Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

Ottawa Hospital Research Institute

Status and phase: Unknown; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: Tenofovir; Drug: Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03759782

20180733

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group 1

Experimental group

Description:

Tenofovir (TDF) 300 mg po once a day (OD)

Treatment:

Drug: Tenofovir

Group 2

Active Comparator group

Description:

Tenofovir 300 mg po OD + Ribavirin 400 mg twice a day (BID) if \<70kg / 600 mg every (q) in the morning (AM) and 400 mg q in the evening (PM) if ≥70kg

Treatment:

Drug: Tenofovir

Drug: Ribavirin