Tenofovir Plus Entecavir vs. Tenofovir in Adefovir-Resistant Chronic Hepatitis B
Status:
Completed
Trial end date:
2017-09-22
Target enrollment:
Participant gender:
Summary
With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil
fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by
polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve patients.
Until recently, however, many patients commenced antiviral treatment with inferior NAs prior
to the availability of TDF or ETV, such as lamivudine (LAM) or adefovir (ADV) which has a low
genetic barrier to resistance.
For patients who developed genotypic resistance against ADV, the efficacy of TDF monotherapy
is controversial. In recent studies, TDF monotherapy produced significant suppression of HBV
replication. However, only half of patients with initial ADV resistance achieved an
undetectable viral load (<15 IU/ml) with 48 weeks of therapy.
On the other hand, there was a retrospective cohort study reporting that, with the
combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6
months of treatment. Probability of reaching complete HBV DNA suppression was not decreased
in patients with ADV or ETV resistance.
Together, these observations indicate that there is a controversy about the efficacy of TDF
monotherapy in patients with genotypic resistance to ADV.
Thus, in this clinical trial, the investigators will clarify whether tenofovir monotherapy is
effective in inducing complete virologic response compared with tenofovir plus entecavir in
CHB patients with genotypic resistance to ADV and partial virologic response to ongoing
treatment.
Phase:
Phase 4
Details
Lead Sponsor:
Asan Medical Center
Collaborators:
Konkuk University Medical Center Korea University Guro Hospital Samsung Medical Center Seoul National University Hospital