What side effects are associated with this type of intervention?

Treatments for Chronic Hepatitis Delta, such as Bulevirtide, which inhibit HDV entry by blocking the NTCP receptor, commonly cause side effects like liver enzyme elevations, injection site reactions, and gastrointestinal symptoms. Hepatotoxicity and renal dysfunction are also potential concerns, necessitating regular monitoring of liver function tests.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Chronic Hepatitis Delta (CHD) that function similarly to Bulevirtide by inhibiting HDV entry through blocking the NTCP receptor. Bulevirtide is currently being studied for its efficacy in treating CHD. Other treatments for CHD have focused on antiviral therapies, but none have been specifically approved by the FDA for this mechanism of action.

What other types of research exist?

Promising novel alternatives to Bulevirtide for Chronic Hepatitis Delta patients may include nucleoside/nucleotide analogues and other antiviral agents with different mechanisms of action. These alternatives are currently being developed and tested for various hepatitis viruses and could potentially be adapted for CHD treatment.

← Back to Search

Virus Therapy

Bulevirtide for Hepatitis D

Phase 3

Waitlist Available

Led By Pavel Bogomolov, MD

Research Sponsored by MYR GmbH

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Use of interferons within 6 months before Screening

Hepatitis C virus (HCV) or uncontrolled human immunodeficiency virus (HIV) coinfection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delayed treatment/bulevirtide 10 mg/day arm: week 48 up to week 144; bulevirtide 2mg/day and 10 mg/day arms: first dose date up to week 144

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing bulevirtide, a medication for people with chronic hepatitis delta, a tough-to-treat liver infection. Bulevirtide works by stopping the virus from entering liver cells. The study compares different treatment timings to see which is more effective. Bulevirtide was approved in the European Union for treating chronic hepatitis delta virus (HDV) infection.

Who is the study for?

This trial is for adults with chronic hepatitis delta (CHD) who have detectable HDV RNA, moderately elevated liver enzymes, and normal serum albumin levels. Women must not be pregnant and should use effective contraception or be postmenopausal/surgically sterile. Participants cannot join if they have severe kidney issues, certain heart conditions, uncontrolled hypertension, mental disorders affecting protocol adherence, recent serious liver disease events, low blood counts, recent interferon treatment or organ transplants.

What is being tested?

The study tests the effectiveness of bulevirtide in treating CHD compared to a delayed treatment approach. It aims to see how well bulevirtide works over time by monitoring participants' health status before starting them on the drug.

What are the potential side effects?

While specific side effects are not listed here for bulevirtide in this summary context; generally speaking treatments like antiviral drugs can cause headaches, fatigue, nausea and potential injection site reactions.

Eligibility Criteria

Exclusion Criteria

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

Select...

I haven't used interferons in the last 6 months.

Select...

I have Hepatitis C or uncontrolled HIV.

Select...

I can follow all study requirements and undergo necessary procedures.

Select...

I am not using any disallowed mental health medications.

Select...

I regularly use medication that affects my immune system.

Select...

I have a systemic connective tissue disorder.

Select...

I have severe heart failure.

Select...

My high blood pressure is not under control.

Select...

I have a liver condition not caused by hepatitis B.

Select...

I have had a solid organ transplant.

Select...

I have taken bulevirtide before.

Select...

My kidney function, measured by creatinine clearance, is below 60 mL/min.

Select...

I have or might have cancer, or had it, or a pre-cancer condition in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delayed treatment/bulevirtide 10 mg/day arm: week 48 up to week 144; bulevirtide 2mg/day and 10 mg/day arms: first dose date up to week 144

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delayed treatment/bulevirtide 10 mg/day arm: week 48 up to week 144; bulevirtide 2mg/day and 10 mg/day arms: first dose date up to week 144

This trial's timeline: 3 weeks for screening, Varies for treatment, and delayed treatment/bulevirtide 10 mg/day arm: week 48 up to week 144; bulevirtide 2mg/day and 10 mg/day arms: first dose date up to week 144 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants With Combined Response at Week 48

Secondary study objectives

Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144

Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48

Liver

+3 more

Side effects data

From 2024 Phase 3 trial • 150 Patients • NCT03852719

45%

Vitamin D deficiency

20%

Thrombocytopenia

20%

Leukopenia

20%

Headache

16%

Neutropenia

16%

Lymphopenia

14%

Fatigue

14%

Arthralgia

12%

Pruritus

10%

Anaemia

10%

Eosinophilia

10%

Nasopharyngitis

10%

Covid-19

10%

Alanine aminotransferase increased

Alpha-2 macroglobulin increased

Hyperbilirubinaemia

Proteinuria

Amylase increased

Blood bilirubin increased

Lipase increased

Osteopenia

Nausea

Injection site reaction

Injection site erythema

Pyrexia

Neck pain

Alopecia

Hypertension

Sinus bradycardia

Abdominal pain

Abdominal pain upper

Injection site pruritus

Urinary tract infection

Dizziness

Aspartate aminotransferase increased

Gamma-glutamyltransferase increased

Varices oesophageal

Hepatic fibrosis

Myalgia

Foot fracture

Bradycardia

Hemiparesis

Depression

Injection site swelling

Muscle spasms

100%

80%

60%

40%

20%

Study treatment Arm

Bulevirtide 2 mg/Day (Baseline to Week 144)

Delayed Treatment/Bulevirtide 10 mg/Day (Week 48 to Week 144 )

Bulevirtide 10 mg/Day (Baseline to Week 144)

Delayed Treatment (Baseline to Week 48)

Bulevirtide 2 mg/Day (Baseline to Week 48)

Bulevirtide 10 mg/Day (Baseline to Week 48)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Delayed Treatment/Bulevirtide 10 mg/dayExperimental Treatment1 Intervention

Participants will receive delayed treatment with bulevirtide 10 mg/day subcutaneously (SC) for 96 weeks after an observational period of 48 weeks.

Group II: Bulevirtide 2 mg/dayExperimental Treatment1 Intervention

Participants will receive bulevirtide 2 mg/day SC for 144 weeks.

Group III: Bulevirtide 10 mg/dayExperimental Treatment1 Intervention

Participants will receive bulevirtide 10 mg/day SC for 144 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bulevirtide

2019

Completed Phase 3

~380

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bulevirtide, a treatment for Chronic Hepatitis Delta (CHD), functions by inhibiting the entry of the Hepatitis Delta Virus (HDV) into liver cells through blocking the NTCP receptor. This mechanism is significant for CHD patients as it prevents the virus from entering and replicating within liver cells, thereby reducing viral load and slowing liver disease progression. Other treatments for CHD generally aim to reduce viral replication or boost the immune response to control the infection and mitigate liver damage.