187
Views
0
CrossRef citations to date
0
Altmetric
Review

Challenges, risks, and opportunities of antiretroviral drugs in women of reproductive potential

, , &
Pages 153-167 | Received 08 Dec 2023, Accepted 19 Mar 2024, Published online: 27 Mar 2024

References

  • World Health Organization. HIV data and statistics. World Health Organization; Jul 2023. Available from: https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/hiv/strategic-information/hiv-data-and-statistics
  • The path that ends AIDS: uNAIDS global AIDS update 2023. Geneva: Joint United Nations Programme on HIV/AIDS; 2023. Licence: CC BY-NC-SA 3.0 IGO.
  • Center for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2015–2019. HIV Surv Supple Rep. 2021;26(1).
  • Centers for Disease Control. Unexplained immunodeficiency and opportunistic infections in infants–New York, New Jersey, California. MMWR Morb Mortal Wkly Rep. 1982 Dec 17;31(49):665–667.
  • Lindegren ML, Byers JR, Thomas P, et al. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA J Am Med Ass. 1999;282(6):521–538. doi: 10.1001/jama.282.6.531
  • Davis SF, RH B Jr, Lindegren ML, et al. Prevalence and incidence of vertically acquired HIV infection in the United States. JAMA J Am Med Ass. 1995;274(12):952–955. doi: 10.1001/jama.1995.03530120044039
  • Brady MT, Oleske JM, Williams PL, et al. Declines in mortality rates and changes in causes of death in HIV-1-infected children during the HAART era. J Acquir Immune Defic Syndr. 2010 Jan;53(1):86–94.
  • Connor EM, Sperling RS, Gelber R, et al. 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. 1994;331(18):1173–1180. doi: 10.1056/NEJM199411033311801
  • Joint United Nations programme on HIV/AIDS and the United States President’s emergency plan for AIDS Relief. Start Free Stay Free AIDS Free framework; 2019.
  • Lampe M, Nesheim S, Oladapo K, et al. Achieving elimination of perinatal HIV in the United States. Pediatrics. 2023;151(4):e2022059604. doi: 10.1542/peds.2022-059604
  • Nesheim S, Harris LF, Lampe M. Elimination of perinatal HIV infection in the USA and other high-income countries: achievements and challenges. Curr Opin HIV AIDS. 2013;8(5):447–456. doi: 10.1097/COH.0b013e3283636ccb
  • de Ory SJ, Ramos JT, Fortuny C, et al. Sociodemographic changes and trends in the rates of new perinatal HIV diagnoses and transmission in Spain from 1997 to 2015. PLoS One. 2019;14(10):e0223536. doi: 10.1371/journal.pone.0223536
  • Knapp KM. Prevention of mother-to-child human immunodeficiency virus transmission in resource-limited countries. Pediatr Clin North Am. 2022;69(1):1–18. doi: 10.1016/j.pcl.2021.08.007
  • Peters H, Thorne C, Tookey PA, et al. National audit of perinatal HIV infections in the UK, 2006-2013: what lessons can be learnt? HIV Med. 2018;19(4):280–289. doi: 10.1111/hiv.12577
  • Short WR, Anderson JR. Caring for women with HIV: unique needs and challenges. Cleve Clin J Med. 2014;81(11):691–701. doi: 10.3949/ccjm.81a.14009
  • Vella S, Schwartländer B, Sow SP, et al. The history of antiretroviral therapy and of its implementation in resource-limited areas of the world. AIDS. 2012;26(10):1231–1241. doi: 10.1097/QAD.0b013e32835521a3
  • Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. Department of Health and Human Services; 2023 [cited 2023 Oct].
  • World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2nd ed. Geneva: World Health Organization; 2016.
  • Lindegren ML, Byers JR, Thomas P, et al. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA J Am Med Ass. 1999;282(6):531–538. doi: 10.1001/jama.282.6.531
  • Guay LA, Musoke P, Fleming T, et al. 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. 1999;354(9181):795–802. doi: 10.1016/S0140-6736(99)80008-7
  • Lallemant M, Le Coeur S, McIntosh K, et al. AZT trial in Thailand. Science. 1995;270(5238):899–900. doi: 10.1126/science.270.5238.899
  • The INSIGHT START Study Group. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373(9):795–807. doi: 10.1056/NEJMoa1506816
  • Cohen MS, Chen YQ, McCauley M, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med. 2016 Sep 1;375(9):830–839. doi: 10.1056/NEJMoa1600693
  • Joint United Nations Programme on HIV/AIDS (UNAIDS). 90-90-90: an ambitious treatment target to help end the AIDS epidemic. 2014.
