Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients. All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing \< 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.
Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients. All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing \< 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice. The primary objective of this study is: •To evaluate efficacy and safety of SOF/VEL in HBsAg-positive patients with HCV (GT1-6) co-infection. The secondary objectives of this study are: * To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment. * To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV/ HBV.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment .
All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGTo evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
Time frame: The first group of patients was evaluated from 16 weeks to 28 weeks(for 12 weeks)
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
Time frame: The second group of patients was evaluated from 16 weeks to 28 weeks(for 12 weeks)
To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment
The proportion of subjects with HBV is an acute and chronic liver disease caused by hepatitis B virus infection, which can be transmitted through blood, body fluids, contact, sexual contact transmission and vertical transmission of mother and child
Time frame: From the commencement of SOF/VEL treatment(week 4) to week 64.
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
The proportion of subjects with HCV is one of several viruses that cause viral hepatitis.
Time frame: The first group of patients was evaluated at week 16 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
The proportion of subjects with HCV is one of several viruses that cause viral hepatitis.
Time frame: The second group of patients was evaluated at week 16 to week 64
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
The proportion of subjects with HBV is an acute and chronic liver disease caused by hepatitis B virus infection, which can be transmitted through blood, body fluids, contact, sexual contact transmission and vertical transmission of mother and child
Time frame: The first group of patients was evaluated at week 4 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
The proportion of subjects with HBV is an acute and chronic liver disease caused by hepatitis B virus infection, which can be transmitted through blood, body fluids, contact, sexual contact transmission and vertical transmission of mother and child
Time frame: The second group of patients was evaluated at week 4 to week 64
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