Pregnancy Clinical Trial
Official title:
Phase I Pharmacokinetic and Safety Trial of Ledipasvir/Sofosbuvir Fixed Dose Combination in Pregnant Women With Chronic Hepatitis C Virus Infection
Sofosbuvir and ledipasvir (LDV/SOF) are new directly acting antiviral drugs for the treatment of hepatitis C (HCV) that are highly effective, orally administered, well tolerated and preclinical evaluations in animal models indicate safe administration during pregnancy. This project will evaluate the safety and pharmacokinetics of antenatal LDV/SOF treatment for 12 weeks during the second and third trimester. If proven to be effective, antenatal treatment of HCV with LDV/SOF will prevent maternal HCV-related liver disease, perinatal transmission of HCV, and community transmission of HCV.
There are 3.2 million persons in the United States chronically infected with hepatitis C
virus (HCV) with a 1-2.4% prevalence during pregnancy. The recent October 2014 approval of
the fixed dose combination, containing the NS5B polymerase inhibitor sofosbuvir (SOF) 90 mg
and the NS5A inhibitor ledipasvir (LDV) 400mg, marked a new era of IFN and ribavirin free,
directly acting antiviral treatment for HCV. A 12 week treatment course of LDV/SOF resulted
in a 99% cure rate when given as a once-a-day oral pill. Based on the animal model data
submitted to the FDA, this drug combination was given a pregnancy category B designation,
even though there is currently no experience with LDV/SOF in pregnant women.
Pregnancy is a time when women are uniquely motivated to engage in activities which are
geared toward improvement of their own health and ensuring the health of their unborn child.
As such, pregnant women have frequent prenatal care visits; and health care interventions,
such as antiviral therapy and monitoring, can be easily integrated into the existing
healthcare infrastructure of prenatal care. The benefits of HCV treatment are numerous,
including prevention of severe liver disease, hepatocellular carcinoma, and liver
transplantation, as well as improvements physical, emotional and social health. The most
recent guidelines by the Infectious Disease Society of America recommend that all
HCV-infected persons receive treatment. The antenatal period represents an ideal window of
opportunity for treatment of HCV in pregnancy due to increased antenatal health care
utilization and prevention of perinatal transmission of HCV to the infant.
Safe administration of drugs in pregnancy may require dose adjustment due to the
pregnancy-induced physiologic alternations. Therefore, careful pharmacokinetic (PK)
evaluation is a critical first step to ensure safe administration of drugs to both the mother
and the developing fetus. This is a single-arm, single-center, open label Phase 1 evaluation
of the PK and safety of treating HCV with a 12 week course of LDV/SOF in 15 HCV-infected
pregnant women. Therapy will be initiated at approximately 24 weeks of gestation. In this
study we will determine: 1) if the PK of the LDV and SOF are similar in pregnancy as compared
to those in nonpregnant women, 2) if the viral response to LDV/SOF treatment in pregnancy is
similar to that observed in nonpregnant women, and 3) if there are any initial maternal or
neonatal safety concerns detected with antenatal LDV/SOF administration compared with
HCV-infected historical controls delivered at our institution. From the findings of this
study, future studies will seek to optimize the dose, gestational age timing and treatment
duration of LDV/SOF during pregnancy. Antenatal HCV treatment will improve maternal health,
prevent further HCV transmission in the community and perinatal HCV transmission to the
child, and thus enhance the long-term health of two generations.
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