A Korean Cohort Study of TDF Rescue Therapy for Difficult-to-treat CHB Patients: a Comparison Between TDF Monotherapy and TDF-based Combination Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 1, 2, and 3 years after the treatment initiation.
The viral response which is defined as serum HBV DNA \< 60 IU/mL
次要结局
未报告次要终点