- 1Division of Clinical Pharmacology & Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
- 2Division of Maternal Fetal Medicine, Department of Gynecology & Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Introduction: Direct-Acting Antiviral Agents (DAAs) provide safer, efficacious, tolerable, and curative therapy for women with hepatitis C. Their preferred safety and efficacy profile make them potential therapies for the elimination of perinatal transmission of hepatitis C virus (HCV). However, DAAs are not currently recommended for use during pregnancy due to limited pharmacokinetic and safety data.
Areas covered: This review covers the different DAA drug combinations, the available data on their pharmacodynamic and pharmacokinetic properties, how the physiology in pregnancy can potentially affect DAA drug disposition, known drug-drug interactions with DAAs, and available and planned epidemiological and pharmacokinetic studies on DAA use during pregnancy. Although no large randomized clinical trials or prospective cohort studies involving DAAs have been completed in pregnancy, the currently available studies demonstrate no significant changes in pharmacokinetics, and no major safety concerns in women with hepatitis C.
Expert opinion: Initial pharmacokinetic and safety data suggest that DAAs have high efficacy and a low risk of adverse events during pregnancy. As more pharmacokinetic and epidemiologic data become available, DAAs could become a preferred option for treating HCV during pregnancy and elimination of perinatal transmission of hepatitis C virus.