Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients

Safety, Antiviral Activity, and Pharmacokinetics of Multiple Oral Doses of BI 207127 NA Administered q8H for 5 Days as Monotherapy, a Randomised, Double-blind, Placebo Controlled Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02176525

Enrollment

Registered

2014-06-27

Start date

2007-12-31

Completion date

Unknown

Last updated

2016-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Brief summary

The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study medication was examined in a group of patients with liver cirrhosis.

Interventions

DRUGBI 207127 NA

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Adults from 18 - 70 years * Male OR female with documented hysterectomy OR menopausal female with last menstrual period at least 12 months prior to screening * Written informed consent consistent with International Conference on Harmonization/Good Clinical Practice and local legislation given prior to any study procedures * Chronic HCV infection demonstrated by positive HCV immunoglobulin G Antibody * HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2 * For non-cirrhotic cohorts: Liver biopsy obtained within the last 36 months consistent with HCV infection showing minimal to mild liver fibrosis and without cirrhosis (Ishak or Metavir grade ≤ 2). For cirrhotic cohorts, previous liver biopsy or Fibroscan consistent with liver cirrhosis performed at any time before screening * HCV RNA load \> 100,000 IU RNA per ml serum at screening

Exclusion criteria

* All fertile males not willing to use an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/ implantable, intra-uterine device) * Patients who have been treated with at least one dose of any HCV-polymerase inhibitor for acute or chronic hepatitis C infection * Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis * Decompensated liver disease within past 12 months, as indicated by variceal bleeding, ascites, encephalopathy, Prothrombin or International Normalized Ratio (INR) prolonged to \>1.7 x upper limit of normal (ULN), serum bilirubin \> 2 mg/dl or albumin \< 3.5 g/dl (i.e. Child-Pugh grade B, score \> 7) * For non-cirrhotic cohorts: Any previous liver biopsy consistent with cirrhosis. For cirrhotic cohorts: Any liver biopsy or fibroscan result from last 2 years excluding liver cirrhosis. * Positive test for human immunodeficiency virus (HIV) or hepatitis B antigen at screening * Current alcohol or drug abuse, or history of the same, within the past six (6) months. Exception: Occasional use of cannabis is not an exclusion criterion. The investigator must however instruct the patient that consumption of cannabis is not allowed during the treatment period. * Any concurrent disease (cardiovascular, pulmonary, renal, haematological, neurological, psychiatric, immunologic, metabolic or endocrine dysfunction) if clinically significant based on the investigator's medical assessment at screening. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study. Exclusion is also necessary for any pre-existing cardiac abnormality by history. * Clinically significant abnormalities at screening ECG, including but not limited to a QTc longer than 435 msec, Pulse Rate \> 240 msec at baseline and any bundle branch block pattern, but not necessarily non-specific T wave abnormalities * History of malignancy (except for previously cured squamous cell or basal cell carcinoma) * Patients treated with any interferon (IFN) (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening * Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination from 7 days before treatment and during treatment * Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study * Known hypersensitivity to drugs or excipients * Patients with any one of the following laboratory values at screening: * Alanine transaminase (ALT) \> 3x ULN, local lab * Aspartate aminotransferase (AST) \> 3x ULN, local lab * Total bilirubin \> 1.5x ULN, local lab, unless predominantly conjugated and reflecting Gilbert's disease * Alkaline phosphatase \> 1.5x ULN, local lab * Prothrombin time (INR) \> 1.5x ULN, central lab * Creatinine \> 1x ULN, local lab * Urine protein / creatinine ratio \> 0.3 g protein / g creatinine, central lab * Alpha-1-microglobulin / creatinine in urine \> 1x ULN, central lab * Platelet count \< 100,000 / mm3, central lab * White Blood cell count \< 2000 cells/mm3, central lab * Absolute neutrophile count \< 1500 cells, central lab * Hemoglobin \< 12 g/dL, central lab * For patients with liver cirrhosis: * ALT \> 5x ULN, local lab * AST \> 5x ULN, local lab * Platelet count \< 70,000 / mm3, central lab * Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening * Positive urine test for drug abuse at screening * Prior randomisation into this trial * Inability to comply with the protocol * Patients with ongoing or historical photosensitivity or recurrent rash * Alpha fetoprotein value (AFP) \> 100 ng/ml; if AFP is \> 20 and ≤ 100 ng/ml, patients can be included if liver cancer is excluded by a current imaging study (i.e. ultrasound, computer tomography scan or magnetic resonance imaging)

Design outcomes

Primary

Measure	Time frame	Description
Virologic Response (VR)	Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5	Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented.

Secondary

Measure	Time frame	Description
Cmax	5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1	Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose.
Cmin	5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1	Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest.
Tmax	5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1	Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose.
AUC0-τ	5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1	Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug.
Cmax,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only)
Cmin,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.
Tmax,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only)
AUCτ,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.
AUC0-∞,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.
λz,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.
Time Dependent Change From Baseline in Viral Load (VL)	Baseline, up to day 7	Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint.
CL/F,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.
Vz/F,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.
Plasma Concentration Time Profiles	up to day 7	Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated.
Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	Baseline, up to day 14	Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure
Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	up to 14 days	Number of patients with a new onset of an abnormal finding by central assessment are presented.
Number of Patients With Abnormal Changes in Laboratory Tests	Baseline, up to day 14	Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events.
Number of Patients With Adverse Events	up to 14 days	Number of patients with any adverse event (AE)
Number of Patients With Abnormal Findings in Physical Examination	up to day 14	The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study.
Assessment of Global Tolerability on a 4-point Scale	day 6	The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator.
Body Temperature	Visit 1, Visit 7	The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint.
t1/2,ss	5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00, 100:00, 102:00, 104:00, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter	Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\, 4:00, 6:00, 8:00\, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\, 100:00, 102:00, 104:00\, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Participant flow

Recruitment details

acronyms used in pre-assignment details: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)

Pre-assignment details

Each patient participating in the trial (or the patient's legally accepted representative) provided written informed consent according to ICH GCP and the regulatory and legal requirements of the participating country. All subjects were informed that they were free to withdraw their consent at any time during the study without penalty or prejudice.

