Safety of coitally administered tenofovir 1% gel, a vaginal microbicide, in
chronic hepatitis B virus carriers: results from the CAPRISA 004 trial.
Author(s): Baxter C(1), Yende-Zuma N, Tshabalala P, Abdool Karim Q, Abdool Karim SS.
Affiliation(s): Author information:
(1)Centre for the AIDS Programme of Research in South Africa (CAPRISA), University
of KwaZulu-Natal, Durban, South Africa. Electronic address: baxterc1@ukzn.ac.za.
Publication date & source: 2013, Antiviral Res. , 99(3):405-8
Tenofovir disoproxil fumarate, a licensed oral treatment for both HIV and
Hepatitis B virus (HBV) infections, has been associated with severe rebound
hepatic flares when treatment is interrupted. A gel formulation of tenofovir is
currently being assessed as a microbicide against HIV. If licensed, it is
possible that tenofovir gel could be used either intentionally or unintentionally
by HBV carriers. The purpose of this study was to establish the safety of
tenofovir gel use in this patient group participating in the CAPRISA 004
tenofovir gel trial. HBV infection status was assessed at enrolment and study
exit. Liver function testing was performed at enrolment, study months 3, 12, 24,
study exit, and 2 months after exiting the study. At enrolment, 34 women were
identified as being HBV carriers and 22 women acquired HBV infections during
follow-up; 14 and 8 in the tenofovir and placebo gel arms, respectively (p=0.21).
Intermittent tenofovir gel use did not cause an increase in hepatic flares or
impact on viral load suppression in women with HBV infection. There were 2
hepatic flares in each gel arm during follow-up and none 2months after cessation
of gel at study exit. The mean HBV DNA levels were similar at enrolment and exit
in both study arms. Tenofovir gel, when used intermittently, was safe to use in
women with HBV infection.
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