Use of TDF in Patients With Inactive Chronic Hepatitis B Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Recent evidence suggests that patients with inactive chronic hepatitis B (CHB) may develop
      the same types of liver complications that patients in the active state of hepatitis B virus
      (HBV) infection experience. Treatment guidelines for patients in the active state of HBV
      infection indicate that HBsAg clearance is associated with definitive remission of the
      activity of chronic HBV & improved long-term outcome. Clinical data showed that HBsAg
      clearance is achievable, in a small population of patients on continuous treatment with
      potent oral antivirals (OAVs), such as tenofovir disoproxil fumarate (TDF). It is possible
      the same OAVs can have the same effect in patients with inactive CHB, but in a shorter
      treatment duration. The purpose of this study is to find out if TDF is effective in
      controlling HBV DNA & promoting seroconversion from HBsAg-positive to HBsAb-positive in
      patients with inactive CHB.
    

Detailed description: 
      Hepatitis B virus (HBV) infection is a major worldwide health problem. The course of the
      majority of patients with inactive chronic hepatitis B is usually benign; therefore, the
      current treatment guidelines recommend not treating these patients. However, recent evidence
      suggests that the prognosis of these inactive carrier is not exactly benign. For instance,
      patients may develop liver cancer despite their inactive carrier state. Also, approximately
      20-30% of patients with inactive chronic hepatitis B may undergo spontaneous reactivation of
      hepatitis over time. Multiple episodes of reactivation or sustained reactivation can cause
      progressive liver damage and even liver decompensation. However, until there are data to
      support that treatment with oral antivirals can alter the outcome of these patients, they
      will remain untreated. Potent oral antivirals have been shown to suppress HBV DNA and
      normalize liver enzymes in patients with active chronic hepatitis B infection. With continued
      long-term treatment, some of these patients have gone on to clear hepatitis B surface antigen
      and develop hepatitis B surface antibody. Therefore, it is possible that the same oral
      antivirals can have the same effect in patients with inactive chronic hepatitis B, but in a
      shorter duration of treatment. This study will explore the possible use of tenofovir
      disoproxil fumarate in controlling HBV DNA and promoting hepatitis B surface antigen
      seroconversion in patients with inactive chronic hepatitis B.

      After completion of all initial investigations, patients will be started on TDF 300mg daily.
      Patients will be reviewed at 6 monthly intervals as per standard of care. At each clinic
      visit, patients will have blood tests including complete blood count, renal function,
      electrolytes, liver enzyme and liver function tests, as well as HBV serology including
      quantitative HBsAg and HBV DNA. Patients will also receive an abdominal ultrasound, fibroscan
      and fibrotest on an annual basis. Treatment will be stopped when sAg+ve seroconverts to
      sAb+ve or at the end of 3 years whichever comes earlier.
    

Intervention name(s): Tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention description(s): 300 mg, oral, once a day
Other intervention name(s): Viread
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment