Hepatic ImpairmentPhase 1NCT05765344

Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function

A Phase 1 study testing Bulevirtide in people with Hepatic Impairment and Healthy, run by Gilead Sciences at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (liver) function. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment, Healthy
What is being tested?: Bulevirtide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 6 sitesUnited States
Study dates: 15 Mar 2023to 13 Jan 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All individuals:
Body mass index (BMI) of 18 ≤ BMI ≤ 40 kg/m^2 at screening.
Have a calculated creatinine clearance (CLcr) of at least 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening.
Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in the protocol.
Individuals have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.
12-lead electrocardiogram (ECG) evaluations at screening must be without clinically significant abnormalities as assessed by the investigator.

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Aside from hepatic impairment among the individuals with hepatic impairment, the individual must, in the opinion of the investigator, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, and screening laboratory evaluations.
Must be willing and able to comply with all study requirements.
Individuals With Hepatic Impairment:
Have a diagnosis of chronic (> 6 months), stable hepatic impairment (moderate or severe based upon the Child-Pugh-Turcotte (CPT) classification system for moderate or severe hepatic impairment [CPT Class B or C, respectively]) with no clinically significant change in hepatic status (as determined by the investigator) within the 2 months (60 days) prior to screening.
Individuals with moderate or severe hepatic impairment must have a score of 7 to 9 or 10 to 15 on the CPT classification system at screening. If an individual's score changes during the study, the score at screening will be used for classification.
Must meet all of the following laboratory parameters at screening:
alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)
aspartate aminotransferase (AST) ≤ 10 × ULN
platelets ≥ 25,000/mm^3
hemoglobin ≥ 9 g/dL
Individuals with hepatic impairment who have not been on a stable dose of concomitant medications for at least 4 weeks prior to screening (or 5 half-lives, whichever is longer) and/or for whom dose changes are likely to occur during the study should have their medications reviewed and approved by the sponsor.
Matched Control Individuals With Normal Hepatic Function:
Have alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, international normalized ratio, and total bilirubin at or below the ULN; and albumin above the lower limit of normal at screening and at admission.
Must be matched for age (± 10 years), sex (assigned at birth), and BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2) with an individual in the hepatic impairment group.

Who cannot join

All Individuals:
Positive serum pregnancy test at screening and at admission.
Breastfeeding individual.
Have received any study drug within 30 days prior to study dosing.
Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual compliance or individual safety, or a positive drug or alcohol test at screening or admission.
Have poor venous access that limits phlebotomy.

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Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study.
Have a history of any of the following:
Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria.
Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity).
Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients.
Significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction ≤ 40%); or a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years.
Syncope, palpitations, or unexplained dizziness.
Implanted defibrillator or pacemaker.
Have any serious or active medical or psychiatric illness (including depression).
Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.
Individuals With Hepatic Impairment:
Have a positive test result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody with detectable HCV ribonucleic acid (RNA) at screening.
Suspicion of hepatocellular carcinoma (ie, if alpha-fetoprotein > 20 ng/mL at screening).
Anticipated changes in concomitant medications or dosage used to treat symptoms of hepatic impairment or associated comorbid conditions that could lead to clinically significant changes in medical conditions during the study.
Use of known hepatotoxic medications, clinical organic anion transporting polypeptide (OATP)1B1/3 inhibitors, or sodium-taurocholate cotransporting polypeptide (NTCP) inhibitors (half-maximal inhibitory concentration (IC50) or kinetic inhibition constant [Ki] < 20 μM).
Positive test for drugs of abuse, including alcohol at screening or admission, with the exception of opioids and tetrahydrocannabinol (marijuana) under prescription and verified by the investigator as for pain management.
Matched Control Individuals With Normal Hepatic Function:
Have a positive test result for HIV antibody, HBsAg, or HCV antibody.
Have a history of liver disease including Gilbert's disease.
Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Orange County Research Center
Lake Forest, California, 92630
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
Texas Liver Institute
San Antonio, Texas, 78215
Pinnacle Clinical Research LLC
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Parallel-group, Multiple-dose Study to Evaluate the Pharmacokinetics of Bulevirtide in Participants With Normal and Impaired Hepatic Function

Conditions: Hepatic Impairment, Healthy
Being tested: Bulevirtide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BulevirtideDrug
Also called Hepcludex®, Myrcludex B
2 mg administered via subcutaneous injections.
BulevirtideDrug
Also called Hepcludex®, Myrcludex B
10 mg administered via subcutaneous injections.

Study groups in NCT05765344
Study group	Role	What they receive
Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment	Experimental	Participants with moderate hepatic impairment will receive BLV 2 mg subcutaneous (SC) injection, once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide
Group A: BLV 2 mg, Matched Control	Experimental	Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide
Group B: BLV 2 mg, Severe Hepatic Impairment	Experimental	Participants with severe hepatic impairment will receive BLV 2 mg SC injection, once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide
Group B: BLV 2 mg, Matched Control	Experimental	Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide
Group C: BLV 10 mg, Moderate Hepatic Impairment	Experimental	Participants with moderate hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide
Group C: BLV 10 mg, Matched Control	Experimental	Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide
Group D: BLV 10 mg, Severe Hepatic Impairment	Experimental	Participants with severe hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide
Group D: BLV 10 mg, Matched Control	Experimental	Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1. Receives: Drug: Bulevirtide

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)
AUCtau was defined as the area under the concentration versus time curve (AUC) over the dosing interval at steady state.
Measured: Day 6: Predose and up to 24 hours postdose
PK Parameter: Cmax,ss of BLV
Cmax,ss was defined as the maximum observed concentration of drug at steady state.
Measured: Day 6: Predose and up to 24 hours postdose

Secondary outcomes (13)

PK Parameter: AUC0-24h of BLV
AUC0-24h was defined as the partial area under the concentration versus time curve from time zero to time 24 hours.
Measured: Day 1: Predose and up to 24 hours postdose
PK Parameter: Tmax of BLV
Tmax was defined as the time (observed time point) of Cmax.
Measured: Days 1 and 6: Predose and up to 24 hours postdose
PK Parameter: Cmax of BLV
Cmax was defined as the maximum observed plasma concentration of drug.
Measured: Day 1: Predose and up to 24 hours postdose
PK Parameter: t1/2 of BLV
t1/2 was defined as estimate of the terminal elimination half-life of the drug in plasma, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz).
Measured: Day 6: Predose and up to 48 hours postdose
PK Parameter: CLss/F of BLV
CLss/F was defined as the apparent clearance at the steady state (CLss) after administration of the drug:
CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug per interval.
Measured: Day 6: Predose and up to 48 hours postdose
PK Parameter: Vss/F of BLV
Vss/F was defined as the apparent steady-state volume of distribution of the drug.
Measured: Day 6: Predose and up to 48 hours postdose
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Ctrough was defined as the concentration of total BA at the end of the dosing interval.
Measured: Predose on Days 2, 3, 4, 5, 7, and 8
PD Parameter: Cmax of Total BA
Cmax was defined as the maximum observed concentration of total BA.
Measured: Days 1 and 6: Predose and up to 24 hours postdose
PD Parameter: AUC0-24h of Total BA
AUC0-24 was defined as the partial area under the concentration versus time curve from time "0" to time "24" hours for total BA.
Measured: Days 1 and 6: Predose and up to 24 hours postdose
PD Parameter: NetAUC of Total BA
NetAUC was defined as the positive portion of area under the baseline-adjusted biomarker concentration versus time curve over the dosing interval.
Measured: Days 1 and 6: Predose and up to 24 hours postdose
PD Parameter: Tmax of Total BA
Tmax was defined as the time (observed time point) of Cmax of total BA.
Measured: Days 1 and 6: Predose and up to 24 hours postdose
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. If the AE onset date is the same as the date of study drug start date then the AE onset time must be on or after the study drug start time. If the AE onset time is missing when the start dates were the same, the AE were considered treatment emergent. An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment.
Measured: First dose date up to Day 6 plus 30 days
Percentage of Participants With Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment emergent. Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death.
Measured: First dose date up to Day 6 plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202313 Jan 2025

First posted13 Mar 2023
Study start15 Mar 2023
Primary completion10 Jan 2025
Study completion13 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05765344
Sponsor's protocol ID: GS-US-589-6162
Status last verified: Jan 2026
First submitted: 1 Mar 2023
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kumar P, Mercier RC, Nieves W, Pan D, Tseng S, Chee GM, et al. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 2 mg Once Daily for 6 Days in Participants With Moderate and Severe HI and in Matched Control Participants With Normal Hepatic Function. American Association for the Study of Liver Diseases (AASLD); 1154: 15 November 2024
Parag Kumar, Wildaliz Nieves, David Pan, Steve Tseng, Yuejiao Jiang, Yehong Wang, Ann Qin, Teckla Akinyi, Renee-Claude Mercier. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 10 mg Once Daily for 6 Days in Participants With Moderate HI and in Matched Control Participants With Normal Hepatic Function. EASL - European Association for the Study of the Liver May 7-10, 2025 Amsterdam the Netherlands