Participants by arm

Arm	Count
Placebo Fibrosis Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis	14
DBV 100mg Fibrosis DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis	9
DBV 200mg Fibrosis DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis	9
DBV 400mg Fibrosis DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis	9
DBV 400mg Cirrhosis DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis	8
DBV 600mg Cirrhosis DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis	5
DBV 800mg Fibrosis DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis	9
DBV 1200mg Fibrosis DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis	10
Total	73

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007
Overall Study	Adverse Event	0	0	0	1	1	0	1	0
Overall Study	not treated	1	0	0	0	0	1	0	0

Baseline characteristics

Characteristic	Placebo Fibrosis	DBV 100mg Fibrosis	DBV 200mg Fibrosis	DBV 400mg Fibrosis	DBV 400mg Cirrhosis	DBV 600mg Cirrhosis	DBV 800mg Fibrosis	DBV 1200mg Fibrosis	Total
Age, Continuous	47.2 years STANDARD_DEVIATION 9.1	50.3 years STANDARD_DEVIATION 11.9	51.7 years STANDARD_DEVIATION 8.5	52.3 years STANDARD_DEVIATION 8.7	55.4 years STANDARD_DEVIATION 7	56.2 years STANDARD_DEVIATION 8.1	47.3 years STANDARD_DEVIATION 12.7	46.8 years STANDARD_DEVIATION 8.6	50.24 years STANDARD_DEVIATION 9.56
Sex: Female, Male Female	5 Participants	1 Participants	3 Participants	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants	15 Participants
Sex: Female, Male Male	9 Participants	8 Participants	6 Participants	8 Participants	6 Participants	4 Participants	7 Participants	10 Participants	58 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	4 / 14	2 / 9	3 / 9	7 / 9	5 / 8	4 / 5	6 / 9	9 / 10
serious Total, serious adverse events	0 / 14	0 / 9	0 / 9	0 / 9	0 / 8	0 / 5	1 / 9	0 / 10

Outcome results

Primary

Virologic Response (VR)

Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented.

Time frame: Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5

Population: The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Arm	Measure	Value (NUMBER)
Placebo Fibrosis	Virologic Response (VR)	14.3 percentage of participants
DBV 100mg Fibrosis	Virologic Response (VR)	22.2 percentage of participants
DBV 200mg Fibrosis	Virologic Response (VR)	55.6 percentage of participants
DBV 400mg Fibrosis	Virologic Response (VR)	88.9 percentage of participants
DBV 400mg Cirrhosis	Virologic Response (VR)	87.5 percentage of participants
DBV 600mg Cirrhosis	Virologic Response (VR)	100 percentage of participants
DBV 800mg Fibrosis	Virologic Response (VR)	88.9 percentage of participants
DBV 1200mg Fibrosis	Virologic Response (VR)	100 percentage of participants

Secondary

Assessment of Global Tolerability on a 4-point Scale

The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator.

Time frame: day 6

Population: The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.

Arm	Measure	Group	Value (NUMBER)
Placebo Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Satisfactory	3 participants
Placebo Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Good	11 participants
Placebo Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Bad	0 participants
Placebo Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Not satisfactory	0 participants
DBV 100mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Satisfactory	0 participants
DBV 100mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Bad	0 participants
DBV 100mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Not satisfactory	0 participants
DBV 100mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Good	9 participants
DBV 200mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Good	8 participants
DBV 200mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Satisfactory	1 participants
DBV 200mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Not satisfactory	0 participants
DBV 200mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Bad	0 participants
DBV 400mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Satisfactory	3 participants
DBV 400mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Not satisfactory	2 participants
DBV 400mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Good	12 participants
DBV 400mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Bad	0 participants
DBV 400mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Satisfactory	1 participants
DBV 400mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Good	4 participants
DBV 400mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Not satisfactory	0 participants
DBV 400mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Bad	0 participants
DBV 600mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Satisfactory	0 participants
DBV 600mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Good	8 participants
DBV 600mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Bad	1 participants
DBV 600mg Cirrhosis	Assessment of Global Tolerability on a 4-point Scale	Not satisfactory	0 participants
DBV 800mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Bad	0 participants
DBV 800mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Not satisfactory	0 participants
DBV 800mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Good	9 participants
DBV 800mg Fibrosis	Assessment of Global Tolerability on a 4-point Scale	Satisfactory	1 participants

Secondary

AUC0-∞,ss

Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Time frame: 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	AUC0-∞,ss	2560 ng*h/mL	Geometric Coefficient of Variation 91.8
DBV 100mg Fibrosis	AUC0-∞,ss	5420 ng*h/mL	Geometric Coefficient of Variation 87.6
DBV 200mg Fibrosis	AUC0-∞,ss	22800 ng*h/mL	Geometric Coefficient of Variation 41.6
DBV 400mg Fibrosis	AUC0-∞,ss	54300 ng*h/mL	Geometric Coefficient of Variation 110
DBV 400mg Cirrhosis	AUC0-∞,ss	153000 ng*h/mL	Geometric Coefficient of Variation 108
DBV 600mg Cirrhosis	AUC0-∞,ss	51700 ng*h/mL	Geometric Coefficient of Variation 159
DBV 800mg Fibrosis	AUC0-∞,ss	129000 ng*h/mL	Geometric Coefficient of Variation 119

Secondary

AUC0-τ

Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug.

Time frame: 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	AUC0-τ	1410 Nanogramhours/millilitre (ngh/mL)	Geometric Coefficient of Variation 77.9
DBV 100mg Fibrosis	AUC0-τ	2820 Nanogramhours/millilitre (ngh/mL)	Geometric Coefficient of Variation 66.6
DBV 200mg Fibrosis	AUC0-τ	15900 Nanogramhours/millilitre (ngh/mL)	Geometric Coefficient of Variation 27.3
DBV 400mg Fibrosis	AUC0-τ	18600 Nanogramhours/millilitre (ngh/mL)	Geometric Coefficient of Variation 62.7
DBV 400mg Cirrhosis	AUC0-τ	29500 Nanogramhours/millilitre (ngh/mL)	Geometric Coefficient of Variation 49.4
DBV 600mg Cirrhosis	AUC0-τ	23600 Nanogramhours/millilitre (ngh/mL)	Geometric Coefficient of Variation 69.5
DBV 800mg Fibrosis	AUC0-τ	42400 Nanogramhours/millilitre (ngh/mL)	Geometric Coefficient of Variation 42.2

Secondary

AUCτ,ss

Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	AUCτ,ss	1930 ng*h/mL	Geometric Coefficient of Variation 79
DBV 100mg Fibrosis	AUCτ,ss	4130 ng*h/mL	Geometric Coefficient of Variation 79.1
DBV 200mg Fibrosis	AUCτ,ss	17900 ng*h/mL	Geometric Coefficient of Variation 37.1
DBV 400mg Fibrosis	AUCτ,ss	36800 ng*h/mL	Geometric Coefficient of Variation 82.7
DBV 400mg Cirrhosis	AUCτ,ss	86400 ng*h/mL	Geometric Coefficient of Variation 78.1
DBV 600mg Cirrhosis	AUCτ,ss	43500 ng*h/mL	Geometric Coefficient of Variation 118
DBV 800mg Fibrosis	AUCτ,ss	88500 ng*h/mL	Geometric Coefficient of Variation 83.3

Secondary

Body Temperature

The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint.

Time frame: Visit 1, Visit 7

Population: Treated set.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Fibrosis	Body Temperature	Visit 7 (N=13/9/9/15/5/8/10)	36.400 degree (°C)	Standard Deviation 0.283
Placebo Fibrosis	Body Temperature	Visit 1 (N=7/5/8/14/5/7/6)	36.429 degree (°C)	Standard Deviation 0.287
DBV 100mg Fibrosis	Body Temperature	Visit 1 (N=7/5/8/14/5/7/6)	36.780 degree (°C)	Standard Deviation 0.455
DBV 100mg Fibrosis	Body Temperature	Visit 7 (N=13/9/9/15/5/8/10)	36.656 degree (°C)	Standard Deviation 0.403
DBV 200mg Fibrosis	Body Temperature	Visit 1 (N=7/5/8/14/5/7/6)	36.513 degree (°C)	Standard Deviation 0.557
DBV 200mg Fibrosis	Body Temperature	Visit 7 (N=13/9/9/15/5/8/10)	36.156 degree (°C)	Standard Deviation 0.265
DBV 400mg Fibrosis	Body Temperature	Visit 7 (N=13/9/9/15/5/8/10)	36.307 degree (°C)	Standard Deviation 0.451
DBV 400mg Fibrosis	Body Temperature	Visit 1 (N=7/5/8/14/5/7/6)	36.550 degree (°C)	Standard Deviation 0.641
DBV 400mg Cirrhosis	Body Temperature	Visit 1 (N=7/5/8/14/5/7/6)	35.760 degree (°C)	Standard Deviation 0.709
DBV 400mg Cirrhosis	Body Temperature	Visit 7 (N=13/9/9/15/5/8/10)	35.540 degree (°C)	Standard Deviation 0.445
DBV 600mg Cirrhosis	Body Temperature	Visit 1 (N=7/5/8/14/5/7/6)	36.686 degree (°C)	Standard Deviation 0.248
DBV 600mg Cirrhosis	Body Temperature	Visit 7 (N=13/9/9/15/5/8/10)	36.125 degree (°C)	Standard Deviation 0.287
DBV 800mg Fibrosis	Body Temperature	Visit 1 (N=7/5/8/14/5/7/6)	36.517 degree (°C)	Standard Deviation 0.567
DBV 800mg Fibrosis	Body Temperature	Visit 7 (N=13/9/9/15/5/8/10)	36.320 degree (°C)	Standard Deviation 0.744

Secondary

CL/F,ss

Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	CL/F,ss	865 Millilitre per minute (mL/min)	Geometric Coefficient of Variation 79
DBV 100mg Fibrosis	CL/F,ss	806 Millilitre per minute (mL/min)	Geometric Coefficient of Variation 79.1
DBV 200mg Fibrosis	CL/F,ss	372 Millilitre per minute (mL/min)	Geometric Coefficient of Variation 37.1
DBV 400mg Fibrosis	CL/F,ss	181 Millilitre per minute (mL/min)	Geometric Coefficient of Variation 82.7
DBV 400mg Cirrhosis	CL/F,ss	116 Millilitre per minute (mL/min)	Geometric Coefficient of Variation 78.1
DBV 600mg Cirrhosis	CL/F,ss	319 Millilitre per minute (mL/min)	Geometric Coefficient of Variation 132
DBV 800mg Fibrosis	CL/F,ss	226 Millilitre per minute (mL/min)	Geometric Coefficient of Variation 83.3

Secondary

Cmax

Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose.

Time frame: 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

Population: The PK set (PKS) included all patients in the full analysis set (FAS) with evaluable PK data. FAS included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	Cmax	320 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 75
DBV 100mg Fibrosis	Cmax	656 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 73.1
DBV 200mg Fibrosis	Cmax	3500 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 22.1
DBV 400mg Fibrosis	Cmax	4060 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 70.1
DBV 400mg Cirrhosis	Cmax	6760 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 50.6
DBV 600mg Cirrhosis	Cmax	5730 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 74.4
DBV 800mg Fibrosis	Cmax	9570 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 35.9

Secondary

Cmax,ss

The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only)

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	Cmax,ss	391 ng/mL	Geometric Coefficient of Variation 67.8
DBV 100mg Fibrosis	Cmax,ss	910 ng/mL	Geometric Coefficient of Variation 80.3
DBV 200mg Fibrosis	Cmax,ss	3780 ng/mL	Geometric Coefficient of Variation 46.3
DBV 400mg Fibrosis	Cmax,ss	6780 ng/mL	Geometric Coefficient of Variation 76.7
DBV 400mg Cirrhosis	Cmax,ss	15400 ng/mL	Geometric Coefficient of Variation 80.4
DBV 600mg Cirrhosis	Cmax,ss	9030 ng/mL	Geometric Coefficient of Variation 103
DBV 800mg Fibrosis	Cmax,ss	16500 ng/mL	Geometric Coefficient of Variation 66.7

Secondary

Cmin

Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Time frame: 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	Cmin	105 ng/mL	Geometric Coefficient of Variation 83.1
DBV 100mg Fibrosis	Cmin	210 ng/mL	Geometric Coefficient of Variation 80.6
DBV 200mg Fibrosis	Cmin	1190 ng/mL	Geometric Coefficient of Variation 39.3
DBV 400mg Fibrosis	Cmin	1520 ng/mL	Geometric Coefficient of Variation 77
DBV 400mg Cirrhosis	Cmin	3470 ng/mL	Geometric Coefficient of Variation 37.7
DBV 600mg Cirrhosis	Cmin	1800 ng/mL	Geometric Coefficient of Variation 65.8
DBV 800mg Fibrosis	Cmin	5090 ng/mL	Geometric Coefficient of Variation 59.5

Secondary

Cmin,ss

The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	Cmin,ss	109 ng/mL	Geometric Coefficient of Variation 98.5
DBV 100mg Fibrosis	Cmin,ss	201 ng/mL	Geometric Coefficient of Variation 90.9
DBV 200mg Fibrosis	Cmin,ss	1150 ng/mL	Geometric Coefficient of Variation 65.9
DBV 400mg Fibrosis	Cmin,ss	2340 ng/mL	Geometric Coefficient of Variation 110
DBV 400mg Cirrhosis	Cmin,ss	6920 ng/mL	Geometric Coefficient of Variation 93.9
DBV 600mg Cirrhosis	Cmin,ss	2100 ng/mL	Geometric Coefficient of Variation 247
DBV 800mg Fibrosis	Cmin,ss	6630 ng/mL	Geometric Coefficient of Variation 118

Secondary

Number of Patients With Abnormal Changes in Laboratory Tests

Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events.

Time frame: Baseline, up to day 14

Arm	Measure	Value (NUMBER)
Placebo Fibrosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants
DBV 1200mg Fibrosis	Number of Patients With Abnormal Changes in Laboratory Tests	0 participants

Secondary

Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)

Number of patients with a new onset of an abnormal finding by central assessment are presented.

Time frame: up to 14 days

Population: Treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation. Only patients included having no missing ECG measurements .

Arm	Measure	Group	Value (NUMBER)
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Conduction	1 participants
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Sinus rhythm	1 participants
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	None	13 participants
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Morphology	0 participants
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Myocardial infarction	0 participants
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	ST segment	0 participants
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	T-wave	0 participants
Placebo Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	U-wave	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Sinus rhythm	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	U-wave	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Conduction	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Morphology	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Myocardial infarction	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	ST segment	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	T-wave	0 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	None	9 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Conduction	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	U-wave	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Morphology	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Myocardial infarction	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	ST segment	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	T-wave	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Sinus rhythm	0 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	None	9 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Morphology	0 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	U-wave	0 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Myocardial infarction	0 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	ST segment	0 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	T-wave	0 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Conduction	1 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	None	12 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Sinus rhythm	3 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Myocardial infarction	0 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	U-wave	0 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	ST segment	0 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	T-wave	0 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Morphology	0 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	None	5 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Sinus rhythm	0 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Conduction	0 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	ST segment	0 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	U-wave	0 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	T-wave	0 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Myocardial infarction	0 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	None	8 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Sinus rhythm	1 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Conduction	0 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Morphology	0 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	T-wave	0 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	ST segment	0 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	U-wave	0 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	None	7 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Sinus rhythm	2 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Conduction	0 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Morphology	0 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)	Myocardial infarction	0 participants

Secondary

Number of Patients With Abnormal Findings in Physical Examination

The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study.

Time frame: up to day 14

Arm	Measure	Value (NUMBER)
Placebo Fibrosis	Number of Patients With Abnormal Findings in Physical Examination	4 participants
DBV 100mg Fibrosis	Number of Patients With Abnormal Findings in Physical Examination	2 participants
DBV 200mg Fibrosis	Number of Patients With Abnormal Findings in Physical Examination	3 participants
DBV 400mg Fibrosis	Number of Patients With Abnormal Findings in Physical Examination	7 participants
DBV 400mg Cirrhosis	Number of Patients With Abnormal Findings in Physical Examination	5 participants
DBV 600mg Cirrhosis	Number of Patients With Abnormal Findings in Physical Examination	4 participants
DBV 800mg Fibrosis	Number of Patients With Abnormal Findings in Physical Examination	6 participants
DBV 1200mg Fibrosis	Number of Patients With Abnormal Findings in Physical Examination	9 participants

Secondary

Number of Patients With Adverse Events

Number of patients with any adverse event (AE)

Time frame: up to 14 days

Arm	Measure	Value (NUMBER)
Placebo Fibrosis	Number of Patients With Adverse Events	4 participants
DBV 100mg Fibrosis	Number of Patients With Adverse Events	2 participants
DBV 200mg Fibrosis	Number of Patients With Adverse Events	3 participants
DBV 400mg Fibrosis	Number of Patients With Adverse Events	7 participants
DBV 400mg Cirrhosis	Number of Patients With Adverse Events	5 participants
DBV 600mg Cirrhosis	Number of Patients With Adverse Events	4 participants
DBV 800mg Fibrosis	Number of Patients With Adverse Events	6 participants
DBV 1200mg Fibrosis	Number of Patients With Adverse Events	9 participants

Secondary

Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).

Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure

Time frame: Baseline, up to day 14

Arm	Measure	Value (NUMBER)
Placebo Fibrosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	1 participants
DBV 100mg Fibrosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	1 participants
DBV 200mg Fibrosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	0 participants
DBV 400mg Fibrosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	0 participants
DBV 400mg Cirrhosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	0 participants
DBV 600mg Cirrhosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	0 participants
DBV 800mg Fibrosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	0 participants
DBV 1200mg Fibrosis	Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).	0 participants

Secondary

Plasma Concentration Time Profiles

Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated.

Time frame: up to day 7

Population: The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10)	NA ng/mL	—
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10)	329 ng/mL	Geometric Coefficient of Variation 86.9
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10)	52.5 ng/mL	Geometric Coefficient of Variation 136
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10)	274 ng/mL	Geometric Coefficient of Variation 70
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10)	161 ng/mL	Geometric Coefficient of Variation 66.2
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10)	208 ng/mL	Geometric Coefficient of Variation 199
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10)	300 ng/mL	Geometric Coefficient of Variation 70.4
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10)	73.7 ng/mL	Geometric Coefficient of Variation 101
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10)	313 ng/mL	Geometric Coefficient of Variation 64.3
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10)	NA ng/mL	—
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10)	181 ng/mL	Geometric Coefficient of Variation 69.5
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10)	76.2 ng/mL	Geometric Coefficient of Variation 121
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 0.5 hours; N(per Arm)=6/6/7/8/3/5/9)	54.6 ng/mL	Geometric Coefficient of Variation 328
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9)	209 ng/mL	Geometric Coefficient of Variation 88.4
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10)	164 ng/mL	Geometric Coefficient of Variation 98.1
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10)	149 ng/mL	Geometric Coefficient of Variation 90.6
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10)	124 ng/mL	Geometric Coefficient of Variation 113
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10)	105 ng/mL	Geometric Coefficient of Variation 83.1
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10)	20.8 ng/mL	Geometric Coefficient of Variation 138
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10)	158 ng/mL	Geometric Coefficient of Variation 93.7
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10)	162 ng/mL	Geometric Coefficient of Variation 213
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10)	164 ng/mL	Geometric Coefficient of Variation 98
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10)	265 ng/mL	Geometric Coefficient of Variation 69.7
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10)	154 ng/mL	Geometric Coefficient of Variation 81.4
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10)	282 ng/mL	Geometric Coefficient of Variation 88.7
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10)	91.4 ng/mL	Geometric Coefficient of Variation 111
Placebo Fibrosis	Plasma Concentration Time Profiles	PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10)	199 ng/mL	Geometric Coefficient of Variation 92.7
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 0.5 hours; N(per Arm)=6/6/7/8/3/5/9)	15.1 ng/mL	Geometric Coefficient of Variation 57.7
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10)	379 ng/mL	Geometric Coefficient of Variation 155
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10)	769 ng/mL	Geometric Coefficient of Variation 92.8
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10)	NA ng/mL	—
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10)	222 ng/mL	Geometric Coefficient of Variation 90.5
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10)	39.9 ng/mL	Geometric Coefficient of Variation 157
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10)	92.7 ng/mL	Geometric Coefficient of Variation 136
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10)	158 ng/mL	Geometric Coefficient of Variation 115
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10)	246 ng/mL	Geometric Coefficient of Variation 133
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10)	20.2 ng/mL	Geometric Coefficient of Variation 126
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10)	254 ng/mL	Geometric Coefficient of Variation 109
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10)	492 ng/mL	Geometric Coefficient of Variation 99.4
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10)	476 ng/mL	Geometric Coefficient of Variation 74.9
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10)	658 ng/mL	Geometric Coefficient of Variation 109
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10)	565 ng/mL	Geometric Coefficient of Variation 108
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10)	574 ng/mL	Geometric Coefficient of Variation 73.8
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10)	53.0 ng/mL	Geometric Coefficient of Variation 387
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10)	503 ng/mL	Geometric Coefficient of Variation 105
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9)	427 ng/mL	Geometric Coefficient of Variation 86
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10)	377 ng/mL	Geometric Coefficient of Variation 57.6
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10)	366 ng/mL	Geometric Coefficient of Variation 84.7
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10)	383 ng/mL	Geometric Coefficient of Variation 88.7
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10)	210 ng/mL	Geometric Coefficient of Variation 80.6
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10)	378 ng/mL	Geometric Coefficient of Variation 70.7
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10)	403 ng/mL	Geometric Coefficient of Variation 96.6
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10)	646 ng/mL	Geometric Coefficient of Variation 170
DBV 100mg Fibrosis	Plasma Concentration Time Profiles	PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10)	531 ng/mL	Geometric Coefficient of Variation 78.1
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10)	1190 ng/mL	Geometric Coefficient of Variation 39.3
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 0.5 hours; N(per Arm)=6/6/7/8/3/5/9)	163 ng/mL	Geometric Coefficient of Variation 214
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10)	427 ng/mL	Geometric Coefficient of Variation 569
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10)	2290 ng/mL	Geometric Coefficient of Variation 70.8
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10)	2830 ng/mL	Geometric Coefficient of Variation 41.8
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10)	2800 ng/mL	Geometric Coefficient of Variation 35.6
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10)	2030 ng/mL	Geometric Coefficient of Variation 42.9
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10)	4170 ng/mL	Geometric Coefficient of Variation 93.7
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10)	3300 ng/mL	Geometric Coefficient of Variation 31.5
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10)	1180 ng/mL	Geometric Coefficient of Variation 32.7
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10)	2520 ng/mL	Geometric Coefficient of Variation 82.6
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10)	2290 ng/mL	Geometric Coefficient of Variation 48.8
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10)	2200 ng/mL	Geometric Coefficient of Variation 32.6
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10)	1670 ng/mL	Geometric Coefficient of Variation 40.6
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10)	1880 ng/mL	Geometric Coefficient of Variation 34
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10)	1830 ng/mL	Geometric Coefficient of Variation 51.1
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9)	2400 ng/mL	Geometric Coefficient of Variation 56.7
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10)	2760 ng/mL	Geometric Coefficient of Variation 49.7
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10)	2820 ng/mL	Geometric Coefficient of Variation 37.2
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10)	2790 ng/mL	Geometric Coefficient of Variation 50.2
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10)	1630 ng/mL	Geometric Coefficient of Variation 70.6
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10)	867 ng/mL	Geometric Coefficient of Variation 73.1
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10)	553 ng/mL	Geometric Coefficient of Variation 74.8
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10)	321 ng/mL	Geometric Coefficient of Variation 79
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10)	153 ng/mL	Geometric Coefficient of Variation 82.6
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10)	59.0 ng/mL	Geometric Coefficient of Variation 75.9
DBV 200mg Fibrosis	Plasma Concentration Time Profiles	PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10)	NA ng/mL	—
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10)	3570 ng/mL	Geometric Coefficient of Variation 113
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10)	5120 ng/mL	Geometric Coefficient of Variation 93.5
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10)	3220 ng/mL	Geometric Coefficient of Variation 85
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10)	3490 ng/mL	Geometric Coefficient of Variation 119
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10)	3740 ng/mL	Geometric Coefficient of Variation 70.4
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10)	4620 ng/mL	Geometric Coefficient of Variation 77
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10)	2760 ng/mL	Geometric Coefficient of Variation 89.7
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9)	3610 ng/mL	Geometric Coefficient of Variation 76.3
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10)	219 ng/mL	Geometric Coefficient of Variation 269
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10)	2580 ng/mL	Geometric Coefficient of Variation 79.7
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10)	3500 ng/mL	Geometric Coefficient of Variation 74.8
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10)	1160 ng/mL	Geometric Coefficient of Variation 171
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10)	2870 ng/mL	Geometric Coefficient of Variation 97.5
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10)	1520 ng/mL	Geometric Coefficient of Variation 77
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10)	36.2 ng/mL	Geometric Coefficient of Variation 272
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10)	3420 ng/mL	Geometric Coefficient of Variation 90
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10)	1600 ng/mL	Geometric Coefficient of Variation 76.1
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10)	597 ng/mL	Geometric Coefficient of Variation 168
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10)	1720 ng/mL	Geometric Coefficient of Variation 153
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10)	1720 ng/mL	Geometric Coefficient of Variation 62.4
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10)	2710 ng/mL	Geometric Coefficient of Variation 119
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10)	4600 ng/mL	Geometric Coefficient of Variation 102
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10)	2820 ng/mL	Geometric Coefficient of Variation 86.8
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10)	553 ng/mL	Geometric Coefficient of Variation 211
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 0.5 hours; N(per Arm)=6/6/7/8/3/5/9)	45.4 ng/mL	Geometric Coefficient of Variation 632
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10)	2950 ng/mL	Geometric Coefficient of Variation 50.1
DBV 400mg Fibrosis	Plasma Concentration Time Profiles	PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10)	6210 ng/mL	Geometric Coefficient of Variation 89.9
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 0.5 hours; N(per Arm)=6/6/7/8/3/5/9)	NA ng/mL	—
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10)	7690 ng/mL	Geometric Coefficient of Variation 61.5
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10)	1890 ng/mL	Geometric Coefficient of Variation 130
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10)	9200 ng/mL	Geometric Coefficient of Variation 83.6
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10)	3470 ng/mL	Geometric Coefficient of Variation 37.7
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10)	11500 ng/mL	Geometric Coefficient of Variation 77.2
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10)	5600 ng/mL	Geometric Coefficient of Variation 192
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10)	6250 ng/mL	Geometric Coefficient of Variation 57.4
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10)	8360 ng/mL	Geometric Coefficient of Variation 92.7
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9)	8510 ng/mL	Geometric Coefficient of Variation 73.9
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10)	5060 ng/mL	Geometric Coefficient of Variation 83.2
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10)	699 ng/mL	Geometric Coefficient of Variation 185
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10)	10000 ng/mL	Geometric Coefficient of Variation 74.3
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10)	11200 ng/mL	Geometric Coefficient of Variation 79.5
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10)	3330 ng/mL	Geometric Coefficient of Variation 89.9
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10)	14800 ng/mL	Geometric Coefficient of Variation 86.7
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10)	11400 ng/mL	Geometric Coefficient of Variation 76.6
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10)	1390 ng/mL	Geometric Coefficient of Variation 112
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10)	7450 ng/mL	Geometric Coefficient of Variation 91.5
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10)	177 ng/mL	Geometric Coefficient of Variation 258
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10)	5260 ng/mL	Geometric Coefficient of Variation 115
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10)	4040 ng/mL	Geometric Coefficient of Variation 120
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10)	7340 ng/mL	Geometric Coefficient of Variation 49.6
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10)	5230 ng/mL	Geometric Coefficient of Variation 49.2
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10)	56.2 ng/mL	Geometric Coefficient of Variation 186
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10)	5340 ng/mL	Geometric Coefficient of Variation 67.9
DBV 400mg Cirrhosis	Plasma Concentration Time Profiles	PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10)	5770 ng/mL	Geometric Coefficient of Variation 88.6
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10)	3750 ng/mL	Geometric Coefficient of Variation 106
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10)	3350 ng/mL	Geometric Coefficient of Variation 75
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10)	3060 ng/mL	Geometric Coefficient of Variation 165
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10)	7740 ng/mL	Geometric Coefficient of Variation 107
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10)	3120 ng/mL	Geometric Coefficient of Variation 224
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10)	2220 ng/mL	Geometric Coefficient of Variation 96.1
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10)	4450 ng/mL	Geometric Coefficient of Variation 144
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10)	1650 ng/mL	Geometric Coefficient of Variation 240
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10)	2230 ng/mL	Geometric Coefficient of Variation 222
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10)	519 ng/mL	Geometric Coefficient of Variation 570
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10)	4120 ng/mL	Geometric Coefficient of Variation 75.4
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10)	1200 ng/mL	Geometric Coefficient of Variation 316
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10)	3170 ng/mL	Geometric Coefficient of Variation 219
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10)	239 ng/mL	Geometric Coefficient of Variation 436
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10)	681 ng/mL	Geometric Coefficient of Variation 403
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 0.5 hours; N(per Arm)=6/6/7/8/3/5/9)	NA ng/mL	—
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10)	7290 ng/mL	Geometric Coefficient of Variation 48.2
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9)	4350 ng/mL	Geometric Coefficient of Variation 142
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10)	4920 ng/mL	Geometric Coefficient of Variation 78
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10)	4840 ng/mL	Geometric Coefficient of Variation 91.4
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10)	4680 ng/mL	Geometric Coefficient of Variation 157
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10)	7390 ng/mL	Geometric Coefficient of Variation 118
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10)	3330 ng/mL	Geometric Coefficient of Variation 181
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10)	67.2 ng/mL	Geometric Coefficient of Variation 384
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10)	NA ng/mL	—
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10)	1800 ng/mL	Geometric Coefficient of Variation 65.8
DBV 600mg Cirrhosis	Plasma Concentration Time Profiles	PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10)	7990 ng/mL	Geometric Coefficient of Variation 94.2
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10)	4370 ng/mL	Geometric Coefficient of Variation 190
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10)	5090 ng/mL	Geometric Coefficient of Variation 59.5
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10)	316 ng/mL	Geometric Coefficient of Variation 512
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9)	9460 ng/mL	Geometric Coefficient of Variation 118
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 0.5 hours; N(per Arm)=6/6/7/8/3/5/9)	124 ng/mL	Geometric Coefficient of Variation 1250
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10)	4330 ng/mL	Geometric Coefficient of Variation 110
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10)	14000 ng/mL	Geometric Coefficient of Variation 74.7
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10)	7820 ng/mL	Geometric Coefficient of Variation 133
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10)	1780 ng/mL	Geometric Coefficient of Variation 208
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10)	12000 ng/mL	Geometric Coefficient of Variation 89.1
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10)	1110 ng/mL	Geometric Coefficient of Variation 444
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10)	13800 ng/mL	Geometric Coefficient of Variation 64.8
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10)	12700 ng/mL	Geometric Coefficient of Variation 68.1
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10)	11200 ng/mL	Geometric Coefficient of Variation 91.6
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10)	2780 ng/mL	Geometric Coefficient of Variation 314
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10)	5120 ng/mL	Geometric Coefficient of Variation 112
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10)	647 ng/mL	Geometric Coefficient of Variation 275
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10)	8890 ng/mL	Geometric Coefficient of Variation 34.6
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10)	9720 ng/mL	Geometric Coefficient of Variation 48.9
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10)	11400 ng/mL	Geometric Coefficient of Variation 86.7
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10)	6830 ng/mL	Geometric Coefficient of Variation 150
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10)	6930 ng/mL	Geometric Coefficient of Variation 64.9
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10)	7840 ng/mL	Geometric Coefficient of Variation 114
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10)	20.1 ng/mL	Geometric Coefficient of Variation 175
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10)	9440 ng/mL	Geometric Coefficient of Variation 202
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10)	8100 ng/mL	Geometric Coefficient of Variation 108
DBV 800mg Fibrosis	Plasma Concentration Time Profiles	PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10)	12200 ng/mL	Geometric Coefficient of Variation 72.9

