Tenofovir to Prevent HBV Reactivation

University Health Network, Toronto184 enrolled

Overview

The purpose of the study is to determine how effective preemptive tenofovir therapy is in preventing the re-activation of Hepatitis B infection, in patients who are receiving rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation will be compared between patients who receive preemptive tenofovir and patients who receive tenofovir as needed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

184

Conditions

Hepatitis B Lymphoma Non-Hodgkin

Interventions

Tenofovir disoproxilDRUG

Placebo Oral TabletDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 years of age 2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy 3. HBsAg negative, anti-HBc positive Exclusion Criteria: 1. Current therapy with known activity against HBV 2. Screening ALT \> 10 x ULN 3. Screening ALT \>2 and \<10 xULN with HBV DNA \> 2000 IU/mL (indicates active HBV infection despite HBsAg negative and require antiviral therapy) 4. Life expectancy \< 3 months 5. HBsAg positive 6. HIV co-infection 7. Active HCV co-infection (HCV RNA positive) 8. Creatinine clearance \<50 mL/min 9. Intolerance to tenofovir 10. Women of child-bearing potential unwilling to take contraception during the study period

Locations (2)

Toronto General Hospital

Toronto, Ontario, Canada

ACTIVE_NOT_RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Rate of reverse seroconversion

The difference in the rate of reverse seroconversion or Hepatitis B (HBV)-associated hepatitis (definition: appearance of HBsAg in the serum with or without detectable HBV DNA in a patient who was previously HBsAg-/cAb+.) between the intervention and placebo groups.