Trial Outcomes & Findings for BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 (NCT NCT01830127)

NCT ID: NCT01830127

Last Updated: 2015-11-20

Results Overview

Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: 12 weeks after End of Treatment
• Results posted on: 2015-11-20

Participant Flow

35 patients were enrolled and treated with Deleobuvir (DBV) / Faldaprevir (FDV) / Ribavirin (RBV): 18 patients with Child-Pugh A (mild hepatic impairment) and 17 patients with Child-Pugh B (moderate hepatic impairment).

This was phase IIb open label study of BI 207127 (Deleobuvir) in combination with faldaprevir and ribavirin in patients with mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection.

Participant milestones

Measure	Arm1: Child-Pugh A Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Arm2: Child-Pugh B Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Overall Study STARTED	18	17
Overall Study COMPLETED	13	8
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Measure	Arm1: Child-Pugh A Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Arm2: Child-Pugh B Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Overall Study Adverse Event	1	6
Overall Study Lack of Efficacy	3	0
Overall Study Withdrawal by Subject	1	1
Overall Study Other reason not defined above	0	2

Baseline Characteristics

BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

Baseline characteristics by cohort

Measure	Arm1: Child-Pugh A n=18 Participants Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Arm2: Child-Pugh B n=17 Participants Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Total n=35 Participants Total of all reporting groups
Age, Continuous	57.8 Years STANDARD_DEVIATION 8.8 • n=5 Participants	56.6 Years STANDARD_DEVIATION 9.7 • n=7 Participants	57.2 Years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after End of Treatment

Population: (Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.

Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.

Outcome measures

Measure	Arm1: Child-Pugh A n=18 Participants Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Arm2: Child-Pugh B n=17 Participants Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)	61.1 Percentage of participants Interval 38.6 to 83.6	52.9 Percentage of participants Interval 29.2 to 76.7

SECONDARY outcome

Timeframe: 4 weeks after End of Treatment

Population: (Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.

Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.

Outcome measures

Measure	Arm1: Child-Pugh A n=18 Participants Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Arm2: Child-Pugh B n=17 Participants Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)	72.2 Percentage of participants Interval 51.5 to 92.9	76.5 Percentage of participants Interval 56.3 to 96.6

Adverse Events

Arm1: Child-Pugh A

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Arm2: Child-Pugh B

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm1: Child-Pugh A n=18 participants at risk Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Arm2: Child-Pugh B n=17 participants at risk Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Ascites	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Diarrhoea	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Varices oesophageal	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders General physical health deterioration	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Peritonitis bacterial	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Urinary tract infection	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Hepatic encephalopathy	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	23.5% 4/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.

Other adverse events

Measure	Arm1: Child-Pugh A n=18 participants at risk Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.	Arm2: Child-Pugh B n=17 participants at risk Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Blood and lymphatic system disorders Anaemia	33.3% 6/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	47.1% 8/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Blood and lymphatic system disorders Lymphopenia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Cardiac disorders Bradycardia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Cardiac disorders Palpitations	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Ear and labyrinth disorders Vertigo	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Eye disorders Dry eye	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Eye disorders Erythema of eyelid	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Eye disorders Ocular icterus	33.3% 6/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Eye disorders Photophobia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Abdominal distension	27.8% 5/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Abdominal pain	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Abdominal pain upper	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Aphthous stomatitis	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Ascites	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	41.2% 7/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Cheilitis	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Constipation	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Diarrhoea	50.0% 9/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	52.9% 9/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Dry mouth	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Dyspepsia	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Faeces soft	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Flatulence	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Hiatus hernia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Melaena	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Nausea	72.2% 13/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	76.5% 13/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Portal hypertensive gastropathy	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Varices oesophageal	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Gastrointestinal disorders Vomiting	50.0% 9/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	35.3% 6/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Asthenia	38.9% 7/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	41.2% 7/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Chills	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Fatigue	22.2% 4/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Gait disturbance	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Mucosal dryness	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Oedema	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Oedema peripheral	22.2% 4/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	29.4% 5/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
General disorders Pyrexia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Hepatobiliary disorders Bile duct stone	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Hepatobiliary disorders Gallbladder disorder	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Hepatobiliary disorders Hepatomegaly	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Hepatobiliary disorders Hyperbilirubinaemia	44.4% 8/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	23.5% 4/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Hepatobiliary disorders Jaundice	27.8% 5/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	47.1% 8/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Bronchitis	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Gingivitis	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Nasopharyngitis	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Oral candidiasis	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Upper respiratory tract infection	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Infections and infestations Urinary tract infection	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Injury, poisoning and procedural complications Contusion	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Injury, poisoning and procedural complications Fall	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Injury, poisoning and procedural complications Injury	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Injury, poisoning and procedural complications Limb injury	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Injury, poisoning and procedural complications Muscle injury	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Injury, poisoning and procedural complications Wound	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Electrocardiogram QT prolonged	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Glomerular filtration rate decreased	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Hepatic enzyme increased	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Hepatitis C RNA increased	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Lipase increased	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Liver function test abnormal	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Waist circumference increased	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Weight decreased	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Investigations Weight increased	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Decreased appetite	27.8% 5/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hyperglycaemia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hyperuricaemia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Musculoskeletal and connective tissue disorders Monarthritis	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Musculoskeletal and connective tissue disorders Muscle tightness	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Burning sensation	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Disturbance in attention	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Dizziness	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	29.4% 5/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Dysgeusia	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Encephalopathy	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Headache	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Hepatic encephalopathy	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Hyperaesthesia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Hypertonia	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Memory impairment	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Migraine	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Paraesthesia	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Parosmia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Presyncope	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Restless legs syndrome	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Sensory loss	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Somnolence	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Syncope	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Nervous system disorders Tremor	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Anxiety	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Bradyphrenia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Depressed mood	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Depression	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Disorientation	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Insomnia	16.7% 3/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	23.5% 4/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Libido increased	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Psychiatric disorders Nightmare	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Renal and urinary disorders Chromaturia	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Renal and urinary disorders Proteinuria	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Renal and urinary disorders Renal colic	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Renal and urinary disorders Renal failure	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Reproductive system and breast disorders Breast pain	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	17.6% 3/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Respiratory, thoracic and mediastinal disorders Nasal dryness	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Blister	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Dry skin	11.1% 2/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Eczema	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Erythema	16.7% 3/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Night sweats	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Onychalgia	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Photosensitivity reaction	16.7% 3/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Pruritus	44.4% 8/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	29.4% 5/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Pruritus generalised	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Rash	16.7% 3/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	11.8% 2/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Rash papular	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Skin exfoliation	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Skin and subcutaneous tissue disorders Urticaria	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Surgical and medical procedures Tooth extraction	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Vascular disorders Hypotension	0.00% 0/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	5.9% 1/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Vascular disorders Vasospasm	5.6% 1/18 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.	0.00% 0/17 • From first drug administration until last drug administration plus 28 days, up to 28 weeks.

Additional Information

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