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Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

Sponsor
Debiopharm International SA (Industry)
Overall Status
Completed
CT.gov ID
NCT01215643
Collaborator
(none)
340
Enrollment
73
Locations
5
Arms
19
Duration (Months)
4.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: ALV 1000 mg

Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.

Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV

    		•
    Experimental: ALV 600 mg+RBV

    Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.

    Drug: Alisporivir
    ALV 200 mg soft gel capsules administered orally
    Other Names:
  • DEB025
  • ALV

    • Drug: Ribavirin
    RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
    Other Names:
  • Copegus®
  • RBV

    		•
    Experimental: ALV 800 mg+RBV

    Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.

    Drug: Alisporivir
    ALV 200 mg soft gel capsules administered orally
    Other Names:
  • DEB025
  • ALV

    • Drug: Ribavirin
    RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
    Other Names:
  • Copegus®
  • RBV

    		•
    Experimental: ALV 600 mg+PEG

    Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.

    Drug: Alisporivir
    ALV 200 mg soft gel capsules administered orally
    Other Names:
  • DEB025
  • ALV

    • Drug: Peginterferon alfa-2a
    PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
    Other Names:
  • Pegasys®
  • PEG

    		•
    Active Comparator: PEG+RBV

    Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.

    Drug: Peginterferon alfa-2a
    PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
    Other Names:
  • Pegasys®
  • PEG

    • Drug: Ribavirin
    RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
    Other Names:
  • Copegus®
  • RBV

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ) [after 4 weeks of treatment]

      RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.

    Secondary Outcome Measures

    1. Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD) [after 4 weeks of treatment]

      RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.

    2. Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2) [after 4 weeks of treatment]

    3. Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3) [after 4 weeks of treatment]

    4. Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD) [after 12 weeks of treatment]

      cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.

    5. Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2) [after 12 weeks of treatment]

    6. Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3) [after 12 weeks of treatment]

    7. Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD) [at end of treatment, within 24 weeks]

      ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.

    8. Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2) [at end of treatment, within 24 weeks]

    9. Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3) [at end of treatment, within 24 weeks]

    10. Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD) [12 weeks after the end of treatment]

      SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.

    11. Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2) [12 weeks after the end of treatment]

    12. Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3) [12 weeks after the end of treatment]

    13. Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD) [24 weeks after the end of treatment]

    14. Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2) [24 weeks after the end of treatment]

    15. Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3) [24 weeks after the end of treatment]

    16. Percentage of Participants With On-treatment Viral Breakthrough [within 24 weeks of treatment]

      Viral breakthrough was defined as either: Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment

    17. Percentage of Participants With Viral Relapse [within 24 weeks after the end of treatment]

      Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.

    Eligibility Criteria

    Criteria

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

    • Chronic hepatitis C viral infection

    • Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)

    • HCV genotype 2 or 3

    • No previous treatment for hepatitis C infection

    Exclusion criteria:

    • Evidence of cirrhosis at the time of screening

    • Evidence of hepatocellular carcinoma at the time of screening

    • Any other cause of relevant liver disease other than HCV

    • Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)

    • Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Clinic La Jolla California United States 92037
    2 Sharp Rees-Stealy Medical Group, Inc. San Diego California United States 92101
    3 Research and Education Inc. San Diego California United States 92105
    4 Island View Gastroenterology Associates Ventura California United States 93003
    5 Hawai Medical Center East LLC Honolulu Hawaii United States 96817
    6 Cotton O'Neil Clinical Research Topeka Kansas United States 66606
    7 The Office of Dr. Claudia Martorell Springfield Massachusetts United States 01107
    8 Saint Louis University St. Louis Missouri United States 63104
    9 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0001
    10 Weill Cornell Medical Center New York New York United States 10021
    11 Mount Sinai Medical Center New York New York United States 10029
    12 Columbia University Medical Center New York New York United States 10032
    13 The North Texas Research Institute Arlington Texas United States 76012
    14 Liver Associates of Texas Houston Texas United States 77030
    15 Liver Specialist of Texas Houston Texas United States 77030
    16 Alamo Medical Research San Antonio Texas United States 78215
    17 Novartis Investigative Site Kingswood New South Wales Australia 2747
    18 Novartis Investigative Site Kogarah New South Wales Australia 2217
    19 Novartis Investigative Site Westmead New South Wales Australia 2145
    20 Novartis Investigative Center Greenslopes Queensland Australia 4120
    21 Novartis Investigative Site Clayton Victoria Australia 3168
    22 Novartis Investigative Site Fitzroy Victoria Australia 3065
    23 Novartis Investigative Site Bruxelles Belgium 1070
    24 Novartis Investigative Site Gent Belgium 9000
    25 Novartis Investigative Site Leuven Belgium 3000
    26 Novartis Investigative Site Vancouver British Columbia Canada V5Z 1H2
    27 Novartis Investigative Site Toronto Ontario Canada M4V 1P7
    28 Novartis Investigative Site Clichy Cedex France 92118
    29 Novartis Investigative Site Creteil France 94000
    30 Novartis Investigative Site Marseille France 13008
    31 Novartis Investigative Site Paris France 75006
    32 Novartis Investigative Site Berlin Germany 10969
    33 Novartis Investigative Site Frankfurt Germany 60590
    34 Novartis Investigative Site Freiburg Germany 79095
    35 Novartis Investigative Site Hannover Germany 30625
    36 Novartis Investigative Site Leipzig Germany 04103
    37 Novartis Investigative Site Trivandrum Kerala India 695607
    38 Novartis Investigative Site Mumbai Maharashtra India 400036
    39 Novartis Investigative Site Ludhiana Punjab India 141001
    40 Novartis Investigative Site Lucknow Uttar Pradesh India 226014
    41 Novartis Investigative Site Guwahati India 781006
    42 Novartis Investigative Site Haryana India 122001
    43 Novartis Investigative Site Hyderabad - Andhra Pradesh India 500012
    44 Novartis Investigative Site Mumbai India 400020
    45 Novartis Investigative Site New Delhi India 110070
    46 Novartis Investigative Site Bologna Italy 40138
    47 Novartis Investigative Site Brescia Italy 25123
    48 Novartis Investigative Site Pavia Italy 27100
    49 Novartis Inestigative Site Roma Italy 00133
    50 Novartis Investigative Site Torino Italy 10126
    51 Novartis Inestigative Center Pusan Korea, Republic of 602-739
    52 Novartis Investigative Site Pusan Korea, Republic of 614-735
    53 Novartis Korea Ltd. Seoul Korea, Republic of 120-752
    54 Novartis Investigative Site Seoul Korea, Republic of 738-736
    55 Novartis Investigative Site Bialystok Poland 15-540
    56 Novartis Investigative Site Lódz Poland 91-347
    57 Novartis Investigative Site Warsaw Poland 01 - 201
    58 Fundacion de Investigacion de Diego San Juan Puerto Rico 00927
    59 Novartis Investigative Site Kaohsiung Taiwan 807
    60 Novartis Investigative Site Niaosong Township Taiwan 83301
    61 Novartis Investigative Site Taichung Taiwan 40447
    62 Novartis Investigative Site Taipei Taiwan 10002
    63 Novartis Investigative Site Taipei Taiwan ROC112
    64 Novartis Investigative Site Yun-Lin Taiwan
    65 Novartis Investigative Site Bangkok Thailand 10700
    66 Novartis Investigative Site Chiang Mai Thailand 50200
    67 Novartis Investigative Site Songkla Thailand 90110
    68 Novartis Investigative Site Glasgow - Scotland United Kingdom G12 OYN
    69 Novartis Investigative Site London United Kingdom E1 1BB
    70 Novartis Investigative Site London United Kingdom SE5 9RS
    71 Novartis Investigative Site London United Kingdom SW17 0QT
    72 Novartis Investigative Site London United Kingdom W2 1NY
    73 Novartis Investigative Site Plymouth United Kingdom PL6 8DH

    Sponsors and Collaborators

    • Debiopharm International SA

    Investigators

    • Study Director: Novartis Pharmceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Debiopharm International SA
    ClinicalTrials.gov Identifier:
    NCT01215643
    Other Study ID Numbers:
    • CDEB025A2211
    • 2010-020034-26
    First Posted:
    Oct 6, 2010
    Last Update Posted:
    Aug 30, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Debiopharm International SA
    Chronic hepatitis C genotype 2
    Chronic hepatitis C genotype 3
    Cyclophilin inhibitor
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis
    Chronic Pain
    Ribavirin
    Peginterferon alfa-2a

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24. ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Period Title: Overall Study
    STARTED 83 84 94 39 40
    COMPLETED 74 80 82 35 29
    NOT COMPLETED 9 4 12 4 11

