Chronic Hepatitis C Infection, HBV Coinfection, Hepatitis B Reactivation
Conditions
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.
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.
Interventions
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.
DRUGOmbitasvir, 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.
DRUGEntecavir
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
DRUGTenofovir disoproxil
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
Sponsors
Beijing 302 Hospital
Nanfang Hospital, Southern Medical University
Humanity and Health Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participant who experience liver failure | From the commencement of DAAs treatment to 12 weeks post DAAs treatment | Diagnosis of liver failure |
Countries
China
Outcome results
None listed