TerminatedPhase 4ACTRN12619000054112

A study of therapy for hepatitis C in pregnancy

A pharmacokinetic (PK) study of directly acting antiviral therapy for hepatitis C in pregnancy

Sponsor

Monash Health

Enrollment

10 participants

Start Date

Feb 19, 2020

Study Type

Interventional

Conditions

Pregnancy Hepatitis C

Summary

Sofosbuvir and Velpatasvir (SOF/VEL) are new antiviral drugs recently registered and listed in Australia for the treatment of hepatitis C (HCV). These medications are highly effective, orally administered, well tolerated and work against all the different genotypes of Hepatitis C. In preclinical evaluations in animals they have been shown to be safe during pregnancy. This study will evaluate the safety and pharmacokinetics of antenatal SOF/VEL treatment given for 12 weeks during the second and third trimester. If proven to be effective, antenatal treatment of HCV with SOF/VEL will prevent transmission of HCV to the baby, community transmission of HCV and maternal HCV-related liver disease . It will also reduce the maternal anxiety and stigma of potential transmission.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria1

Pregnant women mono-infected with hepatitis C, able to provide written, informed consent, will need to be able to provide contact details, have any HCV genotype with a detectable HCV RNA viral load at screening >1000 IU/ml, a gestational age of 22 weeks at enrollment and a singleton pregnancy with no known fetal anomalies (as confirmed on routine 18-22 week ultrasound).

Exclusion Criteria1

Women will be excluded from the study if they have previously had treatment for HCV with a NS5A inhibitor, use of any medications contraindicated with SOF/VEL, have a history of cirrhosis, have any significant uncontrolled active or chronic cardiovascular, renal, or liver disease, haematological, neurological, immunological or infectious disease (other than HCV), have a high risk of preterm birth (defined as a history of preterm birth at less than 34 weeks or a shortened cervical length of less than 20 millimeters).

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Interventions

Pregnant women will be treated with Sofosbuvir (SOF) 400mg and Velpatasvir (VEL) 100mg tablet orally, once daily for 12 weeks starting between 22 and 24 weeks gestation. Adherence to the intervention

Pregnant women will be treated with Sofosbuvir (SOF) 400mg and Velpatasvir (VEL) 100mg tablet orally, once daily for 12 weeks starting between 22 and 24 weeks gestation. Adherence to the intervention will be only be monitored by asking the woman if she has missed any tablets and the number missed.