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A study of therapy for hepatitis C in pregnancy with Sofosbuvir/Velpatasvir in Australia
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A pharmacokinetic (PK) study of directly acting antiviral therapy for hepatitis C in pregnancy
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.
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.
No control group
Phase 4
Type of endpoint(s): Pharmacokinetics
This study proposes to recruit 10 participants. This study is primarily to analyse PK. Although endpoints such as maternal cure and perinatal transmission will be included, these are not the primary endpoints and the study is therefore not powered to analyse these.
Date of first participant enrolment
Anticipated
31/01/2020
Recruitment hospital [1]
Monash Medical Centre - Clayton campus - Clayton
Funding source category:
Commercial sector/Industry
Name:
Gilead Sciences PTY Ltd
Associate Professor Michelle Giles
Department of Obstetrics and Gynaecology
Monash University
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Australia
USA study: Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir - (12/04/20)
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