    Baseline Characteristics

    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV Total
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24. Total of all reporting groups
    Overall Participants 83 84 94 39 40 340
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    40.2
    (11.27)
    42.8
    (11.77)
    42.6
    (11.00)
    43.2
    (10.56)
    39.9
    (11.20)
    41.8
    (11.25)
    Sex: Female, Male (Count of Participants)
    Female
    32
    38.6%
    28
    33.3%
    33
    35.1%
    14
    35.9%
    16
    40%
    123
    36.2%
    Male
    51
    61.4%
    56
    66.7%
    61
    64.9%
    25
    64.1%
    24
    60%
    217
    63.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
    Description RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.
    Time Frame after 4 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    Number [percentage of participants]
    28.4
    34.2%
    36.9
    43.9%
    41.9
    44.6%
    84.6
    216.9%
    72.5
    181.3%
    2. Secondary Outcome
    Title Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
    Description RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.
    Time Frame after 4 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    Number [percentage of participants]
    18.5
    22.3%
    14.3
    17%
    23.7
    25.2%
    69.2
    177.4%
    60.0
    150%
    3. Secondary Outcome
    Title Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
    Description
    Time Frame after 4 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 2 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 23 30 26 11 13
    RVR4LOQ
    21.7
    26.1%
    23.3
    27.7%
    46.2
    49.1%
    81.8
    209.7%
    76.9
    192.3%
    RVR4LOD
    13.0
    15.7%
    10.0
    11.9%
    26.9
    28.6%
    63.6
    163.1%
    53.8
    134.5%
    4. Secondary Outcome
    Title Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
    Description
    Time Frame after 4 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 3 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 58 54 67 28 27
    RVR4LOQ
    31.0
    37.3%
    44.4
    52.9%
    40.3
    42.9%
    85.7
    219.7%
    70.4
    176%
    RVR4LOD
    20.7
    24.9%
    16.7
    19.9%
    22.4
    23.8%
    71.4
    183.1%
    63.0
    157.5%
    5. Secondary Outcome
    Title Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
    Description cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
    Time Frame after 12 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    cEVR12LOQ
    93.8
    113%
    95.2
    113.3%
    90.3
    96.1%
    94.9
    243.3%
    85.0
    212.5%
    cEVR12LOD
    91.4
    110.1%
    86.9
    103.5%
    90.3
    96.1%
    84.6
    216.9%
    82.5
    206.3%
    6. Secondary Outcome
    Title Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
    Description
    Time Frame after 12 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 2 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 23 30 26 11 13
    cEVR12LOQ
    100.0
    120.5%
    96.7
    115.1%
    80.8
    86%
    100.0
    256.4%
    84.6
    211.5%
    cEVR12LOD
    100.0
    120.5%
    83.3
    99.2%
    80.8
    86%
    90.9
    233.1%
    84.6
    211.5%
    7. Secondary Outcome
    Title Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
    Description
    Time Frame after 12 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 3 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 58 54 67 28 27
    cEVR12LOQ
    91.4
    110.1%
    94.4
    112.4%
    94.0
    100%
    92.9
    238.2%
    85.2
    213%
    cEVR12LOD
    87.9
    105.9%
    88.9
    105.8%
    94.0
    100%
    82.1
    210.5%
    81.5
    203.8%
    8. Secondary Outcome
    Title Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
    Description ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
    Time Frame at end of treatment, within 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    ETR24LOQ
    95.1
    114.6%
    96.4
    114.8%
    95.7
    101.8%
    94.9
    243.3%
    87.5
    218.8%
    ETR24LOD
    92.6
    111.6%
    94.0
    111.9%
    92.5
    98.4%
    92.3
    236.7%
    82.5
    206.3%
    9. Secondary Outcome
    Title Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
    Description
    Time Frame at end of treatment, within 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 2 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 23 30 26 11 13
    ETR24LOQ
    100.0
    120.5%
    96.7
    115.1%
    84.6
    90%
    100.0
    256.4%
    92.3
    230.8%
    ETR24LOD
    100.0
    120.5%
    96.7
    115.1%
    76.9
    81.8%
    100.0
    256.4%
    84.6
    211.5%
    10. Secondary Outcome
    Title Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
    Description
    Time Frame at end of treatment, within 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 3 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 58 54 67 28 27
    ETR24LOQ
    93.1
    112.2%
    96.3
    114.6%
    100.0
    106.4%
    92.9
    238.2%
    85.2
    213%
    ETR24LOD
    89.7
    108.1%
    92.6
    110.2%
    98.5
    104.8%
    89.3
    229%
    81.5
    203.8%
    11. Secondary Outcome
    Title Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
    Description SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
    Time Frame 12 weeks after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    SVR12LOQ
    81.5
    98.2%
    84.5
    100.6%
    80.6
    85.7%
    76.9
    197.2%
    62.5
    156.3%
    SVR12LOD
    80.2
    96.6%
    84.5
    100.6%
    80.6
    85.7%
    74.4
    190.8%
    60.0
    150%
    12. Secondary Outcome
    Title Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
    Description
    Time Frame 12 weeks after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 2 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 23 30 26 11 13
    SVR12LOQ
    78.3
    94.3%
    76.7
    91.3%
    76.9
    81.8%
    72.7
    186.4%
    61.5
    153.8%
    SVR12LOD
    78.3
    94.3%
    76.7
    91.3%
    76.9
    81.8%
    72.7
    186.4%
    53.8
    134.5%
    13. Secondary Outcome
    Title Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
    Description
    Time Frame 12 weeks after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 3 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 58 54 67 28 27
    SVR12LOQ
    82.8
    99.8%
    88.9
    105.8%
    82.1
    87.3%
    78.6
    201.5%
    63.0
    157.5%
    SVR12LOD
    81.0
    97.6%
    88.9
    105.8%
    82.1
    87.3%
    75.0
    192.3%
    63.0
    157.5%
    14. Secondary Outcome
    Title Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
    Description
    Time Frame 24 weeks after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    SVR24LOQ
    80.2
    96.6%
    84.5
    100.6%
    80.6
    85.7%
    79.5
    203.8%
    57.5
    143.8%
    SVR24LOD
    80.2
    96.6%
    84.5
    100.6%
    79.6
    84.7%
    79.5
    203.8%
    57.5
    143.8%
    15. Secondary Outcome
    Title Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
    Description
    Time Frame 24 weeks after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 2 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 23 30 26 11 13
    SVR24LOQ
    78.3
    94.3%
    76.7
    91.3%
    76.9
    81.8%
    72.7
    186.4%
    53.8
    134.5%
    SVR24LOD
    78.3
    94.3%
    76.7
    91.3%
    76.9
    81.8%
    72.7
    186.4%
    53.8
    134.5%
    16. Secondary Outcome
    Title Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
    Description
    Time Frame 24 weeks after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with genotype 3 HCV infection
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 58 54 67 28 27
    SVR24LOQ
    81.0
    97.6%
    88.9
    105.8%
    82.1
    87.3%
    82.1
    210.5%
    59.3
    148.3%
    SVR24LOD
    81.0
    97.6%
    88.9
    105.8%
    80.6
    85.7%
    82.1
    210.5%
    59.3
    148.3%
    17. Secondary Outcome
    Title Percentage of Participants With On-treatment Viral Breakthrough
    Description Viral breakthrough was defined as either: Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment
    Time Frame within 24 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    Number [percentage of participants]
    2.5
    3%
    3.6
    4.3%
    2.2
    2.3%
    5.1
    13.1%
    0.0
    0%
    18. Secondary Outcome
    Title Percentage of Participants With Viral Relapse
    Description Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.
    Time Frame within 24 weeks after the end of treatment

