'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT

Study Overview
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Brief Summary
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After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT >/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response

Official Title
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To Study the Efficacy of 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT - A Randomized Control Trial

Conditions
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HBV

Intervention / Treatment
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* Drug: Tenofovir + Interferon alpha 2b
* Drug: Tenofovir disoproxil Fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment naive chronic HBV infection i.e detectable HBsAg for past 6 months, HBeAg (+), ALT < ULN (Upper Limit Normal) on 2 or more occasions in last 6 months [ULN: 45] HBV DNA >2000 IU/mL Age > 18 years Exclusion Criteria: Decompensated Cirrhosis Severe HBV flare with reactivation Presentation as ACLF (Acute on Chronic liver Failure) Baseline ALT > ULN (Upper Limit Normal) Contraindications to PEG-IFN therapy Prior HBV antiviral therapy within 6 months of enrollment Co-infections with HCV/HIV ANA +(autoantibodies suggestive of autoimmune disease) >1:80 Patient not willing for enrollment in the study Pregnancy, lactation Patients who leave the study/ discontinue the therapy before completion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenofovir + Interferon alpha 2 b<br> | Drug: Tenofovir disoproxil Fumarate<br> <br> |
| Active Comparator: Tenofovir<br> | Drug: Tenofovir + Interferon alpha 2b<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart |  | 65 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAg loss |  | 64 weeks | 
| Absence of quantifiable serum HBV DNA |  | 64 weeks | 
| Development of serious adverse effects, acute hepatitis or hepatic decompensation |  | 64 weeks |