What is the mechanism of action of this treatment?

The investigational drug JNJ-73763989 likely targets HDV replication, reducing the viral load and preventing liver damage. Nucleos(t)ide analogs inhibit viral replication by mimicking the building blocks of viral DNA/RNA, preventing the virus from multiplying. This combination is significant for Chronic Hepatitis D patients as it addresses both the replication of the hepatitis D virus and the underlying hepatitis B virus, offering a comprehensive approach to managing the co-infection.

What side effects are associated with this type of intervention?

Common treatments for Chronic Hepatitis D, such as the investigational drug JNJ-73763989 combined with nucleos(t)ide analogs, can have side effects including mitochondrial damage, lactic acidosis, acute fatty liver, and bone abnormalities. Additionally, investigational drugs targeting viral replication may cause gastrointestinal issues, fatigue, and liver enzyme abnormalities.

What prior FDA approvals exist?

As of now, there are limited FDA-approved treatments specifically for Chronic Hepatitis D. The primary approach has been the use of pegylated interferon-alpha, which has shown some efficacy in suppressing HDV replication. Nucleos(t)ide analogs, such as tenofovir and entecavir, are primarily used to manage HBV co-infection, which indirectly helps control HDV by reducing HBV replication. The investigational drug JNJ-73763989, combined with nucleos(t)ide analogs, represents a novel approach targeting both HDV and HBV replication mechanisms.

What other types of research exist?

Promising alternatives to JNJ-73763989 + Nucleos(t)ide Analog for Chronic Hepatitis D patients include Pegylated Interferon (PegIFN) which has shown efficacy in achieving virological response and sustained suppression of HBV DNA levels. Additionally, novel imino sugars with potent antiviral activity and favorable selectivity indices against HBV could be considered. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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Nucleos(t)ide Analog

JNJ-73763989 + Antivirals for Hepatitis B and D Co-Infection (REEF-D Trial)

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening

Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 196

Awards & highlights

REEF-D Trial Summary

This trial will compare the effectiveness of a new hepatitis drug regimen against the current standard of care.

Who is the study for?

This trial is for adults with chronic hepatitis B and D co-infection, stable health, no liver disease from other causes, no recent cancer, and not pregnant. They must have certain levels of HDV RNA in their blood and can't be too sick with liver problems or have a history of heart issues.Check my eligibility

What is being tested?

The study tests the effectiveness of JNJ-73763989 combined with nucleos(t)ide analogs (like Tenofovir or Entecavir) against hepatitis D virus compared to just the nucleos(t)ide analogs alone in treating co-infected patients.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site for JNJ-73763989, kidney issues from Tenofovir use, digestive disturbances from Entecavir, as well as general symptoms like fatigue or headaches.

REEF-D Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My recent health checks show no major concerns.

Select...

I am using or my partner is using highly effective birth control.

REEF-D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 196

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 196

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 196 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination with Normal ALT at Week 48

Secondary outcome measures

Change from Baseline Over Time in HBV DNA

Change from Baseline Over Time in HBeAg

Change from Baseline Over Time in HBsAg

+34 more

Side effects data

From 2024 Phase 2 trial • 24 Patients • NCT04585789

40%

Headache

30%

Covid-19

20%

Fatigue

20%

Nasopharyngitis

20%

Thrombocytopenia

20%

Nausea

20%

Pyrexia

20%

Myalgia

20%

Decreased Appetite

10%

Influenza Like Illness

10%

Root Canal Infection

10%

Glomerular Filtration Rate Decreased

10%

Alanine Aminotransferase Increased

10%

Asthenia

10%

Injection Site Erythema

10%

Procedural Pain

10%

Neutropenia

10%

Injection Site Bruising

10%

Eye Pruritus

10%

Pruritus

10%

Urinary Tract Infection

10%

Oropharyngeal Pain

10%

Musculoskeletal Pain

10%

Diarrhoea

10%

Bronchitis

10%

Body Temperature Increased

10%

Arthralgia

10%

Sciatica

10%

Depressed Mood

10%

Tinnitus

10%

Blood Creatine Phosphokinase Increased

100%

80%

60%

40%

20%

Study treatment Arm

Panel 2

Panel 1

REEF-D Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Immediate Active Treatment arm: JNJ-73763989 + NAExperimental Treatment4 Interventions

Participants will receive JNJ-73763989 subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir [ETV], tenofovir disoproxil, or tenofovir alafenamide [TAF]) once daily for 144 Weeks in Part 1 and for at least 96 weeks in Part 2.

Group II: Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NAPlacebo Group5 Interventions

Participants will receive matching placebo to JNJ-73763989 SC injection Q4W along with NA (ETV, tenofovir disoproxil, or TAF) once daily for 52 Weeks followed by JNJ-73763989 SC injection Q4W along with NA once daily for 96 weeks in Part 1 and for at least 48 weeks in Part 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenofovir disoproxil

2016

Completed Phase 3

~3910

Entecavir (ETV) monohydrate

2021

Completed Phase 2

~180

Tenofovir alafenamide (TAF)

2019

Completed Phase 2

~330

JNJ-73763989

2021

Completed Phase 2

~820

0 / 2Eligibility 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

The investigational drug JNJ-73763989 likely targets HDV replication, reducing the viral load and preventing liver damage. Nucleos(t)ide analogs inhibit viral replication by mimicking the building blocks of viral DNA/RNA, preventing the virus from multiplying. This combination is significant for Chronic Hepatitis D patients as it addresses both the replication of the hepatitis D virus and the underlying hepatitis B virus, offering a comprehensive approach to managing the co-infection.

New approaches in the management of chronic hepatitis B: role of tenofovir.