Safety of tenofovir disoproxil fumarate-based antiretroviral therapy regimens in pregnancy for HIV-infected women and their infants: A systematic review and meta-analysis

Journal of Acquired Immune Deficiency Syndromes

Volumn 76, Issue 1, 2017, Pages 1-12

  Nachega, Jean B ^a,b,c   Uthman, Olalekan A ^b,d,e   Mofenson, Lynne M ^f   Anderson, Jean R ^g   Kanters, Steve ^h,i   Renaud, Francoise ^j   Ford, Nathan ^j   Essajee, Shaffiq ^j   Doherty, Meg C ^j   Mills, Edward J ⁱ  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b STELLENBOSCH UNIVERSITY   (South Africa)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d UNIVERSITY OF WARWICK   (United Kingdom)

^e KAROLINSKA INSTITUTE   (Sweden)

^f ELIZABETH GLASER PEDIATRIC AIDS FOUNDATION   (United States)

^g JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF BRITISH COLUMBIA   (Canada)

ⁱ Global Evaluative Sciences   (Canada)

^j WORLD HEALTH ORGANIZATION   (Switzerland)

more..

Author keywords

HIV; pregnancy; tenofovir; toxicity

Indexed keywords

ABACAVIR; ATAZANAVIR PLUS RITONAVIR; EFAVIRENZ; EMTRICITABINE; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; STAVUDINE; TENOFOVIR DISOPROXIL; ZIDOVUDINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; TENOFOVIR;

ADVERSE OUTCOME; ANTIRETROVIRAL THERAPY; CONFIDENCE INTERVAL; CONGENITAL MALFORMATION; DISEASE SEVERITY; DRUG SAFETY; FEMALE; HEAD CIRCUMFERENCE; HIGH RISK PREGNANCY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFANT; INFANT MORTALITY; LOW BIRTH WEIGHT; META ANALYSIS; NEWBORN MORTALITY; PREGNANCY; PREGNANT WOMAN; PREMATURE LABOR; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; SCORING SYSTEM; SMALL FOR DATE INFANT; SPONTANEOUS ABORTION; STILLBIRTH; SYSTEMATIC REVIEW; VERY LOW BIRTH WEIGHT; BIRTH WEIGHT; CD4 LYMPHOCYTE COUNT; DRUG EFFECTS; HIV INFECTIONS; NEWBORN; PATIENT SAFETY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY OUTCOME; PREVENTION AND CONTROL; TRANSMISSION; VERTICAL TRANSMISSION;

ANTI-HIV AGENTS; BIRTH WEIGHT; CD4 LYMPHOCYTE COUNT; FEMALE; HIV INFECTIONS; HUMANS; INFANT, LOW BIRTH WEIGHT; INFANT, NEWBORN; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; PATIENT SAFETY; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY OUTCOME; TENOFOVIR;

EID: 85015202852     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0000000000001359     Document Type: Review

References (47)

