References

1. UNAIDS, Global HIV & AIDS statistics — Fact sheet . 2022, UNAIDS: Geneva.
2. WHO, G., Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. World Health Organization, 2016.
3. Phanuphak, N., P. Seekaew, and P. Phanuphak, Optimising treatment in the test-and-treat strategy: what are we waiting for?Lancet HIV, 2019. 6 (10): p. e715-e722.
4. Labhardt, N.D., et al., Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial. Jama, 2018. 319 (11): p. 1103-1112.
5. Rosen, S., et al., Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial.PLoS Med, 2016. 13 (5): p. e1002015.
6. Okere, N.E., et al., Beyond viral suppression: Quality of life among stable ART clients in a differentiated service delivery intervention in Tanzania. Qual Life Res, 2022. 31 (1): p. 159-170.
7. Harris, K. and M.H. Yudin, HIV Infection in Pregnant Women: A 2020 Update. Prenat Diagn, 2020. 40 (13): p. 1715-1721.
8. Logrippo, S., et al., Oral drug therapy in elderly with dysphagia: between a rock and a hard place! Clin Interv Aging, 2017.12 : p. 241-251.
9. Schrager, N.L., et al., Trends in first-trimester nausea and vomiting of pregnancy and use of select treatments: Findings from the National Birth Defects Prevention Study. Paediatr Perinat Epidemiol, 2021. 35 (1): p. 57-64.
10. Chesney, M.A., Factors Affecting Adherence to Antiretroviral Therapy. Clinical Infectious Diseases, 2000.30 (Supplement_2): p. S171-S176.
11. Thoueille, P., et al., Long-acting antiretrovirals: a new era for the management and prevention of HIV infection. J Antimicrob Chemother, 2022. 77 (2): p. 290-302.
12. Benítez-Gutiérrez, L., et al., Treatment and prevention of HIV infection with long-acting antiretrovirals. Expert Rev Clin Pharmacol, 2018. 11 (5): p. 507-517.
13. Hodge, D., et al., Pharmacokinetics and Drug-Drug Interactions of Long-Acting Intramuscular Cabotegravir and Rilpivirine. Clin Pharmacokinet, 2021. 60 (7): p. 835-853.
14. Hazenberg, P., et al., Anti-Infective Dosing in Special Populations: Pregnancy. Clin Pharmacol Ther, 2021. 109 (4): p. 977-986.
15. Hodel, E.M., et al., Pharmacokinetics, Placental and Breast Milk Transfer of Antiretroviral Drugs in Pregnant and Lactating Women Living with HIV. Curr Pharm Des, 2019. 25 (5): p. 556-576.
16. ViiV Healthcare, CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension). US Prescribing Information, 2021.
17. Abduljalil, K., et al., Anatomical, physiological and metabolic changes with gestational age during normal pregnancy: a database for parameters required in physiologically based pharmacokinetic modelling. Clin Pharmacokinet, 2012. 51 (6): p. 365-96.
18. Freriksen, J.J.M., et al., Assessment of Maternal and Fetal Dolutegravir Exposure by Integrating Ex Vivo Placental Perfusion Data and Physiologically-Based Pharmacokinetic Modeling. Clin Pharmacol Ther, 2020. 107 (6): p. 1352-1361.
19. Néant, N., et al., Usefulness of therapeutic drug monitoring of rilpivirine and its relationship with virologic response and resistance in a cohort of naive and pretreated HIV-infected patients.British Journal of Clinical Pharmacology, 2020. 86 (12): p. 2404-2413.
20. Tran, A.H., et al., Pharmacokinetics of Rilpivirine in HIV-Infected Pregnant Women. JAIDS Journal of Acquired Immune Deficiency Syndromes, 2016. 72 (3): p. 289-296.
21. Osiyemi, O., et al., Pharmacokinetics, Antiviral Activity, and Safety of Rilpivirine in Pregnant Women with HIV-1 Infection: Results of a Phase 3b, Multicenter, Open-Label Study. Infectious Diseases and Therapy, 2018. 7 (1): p. 147-159.
22. Weld, E.D., T.C. Bailey, and C. Waitt, Ethical issues in therapeutic use and research in pregnant and breastfeeding women. Br J Clin Pharmacol, 2022. 88 (1): p. 7-21.
