Tenofovir Alafenamide (TAF) Breast Milk Pharmacokinetics (PK) study

Phase 4

Completed

• Conditions: hepatitis B infection; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000419167
• Lead Sponsor: South Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Study Completion: 2020-06-29
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

Pregnant women with HBV and high viral load (greater than or equal to 6 log10 IU/ml)
- Aged 18 years or older at the time of Screening
- Taking antiviral therapy for the prevention of mother to child transmission (MTCT) of HBV
- Willing to take 25mg of TAF routinely, ideally commenced at 28-32 weeks of gestation and continued to 12 weeks post-partum OR Willing to take TAF postpartum switching from routine tenofovir disoproxil fumurate (TDF) during pregnancy.
- Pregnant women presenting later than 32 weeks gestation (including post-partum) can be included, but TAF must have been commenced no less than 4 weeks prior to the PK study visit
- Pregnant women already taking TDF for the prevention of MTCT can be included if willing to switch to TAF either during the pregnancy or after delivery, (PK study will be performed after a minimum of 4 weeks on TAF which is a sufficient time period for full washout of any TFV present attributable to TDF).
- Willing to participate in PK study (over 24 hours) between 2-12 weeks post-partum, in a totally breast fed infant a minimum of 4 weeks after commencing TAF.
- Willingness to give informed consent and willingness to participate and comply with the study.

Exclusion Criteria

- Nucleos(t)ide analogue therapy within prior 6 months except for TDF
- Significant co-morbidities including advanced liver disease and systemic disease
- Any concomitant regular medications except iron or folate for pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified