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

Phase 2

Completed

• Conditions: Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation
• Interventions: Drug: Ledipasvir/Sofosbuvir; Drug: Sofosbuvir and Daclatasvir; Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; Drug: Entecavir; Drug: Tenofovir disoproxil

• Registration Number: NCT02555943
• Lead Sponsor: Humanity and Health Research Centre

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-09-20
• Study First Submitted QC: 2015-09-20
• Study First Posted: 2015-09-22
• Primary Completion: 2021-05
• Status Verified: 2021-08
• Study Completion: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic/Early anti-HBV treatment	Ledipasvir/Sofosbuvir	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). .
Prophylactic/Early anti-HBV treatment	Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir	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	Ledipasvir/Sofosbuvir	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).
Deferred anti-HBV treatment	Sofosbuvir and Daclatasvir	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).
Deferred anti-HBV treatment	Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir	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).
Prophylactic/Early anti-HBV treatment	Sofosbuvir and Daclatasvir	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). .
Prophylactic/Early anti-HBV treatment	Tenofovir disoproxil	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). .
Prophylactic/Early anti-HBV treatment	Entecavir	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	Entecavir	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).
Deferred anti-HBV treatment	Tenofovir disoproxil	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of participant who experience biochemical rebound	From the commencement of DAAs treatment to 12 weeks post DAAs treatment	Biochemical rebound is defined as

Trial Locations

Locations (1)

Humanity and Health GI and Liver Centre; 🇨🇳 Hong Kong, Hong Kong, China