2012; 9:e1001217
29. Baroncelli S, Tamburrini E, Ravizza M, et al. Antiretroviral treatment in pregnancy: A six-year perspective on recent trends in prescription patterns, viral load suppression, and pregnancy outcomes. AIDS Patient Care STDS 2009; 23:513-20
30. Griner R, Williams PL, Read JS, et al. In utero and postnatal exposure to antiretrovirals among HIV-exposed but uninfected children in the United States. AIDS Patient Care STDS 2011; 25:385-94
31. Pan CQ, Mi LJ, Bunchorntavakul C, et al. Tenofovir disoproxil fumarate for prevention of vertical transmission of hepatitis B virus infection by highly viremic pregnant women: A case series. Dig Dis Sci 2012; 57:2423-9
32. Beigi R, Noguchi L, Parsons T, et al. Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy. J Infect Dis 2011; 204:1527-31
33. Sabbatini F, Prati F, Borghi V, et al. Congenital pyelectasis in children born from mothers on tenofovir containing therapy during pregnancy: Report of two cases. Infection 2007; 35:474-6
34. Vigano A, Mora S, Giacomet V, et al. In utero exposure to tenofovir disoproxil fumarate does not impair growth and bone health in HIVuninfected children born to HIV-infected mothers. Antivir Ther 2011; 16:1259-66
35. Siberry GK, Williams PL, Mendez H, et al. Safety of tenofovir use during pregnancy: Early growth outcomes in HIV-exposed uninfected infants. AIDS 2012; 26:1151-9
36. Kinai E, Hosokawa S, Gomibuchi H, et al. Blunted fetal growth by tenofovir in late pregnancy. AIDS 2012; 26:2119-20
37. Arrive E, Newell ML, Ekouevi DK, et al. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: A meta-analysis. Int J Epidemiol 2007; 36:1009-21
38. Lyseng-Williamson KA, Reynolds NA, Plosker GL. Tenofovir disoproxil fumarate: A review of its use in the management of HIV infection. Drugs 2005; 65:413-32
39. Grigsby IF, Pham L, Mansky LM, et al. Tenofovir-associated bone density loss. Ther Clin Risk Manag 2010; 6:41-7
40. Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med 2006; 354:251-60
41. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Geneva, Switzerland:WHO, 2013. Available at: Http://apps.who.int/iris/bitstream/ 10665/85321/1/9789241505727-eng.pdf. Accessed 6 August 2013
42. Sims EA, Krantz KE. Serial studies of renal function during pregnancy and the puerperium in normal women. J Clin Invest 1958; 37:1764-74
43. Johnson DC, Chasela C, Maliwichi M, et al. Tenofovir use and renal insufficiency among pregnant and general adult population of HIVinfected, ART-naive individuals in Lilongwe, Malawi. PLoS One 2012; 7:e41011
44. Brinkman K, ter Hofstede HJ, Burger DM, et al. Adverse effects of reverse transcriptase inhibitors: Mitochondrial toxicity as common pathway. AIDS 1998; 12:1735-44
45. Moyle G. Clinical manifestations andmanagement of antiretroviral nucleoside analog-related mitochondrial toxicity. Clin Ther 2000; 22:911-36
46. Kakuda TN. Pharmacology of nucleoside and nucleotide reverse transcriptase inhibitor-induced mitochondrial toxicity. Clin Ther 2000; 22:685-708
47. Lewis W, Dalakas MC. Mitochondrial toxicity of antiviral drugs. Nat Med 1995; 1:417-22
48. Birkus G, Hitchcock MJ, Cihlar T. Assessment of mitochondrial toxicity in human cells treated with tenofovir: Comparison with other nucleoside reverse transcriptase inhibitors. Antimicrob Agents Chemother 2002; 46:716-23
49. Kourtis AP, Bulterys M, Hu DJ, Jamieson DJ. HIV-HBV coinfection - A global challenge. N Engl J Med 2012; 366:1749-52
50. Dusheiko G. Interruption of mother-to-infant transmission of hepatitis B: Time to include selective antiviral prophylaxis? Lancet 2012; 379:2019-21
51. Han L, Zhang HW, Xie JX, et al. A meta-analysis of lamivudine for interruption of mother-to-child transmission of hepatitis B virus. World J Gastroenterol 2011; 17:4321-33
52. Deng M, Zhou X, Gao S, et al. The effects of telbivudine in late pregnancy to prevent intrauterine transmission of the hepatitis B virus: A systematic review and meta-analysis. Virol J 2012; 9:185
53. Xu WM, Cui YT, Wang L, et al. Lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus infection: A multicentre, randomized, double-blind, placebo-controlled study. J Viral Hepat 2009; 16:94-103
54. van Zonneveld M, van Nunen AB, Niesters HG, et al. Lamivudine treatment during pregnancy to prevent perinatal transmission of hepatitis B virus infection. J Viral Hepat 2003; 10:294-7
55. Dusheiko G. Candidates for therapy: HBV. J Hepatol 2006; 44(suppl 1): S84-9
56. Jonas MM. Hepatitis B and pregnancy: An underestimated issue. Liver Int 2009; 29(suppl 1):133-9
57. ter Borg MJ, Leemans WF, de Man RA, et al. Exacerbation of chronic hepatitis B infection after delivery. J Viral Hepat 2008; 15:37-41