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Parallel-group, Multiple-dose Study to Evaluate the Pharmacokinetics of Bulevirtide in Participants With Normal and Impaired Hepatic Function
ClinicalTrials.gov ID: NCT05765344
Acronym / sponsor ID: GS-US-589-6162
Conditions: Hepatic Impairment, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 15 Mar 2023 (actual)
Primary completion: 10 Jan 2025 (actual)
Study completion: 13 Jan 2025 (actual)
First posted: 13 Mar 2023 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment	Experimental	Drug: BulevirtideParticipants with moderate hepatic impairment will receive BLV 2 mg subcutaneous (SC) injection, once daily for 6 days starting on Day 1.
Group A: BLV 2 mg, Matched Control	Experimental	Drug: BulevirtideControl group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1.
Group B: BLV 2 mg, Severe Hepatic Impairment	Experimental	Drug: BulevirtideParticipants with severe hepatic impairment will receive BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
Group B: BLV 2 mg, Matched Control	Experimental	Drug: BulevirtideControl group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1.
Group C: BLV 10 mg, Moderate Hepatic Impairment	Experimental	Drug: BulevirtideParticipants with moderate hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
Group C: BLV 10 mg, Matched Control	Experimental	Drug: BulevirtideControl group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1.
Group D: BLV 10 mg, Severe Hepatic Impairment	Experimental	Drug: BulevirtideParticipants with severe hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
Group D: BLV 10 mg, Matched Control	Experimental	Drug: BulevirtideControl group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Body mass index (BMI) of 18 ≤ BMI ≤ 40 kg/m^2 at screening.
Have a calculated creatinine clearance (CLcr) of at least 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening.
Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in the protocol.
Individuals have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.
12-lead electrocardiogram (ECG) evaluations at screening must be without clinically significant abnormalities as assessed by the investigator.

Key exclusion criteria (27 listed)

Positive serum pregnancy test at screening and at admission.
Breastfeeding individual.
Have received any study drug within 30 days prior to study dosing.
Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual compliance or individual safety, or a positive drug or alcohol test at screening or admission.
Have poor venous access that limits phlebotomy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BulevirtideAlso: Hepcludex®, Myrcludex B2 mg administered via subcutaneous injections.	Drug	Group A: BLV 2 mg, Matched Control, Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment, Group B: BLV 2 mg, Matched Control, Group B: BLV 2 mg, Severe Hepatic Impairment
BulevirtideAlso: Hepcludex®, Myrcludex B10 mg administered via subcutaneous injections.	Drug	Group C: BLV 10 mg, Matched Control, Group C: BLV 10 mg, Moderate Hepatic Impairment, Group D: BLV 10 mg, Matched Control, Group D: BLV 10 mg, Severe Hepatic Impairment

Primary outcome

Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)
Time frame: Day 6: Predose and up to 24 hours postdose
AUCtau was defined as the area under the concentration versus time curve (AUC) over the dosing interval at steady state.
PK Parameter: Cmax,ss of BLV
Time frame: Day 6: Predose and up to 24 hours postdose
Cmax,ss was defined as the maximum observed concentration of drug at steady state.

13 secondary outcomes

PK Parameter: AUC0-24h of BLV
Time frame: Day 1: Predose and up to 24 hours postdose
PK Parameter: Tmax of BLV
Time frame: Days 1 and 6: Predose and up to 24 hours postdose
PK Parameter: Cmax of BLV
Time frame: Day 1: Predose and up to 24 hours postdose
PK Parameter: t1/2 of BLV
Time frame: Day 6: Predose and up to 48 hours postdose
PK Parameter: CLss/F of BLV
Time frame: Day 6: Predose and up to 48 hours postdose
PK Parameter: Vss/F of BLV
Time frame: Day 6: Predose and up to 48 hours postdose
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Time frame: Predose on Days 2, 3, 4, 5, 7, and 8
PD Parameter: Cmax of Total BA
Time frame: Days 1 and 6: Predose and up to 24 hours postdose
PD Parameter: AUC0-24h of Total BA
Time frame: Days 1 and 6: Predose and up to 24 hours postdose
PD Parameter: NetAUC of Total BA
Time frame: Days 1 and 6: Predose and up to 24 hours postdose
PD Parameter: Tmax of Total BA
Time frame: Days 1 and 6: Predose and up to 24 hours postdose
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to Day 6 plus 30 days
Percentage of Participants With Laboratory Abnormalities
Time frame: First dose date up to Day 6 plus 30 days

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment	11	10
Group A: BLV 2 mg, Matched Control	11	10
Group B: BLV 2 mg, Severe Hepatic Impairment	8	8
Group B: BLV 2 mg, Matched Control	8	8
Group C: BLV 10 mg, Moderate Hepatic Impairment	10	10
Group C: BLV 10 mg, Matched Control	10	10
Group D: BLV 10 mg, Severe Hepatic Impairment	8	8
Group D: BLV 10 mg, Matched Control	8	8

