TDF Medicine to Prevent Mother to Child Transmission of Hepatitis B (TDF)
Our goal is to determine the viral kinetics of HBV DNA reduction in 170 non-Thai pregnant women receiving Tenofovir disoproxil fumarate (TDF) to inform a subsequent RCT. The investigators also aim to determine adherence to daily TDF in pregnancy as new interventions must not only be effective but also safe, feasible and acceptable in the local, and ideally global, context.
Study Design: One arm, open label, Tenofovir treatment intervention study
Study Participants: Non-Thai pregnant women estimated gestation 12-20 weeks and their offspring
Planned Sample Size: 170
Primary Objective To estimate the time to HBV DNA suppression (<100 IU/ml) in 170 HBV DNA positive women who start TDF late in the first or early in the second trimester.
Outcome Measures Time in months to HBV DNA < 100 IU/ml
- To estimate the proportion of women with HBV DNA <100 IU/ml at delivery.
- To estimate the TDF levels at delivery in women who are HBV DNA detectable and undetectable.
- To monitor safety of TDF in the Thailand-Myanmar border women
- To address potential barriers to implementing TDF in early pregnancy to PMTCT-HBV.
- To determine the rate of hepatic flares post-partum.
- To estimate the proportion of cases of vertical transmission at 2 months of age.
- Fetal growth monthly ultrasound, infant growth at 1,2,3,6,12 and neurodevelopment at 6 and 12 months
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Prevention of Mother-to-child Transmission of Hepatitis B Virus (PMTCT-HBV): a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy|
- Time in months to HBV DNA < 100 IU/ml [ Time Frame: 3 years ]
- Proportion of women with HBV DNA < 100 IU/ml at delivery [ Time Frame: 3 years ]
- Mean TDF level at delivery in selected cases: 10-15 women who are HBV DNA detectable and a matched 20-30 women who are undetectable. [ Time Frame: 3 years ]
- Adverse events specified clinically (headache, nausea, vomiting) [ Time Frame: 3 years ]To monitor safety of TDF
- Laboratory testing (HBV DNA levels, ALT, AST, Cr) and serum phosphate [ Time Frame: 3 years ]To monitor safety of TDF
- Questionnaires [ Time Frame: 3 years ]Adherence by pill counts.
- The proportion of women with elevated AST/ALT (defined as >5x baseline or >10x the upper limit of normal) [ Time Frame: 1 years ]AST/ALT baseline monthly, delivery and post-partum for 3 months after stopping TDF.
- Proportion of infants that are positive for HBsAg and HBV DNA at birth (cord blood) and 2 months of age. [ Time Frame: 1 years ]Infant HBsAg and HBeAg in cord blood and HBV DNA from cord blood and HBsAg at 2 months of age
- Fetal and infant anthropometry and infant neurodevelopment will be compared to normative data from this population. [ Time Frame: 1 years ]Fetal (HC, AC, FL EFW monthly in-utero) and infant anthropometry (body weight, HC, AC at 1,2,3,6,9,12 months), Shoklo Developmental Test at 6, 12 months.
|Anticipated Study Start Date:||June 1, 2017|
|Estimated Study Completion Date:||June 1, 2020|
|Estimated Primary Completion Date:||June 1, 2020 (Final data collection date for primary outcome measure)|
Drug: Tenofovir Disoproxil Fumarate
Daily tenofovir 300 mg will be self-administered by the woman and continued until one month post-partum. Discussions about the study drug are ongoing and the investigators aim to have Gilead, the manufacturer of Tenofovir (VireadTM) provides the drug free of charge, however in the event that this is not possible the investigators will then purchase generic TDF. The drug will be delivered directly to the study site at Mae Sot.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03167229
|Contact: Rose McGready, MDfirstname.lastname@example.org|
|Principal Investigator:||Rose McGready, MD||University of Oxford|