DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)

Humanity and Health Research Centre23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Infection HBV Coinfection Hepatitis B Reactivation

Interventions

Ledipasvir/SofosbuvirDRUG

Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.

Sofosbuvir and DaclatasvirDRUG

TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.

Ombitasvir, Paritaprevir, Ritonavir, DasabuvirDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Secondary Outcomes

Proportion of participant who experience biochemical rebound

Biochemical rebound is defined as

Time frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.