  • Flynn PM, Taha TE, Cababasay M, et al. Prevention of HIV-1 transmission through breastfeeding: efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high CD4 cell count (IMPAACT PROMISE): a randomized, open-label, clinical trial. J Acquir Immune Defic Syndr. 2018;77(4):383–392. doi: 10.1097/QAI.0000000000001612
  • Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services; 2023 [cited 2023 Oct].
  • Temprano ANRS Study Group, Danel C, Moh R, et al. A trial of early antiretrovirals and isoniazid preventive therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808–822.
  • World Health Organization. Guideline: updates on HIV and infant feeding: the duration of breastfeeding, and support from health services to improve feeding practices among mothers living with HIV. Geneva Switzerland: World Health Organization; 2016.
  • Centers for disease control and prevention: US Public Health Service: preexposure prophylaxis for the prevention of HIV infection in the United States—2021 update: a clinical practice guideline. Dec 2021.
  • Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411–422. doi: 10.1056/NEJMoa1202614
  • Peterson L, Taylor D, Roddy R, et al. Tenofovir disoproxil fumarate for prevention of HIV infection in women: a phase 2, double-blind, randomized, placebo-controlled trial PLoS clin trial. PLoS Clin Trials. 2007;2(5):e27. doi: 10.1371/journal.pctr.0020027
  • Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–518. doi: 10.1056/NEJMoa1402269
  • Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367(5):423–434. doi: 10.1056/NEJMoa1110711
  • Baeten JM, Donnell D, Ndase P, 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
  • Donnell D, Baeten JM, Bumpus NN, et al. HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. J Acquir Immune Defic Syndr. 2014;66(3):340–348. doi: 10.1097/QAI.0000000000000172
  • Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022;399(10337):1779–1789. doi: 10.1016/S0140-6736(22)00538-4
  • Celum C, Hosek S, Tsholwana M, et al. PrEP uptake, persistence, adherence, and effect of retrospective drug level feedback on PrEP adherence among young women in southern Africa: results from HPTN 082, a randomized controlled trial. PLoS Med. 2021;18(6):e1003670. doi: 10.1371/journal.pmed.1003670
  • Centers for Disease Control and Prevention. PrEP for HIV prevention in the U.S. 2023 Sep 29. Available from: https://www.cdc.gov/nchhstp/newsroom/fact-sheets/hiv/PrEP-for-hiv-prevention-in-the-US-factsheet.html
  • Crooks N, Singer RB, Smith A, et al. Barriers to PrEP uptake among black female adolescents and emerging adults. Prev Med Rep. 2022;31:102062. doi: 10.1016/j.pmedr.2022.102062
  • Fields SD, Gruber J, Clue J, et al. Prevalence of renal and bone risk factors among individuals prescribed oral pre-exposure prophylaxis for HIV. IJID Reg. 2023 Jan 11;6:68–75. doi: 10.1016/j.ijregi.2023.01.004
  • Pilkington V, Hill A, Hughes S, et al. How safe is TDF/FTC as PrEP? A systematic review and meta-analysis of the risk of adverse events in 13 randomised trials of PrEP. J Virus Erad. 2018;4(4):215–224. doi: 10.1016/S2055-6640(20)30312-5
  • Landovitz RJ, Li S, JJ E Jr, et al. Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial. Lancet HIV. 2020;7(7):e472–e481. doi: 10.1016/S2352-3018(20)30106-5
  • Stranix-Chibanda L, Anderson PL, Kacanek D, et al. Tenofovir diphosphate concentrations in dried blood spots from pregnant and postpartum adolescent and young women receiving daily observed pre-exposure prophylaxis in Sub-Saharan Africa. Clinical Infectious Diseases. 2020;73(7):e1893–e1900. doi: 10.1093/cid/ciaa1872
  • Hannaford A, Arens Y, Koenig H. Real-time monitoring and point-of-care testing: a review of the Current landscape of PrEP adherence monitoring. Patient Prefer Adherence. 2021;5(15):259–269. doi: 10.2147/PPA.S248696
  • Delany-Moretlwe S, Hughes J, Guo X, et al. Evaluation of CAB-LA safety and PK in pregnant women in the blinded phase of HPTN 084. Conference on Retroviruses and Opportunistic Infections (CROI); Virtual 2022.
  • Joseph Davey DL, Pintye J, Baeten JM, et al. Emerging evidence from a systematic review of safety of pre-exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading. J Int AIDS Soc. 2020;23(1):e25426. doi: 10.1002/jia2.25426
  • Mugo NR, Hong T, Celum C, et al. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: a randomized clinical trial. JAMA. 2014;312(4):362–371. doi: 10.1001/jama.2014.8735
  • Callahan R, Nanda K, Kapiga S, et al. Pregnancy and contraceptive use among women participating in the FEM-PrEP trial. J Acquir Immune Defic Syndr. 2015;68(2):196–203. doi: 10.1097/QAI.0000000000000413
  • Heffron R, Mugo N, Hong T, et al. Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention. AIDS. 2018;32(12):1707–1713. doi: 10.1097/QAD.0000000000001867
  • Pintye J, Kinuthia J, Roberts DA, et al. Brief report: integration of PrEP services into routine antenatal and postnatal care: experiences from an implementation program in Western Kenya. J Acquir Immune Defic Syndr. 2018;29(5):590–595. doi: 10.1097/QAI.0000000000001850
  • Dettinger JC, Kinuthia J, Pintye J, et al. Perinatal outcomes following maternal pre-exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya. J Int AIDS Soc. 2019;22(9):e25378. doi: 10.1002/jia2.25378
  • Bunge K, Balkus JE, Fairlie L, et al. DELIVER: a safety study of a dapivirine vaginal ring and oral PrEP for the prevention of HIV during pregnancy. J Acquir Immune Defic Syndr. 2024;95(1):65–73. doi: 10.1097/QAI.0000000000003312
  • Makanani B, Balkus JE, Jiao Y, et al. Pregnancy and infant outcomes among women using the dapivirine vaginal ring in early pregnancy. J Acquir Immune Defic Syndr. 2018;79(5):566–572. doi: 10.1097/QAI.0000000000001861
  • Baeten JM, Palanee-Phillips T, Brown ER, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016;375(22):2121–2132. doi: 10.1056/NEJMoa1506110
  • Landovitz RJ, Li S, Grinsztejn B, et al. Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS Med. 2018;15(11):e1002690. doi: 10.1371/journal.pmed.1002690
  • Fonner VA, Ridgeway K, van der Straten A, et al. Safety and efficacy of long-acting injectable cabotegravir as preexposure prophylaxis to prevent HIV acquisition. AIDS. 2023 May;37(8):957–966.
  • Aaron E, Blum C, Seidman D, et al. Optimizing delivery of HIV preexposure prophylaxis for women in the United States. AIDS Patient Care STDS. 2018;31(1):16–23. doi: 10.1089/apc.2017.0201
  • Calabrese SK, Dovidio JF, Tekeste M, et al. HIV pre-exposure prophylaxis stigma as a multidimensional barrier to uptake among women who attend planned parenthood. J Acquir Immune Defic Syndr. 2018;79(1):46–53. doi: 10.1097/QAI.0000000000001762
  • Kinuthia J, Pintye J, Abuna F, et al. Pre-exposure prophylaxis uptake and early continuation among pregnant and post-partum women within maternal and child health clinics in Kenya: results from an implementation programme. Lancet HIV. 2020;7(1):e38–e48. doi: 10.1016/S2352-3018(19)30335-2
  • Corneli A, Perry B, McKenna K, et al. Participants’ explanations for nonadherence in the FEM-PrEP clinical trial. J Acquir Immune Defic Syndr. 2016;71(4):452–461. doi: 10.1097/QAI.0000000000000880
  • d’Arminio Monforte A, Anderson J, Olczak A. What do we know about antiretroviral treatment of HIV in women? Antivir Ther. 2014;18(2_suppl):27–34. doi: 10.3851/IMP2647
  • World Health Organization. The world health report: 2004: changing history. 2004.
  • Kalungwe M, Mbalinda SN, Karonga T, et al. Exploring barriers to antiretroviral therapy adherence among pregnant women: a scoping literature review. Int J Gynaecol Obstet. 2022;159(2):343–350. doi: 10.1002/ijgo.14130
  • Adeniyi OV, Ajayi AI, Ter Goon D, et al. Factors affecting adherence to antiretroviral therapy among pregnant women in the Eastern Cape, South Africa. BMC Infect Dis. 2018;18(1):175. doi: 10.1186/s12879-018-3087-8
  • Colvin CJ, Konopka S, Chalker JC, et al. A systematic review of health system barriers and enablers for antiretroviral therapy (ART) for HIV-Infected pregnant and postpartum women. PLoS One. 2014;9(10):e108150. doi: 10.1371/journal.pone.0108150
  • Wanga I, Helova A, Abuogi LL, et al. Acceptability of community-based mentor mothers to support HIV-positive pregnant women on antiretroviral treatment in western Kenya: a qualitative study. Bmc Pregnancy Childbirth. 2019;19(288). doi: 10.1186/s12884-019-2419-z
  • Rendell S, Schmidt H, Neergaard R, et al. Integrating ART adherence support technologies in the care of pregnant and postpartum people with HIV: a qualitative study. Implement Sci Commun. 2022;3(1):85. doi: 10.1186/s43058-022-00331-0
  • Abrams EJ, Mofenson LM, Pozniak A, et al. Enhanced and timely investigation of ARVs for use in pregnant women. J Acquir Immune Defic Syndr. 2021;86(5):607–615. doi: 10.1097/QAI.0000000000002597
  • Haberl A, R A. How does HIV affect the reproductive choices of women of childbearing age? Antivir Ther. 2013;18(2_suppl):35–44. doi: 10.3851/IMP2638
  • Colbers A, Mirochnick M, Schalkwijk S, et al. Importance of prospective studies in pregnant and breastfeeding women living with human immunodeficiency virus. Clin Infect Dis. 2019;69(7):1254–1258. doi: 10.1093/cid/ciz121
  • Ofotokum I, Chuck SK, H JE. Antiretroviral pharmacokinetic profile: a review of sex differences. Gender med. 2007;4(2):106–119. doi: 10.1016/S1550-8579(07)80025-8
  • FDA. Pregnant women: scientific and ethical considerations for inclusion in clinical trials guidance for industry. Rockville (MD): U.S. Department of Health and Human Services Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); 2018.
  • IMPAACT P1026S/PK in pregnancy: pharmacokinetic properties of antiretroviral and related drugs during pregnancy and postpartum [Internet]. 2020. Available from: https://www.impaactnetwork.org/studies/p1026s.
  • IMPAACT 2026: pharmacokinetic properties of antiretroviral and anti-tuberculosis drugs during pregnancy and postpartum [Internet]. 2021. Available from: https://www.impaactnetwork.org/studies/impaact2026.
  • The PHASES Working Group. Ending the evidence gap for pregnant women around HIV & co-infections: a call to action [internet]. Chapel Hill (NC): 2020 [cited Feb 2024]. Available from: http://hiv.pregnancyethics.org.
  • Liu XI, Momper JD, Rakhmanina NY, et al. Prediction of maternal and fetal pharmacokinetics of dolutegravir and raltegravir using physiologically based pharmacokinetic modeling. Clin Pharmacokinet. 2020;59(11):1433–1450. doi: 10.1007/s40262-020-00897-9
  • Liu XI, Momper JD, Rakhmanina NY, et al. Physiologically based pharmacokinetic modeling framework to predict neonatal pharmacokinetics of transplacentally acquired emtricitabine, Dolutegravir, and Raltegravir. Clin Pharmacokinet. 2021;60(6):795–809. doi: 10.1007/s40262-020-00977-w
  • Patel K, Huo Y, Jao J, et al. Dolutegravir in pregnancy as compared with Current HIV regimens in the United States. N Engl J Med. 2022;387(9):799–809. doi: 10.1056/NEJMoa2200600
  • Buckoreelall K, Cressey TR, K JR. Pharmacokinetic optimization of antiretroviral therapy in pregnancy. Clin Pharmacokinet. 2012;51(10):639–659. doi: 10.1007/s40262-012-0002-0
  • Bierhoff M, Smolders EJ, Tarning J, et al. Pharmacokinetics of oral tenofovir disoproxil fumarate in pregnancy and lactation: a systematic review. Antivir Ther. 2019;24(7):529–540. doi: 10.3851/IMP3341
  • Best BM, Burchett S, Li H, et al. Pharmacokinetics of tenofovir during pregnancy and postpartum. HIV Med. 2015;16(8):502–511. doi: 10.1111/hiv.12252
  • Bukkems VE, Colbers A, Marzolini C, et al. Drug-drug interactions with antiretroviral drugs in pregnant women living with HIV: are they different from non-pregnant individuals? Clin Pharmacokinet. 2020;59(10):1217–1236. doi: 10.1007/s40262-020-00914-x
  • Guttmacher Institute. Contraceptive use in the United States by method - fact sheet. 2021 May.
