A study of therapy for hepatitis C in pregnancy

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000054112

Enrollment

Registered

2019-01-15

Start date

2020-02-19

Completion date

2022-12-01

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 will be only be monitored by asking the woman if she has missed any tablets and the number missed.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

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 criteria

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).

Outcome results