Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01358864
• Collaborator: (none)
• Enrollment: 678
• Locations: 116
• Arms: 3
• Duration (Months): 35
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 678 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Placebo/PegIFN/RBV patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks	Drug: Pegylated Interferon-alpha (IFN); Pegylated Interferon-alpha for 48 weeks; Drug: Ribavirin (RBV); Ribavirin (RBV) for 24 or 48 weeks; Drug: Placebo; Placebo to BI201335 for 24 weeks
Experimental: BI201335 12 weeks patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks	Drug: BI 201335; BI 201335 once a day (QD) for 24 weeks; Drug: Pegylated Interferon-alpha (IFN); Pegylated Interferon-alpha for 48 weeks; Drug: Ribavirin (RBV); Ribavirin (RBV) for 24 or 48 weeks
Experimental: BI201335 24 weeks patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks	Drug: BI 201335; BI 201335 once a day (QD) for 24 weeks; Drug: Pegylated Interferon-alpha (IFN); Pegylated Interferon-alpha for 48 weeks; Drug: Ribavirin (RBV); Ribavirin (RBV) for 24 or 48 weeks

Outcome Measures

Primary Outcome Measures

1. Sustained Virological Response 12 Weeks Post Treatment (SVR12) [12 weeks post treatment, up to 60 weeks]

   Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Secondary Outcome Measures

1. Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) [24 weeks post treatment, up to 72 weeks]

   Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

2. Early Treatment Success (ETS) [Week 4 and Week 8]

   Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.

3. ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO [End of treatment, up to 48 weeks]

   The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

4. ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES [End of treatment, up to 48 weeks]

   The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

5. AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO [End of treatment, up to 48 weeks]

   The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

6. AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES [End of treatment, up to 48 weeks]

   The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline

7. ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO [12 weeks post treatment, up to 60 weeks]

   The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

8. ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES [12 weeks post treatment, up to 60 weeks]

   The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

9. AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO [12 weeks post treatment, up to 60 weeks]

   The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

10. AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES [12 weeks post treatment, up to 60 weeks]

    The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening

2. Confirmed prior virological failure with an approved dose of PegIFN/RBV

3. Age 18 to 70 years,

4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion criteria:

1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection

2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,

3. Decompensated liver disease, or history of decompensated liver disease,

4. Body weight < 40 or > 125 kg,

5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder

6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study

7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)

