Trial Outcomes & Findings for Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (NCT NCT01728324)
NCT ID: NCT01728324
Last Updated: 2016-02-12
Results Overview
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level \<25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
496 participants
Primary outcome timeframe
12 Week (post-treatment)
Results posted on
2016-02-12
Participant Flow
Participant milestones
| Measure |
24-wk Non-cirrhotic (NC) Treatment Group
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
|
16-wk Non-cirrhotic (NC) Treatment Group
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
|
24-wk Cirrhotic (CR) Treatment Group
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
Termination of DBV
STARTED
|
211
|
213
|
72
|
|
Termination of DBV
COMPLETED
|
173
|
177
|
58
|
|
Termination of DBV
NOT COMPLETED
|
38
|
36
|
14
|
|
Termination of FDV
STARTED
|
211
|
213
|
72
|
|
Termination of FDV
COMPLETED
|
173
|
177
|
58
|
|
Termination of FDV
NOT COMPLETED
|
38
|
36
|
14
|
|
Termination of RBV
STARTED
|
211
|
213
|
72
|
|
Termination of RBV
COMPLETED
|
172
|
176
|
57
|
|
Termination of RBV
NOT COMPLETED
|
39
|
37
|
15
|
Reasons for withdrawal
| Measure |
24-wk Non-cirrhotic (NC) Treatment Group
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
|
16-wk Non-cirrhotic (NC) Treatment Group
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
|
24-wk Cirrhotic (CR) Treatment Group
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
Termination of DBV
Adverse Event
|
14
|
13
|
4
|
|
Termination of DBV
Lack of Efficacy
|
14
|
12
|
8
|
|
Termination of DBV
Withdrawal by Subject
|
9
|
6
|
2
|
|
Termination of DBV
Other than stated
|
1
|
3
|
0
|
|
Termination of DBV
Adverse Event (Placebo Period)
|
0
|
1
|
0
|
|
Termination of DBV
Protocol Violation (Placebo Period)
|
0
|
1
|
0
|
|
Termination of FDV
Adverse Event
|
14
|
13
|
4
|
|
Termination of FDV
Lack of Efficacy
|
14
|
12
|
8
|
|
Termination of FDV
Withdrawal by Subject
|
9
|
6
|
2
|
|
Termination of FDV
Other than stated
|
1
|
3
|
0
|
|
Termination of FDV
Adverse Event (Placebo Period)
|
0
|
1
|
0
|
|
Termination of FDV
Protocol Violation (Placebo Period)
|
0
|
1
|
0
|
|
Termination of RBV
Adverse Event
|
15
|
16
|
5
|
|
Termination of RBV
Lack of Efficacy
|
14
|
11
|
7
|
|
Termination of RBV
Withdrawal by Subject
|
9
|
5
|
2
|
|
Termination of RBV
Other than stated
|
1
|
3
|
1
|
|
Termination of RBV
Adverse Event (Placebo Period)
|
0
|
1
|
0
|
|
Termination of RBV
Protocol Violation (Placebo Period)
|
0
|
1
|
0
|
Baseline Characteristics
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
Baseline characteristics by cohort
| Measure |
24-wk Non-cirrhotic (NC) Treatment Group
n=211 Participants
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
|
16-wk Non-cirrhotic (NC) Treatment Group
n=213 Participants
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
|
24-wk Cirrhotic (CR) Treatment Group
n=72 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
Total
n=496 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.3 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
50.5 Years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
58.0 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
51.5 Years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
255 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 Week (post-treatment)Population: Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level \<25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed.
Outcome measures
| Measure |
24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=283 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
|
16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=283 Participants
This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
|
24-wk Cirrhotic (CR) Treatment Group
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
SVR12 Rates With Historical Control
PegIFN eligible
|
79.95 percentage of participants
|
76.68 percentage of participants
|
—
|
|
SVR12 Rates With Historical Control
PegIFN ineligible
|
88.28 percentage of participants
|
70.78 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 12 Week (post-treatment)Population: FAS
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Outcome measures
| Measure |
24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=211 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
|
16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=213 Participants
This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
|
24-wk Cirrhotic (CR) Treatment Group
n=72 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
Comparisons of SVR12 Rates Across Treatment Arms
|
82.0 Percentage of participants
Interval 76.8 to 87.2
|
75.6 Percentage of participants
Interval 69.8 to 81.4
|
73.6 Percentage of participants
Interval 63.4 to 83.8
|
SECONDARY outcome
Timeframe: 4 weeks (after End Of Treatment)Population: FAS
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level \<25 IU/mL at 4 weeks after EOT.
Outcome measures
| Measure |
24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=211 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
|
16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=213 Participants
This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
|
24-wk Cirrhotic (CR) Treatment Group
n=72 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
|
83.9 percentage of participants
Interval 78.9 to 88.8
|
80.3 percentage of participants
Interval 74.9 to 85.6
|
77.8 percentage of participants
Interval 68.2 to 87.4
|
SECONDARY outcome
Timeframe: 4 weeks (after End Of Treatment)Population: FAS
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level \<25 IU/mL at 24 weeks after EOT.
