TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load.

NCT05195450 | Recruiting

• 1 other identifier: ILBS-HBV-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of therapy for patients with chronic HBV infection with no significant liver disease is to improve survival and quality of life by preventing disease progression, development of liver cirrhosis and consequently HCC development. The likelihood of achieving these goals depends on the timing of therapy during the natural course of the infection but also on the stage of the disease and the patients' age when treatment is started. The inhibition of viral replication and normalization of ALT by antiviral treatment has been shown to achieve the elimination of chronic HBV-induced necroinflammatory activity and progressive fibrotic liver progression in the vast majority of patients, in turn reducing the risk of HCC. Even in HBeAg positive patients, treatment-induced HBeAg loss and seroconversion to antiHBe characterizes the induction of a partial immune control often leading to a low replicative phase of the chronic HBV infection and good outcomes. Treatment in chronic HBV infection is indicated in - presence of advanced fibrosis/cirrhosis (LSM \>11 KPA) or patients with significant fibrosis (LSM \>8 or APRI \>1.5 or \>F2 on liver biopsy) with high viral load (\>2000 IU/ml) or significantly elevated ALT (x2 ULN). Presence of any of these factors is known to increase the risk of development of cirrhosis and hepatocellular carcinoma. TAF in non-cirrhotic patients (LSM \<8 KPA) with normal ALT and low viral load (HBV DNA \<2000 IU/ml) (currently treatment ineligible) as compared to delayed initiation (on demand) might reduce HCC risk, progression of liver fibrosis and reduction in HBsAg levels. As TAF is known to have favorable effects on the overall long-term outcome, the main clinical challenge is to identify the patients at risk of HCC and cirrhosis who warrant early antiviral therapy.

Conditions

Non-cirrhotic, Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with HBV DNA <2000 IU/ml, normal ALT and no significant fibrosis (as per APASL 2015).

  Any two of the following - 1. Significant fibrosis (LSM \>8 Kpa or APRI \>1.5) 2. Persistently elevated ALT (2 consecutive ALT \>30 U/ml 3-6m apart) 3. HBV DNA \>2000 IU/ml

  upto 5 Years

Secondary Outcomes (16)

• Incidence of HCC

  upto 3 years

• Incidence of HCC

  upto 5 years

• Percentage of patients with LSM >8 Kpa

  upto 5 Years

• Percentage of patients with LSM >11 Kpa

  upto 5 Years

• Number of subjects with no progression of fibrosis

  upto 5 Years

Study Arms (2)

Tenofovir Alafenamide Fumarate

EXPERIMENTAL

• TAF 25 mg OD vs no treatment x 5 years and beyond

Drug: Tenofovir alafenamide fumarate

No Treatment Arm

NO INTERVENTION

No treatment

Interventions

Tenofovir alafenamide fumarate DRUG

• TAF 25 mg OD vs no treatment x 5 years and beyond

Tenofovir Alafenamide Fumarate

Eligibility Criteria

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

You may qualify if:

• \- HBsAg+
• Persistent normal ALT 3-6m apart (\<30 IU/ml in male and \<20 IU/ml in female)
• HBV DNA \< 2000 IU/ml
• LSM \<8 Kpa

You may not qualify if:

• Prior NUC/IFN exposure
• Renal dysfunction (Serum Creatinine \>1.5 mg/dl)
• Known liver cirrhosis/ esophageal varices
• Any clinical decompensation (CD)
• Pre-existing hepatocellular carcinoma
• Pregnancy
• Healthcare workers (HCW)
• Post transplant, patients with advance malignancy or on chemotherapy
• Co-infections - Hepatitis C, Hepatitis D, Human immunodeficiency virus

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Ankur Jindal, DM

CONTACT

01146300000; ankur.jindal3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 19, 2022
• Study Start: February 23, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)