8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men

9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1220.7.0091 Boehringer Ingelheim Investigational Site	North Little Rock	Arkansas	United States
2	1220.7.0082 Boehringer Ingelheim Investigational Site	Englewood	Colorado	United States
3	1220.7.0095 Boehringer Ingelheim Investigational Site	Palm Harbor	Florida	United States
4	1220.7.0039 Boehringer Ingelheim Investigational Site	Columbus	Georgia	United States
5	1220.7.0013 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
6	1220.7.0062 Boehringer Ingelheim Investigational Site	Vaiparaiso	Indiana	United States
7	1220.7.0085 Boehringer Ingelheim Investigational Site	Baton Rouge	Louisiana	United States
8	1220.7.0087 Boehringer Ingelheim Investigational Site	Baton Rouge	Louisiana	United States
9	1220.7.0101 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana	United States
10	1220.7.0027 Boehringer Ingelheim Investigational Site	Framingham	Massachusetts	United States
11	1220.7.0012 Boehringer Ingelheim Investigational Site	New York	New York	United States
12	1220.7.0077 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina	United States
13	1220.7.0058 Boehringer Ingelheim Investigational Site	Portland	Oregon	United States
14	1220.7.0063 Boehringer Ingelheim Investigational Site	Arlington	Texas	United States
15	1220.7.0029 Boehringer Ingelheim Investigational Site	Austin	Texas	United States
16	1220.7.0071 Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
17	1220.7.0009 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
18	1220.7.0016 Boehringer Ingelheim Investigational Site	San Antonio	Texas	United States
19	1220.7.4303 Boehringer Ingelheim Investigational Site	Linz		Austria
20	1220.7.4301 Boehringer Ingelheim Investigational Site	Wien		Austria
21	1220.7.4302 Boehringer Ingelheim Investigational Site	Wien		Austria
22	1220.7.3201 Boehringer Ingelheim Investigational Site	Bruxelles		Belgium
23	1220.7.3207 Boehringer Ingelheim Investigational Site	Bruxelles		Belgium
24	1220.7.3204 Boehringer Ingelheim Investigational Site	Edegem		Belgium
25	1220.7.3205 Boehringer Ingelheim Investigational Site	Gent		Belgium
26	1220.7.3206 Boehringer Ingelheim Investigational Site	Jette		Belgium
27	1220.7.3202 Boehringer Ingelheim Investigational Site	Leuven		Belgium
28	1220.7.3203 Boehringer Ingelheim Investigational Site	Liège		Belgium
29	1220.7.1011 Boehringer Ingelheim Investigational Site	Calgary	Alberta	Canada
30	1220.7.1012 Boehringer Ingelheim Investigational Site	Edmonton	Alberta	Canada
31	1220.7.1003 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia	Canada
32	1220.7.1016 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia	Canada
33	1220.7.1007 Boehringer Ingelheim Investigational Site	Victoria	British Columbia	Canada
34	1220.7.1004 Boehringer Ingelheim Investigational Site	Ottawa	Ontario	Canada
35	1220.7.1006 Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
36	1220.7.1010 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
37	1220.7.1014 Boehringer Ingelheim Investigational Site	Montreal	Quebec	Canada
38	1220.7.3301 Boehringer Ingelheim Investigational Site	Clichy		France
39	1220.7.3311 Boehringer Ingelheim Investigational Site	Lille		France
40	1220.7.3303 Boehringer Ingelheim Investigational Site	Marseille		France
41	1220.7.3304 Boehringer Ingelheim Investigational Site	Montpellier		France
42	1220.7.3305 Boehringer Ingelheim Investigational Site	Nice Cedex 3		France
43	1220.7.3302 Boehringer Ingelheim Investigational Site	Paris		France
44	1220.7.3310 Boehringer Ingelheim Investigational Site	Paris		France
45	1220.7.3316 Boehringer Ingelheim Investigational Site	Pessac Cedex		France
46	1220.7.3317 Boehringer Ingelheim Investigational Site	Reims		France
47	1220.7.3315 Boehringer Ingelheim Investigational Site	Rennes Cedex 09		France
48	1220.7.3318 Boehringer Ingelheim Investigational Site	Strasbourg		France
49	1220.7.3308 Boehringer Ingelheim Investigational Site	Vandoeuvre Cedex		France
50	1220.7.4902 Boehringer Ingelheim Investigational Site	Berlin		Germany
51	1220.7.4904 Boehringer Ingelheim Investigational Site	Berlin		Germany
52	1220.7.4913 Boehringer Ingelheim Investigational Site	Dortmund		Germany
53	1220.7.4906 Boehringer Ingelheim Investigational Site	Düsseldorf		Germany
54	1220.7.4901 Boehringer Ingelheim Investigational Site	Frankfurt am Main		Germany
55	1220.7.4908 Boehringer Ingelheim Investigational Site	Hamburg		Germany
56	1220.7.4918 Boehringer Ingelheim Investigational Site	Hannover		Germany
57	1220.7.4907 Boehringer Ingelheim Investigational Site	Herne		Germany
58	1220.7.4903 Boehringer Ingelheim Investigational Site	Leipzig		Germany
59	1220.7.4911 Boehringer Ingelheim Investigational Site	Mainz		Germany
60	1220.7.4905 Boehringer Ingelheim Investigational Site	München		Germany
61	1220.7.8106 Boehringer Ingelheim Investigational Site	Chiba, Chiba		Japan
62	1220.7.8111 Boehringer Ingelheim Investigational Site	Gifu, Gifu		Japan
63	1220.7.8107 Boehringer Ingelheim Investigational Site	Itabashi-ku, Tokyo		Japan
64	1220.7.8112 Boehringer Ingelheim Investigational Site	Izunokuni, Shizuoka		Japan
65	1220.7.8108 Boehringer Ingelheim Investigational Site	Kamakura, Kanagawa		Japan
66	1220.7.8117 Boehringer Ingelheim Investigational Site	Kita-gun, Kagawa		Japan
67	1220.7.8109 Boehringer Ingelheim Investigational Site	Kofu, Yamanashi		Japan
68	1220.7.8116 Boehringer Ingelheim Investigational Site	Kurashiki, Okayama		Japan
69	1220.7.8118 Boehringer Ingelheim Investigational Site	Kurume, Fukuoka		Japan
70	1220.7.8110 Boehringer Ingelheim Investigational Site	Matsumoto, Nagano		Japan
71	1220.7.8124 Boehringer Ingelheim Investigational Site	Matsuyama, Ehime		Japan
72	1220.7.8113 Boehringer Ingelheim Investigational Site	Nagoya, Aichi		Japan
73	1220.7.8105 Boehringer Ingelheim Investigational Site	Namegata, Ibaraki		Japan
74	1220.7.8114 Boehringer Ingelheim Investigational Site	Nishinomiya, Hyogo		Japan
75	1220.7.8125 Boehringer Ingelheim Investigational Site	Ogaki, Gifu		Japan
76	1220.7.8119 Boehringer Ingelheim Investigational Site	Omura, Nagasaki		Japan
77	1220.7.8122 Boehringer Ingelheim Investigational Site	Omuta, Fukuoka		Japan
78	1220.7.8121 Boehringer Ingelheim Investigational Site	Osaka, Osaka		Japan
79	1220.7.8101 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido		Japan
80	1220.7.8102 Boehringer Ingelheim Investigational Site	Sendai, Miyagi		Japan
81	1220.7.8115 Boehringer Ingelheim Investigational Site	Tanabe, Wakayama		Japan
82	1220.7.8123 Boehringer Ingelheim Investigational Site	Toyama,Toyama		Japan
83	1220.7.8126 Boehringer Ingelheim Investigational Site	Tsu, Mie		Japan
84	1220.7.8104 Boehringer Ingelheim Investigational Site	Tsuchiura, Ibaraki		Japan
85	1220.7.3503 Boehringer Ingelheim Investigational Site	Aveiro		Portugal
86	1220.7.3509 Boehringer Ingelheim Investigational Site	Barreiro		Portugal
87	1220.7.3506 Boehringer Ingelheim Investigational Site	Coimbra		Portugal
88	1220.7.3501 Boehringer Ingelheim Investigational Site	Lisboa		Portugal
89	1220.7.3505 Boehringer Ingelheim Investigational Site	Lisboa		Portugal
90	1220.7.3502 Boehringer Ingelheim Investigational Site	Porto		Portugal
91	1220.7.0034 Boehringer Ingelheim Investigational Site	San Juan		Puerto Rico
92	1220.7.3406 Boehringer Ingelheim Investigational Site	A Coruña		Spain
93	1220.7.3402 Boehringer Ingelheim Investigational Site	Barcelona		Spain
94	1220.7.3404 Boehringer Ingelheim Investigational Site	Barcelona		Spain
95	1220.7.3411 Boehringer Ingelheim Investigational Site	Barcelona		Spain
96	1220.7.3412 Boehringer Ingelheim Investigational Site	Barcelona		Spain
97	1220.7.3405 Boehringer Ingelheim Investigational Site	Madrid		Spain
98	1220.7.3409 Boehringer Ingelheim Investigational Site	Madrid		Spain
99	1220.7.3410 Boehringer Ingelheim Investigational Site	Majadahonda-Madrid		Spain
100	1220.7.3408 Boehringer Ingelheim Investigational Site	Santander		Spain
101	1220.7.3403 Boehringer Ingelheim Investigational Site	Sevilla		Spain
102	1220.7.3401 Boehringer Ingelheim Investigational Site	Valencia		Spain
103	1220.7.3407 Boehringer Ingelheim Investigational Site	Vigo (Pontevedra)		Spain
104	1220.7.4106 Boehringer Ingelheim Investigational Site	Bern		Switzerland
105	1220.7.4103 Boehringer Ingelheim Investigational Site	La Chaux-de-Fonds		Switzerland
106	1220.7.4107 Boehringer Ingelheim Investigational Site	Lugano		Switzerland
107	1220.7.4108 Boehringer Ingelheim Investigational Site	St. Gallen		Switzerland
108	1220.7.4101 Boehringer Ingelheim Investigational Site	Zürich		Switzerland
109	1220.7.4405 Boehringer Ingelheim Investigational Site	Bristol		United Kingdom
110	1220.7.4404 Boehringer Ingelheim Investigational Site	London		United Kingdom
111	1220.7.4409 Boehringer Ingelheim Investigational Site	London		United Kingdom
112	1220.7.4410 Boehringer Ingelheim Investigational Site	London		United Kingdom
113	1220.7.4401 Boehringer Ingelheim Investigational Site	Manchester		United Kingdom
114	1220.7.4408 Boehringer Ingelheim Investigational Site	Nottingham		United Kingdom
115	1220.7.4407 Boehringer Ingelheim Investigational Site	Oxford		United Kingdom
116	1220.7.4403 Boehringer Ingelheim Investigational Site	Southampton		United Kingdom

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01358864
• Other Study ID Numbers: 1220.7; 2010-021715-17
• First Posted: May 24, 2011
• Last Update Posted: Aug 29, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Interferons; Ribavirin; Interferon-alpha

Study Results

Participant Flow

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Period Title: Overall Study
STARTED	49	99	103	29	57	55	146	140
COMPLETED	18	86	87	10	46	42	81	85
NOT COMPLETED	31	13	16	19	11	13	65	55

Baseline Characteristics

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks	Total
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Total of all reporting groups
Overall Participants	49	99	103	29	57	55	145	140	677
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (8.29)	53.5 (8.57)	53.7 (8.14)	55.7 (7.50)	52.7 (7.90)	52.0 (10.32)	53.2 (8.76)	53.6 (8.13)	53.4 (8.48)
Sex: Female, Male (Count of Participants)
Female	20 40.8%	44 44.4%	43 41.7%	10 34.5%	20 35.1%	20 36.4%	54 37.2%	63 45%	274 40.5%
Male	29 59.2%	55 55.6%	60 58.3%	19 65.5%	37 64.9%	35 63.6%	91 62.8%	77 55%	403 59.5%

Outcome Measures

1. Secondary Outcome

Title	Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Description	Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Time Frame	24 weeks post treatment, up to 72 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser & Partial: Placebo	Relapser & Partial: Faldaprevir 12 Weeks	Relapser & Partial: Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	78	156	158	145	140
Number (95% Confidence Interval) [percentage of participants]	10.3 21%	63.5 64.1%	59.5 57.8%	33.8 116.6%	32.9 57.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 12 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Adjusted for genotype and previous response to treatment
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	52.8
	Confidence Interval	(2-Sided) 95%; 42.4 to 63.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 24 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Adjusted for genotype and previous response to treatment
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	48.5
	Confidence Interval	(2-Sided) 95%; 38.2 to 58.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Relapser & Partial: Faldaprevir 12 Weeks, Relapser & Partial: Faldaprevir 24 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	4.4
	Confidence Interval	(2-Sided) 95%; -6.0 to 14.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Null:Faldaprevir 12 Weeks, Null:Faldaprevir 24 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -10.9 to 10.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Null:Faldaprevir 12 Weeks
	Comments	Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Normal approximation
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Null:Faldaprevir 24 Weeks
	Comments	Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Normal approximation
	Comments

2. Secondary Outcome

Title	Early Treatment Success (ETS)
Description	Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.
Time Frame	Week 4 and Week 8

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
Number [percentage of participants]	4.1 8.4%	85.9 86.8%	87.4 84.9%	3.4 11.7%	66.7 117%	76.4 138.9%	58.6 40.4%	51.4 36.7%

3. Primary Outcome

Title	Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Description	Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time Frame	12 weeks post treatment, up to 60 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser & Partial: Placebo	Relapser & Partial: Faldaprevir 12 Weeks	Relapser & Partial: Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	78	156	158	145	140
Number (95% Confidence Interval) [percentage of participants]	10.3 21%	65.4 66.1%	61.4 59.6%	33.8 116.6%	32.9 57.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 12 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Adjusted for genotype and previous response to treatment
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	54.7
	Confidence Interval	(2-Sided) 95%; 44.4 to 65.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 24 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Adjusted for genotype and previous response to treatment
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	50.4
	Confidence Interval	(2-Sided) 95%; 40.1 to 60.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Relapser & Partial: Faldaprevir 12 Weeks, Relapser & Partial: Faldaprevir 24 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	4.5
	Confidence Interval	(2-Sided) 95%; -5.8 to 14.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Null:Faldaprevir 12 Weeks, Null:Faldaprevir 24 Weeks
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted percent difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -10.9 to 10.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Null:Faldaprevir 12 Weeks
	Comments	Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Normal approximation
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Null:Faldaprevir 24 Weeks
	Comments	Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Normal approximation
	Comments

4. Secondary Outcome

Title	ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
Description	The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	End of treatment, up to 48 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=NO	42 85.7%	30 30.3%	31 30.1%	28 96.6%	24 42.1%	30 54.5%	96 66.2%	94 67.1%
BL normal to EoT normal	9 18.4%	9 9.1%	6 5.8%	3 10.3%	4 7%	4 7.3%	15 10.3%	14 10%
BL elevated to EoT normal	15 30.6%	10 10.1%	14 13.6%	9 31%	14 24.6%	6 10.9%	34 23.4%	38 27.1%
No EoT data available for ALT	1 2%	0 0%	0 0%	0 0%	0 0%	1 1.8%	1 0.7%	0 0%