  • Nanda K, Stuart GS, Robinson J, et al. Drug interactions between hormonal contraceptives and antiretrovirals. AIDS. 2017;31(7):917–950. doi: 10.1097/QAD.0000000000001392
  • Tepper NK, Curtis KM, Cox S, et al. Update to U.S. Medical eligibility criteria for contraceptive use, 2016: updated recommendations for the use of contraception among women at high risk for HIV infection. MMWR Morb Mortal Wkly Rep. 2020;69(14):405–410. doi: 10.15585/mmwr.mm6914a3
  • Curtis KM, Tepper NK, Jatlaoui TC, et al. US medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep. 2016;65(No. RR–3):1–104. doi: 10.15585/mmwr.rr6503a1
  • Thurman AR, Anderson S, Doncel GF. Effects of hormonal contraception on antiretroviral drug metabolism, pharmacokinetics and pharmacodynamics. Am J Reprod Immunol. 2014;71(6):523–530. doi: 10.1111/aji.12210
  • Scarsi KK, Darin KM, Chappell CA, et al. Drug-drug interactions, effectiveness, and safety of hormonal contraceptives in women living with HIV. Drug Saf. 2016;39(11):1053–1072. doi: 10.1007/s40264-016-0452-7
  • Scarsi KK, Darin KM, Nakalema S, et al. Unintended pregnancies observed with combined use of the levonorgestrel contraceptive implant and efavirenz-based antiretroviral therapy: a three-arm pharmacokinetic evaluation over 48 weeks. Clin Infect Dis. 2016 Mar 15;62(6):675–682. doi: 10.1093/cid/civ1001
  • Scarsi KK, Cramer YS, Rosenkranz SL, et al. Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study. Lancet HIV. 2019;6(9):e601–e612. doi: 10.1016/S2352-3018(19)30155-9
  • American College of Obstetricians and Gynecologists. ACOG practice bulletin. No. 73: use of hormonal contraception in women with coexisting medical conditions, reaffirmed 2011. Obstet Gynecol. 2006;107(6):1453–1472. doi: 10.1097/00006250-200606000-00055
  • Scarsi KK, Smeaton LM, Podany AT, et al. Pharmacokinetics of dose-adjusted levonorgestrel emergency contraception combined with efavirenz-based antiretroviral therapy or rifampicin-containing tuberculosis regimens. Contraception. 2023 May;121:109951. doi: 10.1016/j.contraception.2023.109951
  • Francis J, Mngqibisa R, McIlleron H, et al. A semimechanistic pharmacokinetic model for depot medroxyprogesterone acetate and drug-drug interactions with antiretroviral and antituberculosis treatment. Clin Pharmacol Ther. 2021 Oct;110(4):1057–1065.
  • Watts D. Teratogenicity risk of antiretroviral therapy in pregnancy. Curr HIV/AIDS Rep. 4(3):135–140. doi: 10.1007/s11904-007-0020-y
  • Zash R, Makhema J, Shapiro R. Neural-tube defects with dolutegravir treatment from the time of conception. N Engl J Med. 2018 Sep 6;379(10):979–981. doi: 10.1056/NEJMc1807653
  • Statement on DTG. Potential safety issue affecting women living with HIV using dolutegravir at the time of conception. Geneva: World Health Organization; 2018. Internet.
  • Zash R, Holmes LB, Diseko M, et al. Update on neural tube defects with antiretroviral exposure in the tsepamo study, Botswana. AIDS. 2022.