1. World Health Organization. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection Recommendations for a Public Health Approach. Geneva, Switzerland: World Health Organization; 2013. Available at: http://apps.who.int/iris/bitstream/10665/85321/1/9789241505727-eng.pdf. Accessed September 26, 2015.
2. Cooper RD, Wiebe N, Smith N, et al. Systematic review and metaanalysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis. 2010;51:496-505.
3. Monteiro N, Branco M, Peres S, et al. The impact of tenofovir disoproxil fumarate on kidney function: four-year data from the HIV-infected outpatient cohort. J Int AIDS Soc. 2014;17(4 suppl 3):19565.
4. Winston J, Chonchol M, Gallant J, et al. Discontinuation of tenofovir disoproxil fumarate for presumed renal adverse events in treatment-naive HIV-1 patients: meta-analysis of randomized clinical studies. HIV Clin trials. 2014;15:231-245.
5. McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavirlamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis. 2011;203:1791-1801.
6. Purdy JB, Gafni RI, Reynolds JC, et al. Decreased bone mineral density with off-label use of tenofovir in children and adolescents infected with human immunodeficiency virus. J Pediatr. 2008;152:582-584.
7. Stellbrink HJ, Orkin C, Arribas JR, et al. Comparison of changes in bone density and turnover with abacavir-lamivudine versus tenofoviremtricitabine in HIV-infected adults: 48-week results from the ASSERT study. Clin Infect Dis. 2010;51:963-972.
8. Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367:423-434.
9. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report for 1 Jan 1989-31 July 2015. Wilmington, NC: Registry Coordinating Center; 2016. Available at: www.APRegistry.com. Accessed January 25, 2017.
10. Wang L, Kourtis AP, Ellington S, et al. Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. Clin Infect Dis. 2013;57:1773-1781.
11. Benaboud S, Hirt D, Launay O, et al. Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. Antimicrob Agents Chemother. 2012;56:857-862.
12. Colbers AP, Hawkins DA, Gingelmaier A, et al. The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women. AIDS. 2013;27:739-748.
13. 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. 2015. Available at: http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf. Accessed September 26, 2015.
14. 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;55:5914-5922.
15. Hirt D, Ekouevi DK, Pruvost A, et al. Plasma and intracellular tenofovir pharmacokinetics in the neonate (ANRS 12109 trial, step 2). Antimicrob Agents Chemother. 2011;55:2961-2967.
16. Tarantal AF, Castillo A, Ekert JE, et al. Fetal and maternal outcome after administration of tenofovir to gravid rhesus monkeys (Macaca mulatta). J Acquir Immune Defic Syndr. 2002;29:207-220.
17. 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.
18. Floridia M, Liotta G, Andreotti M, et al. Levels of bone markers in a population of infants exposed in utero and during breastfeeding to tenofovir within an Option B+ programme in Malawi. J Antimicrob Chemother. 2016;71:3206-3211.
19. Ransom CE, Huo Y, Patel K, et al. Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy. J Acquir Immune Defic Syndr. 2013;64:374-381.
20. Vigano A, Mora S, Giacomet V, et al. In utero exposure to tenofovir disoproxil fumarate does not impair growth and bone health in HIV-uninfected children born to HIV-infected mothers. Antivir Ther. 2011;16:1259-1266.
21. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924-926.
22. Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med. 2004;23:1351-1375.
23. Division of AIDS (DAIDS). Division of Aids Table for Grading the Severity of Adult and Pediatric Adverse Events. NIAID DAIDS Regulatory Support Center (RSC); 2017. Available at: http://rsc.techres. com/docs/default-source/safety/table-for-grading-severity-of-adult- pediatric-adverse-events.pdf.Accessed February 01, 2017.
24. Golder S, Loke YK, Bland M. Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: methodological overview. PLoS Med. 2011;8: e1001026.
25. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-560.
26. Brogly SB, Abzug MJ, Watts DH, et al. Birth defects among children born to human immunodeficiency virus-infected women: pediatric AIDS clinical trials protocols 219 and 219C. Pediatr Infect Dis J. 2010; 29:721-727.
27. Jacobson DL, Patel K, Williams PL, et al. Growth at 2 years of age in HIV-exposed uninfected children in the United States by trimester of maternal antiretroviral initiation. Pediatr Infect Dis J. 2017;36: 189-197.
28. Moodley T, Moodley D, Sebitloane M, et al. Improved pregnancy outcomes with increasing antiretroviral coverage in South Africa. BMC Pregnancy Childbirth. 2016;16:35.
29. Mirochnick M, Best BM, Stek AM, et al. Atazanavir pharmacokinetics with and without tenofovir during pregnancy. J Acquir Immune Defic Syndr. 2011;56:412-419.
30. Knapp KM, Brogly SB, Muenz DG, et al. Prevalence of congenital anomalies in infants with in utero exposure to antiretrovirals. Pediatr Infect Dis J. 2012;31:164-170.
31. Siberry GK, Williams PL, Mendez H, et al. Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. AIDS. 2012;26:1151-1159.
32. Sibiude J, Mandelbrot L, Blanche S, et al. Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11). PLoS Med. 2014;11: e1001635.
33. Colbers A, Hawkins D, Hidalgo-Tenorio C, et al. Atazanavir exposure is effective during pregnancy regardless of tenofovir use. Antivir Ther. 2015;20:57-64.
34. Fowler MG, Qin M, Fiscus SA, et al. Benefits and risks of antiretroviral therapy for perinatal HIV prevention. N Engl JMed. 2016;375:1726-1737.
35. Siberry GK, Jacobson DL, Kalkwarf HJ, et al. Lower newborn bone mineral content associated with maternal use of tenofovir disoproxil fumarate during pregnancy. Clin Infect Dis. 2015;61:996-1003.
36. Williams PL, Crain MJ, Yildirim C, et al. Congenital anomalies and in utero antiretroviral exposure in human immunodeficiency virus-exposed uninfected infants. JAMA Pediatr. 2015;169:48-55.
37. Siberry GK, Tierney C, Stranix-Chibanda L, et al. P1084s: Impact of Maternal Tenofovir Disoproxil Fumarate (TDF) Use on HIV-exposed Newborn Bone Mineral Content. 2016. Conference on Retroviruses and Opportunistic Infections; February 2016. Boston, MA. Abstract #36.
38. Zash R, Souda S, Chen JY, et al. Reassuring birth outcomes with tenofovir/emtricitabine/efavirenz used for prevention of mother-to-child transmission of HIV in Botswana. J Acquir Immune Defic Syndr. 2016; 71:428-436.
39. Chagomerana MB, Miller WC, Pence BW, et al. PMTCT Option B+ does not increase preterm birth risk and may prevent extreme prematurity: a retrospective cohort study in Malawi. J Acquir Immune Defic Syndr. 2017;74:367-374.
40. Stek AM, Mirochnick M, Capparelli E, et al. Reduced lopinavir exposure during pregnancy. AIDS. 2006;20:1931-1939.
41. Kearney BP, Mathias A, Mittan A, et al. Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir. J Acquir Immune Defic Syndr. 2006;43:278-283.
42. Kiser JJ, Carten ML, Aquilante CL, et al. The effect of lopinavir/ritonavir on the renal clearance of tenofovir in HIV-infected patients. Clin Pharmacol Ther. 2008;83:265-272.
43. Powis KM, Kitch D, Ogwu A, et al. Increased risk of preterm delivery among HIV-infected women randomized to protease versus nucleoside reverse transcriptase inhibitor-based HAART during pregnancy. J Infect Dis. 2011;204:506-514.
44. Shapiro RL, Hughes MD, Ogwu A, et al. Antiretroviral regimens in pregnancy and breast-feeding in Botswana. N Engl J Med. 2010;362: 2282-2294.
45. Pasley MV, Martinez M, Hermes A. d'Amico R, Nilius A. Safety and efficacy of lopinavir/ritonavir during pregnancy: a systematic review. AIDS Rev. 2013;15:38-48.
46. Srichan W, Thasanasuwan W, Kijboonchoo K, et al. Bone status measured by quantitative ultrasound: a comparison with DXA in Thai children. Eur J Clin Nutr. 2016;70:894-897.
47. Mills EJ, Jansen JP, Kanters S. Heterogeneity in meta-analysis of FDG-PET studies to diagnose lung cancer. JAMA. 2015;313:419.