A Korean Cohort Study of TDF Rescue Therapy for Difficult-to-treat CHB Patients: a Comparison Between TDF Monotherapy and TDF-based Combination Therapy

Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy. In Korea, primarily owing to limited subsidization policy in the health insurance system, many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients, rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available in Korea for patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures. However, which is the better has not been evaluated yet. A long-term efficacy and safety of TDF-based rescue therapies in real practice for those patients should be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near future.

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Key information

Conditions

The Difficult-to-treat Chronic Hepatitis B

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

more than 20 years old adults
chronic hepatitis B
the patients treated by tenofovir alone or tenofovir based combination therapy because of the previous treatment failure
the patients who agree and singed on the consent form

Exclusion criteria

co-infected patients with HCV, HDV or HIV
pregnancy or breast feeding woman or female patients who are planning to be pregnant
past history with hepatocellular carcinoma
combined with other liver disease including wilson, alcoholic, NASH, alpha-1 antitrypsin deficiency liver disease.
patients with hypersensitivity for drugs
patients who were enrolled in other clinical study within 60 days
patients who were eligible for the clinical study according to the investor

Treatment and study plan

Primary outcomes

The proportion of subjects who achieve a sustained HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) at each year during the on treatment follow-up period.

Time frame: 1, 2, and 3 years after the treatment initiation.

The viral response which is defined as serum HBV DNA < 60 IU/mL

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Dec 24, 2013
Registry last updated: Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.