  • Pereira GFM, Kim A, Jalil EM, et al. Dolutegravir and pregnancy outcomes in women on antiretroviral therapy in Brazil: a retrospective national cohort study. Lancet HIV. 2021;8(1):e33–e41. doi: 10.1016/S2352-3018(20)30268-X
  • Kourtis AP, Zhu W, Lampe MA, et al. Dolutegravir and pregnancy outcomes including neural tube defects in the USA during 2008-20: a national cohort study. Lancet HIV. 2023;10(9):e588–e596. doi: 10.1016/S2352-3018(23)00108-X
  • Fairlie L, Lavies D, Kalk E, et al. Safety surveillance for PrEP in pregnant and breastfeeding women. Front Reprod Health. 2023;5:1221101. doi: 10.3389/frph.2023.1221101
  • Ailes E, Zhu W, Clark E, et al. Identification of pregnancies and their outcomes in healthcare claims data, 2008–2019: an algorithm. PLoS One. 2023;18(4):accepted. doi: 10.1371/journal.pone.0284893
  • Scheuerle A, C D. Clinical review procedures for the antiretroviral pregnancy registry. Pharmacoepidemiol Drug Saf. 2004;13(8):529–536. doi: 10.1002/pds.971
  • Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral pregnancy registry interim report for 1 January 1989 through 31 January 2023. Morrisville (NC): Registry Coordinating Center; 2023.
  • Van Dyke RB, Chadwick EG, Hazra R, et al. The PHACS SMARTT Study: assessment of the safety of in utero exposure to antiretroviral drugs. Front Immunol. 2016;7:199. doi: 10.3389/fimmu.2016.00199
  • European Collaborative Study T, Mother-to-child transmission of HIV infection. The European collaborative study. The Lancet. 1988 Nov 5;2(8619):1039–1043. PMID: 2903276. doi: 10.1016/S0140-6736(88)90063-3
  • Lockman S, Brummel SS, Ziemba L, et al. Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomized, controlled, phase 3 trial. Lancet. 2021;397(10281):1276–1292. doi: 10.1016/S0140-6736(21)00314-7
  • Renaud F, Mofenson LM, Bakker C, et al. Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework. J Int AIDS Soc. 2022;25 Suppl 2(Suppl. 2):e25922. doi: 10.1002/jia2.25922
  • Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV infection as a chronic disease. Lancet. 2013;382(9903):1525–1533. doi: 10.1016/S0140-6736(13)61809-7
  • Chawla A, Wang C, Patton C, et al. A review of long-term toxicity of antiretroviral treatment regimens and implications for an aging population. Infect Dis Ther. 2018;7(2):183–195. doi: 10.1007/s40121-018-0201-6
  • Kourtis AP, Wiener J, Wang L, et al. Tenofovir disoproxil fumarate use during pregnancy and infant bone health: the tenofovir in pregnancy pilot stud. Pediatr Infect Dis J. 2018;37(11):e264–e268. doi: 10.1097/INF.0000000000002152
  • Nabwire F, Prentice A, Hamill MM, et al. Changes in bone mineral density during and after lactation in Ugandan women with HIV on tenofovir-based antiretroviral therapy. J Bone Miner Res. 2020;35(11):2091–2102. doi: 10.1002/jbmr.4121
  • Stranix-Chibanda L, Tierney C, Sebikari D, et al. Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial. PLoS One. 2021;16(2):e0246272. doi: 10.1371/journal.pone.0246272
  • Eke AC, Mirochnick M, Lockman S, et al. Antiretroviral therapy and adverse pregnancy outcomes in people living with HIV. N Engl J Med. 2023;388(4):344–356. doi: 10.1056/NEJMra2212877
  • Thimm MA, Livingston A, Ramroop R, et al. Pregnancy outcomes in pregnant women with HIV on tenofovir disoproxil fumarate (TDF) compared to tenofovir alafenamide (TAF). J AIDS HIV Treat. 2022;4(1):6–13.
  • Soepnel LM, Norris SA, Schrier VJ, et al. The association between HIV, antiretroviral therapy, and gestational diabetes mellitus. AIDS. 2017 Jan 2;31(1):113–125. doi: 10.1097/QAD.0000000000001277
  • Asif S, Baxevanidi E, Hill A, et al. The predicted risk of adverse pregnancy outcomes as a result of treatment-associated obesity in a hypothetical population receiving tenofovir alafenamide/emtricitabine/dolutegravir, tenofovir disoproxil fumarate/emtricitabine/dolutegravir or tenofovir disoproxil fumarate/emtricitabine/efavirenz. AIDS. 2021 Dec 15;35:S117–S125.
