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

Humanity and Health Research Centre

Status and phase: Completed; Phase 3; Phase 2

Conditions: HBV Coinfection; Hepatitis B Reactivation; Chronic Hepatitis C Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02555943

H&H_DASCO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Prophylactic/Early anti-HBV treatment

Active Comparator group

Description:

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). .

Treatment:

Drug: Ledipasvir/Sofosbuvir

Drug: Sofosbuvir and Daclatasvir

Drug: Entecavir

Drug: Tenofovir disoproxil

Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir

Deferred anti-HBV treatment

Experimental group

Description:

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).

Treatment:

Drug: Ledipasvir/Sofosbuvir

Drug: Sofosbuvir and Daclatasvir

Drug: Entecavir

Drug: Tenofovir disoproxil

Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir