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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulevirtide | Drug | 2 mg administered via subcutaneous injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 6: Predose and up to 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1: Predose and up to 24 hours postdose |
| PK Parameter: Tmax of BLV |
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Key Inclusion Criteria:
All individuals:
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.
Must meet all of the following laboratory parameters at screening:
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:
Key Exclusion Criteria:
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.
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:
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:
Matched Control Individuals With Normal Hepatic Function:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States | ||
| Clinical Pharmacology of Miami, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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124 participants were screened.
Participants were enrolled at study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment | Participants with moderate hepatic impairment received BLV 2 mg subcutaneous (SC) injection, once daily for 6 days starting on Day 1. |
| FG001 | Group A: BLV 2 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1. |
| FG002 | Group B: BLV 2 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1. |
| FG003 | Group B: BLV 2 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1. |
| FG004 | Group C: BLV 10 mg, Moderate Hepatic Impairment | Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| FG005 | Group C: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
| FG006 | Group D: BLV 10 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| FG007 | Group D: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: BLV 2 mg, Moderate Hepatic Impairment | Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1. |
| BG001 | Group A: BLV 2 mg, Matched Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | h*ng/mL | Day 6: Predose and up to 24 hours postdose |
|
Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: BLV 2 mg, Moderate Hepatic Impairment | Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2024 | Dec 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2025 | Dec 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000718249 | bulevirtide |
| C571888 | myrcludex-B |
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|
| 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. |
|
| 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. |
|
| 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. |
|
|
| Bulevirtide | Drug | 10 mg administered via subcutaneous injections. |
|
|
Tmax was defined as the time (observed time point) of Cmax.
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | First dose date up to Day 6 plus 30 days |
| Miami |
| Florida |
| 33014 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research LLC | San Antonio | Texas | 78229 | United States |
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
| BG002 | Group B: BLV 2 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1. |
| BG003 | Group B: BLV 2 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1. |
| BG004 | Group C: BLV 10 mg, Moderate Hepatic Impairment | Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| BG005 | Group C: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
| BG006 | Group D: BLV 10 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| BG007 | Group D: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
| BG008 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1. |
| OG002 | Group B: BLV 2 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1. |
| OG003 | Group B: BLV 2 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1. |
| OG004 | Group C: BLV 10 mg, Moderate Hepatic Impairment | Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| OG005 | Group C: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
| OG006 | Group D: BLV 10 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| OG007 | Group D: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
|
|
|
| Primary | PK Parameter: Cmax,ss of BLV | Cmax,ss was defined as the maximum observed concentration of drug at steady state. | Participants in the Plasma BLV PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Day 6: Predose and up to 24 hours postdose |
|
|
|
|
| Secondary | 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. | Participants in the Plasma BLV PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1: Predose and up to 24 hours postdose |
|
|
|
| Secondary | PK Parameter: Tmax of BLV | Tmax was defined as the time (observed time point) of Cmax. | Participants in the Plasma BLV PK Analysis Set with available data were analyzed. | Posted | Median | Full Range | hours | Days 1 and 6: Predose and up to 24 hours postdose |
|
|
|
| Secondary | PK Parameter: Cmax of BLV | Cmax was defined as the maximum observed plasma concentration of drug. | Participants in the Plasma BLV PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Day 1: Predose and up to 24 hours postdose |
|
|
|
| Secondary | 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). | Participants in the Plasma BLV PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | hours | Day 6: Predose and up to 48 hours postdose |
|
|
|
| Secondary | 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. | Participants in the Plasma BLV PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | L/h | Day 6: Predose and up to 48 hours postdose |
|
|
|
| Secondary | PK Parameter: Vss/F of BLV | Vss/F was defined as the apparent steady-state volume of distribution of the drug. | Participants in the Plasma BLV PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | liters | Day 6: Predose and up to 48 hours postdose |
|
|
|
| Secondary | 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. | The plasma pharmacodynamic (PD) Analysis Set included all enrolled participants who received at least 1 dose of study drug BLV and had at least 1 measurable plasma PD concentration value reported for the analyte BA. Participants in the Plasma BA PD Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | uM | Predose on Days 2, 3, 4, 5, 7, and 8 |
|
|
|
| Secondary | PD Parameter: Cmax of Total BA | Cmax was defined as the maximum observed concentration of total BA. | Participants in the Plasma BA PD Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | uM | Days 1 and 6: Predose and up to 24 hours postdose |
|
|
|
| Secondary | 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. | Participants in the Plasma BA PD Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | uM*h | Days 1 and 6: Predose and up to 24 hours postdose |
|
|
|
| Secondary | 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. | Participants in the Plasma BA PD Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | uM*h | Days 1 and 6: Predose and up to 24 hours postdose |
|
|
|
| Secondary | PD Parameter: Tmax of Total BA | Tmax was defined as the time (observed time point) of Cmax of total BA. | Participants in the Plasma BA PD Analysis Set with available data were analyzed. | Posted | Median | Full Range | hours | Days 1 and 6: Predose and up to 24 hours postdose |
|
|
|
| Secondary | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 6 plus 30 days |
|
|
|
| Secondary | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 6 plus 30 days |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Group A: BLV 2 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG002 | Group B: BLV 2 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | Group B: BLV 2 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG004 | Group C: BLV 10 mg, Moderate Hepatic Impairment | Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG005 | Group C: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG006 | Group D: BLV 10 mg, Severe Hepatic Impairment | Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG007 | Group D: BLV 10 mg, Matched Control | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1. | 0 | 8 | 0 | 8 | 2 | 8 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 28.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 28.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Geometric least-squares mean ratio (%) |
| 401 |
| 2-Sided |
| 90 |
| 271 |
| 593 |
ANOVA model with hepatic function as fixed effect was fitted to natural log-transformed values of the multiple dose PK parameter under evaluation. Geometric least-squares mean ratio (%) and 90%CI for hepatic impairment versus control were calculated. |
| Other |
| Geometric least-squares mean ratio (%) | 58.3 | 2-Sided | 90 | 40.8 | 83.3 | ANOVA model with hepatic function as fixed effect was fitted to natural log-transformed values of the multiple dose PK parameter under evaluation. Geometric least-squares mean ratio (%) and 90%CI for hepatic impairment versus control were calculated. | Other |
| Geometric least-squares mean ratio (%) | 114 | 2-Sided | 90 | 80.7 | 161 | ANOVA model with hepatic function as fixed effect was fitted to natural log-transformed values of the multiple dose PK parameter under evaluation. Geometric least-squares mean ratio (%) and 90%CI for hepatic impairment versus control were calculated. | Other |
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