  • Sibiude J, Warszawski J, Tubiana R, et al. Liver enzyme elevation in pregnant women receiving antiretroviral therapy in the ANRS-French perinatal cohort. J Acquir Immune Defic Syndr. 2019;81:83–94. doi: 10.1097/QAI.0000000000001963
  • Sansone M, Sarno L, Saccone G, et al. Risk of preeclampsia in human immunodeficiency virus-infected pregnant women. Obstet Gynecol. 2016;127(6):1027–1032. doi: 10.1097/AOG.0000000000001424
  • Browne JL, Schrier VJMM, Grobbee DE, et al. HIV, antiretroviral therapy, and hypertensive disorders in pregnancy: a systematic review and meta-analysis. J Acquir Immune Defic Syndr. 2015;70(1):91–98. doi: 10.1097/QAI.0000000000000686
  • Premkumar A, Dude AM, Haddad LB, et al. Combined antiretroviral therapy for HIV and the risk of hypertensive disorders of pregnancy: a systematic review. Pregnancy Hypertens. 2019;17:178–190. doi: 10.1016/j.preghy.2019.05.015
  • Venkatesh KK, Morrison L, Tuomala RE, et al. Profile of chronic comorbid conditions and obstetrical complications among pregnant women with human immunodeficiency virus and receiving antiretroviral therapy in the United States. Clin Infect Dis. 2021;73(6):969–978. doi: 10.1093/cid/ciab203
  • Wall KM, Haddad LB, Mehta CC, et al. Miscarriage among women in the United States women’s interagency HIV study, 1994–2017. Am J Obstet Gynecol. 2019;221(4):.e347.1–.e347.13. doi: 10.1016/j.ajog.2019.05.034
  • Hoffman RM, Brummel SS, Britto P, et al. Adverse pregnancy outcomes among women who conceive on antiretroviral therapy. Clin Infect Dis. 2019;68:273–279. doi: 10.1093/cid/ciy471
  • Nachega JB, Uthman OA, Mofenson LM, et al. Safety of tenofovir disoproxil fumarate-based antiretroviral therapy regimens in pregnancy for HIV-infected women and their infants: a systematic review and meta-analysis. J Acquir Immune Defic Syndr. 2017;76(1):1–12. doi: 10.1097/QAI.0000000000001359
  • Jiang W, Ronen K, Osborn L, et al. Predictors of adverse pregnancy outcomes among Kenyan women with HIV on antiretroviral treatment in pregnancy. AIDS. 2022;36(7):1007–1019. doi: 10.1097/QAD.0000000000003215
  • Cowdell I, Beck K, Portwood C, et al. Adverse perinatal outcomes associated with protease inhibitor-based antiretroviral therapy in pregnant women living with HIV: a systematic review and meta-analysis. EClinicalMedicine. 2022;46:101368. doi: 10.1016/j.eclinm.2022.101368
  • 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. doi: 10.1093/infdis/jir307
  • Tshivuila-Matala COO, Honeyman S, Nesbitt C, et al. Adverse perinatal outcomes associated with antiretroviral therapy regimens: systematic review and network metaanalysis. AIDS. 2020;34(1643–56):1643–1656. doi: 10.1097/QAD.0000000000002593
  • Koss CA, Natureeba P, Plenty A, et al. Risk factors for preterm birth among HIV-infected pregnant Ugandan women randomized to lopinavir/ritonavir- or efavirenz-based antiretroviral therapy. J Acquir Immune Defic Syndr. 2014;67:128–135. doi: 10.1097/QAI.0000000000000281
  • Saleska JL, Turner AN, Maierhofer C, et al. Use of antiretroviral therapy during pregnancy and adverse birth outcomes among women living with HIV-1 in low- and middle-income countries: a systematic review. J Acquir Immune Defic Syndr. 2018;79(1):1–9. doi: 10.1097/QAI.0000000000001770
  • Ikumi NM, Malaba TR, Pillay K, et al. Differential impact of antiretroviral therapy initiated before or during pregnancy on placenta pathology in HIV-positive women. AIDS. 2021;35(5):717–726. doi: 10.1097/QAD.0000000000002824

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.