Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Proportion of participants who experience virological breakthrough
研究概览
简要总结
This is a prospective study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients.
详细描述
Patients who receive direct-acting anti-HCV treatment will be prospectively studied during 2-year period. All patients have HCV/HBV co-infection.
The inclusion/exclusion criteria and the follow up plan will be listed in following part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA positive,
- •HBsAg positive with detectable or undetectable HBV DNA,
- •Receiving pan oral direct-acting anti-HCV regimen
排除标准
- •Pregnant or nursing female or male with pregnant female partner;
- •HIV infection;
- •Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
- •Active or recent history (≤ 1 year) of drug or alcohol abuse;
- •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
研究组 & 干预措施
Prophylactic/Early anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
.
干预措施: Ledipasvir/Sofosbuvir (Drug)
Prophylactic/Early anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
.
干预措施: Sofosbuvir and Daclatasvir (Drug)
Prophylactic/Early anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
.
干预措施: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir (Drug)
Prophylactic/Early anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
.
干预措施: Entecavir (Drug)
Prophylactic/Early anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
.
干预措施: Tenofovir disoproxil (Drug)
Deferred anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
干预措施: Ledipasvir/Sofosbuvir (Drug)
Deferred anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
干预措施: Sofosbuvir and Daclatasvir (Drug)
Deferred anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
干预措施: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir (Drug)
Deferred anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
干预措施: Entecavir (Drug)
Deferred anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
干预措施: Tenofovir disoproxil (Drug)
结局指标
主要结局
Proportion of participants who experience virological breakthrough
时间窗: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Virological breakthrough is defined as 1 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
Proportion of participants who experience virological rebound
时间窗: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Virological rebound is defined as 2 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
次要结局
- Proportion of participant who experience biochemical rebound(From the commencement of DAAs treatment to 12 weeks post DAAs treatment)
研究者
George Lau
Director
Humanity and Health Research Centre