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

NCT02555943 | Completed Phase 2 DMC

• 1 other identifier: H&H_DASCO
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Proportion of participant who experience biochemical rebound

  From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Other Outcomes (1)

• Proportion of participant who experience liver failure

  From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Study Arms (2)

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). .

Drug: Ledipasvir/Sofosbuvir; Drug: Sofosbuvir and Daclatasvir; Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; Drug: Entecavir; Drug: Tenofovir disoproxil

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).

Drug: Ledipasvir/Sofosbuvir; Drug: Sofosbuvir and Daclatasvir; Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; Drug: Entecavir; Drug: Tenofovir disoproxil

Interventions

Ledipasvir/Sofosbuvir DRUG

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

Also known as: Harvoni®, GS-7977, GS-5885

Deferred anti-HBV treatment; Prophylactic/Early anti-HBV treatment

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.

Also known as: Sovaldi®, GS-7977, Daklinza®,BMS-790052

Deferred anti-HBV treatment; Prophylactic/Early anti-HBV treatment

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.

Also known as: VIEKIRA PAK™

Deferred anti-HBV treatment; Prophylactic/Early anti-HBV treatment

Entecavir DRUG

Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.

Also known as: BARACLUDE®

Deferred anti-HBV treatment; Prophylactic/Early anti-HBV treatment

Tenofovir disoproxil DRUG

VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

Also known as: VIREAD®

Deferred anti-HBV treatment; Prophylactic/Early anti-HBV treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV RNA positive,
• HBsAg positive with detectable or undetectable HBV DNA,
• Receiving pan oral direct-acting anti-HCV regimen

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanity and Health Research Centre: lead
• Beijing 302 Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, China

Location

MeSH Terms

Interventions

ledipasvir, sofosbuvir drug combination; Sofosbuvir; ledipasvir; daclatasvir; Viekira Pak; entecavir; Tenofovir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• George Lau, M.D.

  Humanity and Health GI and Liver Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 20, 2015
• First Posted: September 22, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

CN (1)