Outcome measures
| Measure |
24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=211 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
|
16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=213 Participants
This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
|
24-wk Cirrhotic (CR) Treatment Group
n=72 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
|
81.0 percentage of participants
Interval 75.8 to 86.3
|
74.2 percentage of participants
Interval 68.3 to 80.1
|
72.2 percentage of participants
Interval 61.9 to 82.6
|
SECONDARY outcome
Timeframe: 24 Week (post-treatment)Population: FAS
The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
Outcome measures
| Measure |
24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=211 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
|
16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group
n=213 Participants
This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
|
24-wk Cirrhotic (CR) Treatment Group
n=72 Participants
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
Prognostic Value of SVR12 Predicting SVR24
|
99.0 Percentage of participants
|
99.0 Percentage of participants
|
98.0 Percentage of participants
|
Adverse Events
24-wk Non-cirrhotic (NC) Treatment Group
Serious events: 7 serious events
Other events: 198 other events
Deaths: 0 deaths
16-wk Non-cirrhotic (NC) Treatment Group
Serious events: 12 serious events
Other events: 202 other events
Deaths: 0 deaths
24-wk Cirrhotic (CR) Treatment Group
Serious events: 8 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
24-wk Non-cirrhotic (NC) Treatment Group
n=211 participants at risk
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
|
16-wk Non-cirrhotic (NC) Treatment Group
n=213 participants at risk
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
|
24-wk Cirrhotic (CR) Treatment Group
n=72 participants at risk
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.94%
2/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.94%
2/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.94%
2/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
General disorders
Fatigue
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
General disorders
Malaise
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Immune system disorders
Drug hypersensitivity
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Infections and infestations
Pneumonia
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Nervous system disorders
Loss of consciousness
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Depression
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.94%
2/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.47%
1/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.47%
1/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.00%
0/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
Other adverse events
| Measure |
24-wk Non-cirrhotic (NC) Treatment Group
n=211 participants at risk
24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
|
16-wk Non-cirrhotic (NC) Treatment Group
n=213 participants at risk
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
|
24-wk Cirrhotic (CR) Treatment Group
n=72 participants at risk
24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
|
|---|---|---|---|
|
Investigations
Weight decreased
|
9.0%
19/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.2%
11/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.3%
6/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.3%
26/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
10.3%
22/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
18.1%
13/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
8/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.8%
6/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
6.9%
5/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Eye disorders
Ocular icterus
|
12.8%
27/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
7.5%
16/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.8%
2/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.8%
6/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
3.8%
8/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
9.7%
7/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.6%
16/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
7.5%
16/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.6%
4/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.3%
26/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.9%
19/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
9.7%
7/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Constipation
|
10.4%
22/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
7.5%
16/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
16.7%
12/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.0%
59/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
25.4%
54/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
33.3%
24/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.3%
26/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
12.2%
26/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
18.1%
13/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.3%
9/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.3%
5/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.6%
4/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Nausea
|
61.1%
129/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
56.8%
121/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
56.9%
41/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Gastrointestinal disorders
Vomiting
|
32.7%
69/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
30.0%
64/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
34.7%
25/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
General disorders
Asthenia
|
20.4%
43/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
16.0%
34/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
25.0%
18/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
General disorders
Fatigue
|
35.1%
74/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
34.3%
73/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
36.1%
26/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.8%
8/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.8%
6/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
9.7%
7/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Hepatobiliary disorders
Jaundice
|
12.8%
27/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
7.0%
15/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
25.0%
18/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
11/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
4.2%
9/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.8%
2/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
8/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.9%
4/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
6.9%
5/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Injury, poisoning and procedural complications
Sunburn
|
6.2%
13/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
6.6%
14/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
4.2%
3/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.1%
34/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
12.7%
27/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
19.4%
14/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.8%
8/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.3%
5/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
11.1%
8/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
10/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.8%
6/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.3%
6/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.2%
11/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
3.8%
8/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
2.8%
2/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
7/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.2%
11/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
1/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Nervous system disorders
Dizziness
|
9.0%
19/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
9.9%
21/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.3%
6/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Nervous system disorders
Dysgeusia
|
6.6%
14/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
3.8%
8/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
6.9%
5/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Nervous system disorders
Headache
|
15.6%
33/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
21.6%
46/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
6.9%
5/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
15/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.0%
17/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
4.2%
3/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Nervous system disorders
Tremor
|
0.95%
2/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
0.94%
2/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
6.9%
5/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Anxiety
|
3.8%
8/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
9.9%
21/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.3%
6/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Depression
|
7.6%
16/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
4.2%
9/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.6%
4/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Insomnia
|
16.6%
35/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
11.7%
25/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
13.9%
10/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Psychiatric disorders
Irritability
|
3.8%
8/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
3.8%
8/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.6%
4/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
14/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
9.4%
20/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
9.7%
7/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
18/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.2%
11/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.3%
6/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
15/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
1.4%
3/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
4.2%
3/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.5%
18/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
5.6%
12/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
6.9%
5/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.6%
33/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
18.3%
39/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
13.9%
10/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
18.0%
38/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
12.2%
26/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
8.3%
6/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.3%
47/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
22.1%
47/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
31.9%
23/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.4%
43/211 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
18.3%
39/213 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
13.9%
10/72 • From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
|
Additional Information
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Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER