Chronic Viral Hepatitis B Without Delta-agent Clinical Trial
Official title:
A Multicenter Randomized Controlled Open-label Trial of Tenofovir Plus Entecavir Combination vs. Tenofovir Monotherapy in Chronic Hepatitis B Patients With Genotypic Resistance to Adefovir and Partial Virologic Response to Ongoing Treatment
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.
A multi-center randomized active-controlled open-label trial
- Patients will be randomly assigned 1:1 to receive tenofovir (300 mg/day) or tenofovir
(300 mg/day) plus entecavir (1 mg/day) for 48 weeks.
- Because over 98% of Korean patients with CHB have HBV genotype C, HBV genotype will not
be determined or be regarded as a stratification factor.
- Patients' treatment information before randomization will be retrospectively
collected.(DNA change, HBeAg status, HBsAg titre, ALT, and treatment duration. etc)
- Patients will be screened within 4 weeks before randomization to determine study
eligibility.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01639092 -
Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B
|
Phase 4 | |
| Completed |
NCT01595685 -
Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in Patients With HBeAg-positive Chronic Hepatitis B
|
Phase 3 |