Primary outcome: Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)

Time frame: Day 6: Predose and up to 24 hours postdose. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Group A: BLV 2 mg, Moderate Hepatic Impairment n = 9	Group A: BLV 2 mg, Matched Control n = 7	Group B: BLV 2 mg, Severe Hepatic Impairment n = 8	Group B: BLV 2 mg, Matched Control n = 5	Group C: BLV 10 mg, Moderate Hepatic Impairment n = 10	Group C: BLV 10 mg, Matched Control n = 10	Group D: BLV 10 mg, Severe Hepatic Impairment n = 8	Group D: BLV 10 mg, Matched Control n = 8
Value	152 (110)	150 (66.9)	215 (71.7)	113 (45.8)	1270 (776)	1560 (347)	1520 (459)	1600 (502)

Group A: BLV 2 mg, Moderate Hepatic Impairment vs Group A: BLV 2 mg, Matched Control: Geometric least-squares mean ratio (%): 87.2 (90% CI 49.4 to 154)
Group B: BLV 2 mg, Severe Hepatic Impairment vs Group B: BLV 2 mg, Matched Control: Geometric least-squares mean ratio (%): 197 (90% CI 138 to 281)
Group C: BLV 10 mg, Moderate Hepatic Impairment vs Group C: BLV 10 mg, Matched Control: Geometric least-squares mean ratio (%): 73.4 (90% CI 54.4 to 99.2)

Population analysed: The plasma PK Analysis Set included all enrolled participants who took at least 1 dose of BLV and had at least 1 measurable plasma PK concentration data reported by PK laboratory for the analyte BLV. Participants in the plasma PK Analysis Set with available data were analyzed.

Primary outcome: PK Parameter: Cmax,ss of BLV

Time frame: Day 6: Predose and up to 24 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Group A: BLV 2 mg, Moderate Hepatic Impairment n = 10	Group A: BLV 2 mg, Matched Control n = 10	Group B: BLV 2 mg, Severe Hepatic Impairment n = 8	Group B: BLV 2 mg, Matched Control n = 8	Group C: BLV 10 mg, Moderate Hepatic Impairment n = 10	Group C: BLV 10 mg, Matched Control n = 10	Group D: BLV 10 mg, Severe Hepatic Impairment n = 8	Group D: BLV 10 mg, Matched Control n = 8
Value	29.5 (23.8)	22.7 (14.7)	61.4 (27.6)	15.2 (6.64)	175 (113)	261 (64.1)	293 (96.8)	263 (101)

Group A: BLV 2 mg, Moderate Hepatic Impairment vs Group A: BLV 2 mg, Matched Control: Geometric least-squares mean ratio (%): 117 (90% CI 67.1 to 205)
Group B: BLV 2 mg, Severe Hepatic Impairment vs Group B: BLV 2 mg, Matched Control: Geometric least-squares mean ratio (%): 401 (90% CI 271 to 593)
Group C: BLV 10 mg, Moderate Hepatic Impairment vs Group C: BLV 10 mg, Matched Control: Geometric least-squares mean ratio (%): 58.3 (90% CI 40.8 to 83.3)

Population analysed: Participants in the Plasma BLV PK Analysis Set with available data were analyzed.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 6 plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: BLV 2 mg, Moderate Hepatic Impairment	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Group A: BLV 2 mg, Matched Control	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Group B: BLV 2 mg, Severe Hepatic Impairment	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Group B: BLV 2 mg, Matched Control	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Group C: BLV 10 mg, Moderate Hepatic Impairment	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Group C: BLV 10 mg, Matched Control	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Group D: BLV 10 mg, Severe Hepatic Impairment	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Group D: BLV 10 mg, Matched Control	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundKumar P, Mercier RC, Nieves W, Pan D, Tseng S, Chee GM, et al. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 2 mg Once Daily for 6 Days in Participants With Moderate and Severe HI and in Matched Control Participants With Normal Hepatic Function. American Association for the Study of Liver Diseases (AASLD); 1154: 15 November 2024
BackgroundParag Kumar, Wildaliz Nieves, David Pan, Steve Tseng, Yuejiao Jiang, Yehong Wang, Ann Qin, Teckla Akinyi, Renee-Claude Mercier. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 10 mg Once Daily for 6 Days in Participants With Moderate HI and in Matched Control Participants With Normal Hepatic Function. EASL - European Association for the Study of the Liver May 7-10, 2025 Amsterdam the Netherlands
Gilead Clinical Trials WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bulevirtide in people with Hepatic Impairment and Healthy, run by Gilead Sciences at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV) (time frame: Day 6: Predose and up to 24 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05765344, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.