Affiliation:
1. Division of Infectious Disease Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration Silver Spring Maryland USA
2. Division of Antivirals Office of Infectious Diseases Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration Silver Spring Maryland USA
Abstract
AbstractDetermining the appropriate dosing regimens of antiretroviral (ARV) drugs for pregnant individuals living with HIV‐1 infection is critical to maximize maternal health and prevent perinatal HIV transmission. Throughout pregnancy, pharmacokinetics (PK) of ARVs can be significantly altered due to physiological, anatomic, and metabolic changes. As such, conducting PK studies of ARVs during pregnancy is crucial to optimize dosing regimens. In this article, we summarize available data, key issues, challenges, and considerations in interpreting results of ARV PK studies in pregnant individuals. Discussion topics include the choice of the reference population (postpartum vs historical control), pregnancy trimester‐dependent changes in ARV PK, effects of pregnancy on once‐ versus twice‐daily dosing, factors to consider for ARVs that are administered with a PK booster such as ritonavir and cobicistat, and considerations when evaluating the effects of pregnancy on unbound ARV concentrations. Common approaches for the translation of the results into clinical recommendations and rationales and considerations when making clinical recommendations are summarized. Currently, limited PK data in pregnancy are available with long‐acting ARVs. Collection of PK data to characterize the PK profile of long‐acting ARVs is an important goal shared by many stakeholders.
Subject
Pharmacology (medical),Pharmacology
Reference44 articles.
1. The World Health Organization Estimated Percentage of Pregnant Women Living with HIV Who Received Antiretrovirals for Preventing Mother‐to‐Child Transmission. Accessed November 11 2022.https://www.who.int/data/gho/data/indicators/indicator‐details/GHO/estimated‐percentage‐of‐pregnant‐women‐living‐with‐hiv‐who‐received‐antiretrovirals‐for‐preventing‐mother‐to‐child‐transmission#:∼:text=Globally%2C%20there%20were%201.3%20million mother%2Dto%2Dchild%20transmission.
2. 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. Accessed November 11 2022.https://clinicalinfo.hiv.gov/en/guidelines/perinatal.
3. Pharmacometrics in Pregnancy: An Unmet Need
4. Anatomical, Physiological and Metabolic Changes with Gestational Age during Normal Pregnancy
5. Pharmacokinetics of drugs in pregnancy