This page shows what was measured, who it was measured in, and what that does not settle.
What Bulevirtide does in the body
Chronic hepatitis delta virus (HDV) infection
4) ]. Mechanism of Action Bulevirtide is a synthetic 47-amino acid lipopeptide with a myristoylated N-terminus and an amidated C-terminus derived from amino acids 13-59 of the L-HBsAg preS1 domain from an HBV genotype (GT)-C consensus sequence (corresponding to GT-D preS1 amino acids 2-48). Bulevirtide inhibits HDV infection by binding to the HDV receptor NTCP on the plasma membrane of hepatocytes, blocking HDV attachment to NTCP.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · LLM855Y3S3 · read 2026-08-29
Its recorded molecular formula is C248H355N65O72, weighing 5398.9 Da.
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 85 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24)
✗ The study did not show it
Who was studied
NCT03852433
How many people
175
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of participants with a composite endpoint of virologic response and ALT normalization
✗ The study did not show it
Who was studied
NCT07200908
How many people
172
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Participants With Combined Response at Week 48
✗ The study did not show it
Who was studied
NCT03852719
How many people
150
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24
✗ The study did not show it
Who was studied
NCT07128550
How many people
150
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])
✗ The study did not show it
Who was studied
NCT07454837
How many people
120
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48
✗ The study did not show it
Who was studied
NCT07142811
How many people
100
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14) ]. An improvement in disease-related clinical outcomes has not been established.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of HEPCLUDEX in pediatric patients less than 18 years of age have not been established.”
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
On older people, the label states: “Clinical trials of HEPCLUDEX did not include participants aged 65 and over to determine whether they respond differently from younger participants [see Clinical Pharmacology (12.3) ].”
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are insufficient human data on the use of HEPCLUDEX during pregnancy to inform a drug-associated risk of birth defects and miscarriage.”
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary It is not known whether bulevirtide is present in human breast milk, affects human milk production, or has effects on the breastfed infant.”
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
On people with reduced liver function, the label states: “No dosage adjustment of HEPCLUDEX is recommended in patients with mild hepatic impairment (Child-Pugh Class A) [see Clinical Pharmacology (12.3) ].”
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage adjustment of HEPCLUDEX is recommended in patients with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] greater than or equal to 15 mL per minute) [see Clinical Pharmacology (12.3) ].”
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Still being tested
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Subcutaneous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as investigational; no register records an approval.
No source is stored against this line.
What is in the pack
Sold as injection, powder, lyophilized, for solution, given by the subcutaneous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Subcutaneous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
2 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.
FDA National Drug Code directory · 65044-3633 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, taken subcutaneous.
FDA National Drug Code directory · 65044-3633 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-29
HEPCLUDEX is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS For injection: 8.5 mg as a white to off-white lyophilized powder or cake in a single-dose vial for reconstitution., recorded as fda label in effect 2026-05-22 in the United States.
US prescribing information · 12391cc2-38c2-4cf5-86d3-2be9370127fc · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine, investigational agent. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Bulevirtide studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Bulevirtide are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
LLM855Y3S3
RxNorm concept
2743611
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
The identity record classes it as investigational; no register records an approval.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
The earliest marketing start date recorded for a listed product is 20260522.
FDA National Drug Code directory · 65044-3633 · read 2026-08-29
What is missing or unclear◇Read from sources, not yet reviewed
What to learn next
Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.
This order is fixed in code and does not count clicks or time on the page.
What is not here
8 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (9)
Q1
What did Bulevirtide's largest trial (400 people) and its longest (9.4 years) measure?
400 people in Bulevirtide's largest registered study, 9.4 years in its longest registered window, measuring Salivary inflammatory biomarker levels. ClinicalTrials.gov · 2026-09-01
10 na or unstated, 6 phase2, 4 phase1, 4 phase3; NCT06051045; 2033-03; no ageing endpoint recorded. Last human test completed 2025, NCT05765344.
Interpretation These counts include studies where Bulevirtide was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
na or unstated
10
phase2
6
phase1
4
phase3
4
Last recorded human testNCT05765344
2025-01-13
recorded 2026-09-01 · last checked 2026-09-04
Q2
Bulevirtide was tested only in human — what did it show?
Could one person measure Bulevirtide's effect on hepatitis b surface antigen response at week 12 of therapy?
Hepatitis b surface antigen response at week 12 of therapy: measured in Bulevirtide's trials.
hepatitis b surface antigen response at week 12 of therapy is the recorded endpoint.
Show the evidence
biomarkers
hepatitis b surface antigen response at week 12 of therapy; 2026-09-01
negative hdv rna by pcr; 2026-09-01
response at week 48; 2026-09-01
half life
2026-09-04; halfLife; 2026-05-22
human trials at or under30
3
smallest human trial
11; NCT04863703; NA_OR_UNSTATED; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; ACTIVE_NOT_RECRUITING
Q5
Which of hepatitis b surface antigen response at week 12 of therapy, negative hdv rna by pcr and response at week 48 did Bulevirtide's trials measure?
hepatitis b surface antigen response at week 12 of therapy, negative hdv rna by pcr and response at week 48 lead 3 outcome terms across Bulevirtide's trials. ClinicalTrials.gov · 2026-09-01
3 terms in all.
Show the evidence
hepatitis b surface antigen response at week 12 of therapy
1
negative hdv rna by pcr
1
response at week 48
1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of Bulevirtide's 10 ongoing trials reports first?
Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide; Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death; latest 2033-03
Show the evidence
Trial
NCT04863703
"Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)"; n 11; "Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide"; 2026-12-31
NCT05718700
"Study of Bulevirtide in Participants With Chronic Hepatitis D Infection"; n 170; "Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death"; 2028-07
NCT06051045
"Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients"; n 400; "Percentage of patients with virological response of Hepatitis D virus (HDV) RNA < Limit of Detection (LoD) at FU 12 months after End of Treatment (EOT)."; 2033-03
NCT06122285
"Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)"; n 100; "Describe the virological response to BLV in all patients starting BLV therapy for CHD"; 2025-12-31
NCT06504485
"Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment"; n 192; "Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide"; 2026-02-28
NCT07128550
"A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide"; n 150; "HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24"; 2031-07
4 further recorded trials
NCT07142811
"A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection"; n 100; "HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48"; 2030-07
NCT07200908
"A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)"; n 172; "Percentage of participants with a composite endpoint of virologic response and ALT normalization"; 2029-09-30
NCT07454837
"Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide"; n 120; "Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])"; 2029-03-30
NCT07491848
"Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D"; n 25; "Salivary inflammatory biomarker levels"; 2027-02-15
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which one trial of Bulevirtide posted no result?
Posted no result
1 of 1 completed trials
Registrations
NCT05962307
Completion dates
oldest 2023-05-31
Show the evidence
TrialNCT05962307
2023-05-31
Q8
At the median, Bulevirtide's trials enrolled 100 people — anything larger?
Median enrolment
100
Largest enrolment
400
Registered trials counted
20
Q9
Bulevirtide and CYP3A4, CYP1A2 and CYP2B6: shared by which compounds?
CYP3A4, CYP1A2 and CYP2B6 appear in Bulevirtide's recorded interaction sentences, 11 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2
pharmacokinetics
Bulevirtide is not an inducer of CYP1A2, CYP2B6, or CYP3A4.
pharmacokinetics
Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
CYP2A6pharmacokinetics
Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
CYP2B6
pharmacokinetics
Bulevirtide is not an inducer of CYP1A2, CYP2B6, or CYP3A4.
pharmacokinetics
Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
CYP2C19pharmacokinetics
Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
CYP2C9pharmacokinetics
Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
CYP2D6pharmacokinetics
Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
CYP3A4
pharmacokinetics
Bulevirtide is not an inducer of CYP1A2, CYP2B6, or CYP3A4.
pharmacokinetics
Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
pharmacokinetics
Consistent with in vitro results, bulevirtide at steady state did not impact the pharmacokinetics of the CYP3A4 probe substrate midazolam, administered as an oral 30 μg microdose, in clinical drug-interaction studies.
recorded 2026-08-30 · last checked 2026-09-04
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