5. Secondary Outcome

Title	ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
Description	The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	End of treatment, up to 48 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=YES	7 14.3%	69 69.7%	72 69.9%	1 3.4%	33 57.9%	25 45.5%	49 33.8%	46 32.9%
BL normal to EoT normal	3 6.1%	30 30.3%	30 29.1%	0 0%	10 17.5%	8 14.5%	12 8.3%	9 6.4%
BL elevated to EoT normal	4 8.2%	29 29.3%	26 25.2%	1 3.4%	14 24.6%	8 14.5%	23 15.9%	27 19.3%

6. Secondary Outcome

Title	AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
Description	The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	End of treatment, up to 48 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=NO	42 85.7%	30 30.3%	31 30.1%	28 96.6%	24 42.1%	30 54.5%	96 66.2%	94 67.1%
BL normal to EoT normal	19 38.8%	16 16.2%	12 11.7%	4 13.8%	3 5.3%	5 9.1%	18 12.4%	21 15%
BL elevated to EoT normal	5 10.2%	5 5.1%	9 8.7%	9 31%	14 24.6%	6 10.9%	24 16.6%	28 20%

7. Secondary Outcome

Title	AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
Description	The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	End of treatment, up to 48 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=YES	7 14.3%	69 69.7%	72 69.9%	1 3.4%	33 57.9%	25 45.5%	49 33.8%	46 32.9%
BL normal to EoT normal	2 4.1%	35 35.4%	39 37.9%	0 0%	13 22.8%	10 18.2%	15 10.3%	16 11.4%
BL elevated to EoT normal	4 8.2%	24 24.2%	22 21.4%	1 3.4%	10 17.5%	9 16.4%	21 14.5%	20 14.3%
No EoT data available for AST	1 2%	0 0%	0 0%	0 0%	0 0%	1 1.8%	1 0.7%	0 0%

8. Secondary Outcome

Title	ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Description	The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	12 weeks post treatment, up to 60 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=NO	42 85.7%	30 30.3%	31 30.1%	28 96.6%	24 42.1%	30 54.5%	96 66.2%	94 67.1%
BL normal to SVR12 normal	0 0%	9 9.1%	6 5.8%	0 0%	2 3.5%	4 7.3%	11 7.6%	6 4.3%
BL elevated to SVR12 normal	1 2%	6 6.1%	6 5.8%	0 0%	4 7%	3 5.5%	7 4.8%	9 6.4%
No ALT data available at SVR12 visit	33 67.3%	7 7.1%	3 2.9%	23 79.3%	6 10.5%	5 9.1%	27 18.6%	30 21.4%

9. Secondary Outcome

Title	ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
Description	The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	12 weeks post treatment, up to 60 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=YES	7 14.3%	69 69.7%	72 69.9%	1 3.4%	33 57.9%	25 45.5%	49 33.8%	46 32.9%
BL normal to SVR12 normal	3 6.1%	31 31.3%	31 30.1%	0 0%	13 22.8%	10 18.2%	13 9%	10 7.1%
BL elevated to SVR12 normal	3 6.1%	35 35.4%	38 36.9%	1 3.4%	20 35.1%	11 20%	32 22.1%	35 25%
No ALT data available at SVR12 visit	1 2%	1 1%	0 0%	0 0%	0 0%	0 0%	1 0.7%	0 0%

10. Secondary Outcome

Title	AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Description	The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	12 weeks post treatment, up to 60 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=NO	42 85.7%	30 30.3%	31 30.1%	28 96.6%	24 42.1%	30 54.5%	96 66.2%	94 67.1%
BL normal to SVR12 normal	0 0%	14 14.1%	10 9.7%	0 0%	3 5.3%	3 5.5%	13 9%	14 10%
BL elevated to SVR12 normal	2 4.1%	2 2%	6 5.8%	0 0%	6 10.5%	3 5.5%	6 4.1%	3 2.1%
No AST data available at SVR12 visit	33 67.3%	7 7.1%	3 2.9%	23 79.3%	6 10.5%	6 10.9%	27 18.6%	30 21.4%