Secondary

t1/2,ss

Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Population: PKS

Arm	Measure	Value (MEDIAN)
Placebo Fibrosis	t1/2,ss	3.67 h
DBV 100mg Fibrosis	t1/2,ss	3.84 h
DBV 200mg Fibrosis	t1/2,ss	5.31 h
DBV 400mg Fibrosis	t1/2,ss	5.90 h
DBV 400mg Cirrhosis	t1/2,ss	5.95 h
DBV 600mg Cirrhosis	t1/2,ss	4.48 h
DBV 800mg Fibrosis	t1/2,ss	4.79 h

Secondary

Time Dependent Change From Baseline in Viral Load (VL)

Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint.

Time frame: Baseline, up to day 7

Population: The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-0.17 log10 (U/L)	Standard Deviation 0.24
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-0.16 log10 (U/L)	Standard Deviation 0.37
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-0.06 log10 (U/L)	Standard Deviation 0.16
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-0.08 log10 (U/L)	Standard Deviation 0.26
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	-0.07 log10 (U/L)	Standard Deviation 0.19
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-0.01 log10 (U/L)	Standard Deviation 0.18
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-0.03 log10 (U/L)	Standard Deviation 0.18
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.11 log10 (U/L)	Standard Deviation 0.09
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.00 log10 (U/L)	Standard Deviation 0.19
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.06 log10 (U/L)	Standard Deviation 0.19
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-0.04 log10 (U/L)	Standard Deviation 0.27
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-0.06 log10 (U/L)	Standard Deviation 0.2
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.01 log10 (U/L)	Standard Deviation 0.18
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	0.02 log10 (U/L)	Standard Deviation 0.76
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-0.14 log10 (U/L)	Standard Deviation 0.5
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	0.01 log10 (U/L)	Standard Deviation 0.17
Placebo Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	-0.01 log10 (U/L)	Standard Deviation 0.15
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-0.33 log10 (U/L)	Standard Deviation 0.37
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-0.50 log10 (U/L)	Standard Deviation 0.65
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-0.46 log10 (U/L)	Standard Deviation 0.65
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-0.56 log10 (U/L)	Standard Deviation 0.5
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-0.56 log10 (U/L)	Standard Deviation 0.53
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-0.60 log10 (U/L)	Standard Deviation 0.58
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	-0.53 log10 (U/L)	Standard Deviation 0.64
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-0.37 log10 (U/L)	Standard Deviation 0.41
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.02 log10 (U/L)	Standard Deviation 0.21
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	-0.03 log10 (U/L)	Standard Deviation 0.15
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.55 log10 (U/L)	Standard Deviation 0.49
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	-0.77 log10 (U/L)	Standard Deviation 0.63
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-0.66 log10 (U/L)	Standard Deviation 0.65
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.53 log10 (U/L)	Standard Deviation 0.57
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	-0.19 log10 (U/L)	Standard Deviation 0.38
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.43 log10 (U/L)	Standard Deviation 0.55
DBV 100mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-0.61 log10 (U/L)	Standard Deviation 0.65
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	-1.08 log10 (U/L)	Standard Deviation 0.92
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-1.07 log10 (U/L)	Standard Deviation 0.94
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.96 log10 (U/L)	Standard Deviation 0.78
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-0.90 log10 (U/L)	Standard Deviation 1.01
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-0.53 log10 (U/L)	Standard Deviation 0.6
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-0.70 log10 (U/L)	Standard Deviation 0.68
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-1.05 log10 (U/L)	Standard Deviation 0.8
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	-0.93 log10 (U/L)	Standard Deviation 0.82
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-0.87 log10 (U/L)	Standard Deviation 0.85
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-1.16 log10 (U/L)	Standard Deviation 0.92
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.94 log10 (U/L)	Standard Deviation 0.69
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.80 log10 (U/L)	Standard Deviation 0.59
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.16 log10 (U/L)	Standard Deviation 0.18
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-1.08 log10 (U/L)	Standard Deviation 0.89
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-1.14 log10 (U/L)	Standard Deviation 1.26
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	-0.06 log10 (U/L)	Standard Deviation 0.26
DBV 200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	-0.40 log10 (U/L)	Standard Deviation 0.93
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	-1.96 log10 (U/L)	Standard Deviation 1.25
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.25 log10 (U/L)	Standard Deviation 0.17
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-1.80 log10 (U/L)	Standard Deviation 1.25
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-1.64 log10 (U/L)	Standard Deviation 1.35
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-0.96 log10 (U/L)	Standard Deviation 0.51
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	-0.76 log10 (U/L)	Standard Deviation 1.07
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.21 log10 (U/L)	Standard Deviation 0.6
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.66 log10 (U/L)	Standard Deviation 0.96
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	-0.13 log10 (U/L)	Standard Deviation 0.11
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.64 log10 (U/L)	Standard Deviation 0.96
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	-1.67 log10 (U/L)	Standard Deviation 1.02
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-1.79 log10 (U/L)	Standard Deviation 1.25
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-1.84 log10 (U/L)	Standard Deviation 1.43
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-1.47 log10 (U/L)	Standard Deviation 1.29
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-1.87 log10 (U/L)	Standard Deviation 1.33
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-1.93 log10 (U/L)	Standard Deviation 1.29
DBV 400mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-1.94 log10 (U/L)	Standard Deviation 1.24
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-2.50 log10 (U/L)	Standard Deviation 0.93
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-2.64 log10 (U/L)	Standard Deviation 1.13
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-2.61 log10 (U/L)	Standard Deviation 1.17
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-2.64 log10 (U/L)	Standard Deviation 1.19
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-0.90 log10 (U/L)	Standard Deviation 0.53
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	NA log10 (U/L)	—
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.07 log10 (U/L)	Standard Deviation 0.22
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-2.95 log10 (U/L)	Standard Deviation 1.25
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	NA log10 (U/L)	—
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-2.70 log10 (U/L)	Standard Deviation 1.23
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.96 log10 (U/L)	Standard Deviation 0.69
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	-2.03 log10 (U/L)	Standard Deviation 0.79
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.89 log10 (U/L)	Standard Deviation 0.69
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-2.43 log10 (U/L)	Standard Deviation 0.88
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-2.20 log10 (U/L)	Standard Deviation 1.46
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	0.09 log10 (U/L)	Standard Deviation 0.1
DBV 400mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.26 log10 (U/L)	Standard Deviation 0.53
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	-0.01 log10 (U/L)	Standard Deviation 0.16
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-3.17 log10 (U/L)	Standard Deviation 0.59
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	-2.93 log10 (U/L)	—
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-3.19 log10 (U/L)	Standard Deviation 0.58
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-2.49 log10 (U/L)	Standard Deviation 0.57
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-3.19 log10 (U/L)	Standard Deviation 0.56
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-2.30 log10 (U/L)	Standard Deviation 0.55
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.57 log10 (U/L)	Standard Deviation 0.56
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	NA log10 (U/L)	—
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-3.13 log10 (U/L)	Standard Deviation 0.67
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-1.05 log10 (U/L)	Standard Deviation 0.3
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.03 log10 (U/L)	Standard Deviation 0.34
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-3.16 log10 (U/L)	Standard Deviation 0.83
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-3.12 log10 (U/L)	Standard Deviation 0.71
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-3.14 log10 (U/L)	Standard Deviation 0.67
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-2.97 log10 (U/L)	Standard Deviation 1.13
DBV 600mg Cirrhosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	-2.75 log10 (U/L)	Standard Deviation 0.77
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-2.98 log10 (U/L)	Standard Deviation 1.3
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	0.05 log10 (U/L)	Standard Deviation 0.25
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.26 log10 (U/L)	Standard Deviation 0.17
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-1.41 log10 (U/L)	Standard Deviation 0.53
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.82 log10 (U/L)	Standard Deviation 0.59
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-2.40 log10 (U/L)	Standard Deviation 0.76
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-2.51 log10 (U/L)	Standard Deviation 0.86
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	-2.46 log10 (U/L)	Standard Deviation 1.04
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-3.00 log10 (U/L)	Standard Deviation 1.14
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-3.02 log10 (U/L)	Standard Deviation 1.3
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-3.11 log10 (U/L)	Standard Deviation 1.23
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-3.17 log10 (U/L)	Standard Deviation 1.29
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-3.06 log10 (U/L)	Standard Deviation 1.4
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	-3.27 log10 (U/L)	Standard Deviation 1.3
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-3.11 log10 (U/L)	Standard Deviation 1.2
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-2.82 log10 (U/L)	Standard Deviation 1.4
DBV 800mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	-1.88 log10 (U/L)	Standard Deviation 1.64
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-2.91 log10 (U/L)	Standard Deviation 0.9
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10	-3.02 log10 (U/L)	Standard Deviation 0.78
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10	-3.01 log10 (U/L)	Standard Deviation 0.77
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-2.94 log10 (U/L)	Standard Deviation 0.83
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10	-2.97 log10 (U/L)	Standard Deviation 0.82
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10	-3.01 log10 (U/L)	Standard Deviation 0.59
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10	-2.45 log10 (U/L)	Standard Deviation 0.83
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10	-1.61 log10 (U/L)	Standard Deviation 0.87
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10	-2.64 log10 (U/L)	Standard Deviation 1.07
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-2.40 log10 (U/L)	Standard Deviation 0.63
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10	-2.31 log10 (U/L)	Standard Deviation 0.57
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-1.59 log10 (U/L)	Standard Deviation 0.54
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9	-1.11 log10 (U/L)	Standard Deviation 0.51
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10	-0.15 log10 (U/L)	Standard Deviation 0.2
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 2:00 hours; N (per arm): 14/8/9/9/8/5/8/10	0.03 log10 (U/L)	Standard Deviation 0.11
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10	-3.03 log10 (U/L)	Standard Deviation 0.83
DBV 1200mg Fibrosis	Time Dependent Change From Baseline in Viral Load (VL)	PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10	-3.11 log10 (U/L)	Standard Deviation 0.82

