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Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B

NCT01639092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-05-09

No results posted yet for this study

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) which has a low genetic barrier to resistance.

ETV resistance increase up to 51% of patients after 5 years of ETV treatment in lamivudine-refractory patients. Resistance to ETV appears to occur through a two-hit mechanism with initial selection of M204V/I mutation followed by amino acid substitutions at rtT184, rtS202, or rtM250.

In vitro studies showed that ETV-resistant mutations are susceptible to TDF, but there are little clinical data on the efficacy of TDF monotherapy in patients with ETV-resistance.

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.

Thus, there is no consistent treatment recommendation for patients with ETV-resistance.

In this clinical trial, the investigators will clarify whether tenofovir monotherapy is as effective as tenofovir plus entecavir in inducing complete virologic response in CHB patients with genotypic resistance to ETV and partial virologic response to ongoing treatment.

Conditions

  • Chronic Viral Hepatitis B Without Delta-agent

Interventions

DRUG

Tenofovir

Tenofovir 300mg Daily Oral

DRUG

Tenofovir

Tenofovir 300mg Daily Oral

DRUG

Entecavir

Entecavir 1 mg daily Oral

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Konkuk University Medical Center

    collaborator OTHER

  • Korea University Guro Hospital

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Young-Suk Lim, M.D.,Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-28
Primary Completion
2018-03-29
Completion
2018-03-29

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639092 on ClinicalTrials.gov