DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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). . |
Drug: Ledipasvir/Sofosbuvir
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
Other Names:
Drug: Sofosbuvir and Daclatasvir
TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.
Other Names:
Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir
VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.
Other Names:
Drug: Entecavir
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
Other Names:
Drug: Tenofovir disoproxil
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
Other Names:
|
| Experimental: 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). |
Drug: Ledipasvir/Sofosbuvir
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
Other Names:
Drug: Sofosbuvir and Daclatasvir
TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.
Other Names:
Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir
VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.
Other Names:
Drug: Entecavir
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
Other Names:
Drug: Tenofovir disoproxil
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants who experience virological breakthrough [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 [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.
Secondary Outcome Measures
- Proportion of participant who experience biochemical rebound [From the commencement of DAAs treatment to 12 weeks post DAAs treatment]
Biochemical rebound is defined as
Other Outcome Measures
- Proportion of participant who experience liver failure [From the commencement of DAAs treatment to 12 weeks post DAAs treatment]
Diagnosis of liver failure
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HCV RNA positive,
-
HBsAg positive with detectable or undetectable HBV DNA,
-
Receiving pan oral direct-acting anti-HCV regimen
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Humanity and Health GI and Liver Centre | Hong Kong | Hong Kong | China | 00852 |
Sponsors and Collaborators
- Humanity and Health Research Centre
- Beijing 302 Hospital
- Nanfang Hospital of Southern Medical University
Investigators
- Principal Investigator: George Lau, M.D., Humanity and Health GI and Liver Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H&H_DASCO