Hepatitis B Clinical Trial
Official title:
Tenofovir Reduces Morbidity and Mortality in Patients With Spontaneous Reactivation of Hepatitis B Presenting as Acute-on-chronic Liver Failure (ACLF): A Randomized Placebo Controlled Trial
Background: Reactivation of hepatitis B is a well-characterized syndrome marked by the
abrupt reappearance or rise of hepatitis B virus (HBV) DNA in the serum of a patient with
previously inactive or resolved HBV infection. Reactivation can be spontaneous, but is most
commonly triggered by cancer chemotherapy, immune suppression, or alteration in immune
function. Spontaneous acute exacerbation of chronic hepatitis B infection is seen with a
cumulative probability of 15±37% after 4 years of follow-up.2 Significant number of patients
of spontaneous acute exacerbation of chronic hepatitis B may present with very high ALT
levels, jaundice and liver failure.3 This condition should be defined as acute-on-chronic
liver failure (ACLF) according to a recent Asia-Pacific consensus recommendation.
The short term prognosis of patients of spontaneous acute exacerbation of chronic hepatitis
B leading to ACLF like presentation is extremely poor, with a mortality of 30-70% in
different series.8,9,10 Liver transplantation has been the only definitive therapy available
to salvage this group of patients. However ,this is not readily available and affordable.
Another therapeutic option is antiviral therapy but has limited data. The efficacy of
lamivudine was evaluated and compared by historical control but was not found to be
beneficial.8,9,10 However ,a study from Taiwan showed a survival benefit in a subgroup of
patients who were on lamivudine and had baseline bilirubin below 342 mmol/L (20 mg/dL).11
Tenofovir disoproxil fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide
analogue, reverse transcriptase inhibitor that has been shown to be highly effective in
suppressing hepatitis B virus replication.12 Tenofovir has also shown excellent activity
against HBV in both LAM- naïve and LAM-resistant patients.13,14. Its efficacy has not been
evaluated in patients of reactivation of hepatitis B who present as ACLF Hypothesis: The
investigators hypothesis that Tenofovir reduces the morbidity and mortality in patients with
Spontaneous reactivation of hepatitis B by reducing HBV DNA.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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