Hepatitis B, Chronic
Conditions
Brief summary
Hepatitis B virus (HBV) leads to life-threatening disease like liver failure and liver cancer. For most, a cure is unattainable as current HBV antiviral therapy (using nucleoside analogues) are not able to clear the virus from their liver. While HBV treatments are typically administered alone (monotherapy), this study will explore the use of Ribavirin in combination with standard therapy to enhance current treatment regimens. Ribavirin is commonly used to treat Hepatitis C Virus (HCV) but there is evidence that Ribavirin also induces immune effects that are beneficial in HBV treatment. The aim of this study is to determine whether combination of Ribavirin and a nucleoside analog is more effective compared to nucleoside analog treatment alone. Enrolled patients will be followed for treatment response according to standard clinical and virological tests, as well as immune response to HBV. Our ultimate goal is to find a more effective treatment and improve health outcomes for persons living with HBV.
Interventions
DRUGRibavirin
Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks.
DRUGTenofovir
Tenofovir as per standard of care
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HBV Hepatitis B surface antigen (HBsAg) positive for a minimum of 24 weeks 2. HBV DNA level \>20,000 IU/mL 3. ≥ 18 years of age
Exclusion criteria
1. Willingness and ability to sign an informed consent 2. HBV nucleos(t)ides and/or interferon exposure within 24 weeks of study medication dosing 3. HIV and other immune compromising condition (e.g. cancer with the exception of non-invasive cutaneous malignancy, autoimmune condition) or therapy (i.e. systemic steroids, chemotherapy) 4. HCV co-infected 5. Cirrhosis (defined by biopsy criteria or as \>18.4 kilopascal (kPa) by transient elastography) 6. Creatinine Clearance \<60 ml/min 7. Baseline hemoglobin \<130 g/L in males and \<120 g/L in females 8. Unwilling or unable to use contraception (unless confirmed surgical sterilization) 9. Pregnancy confirmed by blood test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Decline of Participants Serum HBV DNA values for both study arms at each study. | 24 weeks | The absolute decline in HBV DNA and quantitative HBsAg titre will be compared with baseline level at each study visit overall and between study arms (with or without RBV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibroscan score | 24 weeks | Individual fibroscan scores pre and post treatment for each group, using fibrosis scores calculated in kilopascal F0 representing no fibrosis and F4 value indicating cirrhosis. |
| Liver enzyme values | 24 weeks | Participants individual reduction in liver enzymes at each visit. |
| Number of participants with treatment related adverse events as assessed by CTCAE v4.0. | 28 weeks | Safety profile of TDF plus Ribavirin regime |
Countries
Canada
Contacts
Primary ContactCurtis L Cooper, MD
Backup ContactMiriam I Muir, RN BA
Outcome results
None listed