23. Atoyebi, S.A., et al., Using mechanistic physiologically-based pharmacokinetic models to assess prenatal drug exposure: Thalidomide versus efavirenz as case studies. Eur J Pharm Sci, 2019. 140 : p. 105068.
24. Ke, A.B., et al., Expansion of a PBPK model to predict disposition in pregnant women of drugs cleared via multiple CYP enzymes, including CYP2B6, CYP2C9 and CYP2C19. Br J Clin Pharmacol, 2014.77 (3): p. 554-70.
25. Siccardi, M., et al., Physiologically based pharmacokinetic models for the optimization of antiretroviral therapy: recent progress and future perspective. Future Virology, 2013. 8 (9): p. 871-890.
26. Montanha, M.C., et al., Predicting Drug–Drug Interactions between Rifampicin and Ritonavir-Boosted Atazanavir Using PBPK Modelling. Clinical Pharmacokinetics, 2022. 61 (3): p. 375-386.
27. Bosgra, S., et al., An improved model to predict physiologically based model parameters and their inter-individual variability from anthropometry. Crit Rev Toxicol, 2012. 42 (9): p. 751-67.
28. Brown, R.P., et al., Physiological Parameter Values for Physiologically Based Pharmacokinetic Models. Toxicology and Industrial Health, 1997. 13 (4): p. 407-484.
29. Birnbaum L, et al., Physiological parameter values for PBPK models. A report prepared by the International Life Sciences Institute Risk Science Institute. . 1994: Washington, DC.
30. Yu, L.X. and G.L. Amidon, A compartmental absorption and transit model for estimating oral drug absorption. International Journal of Pharmaceutics, 1999. 186 (2): p. 119-125.
31. Gertz, M., et al., Prediction of Human Intestinal First-Pass Metabolism of 25 CYP3A Substrates from In Vitro Clearance and Permeability Data. Drug Metabolism and Disposition, 2010.38 (7): p. 1147.
32. Rajoli, R.K.R., et al., Physiologically Based Pharmacokinetic Modelling to Inform Development of Intramuscular Long-Acting Nanoformulations for HIV. Clinical Pharmacokinetics, 2015.54 (6): p. 639-650.
33. Spreen, W., et al., GSK1265744 pharmacokinetics in plasma and tissue after single-dose long-acting injectable administration in healthy subjects. J Acquir Immune Defic Syndr, 2014. 67 (5): p. 481-6.
34. Spreen, W., et al., Pharmacokinetics, safety, and tolerability with repeat doses of GSK1265744 and rilpivirine (TMC278) long-acting nanosuspensions in healthy adults. J Acquir Immune Defic Syndr, 2014.67 (5): p. 487-92.
35. Merck & Co., ISENTRESS (raltegravir) Tablets. US Prescribing Information, 2009.
36. Paine, M.F., et al., The human intestinal cytochrome P450 “pie”. Drug metabolism and disposition, 2006. 34 (5): p. 880-886.
37. Yang, J., et al., Prediction of intestinal first-pass drug metabolism. Curr Drug Metab, 2007. 8 (7): p. 676-84.
38. Poulin, P. and F.P. Theil, Prediction of Pharmacokinetics Prior to In Vivo Studies. 1. Mechanism‐Based Prediction of Volume of Distribution. Journal of Pharmaceutical Sciences, 2002. 91 (1): p. 129-156.
39. Dallmann, A., et al., Physiologically based pharmacokinetic modeling of renally cleared drugs in pregnant women. Clinical pharmacokinetics, 2017. 56 (12): p. 1525-1541.
40. Rajoli, R.K.R., et al., In Silico Dose Prediction for Long-Acting Rilpivirine and Cabotegravir Administration to Children and Adolescents. Clinical Pharmacokinetics, 2018. 57 (2): p. 255-266.
41. Schalkwijk, S., et al., Lowered Rilpivirine Exposure During the Third Trimester of Pregnancy in Human Immunodeficiency Virus Type 1–Infected Women. Clinical Infectious Diseases, 2017. 65 (8): p. 1335-1341.
42. Ford, S.L., et al., Effect of Rifampin on the Single-Dose Pharmacokinetics of Oral Cabotegravir in Healthy Subjects. Antimicrob Agents Chemother, 2017. 61 (10).
43. Center for Drug Evaluation and Research, Clinical Pharmacology and Biopharmaceutics Review(s). Addendum to Ondqa Biopharmaceutics review, 2011.
