Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission
Status:
Unknown status
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
Summary
The World Health Organization recommends that all high endemic countries for HBV infection
based their mother to child transmission prevention strategies on vaccination of all children
and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first
24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results
in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15%
of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high
levels of HBV replication occurring in the third quarter of pregnancy act as a major risk
factor.
The objective of this study is to assess the effectiveness of an operational strategy to
prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests
HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive
HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24
weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according
to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of
age.
A phase IV multicenter observational and interventional non randomized prospective study will
be conducted in 4 maternity in Cambodia.
The primary outcome will be the proportion of active HBV infection in new-born at 6 months of
life estimated by HBs Ag positivity.
The study will aim to document the acceptability and the operational implementation of the
study using rapid tests usable in all health centers and a drug available in all the country
thanks to HIV national program. The results will be helpful for Cambodian government in order
to implement guidelines and algorithm follow-up for HBV-infected pregnant women.
Phase:
Phase 4
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)