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).