Secondary

Tmax

Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose.

Time frame: 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

Population: PKS

Arm	Measure	Value (MEDIAN)
Placebo Fibrosis	Tmax	3.00 hours (h)
DBV 100mg Fibrosis	Tmax	3.03 hours (h)
DBV 200mg Fibrosis	Tmax	3.00 hours (h)
DBV 400mg Fibrosis	Tmax	4.00 hours (h)
DBV 400mg Cirrhosis	Tmax	6.00 hours (h)
DBV 600mg Cirrhosis	Tmax	4.00 hours (h)
DBV 800mg Fibrosis	Tmax	6.00 hours (h)

Secondary

Tmax,ss

Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only)

Population: PKS

Arm	Measure	Value (MEDIAN)
Placebo Fibrosis	Tmax,ss	2.02 h
DBV 100mg Fibrosis	Tmax,ss	4.00 h
DBV 200mg Fibrosis	Tmax,ss	2.52 h
DBV 400mg Fibrosis	Tmax,ss	4.00 h
DBV 400mg Cirrhosis	Tmax,ss	4.00 h
DBV 600mg Cirrhosis	Tmax,ss	4.00 h
DBV 800mg Fibrosis	Tmax,ss	4.10 h

Secondary

Vz/F,ss

Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Population: PKS

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo Fibrosis	Vz/F,ss	279 Litre (L)	Geometric Coefficient of Variation 53.1
DBV 100mg Fibrosis	Vz/F,ss	254 Litre (L)	Geometric Coefficient of Variation 49.8
DBV 200mg Fibrosis	Vz/F,ss	164 Litre (L)	Geometric Coefficient of Variation 41.4
DBV 400mg Fibrosis	Vz/F,ss	83.9 Litre (L)	Geometric Coefficient of Variation 58.2
DBV 400mg Cirrhosis	Vz/F,ss	59.7 Litre (L)	Geometric Coefficient of Variation 72.8
DBV 600mg Cirrhosis	Vz/F,ss	110 Litre (L)	Geometric Coefficient of Variation 108
DBV 800mg Fibrosis	Vz/F,ss	96.8 Litre (L)	Geometric Coefficient of Variation 86.5

Secondary

λz,ss

Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00\*, 4:00, 6:00, 8:00\*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00\*, 100:00, 102:00, 104:00\*, 106:00, 108:00, 112:00, 120:00, 144:00 h (\*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest.

Population: PKS

Arm	Measure	Value (MEDIAN)
Placebo Fibrosis	λz,ss	0.189 1/h
DBV 100mg Fibrosis	λz,ss	0.180 1/h
DBV 200mg Fibrosis	λz,ss	0.131 1/h
DBV 400mg Fibrosis	λz,ss	0.117 1/h
DBV 400mg Cirrhosis	λz,ss	0.117 1/h
DBV 600mg Cirrhosis	λz,ss	0.155 1/h
DBV 800mg Fibrosis	λz,ss	0.145 1/h

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Virologic Response (VR)

Assessment of Global Tolerability on a 4-point Scale

AUC0-∞,ss

AUC0-τ

AUCτ,ss

Body Temperature

CL/F,ss

Cmax

Cmax,ss

Cmin

Cmin,ss

Number of Patients With Abnormal Changes in Laboratory Tests

Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)

Number of Patients With Abnormal Findings in Physical Examination

Number of Patients With Adverse Events

Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).

Plasma Concentration Time Profiles

t1/2,ss

Time Dependent Change From Baseline in Viral Load (VL)

Tmax

Tmax,ss

Vz/F,ss

λz,ss