NUC in Preventing HBV Reactivation in HCV/HBV Co-infected Patients Receiving DAA for CHC

• Status: Recruiting
• Trial end date: 2020-12-28
• Target enrollment: 0
• Participant gender: All

Summary

HBV reactivation is common in HCV/HBV coinfected patients receiving DAA therapy for chronic hepatitis C. How to prevent HBV reactivation remains unclear. In this trial, we aim to investigate whether prophylactic nucleos(t)ide analogue (NUC) at the start of DAA could prevent HBV reactivation or not. And whether prolonged NUC prophylaxis (24 weeks) would be better than 12-week prophylaxis. This will be a three-arm, open-label, randomized, active controlled, study. Totally, 60 HBV/HCV co-infected treatment-naïve or treatment-experienced patients without decompensated liver cirrhosis will be included in this study. Group 1 patients (n=20) will receive 12-week ETV from the start of DAA therapy. Group 2 patients (n=20) will receive 24-week ETV from the start of DAA till 12 weeks after end of DAA. Group 3 patients (n=20) will not receive ETV during the period of DAA and will serve as controls. The rate of HBV reactivation and clinical reactivation will be compared among 3 groups of patients. Expected outcomes: The rate of HBV reactivation and clinical reactivation will be lower in the ETV prophylaxis group, and will be the lowest in the group receiving 24-week ETV prophylaxis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Entecavir

Criteria

Inclusion criteria

1. Age ≥20 years;

2. Anti-HCV positive and HCV RNA >1000 IU/ml;

3. Any HCV genotype; all received 12 weeks of DAA treatment.

4. Treatment naïve or experienced of pegylated interferon/ribavirin;

5. Concurrent HBV infection which is defined by positive HBsAg for at least 6 months.

Exclusion criteria

1. History of treatment regimen that included any kind of direct antiviral agents;

2. Presence of other etiology of chronic hepatitis including HIV, autoimmune hepatitis, NASH, etc;

3. Uncontrolled diabetes mellitus (Hba1c >8.5);

4. Current evidence or suspicion of malignancy;

5. Severe cardiovascular or other severe comorbid diseases;

6. Autoimmune disorders;

7. Presence of liver cirrhosis clinically or pathologically;

8. Any one of following hematology or biochemical or clinical abnormalities:

AST/ALT >10x ULN, Albumin <3.5g/dL, Bilirubin >2.5mg/dL, eGFR <30 ml/min/1.73m2, prothrombin time prolongation >4 sec or INR >1.7, platelet count <100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.

9. Child-bearing age women without the willing to contraceptive control; pregnant women or lactating women.