11. Secondary Outcome

Title	AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
Description	The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame	12 weeks post treatment, up to 60 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Relapser:Placebo	Relapser:Faldaprevir 12 Weeks	Relapser:Faldaprevir 24 Weeks	Partial:Placebo	Partial:Faldaprevir 12 Weeks	Partial:Faldaprevir 24 Weeks	Null:Faldaprevir 12 Weeks	Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Measure Participants	49	99	103	29	57	55	145	140
SVR12=YES	7 14.3%	69 69.7%	72 69.9%	1 3.4%	33 57.9%	25 45.5%	49 33.8%	46 32.9%
BL normal to SVR12 normal	2 4.1%	36 36.4%	41 39.8%	0 0%	16 28.1%	13 23.6%	16 11%	17 12.1%
BL elevated to SVR12 normal	4 8.2%	29 29.3%	28 27.2%	1 3.4%	16 28.1%	8 14.5%	28 19.3%	25 17.9%
No AST data available at SVR12 visit	1 2%	1 1%	0 0%	0 0%	0 0%	0 0%	1 0.7%	0 0%

Adverse Events

Time Frame	During the course of the study (48 weeks)
Arm/Group Title	Relapser & Partial: Placebo		Relapser & Partial: Faldaprevir 12 Weeks		Relapser & Partial: Faldaprevir 24 Weeks		Null:Faldaprevir 12 Weeks		Null:Faldaprevir 24 Weeks
Arm/Group Description	Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.		Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).		Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).		Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.		Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
All Cause Mortality
	Relapser & Partial: Placebo		Relapser & Partial: Faldaprevir 12 Weeks		Relapser & Partial: Faldaprevir 24 Weeks		Null:Faldaprevir 12 Weeks		Null:Faldaprevir 24 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Relapser & Partial: Placebo		Relapser & Partial: Faldaprevir 12 Weeks		Relapser & Partial: Faldaprevir 24 Weeks		Null:Faldaprevir 12 Weeks		Null:Faldaprevir 24 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/78 (1.3%)		14/156 (9%)		13/158 (8.2%)		16/145 (11%)		11/140 (7.9%)
Blood and lymphatic system disorders
Anaemia	0/78 (0%)		1/156 (0.6%)		1/158 (0.6%)		2/145 (1.4%)		1/140 (0.7%)
Haemolytic anaemia	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Leukopenia	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Thrombocytopenia	0/78 (0%)		0/156 (0%)		3/158 (1.9%)		0/145 (0%)		0/140 (0%)
Cardiac disorders
Atrial fibrillation	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Bradycardia	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Cardiac failure congestive	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Cardio-respiratory arrest	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Congenital, familial and genetic disorders
Keratosis follicular	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Gastrointestinal disorders
Abdominal pain	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Ascites	0/78 (0%)		0/156 (0%)		0/158 (0%)		2/145 (1.4%)		0/140 (0%)
Diarrhoea	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		2/145 (1.4%)		2/140 (1.4%)
Haematochezia	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Nausea	0/78 (0%)		1/156 (0.6%)		1/158 (0.6%)		1/145 (0.7%)		0/140 (0%)
Oral lichen planus	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Pancreatitis	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Pancreatitis acute	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Peritoneal haemorrhage	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Salivary gland calculus	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Vomiting	0/78 (0%)		2/156 (1.3%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
General disorders
Asthenia	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Chest pain	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Fatigue	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Malaise	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		1/140 (0.7%)
Pyrexia	0/78 (0%)		3/156 (1.9%)		1/158 (0.6%)		3/145 (2.1%)		1/140 (0.7%)
Hepatobiliary disorders
Biliary colic	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Cholelithiasis	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		1/145 (0.7%)		0/140 (0%)