44. Ford, S.L., et al., Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744. Antimicrobial agents and chemotherapy, 2013.57 (11): p. 5472-5477.
45. Crauwels, H., et al., Pharmacokinetic Parameters of Once-Daily Rilpivirine following Administration of Efavirenz in Healthy Subjects.Antiviral Therapy, 2012. 17 (3): p. 439-446.
46. Rajoli, R.K.R., et al., Predicting Drug-Drug Interactions Between Rifampicin and Long-Acting Cabotegravir and Rilpivirine Using Physiologically Based Pharmacokinetic Modeling. J Infect Dis, 2019.219 (11): p. 1735-1742.
47. Brainard, D.M., et al., Effect of low-, moderate-, and high-fat meals on raltegravir pharmacokinetics. J Clin Pharmacol, 2011.51 (3): p. 422-7.
48. Iwamoto, M., et al., Effects of omeprazole on plasma levels of raltegravir. Clin Infect Dis, 2009. 48 (4): p. 489-92.
49. European Medicines Agency, Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation . 2016.
50. Valentin, J., Basic anatomical and physiological data for use in radiological protection: reference values: ICRP Publication 89.Annals of the ICRP, 2002. 32 (3-4): p. 1-277.
51. Blonk, M.I., et al., Raltegravir in HIV-1-Infected Pregnant Women: Pharmacokinetics, Safety, and Efficacy. Clin Infect Dis, 2015.61 (5): p. 809-16.
52. Watts, D.H., et al., Raltegravir pharmacokinetics during pregnancy. J Acquir Immune Defic Syndr, 2014. 67 (4): p. 375-81.
53. Han, K., et al., Long-Acting Cabotegravir Pharmacokinetics with and without Oral Lead-in for HIV PrEP , in International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs 2022 . 2022: Barcelona, Spain.
54. Bunglawala, F., et al., Prediction of dolutegravir pharmacokinetics and dose optimization in neonates via physiologically based pharmacokinetic (PBPK) modelling. J Antimicrob Chemother, 2020.75 (3): p. 640-647.
55. Han, K., et al., Population pharmacokinetics of cabotegravir following administration of oral tablet and long-acting intramuscular injection in adult HIV-1-infected and uninfected subjects. Br J Clin Pharmacol, 2022. 88 (10): p. 4607-4622.
56. Patel, P., et al., CABOTEGRAVIR PHARMACOKINETIC TAIL IN PREGNANCY AND NEONATAL OUTCOMES , in Conference on Retroviruses and Opportunistic Infections 2020 . 2020: Boston, Massachusetts, USA.
57. ViiV Healthcare, VOCABRIA (cabotegravir) tablets, for oral use. US Prescribing Information, 2021.
58. Huang, Q.T., et al., P-glycoprotein expression and localization in the rat uterus throughout gestation and labor.Reproduction, 2016. 152 (3): p. 195-204.
59. Wang, H., et al., Expression of the breast cancer resistance protein (Bcrp1/Abcg2) in tissues from pregnant mice: effects of pregnancy and correlations with nuclear receptors. American Journal of Physiology-Endocrinology and Metabolism, 2006. 291 (6): p. E1295-E1304.
60. McCarver, D.G. and R.N. Hines, The Ontogeny of Human Drug-Metabolizing Enzymes: Phase II Conjugation Enzymes and Regulatory Mechanisms. Journal of Pharmacology and Experimental Therapeutics, 2002. 300 (2): p. 361-366.
61. Quinney, S.K., et al., Characterization of Maternal and Fetal CYP3A-Mediated Progesterone Metabolism. Fetal and Pediatric Pathology, 2017. 36 (5): p. 400-411.
62. Iwamoto, M., et al., Effects of Omeprazole on Plasma Levels of Raltegravir. Clinical Infectious Diseases, 2009. 48 (4): p. 489-492.
63. Nguyen, T., et al., Long-acting injectable antipsychotic treatment during pregnancy: Outcomes for women at a tertiary maternity hospital. Psychiatry Res, 2022. 313 : p. 114614.
64. Reinstein, S.A., et al., Long-Acting Injectable Antipsychotic Use During Pregnancy: A Brief Review and Concise Guide for Clinicians.J Clin Psychiatry, 2020. 81 (6).