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Interferon

VIR-2218 + Peginterferon Alfa-2a for Chronic Hepatitis B

Phase 2

Waitlist Available

Led By Marc G Ghany, M.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18-65 years

HBsAg positive with a level <2,000 IU/mL at the time of screening

Must not have

Presence of other causes of liver disease, (i.e. hemochromatosis, Wilson disease, alcoholic liver disease, severe steatosis, alpha-1-anti-trypsin deficiency)

Known history of hypersensitivity or contraindication to an siRNA, oligonucleotide, or GalNAc or any interferon product

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months off-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test 2 drugs to treat HBV infection in people aged 18-65. Participants receive injections and hospital visits for over 2 years.

Who is the study for?

Adults aged 18 to 65 with mild or inactive chronic hepatitis B can join this trial. They must have specific levels of HBV DNA and antigens, normal liver enzyme levels, and agree to use effective contraception. Those who are pregnant, breastfeeding, have other liver infections or diseases like cirrhosis or cancer, recent treatments for HBV, certain medical conditions or drug use that could interfere with the study cannot participate.

What is being tested?

The trial is testing VIR-2218 and peginterferon alfa-2a in people with chronic hepatitis B over a period of more than two years. Participants will receive monthly injections of VIR-2218 for six months and weekly shots of peginterferon for six months at home or in the clinic. The study includes hospital stays for liver biopsies and other tests.

What are the potential side effects?

Possible side effects from VIR-2218 and peginterferon alfa-2a may include flu-like symptoms such as fever, chills, muscle aches; injection site reactions; fatigue; changes in blood counts; thyroid issues; depression; vision changes due to eye exams required by the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have hepatitis B with a low viral load.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have other liver conditions like hemochromatosis or alcoholic liver disease.

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I am allergic to specific genetic therapies or interferon treatments.

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I have not been treated for hepatitis B in the last 24 weeks.

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I have been treated with siRNA before.

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I have been diagnosed with cirrhosis, either through a liver biopsy or a test showing a score above 13 kPa.

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My liver is not functioning properly, shown by high bilirubin levels or other specific symptoms.

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I am not on more than 10 mg of prednisone daily or biologics in the last 3 months.

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My kidney function is reduced with an eGFR below 60 and creatinine above 1.3.

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I haven't had cancer or cancer treatment in the last 3 years, except for certain skin cancers.

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I have liver cancer or a liver mass that may be cancer, or my alpha-fetoprotein level is over 500 ng/mL.

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I do not have severe autoimmune diseases or uncontrolled chronic conditions.

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I am unable or unwilling to sign the consent form.

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My hemoglobin level is below the normal range for my gender.

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I am co-infected with Hepatitis C.

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I have had a solid organ or bone marrow transplant.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months off-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months off-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months off-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decline in log quantitative HBsAg level

Secondary study objectives

Changes in innate and adaptive host immune responses to HBV during and after treatment.

Functional cure which is defined as undetectable HBsAg (<0.085 IU/ml) AND sustained suppression of HBV DNA [< LLOQ], <10 IU/ml)] for more than 6 months after discontinuation of all treatment

HBV DNA <10 IU/ml at end of treatment and 6 months off treatment. The response will be reported as HBV DNA <LLOQ target detected (TD) or target not detected (TND)

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