Hepatic failure	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Hepatorenal failure	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Hyperbilirubinaemia	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Jaundice	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		1/145 (0.7%)		0/140 (0%)
Infections and infestations
Appendicitis	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		1/140 (0.7%)
Cellulitis	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Gastroenteritis	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Gastroenteritis viral	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Peritonitis bacterial	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Pneumonia	0/78 (0%)		1/156 (0.6%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Sepsis	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		1/145 (0.7%)		0/140 (0%)
Streptococcal infection	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Viral infection	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Injury, poisoning and procedural complications
Fall	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Multiple injuries	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Investigations
Blood lactate dehydrogenase increased	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
International normalised ratio abnormal	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Dehydration	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Hypoglycaemia	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Hypokalaemia	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Metabolic acidosis	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Fasciitis	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Joint instability	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Musculoskeletal discomfort	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Nervous system disorders
Coma	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Headache	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Presyncope	0/78 (0%)		1/156 (0.6%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Psychiatric disorders
Anxiety	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Depression	1/78 (1.3%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Psychiatric decompensation	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Renal and urinary disorders
Renal colic	0/78 (0%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		1/140 (0.7%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/78 (1.3%)		0/156 (0%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Traumatic haemothorax	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		0/145 (0%)		0/140 (0%)
Skin and subcutaneous tissue disorders
Rash erythematous	0/78 (0%)		0/156 (0%)		0/158 (0%)		1/145 (0.7%)		0/140 (0%)
Rash generalised	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Vascular disorders
Hypertensive crisis	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Hypotension	0/78 (0%)		0/156 (0%)		1/158 (0.6%)		1/145 (0.7%)		0/140 (0%)
Venous thrombosis	0/78 (0%)		1/156 (0.6%)		0/158 (0%)		0/145 (0%)		0/140 (0%)
Other (Not Including Serious) Adverse Events
	Relapser & Partial: Placebo		Relapser & Partial: Faldaprevir 12 Weeks		Relapser & Partial: Faldaprevir 24 Weeks		Null:Faldaprevir 12 Weeks		Null:Faldaprevir 24 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	74/78 (94.9%)		148/156 (94.9%)		156/158 (98.7%)		142/145 (97.9%)		139/140 (99.3%)
Blood and lymphatic system disorders
Anaemia	8/78 (10.3%)		30/156 (19.2%)		27/158 (17.1%)		22/145 (15.2%)		19/140 (13.6%)
Neutropenia	12/78 (15.4%)		18/156 (11.5%)		18/158 (11.4%)		16/145 (11%)		13/140 (9.3%)
Thrombocytopenia	3/78 (3.8%)		4/156 (2.6%)		6/158 (3.8%)		13/145 (9%)		3/140 (2.1%)
Ear and labyrinth disorders
Vertigo	3/78 (3.8%)		4/156 (2.6%)		4/158 (2.5%)		6/145 (4.1%)		9/140 (6.4%)
Eye disorders
Dry eye	5/78 (6.4%)		6/156 (3.8%)		7/158 (4.4%)		4/145 (2.8%)		5/140 (3.6%)
Ocular icterus	0/78 (0%)		8/156 (5.1%)		6/158 (3.8%)		6/145 (4.1%)		2/140 (1.4%)
Gastrointestinal disorders
Abdominal pain	2/78 (2.6%)		8/156 (5.1%)		14/158 (8.9%)		7/145 (4.8%)		13/140 (9.3%)
Abdominal pain upper	4/78 (5.1%)		16/156 (10.3%)		15/158 (9.5%)		11/145 (7.6%)		15/140 (10.7%)
Constipation	3/78 (3.8%)		14/156 (9%)		8/158 (5.1%)		7/145 (4.8%)		7/140 (5%)
Diarrhoea	10/78 (12.8%)		45/156 (28.8%)		59/158 (37.3%)		39/145 (26.9%)		47/140 (33.6%)
Dyspepsia	6/78 (7.7%)		13/156 (8.3%)		13/158 (8.2%)		12/145 (8.3%)		9/140 (6.4%)
Gastrooesophageal reflux disease	5/78 (6.4%)		3/156 (1.9%)		0/158 (0%)		3/145 (2.1%)		6/140 (4.3%)
Nausea	18/78 (23.1%)		78/156 (50%)		88/158 (55.7%)		77/145 (53.1%)		75/140 (53.6%)
Vomiting	5/78 (6.4%)		41/156 (26.3%)		47/158 (29.7%)		46/145 (31.7%)		37/140 (26.4%)
General disorders
Asthenia	21/78 (26.9%)		28/156 (17.9%)		28/158 (17.7%)		24/145 (16.6%)		28/140 (20%)
Chills	5/78 (6.4%)		9/156 (5.8%)		14/158 (8.9%)		1/145 (0.7%)		8/140 (5.7%)
Fatigue	16/78 (20.5%)		53/156 (34%)		59/158 (37.3%)		45/145 (31%)		47/140 (33.6%)
Influenza like illness	15/78 (19.2%)		28/156 (17.9%)		29/158 (18.4%)		27/145 (18.6%)		23/140 (16.4%)
Injection site erythema	4/78 (5.1%)		1/156 (0.6%)		3/158 (1.9%)		4/145 (2.8%)		4/140 (2.9%)
Malaise	4/78 (5.1%)		5/156 (3.2%)		10/158 (6.3%)		4/145 (2.8%)		11/140 (7.9%)
Pain	4/78 (5.1%)		5/156 (3.2%)		7/158 (4.4%)		4/145 (2.8%)		4/140 (2.9%)
Pyrexia	14/78 (17.9%)		24/156 (15.4%)		25/158 (15.8%)		26/145 (17.9%)		38/140 (27.1%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/78 (0%)		11/156 (7.1%)		11/158 (7%)		10/145 (6.9%)		9/140 (6.4%)
Jaundice	1/78 (1.3%)		29/156 (18.6%)		27/158 (17.1%)		16/145 (11%)		16/140 (11.4%)
Infections and infestations
Influenza	4/78 (5.1%)		4/156 (2.6%)		6/158 (3.8%)		4/145 (2.8%)		1/140 (0.7%)
Nasopharyngitis	7/78 (9%)		14/156 (9%)		13/158 (8.2%)		6/145 (4.1%)		10/140 (7.1%)
Investigations
Haemoglobin decreased	2/78 (2.6%)		6/156 (3.8%)		4/158 (2.5%)		9/145 (6.2%)		10/140 (7.1%)
Weight decreased	3/78 (3.8%)		7/156 (4.5%)		2/158 (1.3%)		8/145 (5.5%)		8/140 (5.7%)
Metabolism and nutrition disorders
Decreased appetite	10/78 (12.8%)		33/156 (21.2%)		32/158 (20.3%)		27/145 (18.6%)		36/140 (25.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/78 (9%)		14/156 (9%)		21/158 (13.3%)		10/145 (6.9%)		15/140 (10.7%)
Back pain	8/78 (10.3%)		14/156 (9%)		12/158 (7.6%)		5/145 (3.4%)		7/140 (5%)
Muscle spasms	2/78 (2.6%)		7/156 (4.5%)		8/158 (5.1%)		4/145 (2.8%)		8/140 (5.7%)
Myalgia	8/78 (10.3%)		20/156 (12.8%)		19/158 (12%)		15/145 (10.3%)		18/140 (12.9%)
Nervous system disorders
Disturbance in attention	1/78 (1.3%)		4/156 (2.6%)		9/158 (5.7%)		2/145 (1.4%)		4/140 (2.9%)
Dizziness	6/78 (7.7%)		12/156 (7.7%)		11/158 (7%)		9/145 (6.2%)		5/140 (3.6%)
Dysgeusia	4/78 (5.1%)		8/156 (5.1%)		12/158 (7.6%)		7/145 (4.8%)		12/140 (8.6%)
Headache	22/78 (28.2%)		39/156 (25%)		46/158 (29.1%)		52/145 (35.9%)		45/140 (32.1%)
Psychiatric disorders
Anxiety	3/78 (3.8%)		9/156 (5.8%)		12/158 (7.6%)		5/145 (3.4%)		11/140 (7.9%)
Depression	10/78 (12.8%)		11/156 (7.1%)		12/158 (7.6%)		14/145 (9.7%)		15/140 (10.7%)
Insomnia	13/78 (16.7%)		36/156 (23.1%)		35/158 (22.2%)		18/145 (12.4%)		29/140 (20.7%)
Sleep disorder	3/78 (3.8%)		4/156 (2.6%)		5/158 (3.2%)		8/145 (5.5%)		10/140 (7.1%)
Irritability	11/78 (14.1%)		10/156 (6.4%)		16/158 (10.1%)		10/145 (6.9%)		13/140 (9.3%)
Respiratory, thoracic and mediastinal disorders
Cough	16/78 (20.5%)		25/156 (16%)		27/158 (17.1%)		23/145 (15.9%)		24/140 (17.1%)
Dyspnoea	7/78 (9%)		16/156 (10.3%)		16/158 (10.1%)		8/145 (5.5%)		7/140 (5%)
Epistaxis	4/78 (5.1%)		5/156 (3.2%)		3/158 (1.9%)		4/145 (2.8%)		3/140 (2.1%)
Skin and subcutaneous tissue disorders
Alopecia	4/78 (5.1%)		16/156 (10.3%)		16/158 (10.1%)		8/145 (5.5%)		13/140 (9.3%)
Dry skin	12/78 (15.4%)		29/156 (18.6%)		29/158 (18.4%)		19/145 (13.1%)		31/140 (22.1%)
Erythema	4/78 (5.1%)		8/156 (5.1%)		9/158 (5.7%)		11/145 (7.6%)		12/140 (8.6%)
Pruritus	23/78 (29.5%)		54/156 (34.6%)		61/158 (38.6%)		47/145 (32.4%)		63/140 (45%)
Rash	16/78 (20.5%)		37/156 (23.7%)		44/158 (27.8%)		38/145 (26.2%)		41/140 (29.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.