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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic/Early anti-HBV treatment | Active Comparator | 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). . |
|
| Deferred anti-HBV treatment | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ledipasvir/Sofosbuvir | Drug | Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who experience virological breakthrough | Virological breakthrough is defined as 1 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir. | From the commencement of DAAs treatment to 12 weeks post DAAs treatment |
| Proportion of participants who experience virological rebound | Virological rebound is defined as 2 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir. | From the commencement of DAAs treatment to 12 weeks post DAAs treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participant who experience biochemical rebound | Biochemical rebound is defined as | From the commencement of DAAs treatment to 12 weeks post DAAs treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participant who experience liver failure | Diagnosis of liver failure | From the commencement of DAAs treatment to 12 weeks post DAAs treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Lau, M.D. | Humanity and Health GI and Liver Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanity and Health GI and Liver Centre | Hong Kong | Hong Kong | 00852 | China |
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| Sofosbuvir and Daclatasvir | Drug | TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily. |
|
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| Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir | Drug | 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. |
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| Entecavir | Drug | Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. |
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| Tenofovir disoproxil | Drug | VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. |
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|
| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
| D000069474 | Sofosbuvir |
| C586541 | ledipasvir |
| C549273 | daclatasvir |
| C000607373 | Viekira Pak |
| C413685 | entecavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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