Clinical trial NCT02019966: A Korean Cohort Study of TDF Rescue Therapy for Difficult-to-treat CHB Patients: a Comparison Between TDF Monotherapy and TDF-based Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Difficult-to-treat Chronic Hepatitis B
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 1020
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hepatitis B patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1, 2, and 3 years after the treatment initiation.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
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