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ALV 1000 mg ALV 600 mg+RBV ALV 800 mg+RBV ALV 600 mg+PEG PEG+RBV
    Arm/Group Description ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. PEG and RBV during Weeks 1 to 24.
    Measure Participants 81 84 93 39 40
    0 to 12 weeks after the end of treatment
    9.9
    11.9%
    8.3
    9.9%
    6.5
    6.9%
    10.3
    26.4%
    20.0
    50%
    12 to 24 weeks after the end of treatment
    1.2
    1.4%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    5.0
    12.5%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
    Arm/Group Description Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24. AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
    All Cause Mortality
    ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/82 (4.9%) 1/84 (1.2%) 9/94 (9.6%) 4/39 (10.3%) 2/37 (5.4%) 2/82 (2.4%) 4/84 (4.8%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Myocardial infarction 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Tachycardia 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Endocrine disorders
    Hyperthyroidism 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 1/82 (1.2%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Eye disorders
    Retinopathy 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Abdominal pain upper 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Diarrhoea 1/82 (1.2%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Inguinal hernia 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Vomiting 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Infections and infestations
    Cellulitis 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Muscle abscess 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Pneumonia 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Pyelonephritis 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Tubo-ovarian abscess 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Urinary tract infection 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Injury, poisoning and procedural complications
    Alcohol poisoning 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Head injury 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Maternal exposure during pregnancy 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Toxicity to various agents 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Hypercalcaemia 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Musculoskeletal and connective tissue disorders
    Muscle spasms 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic neoplasm malignant 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Psychiatric disorders
    Anxiety 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Homicidal ideation 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Major depression 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Panic attack 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Suicidal ideation 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Renal and urinary disorders
    Calculus ureteric 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Renal colic 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Hyperventilation 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Hypoxia 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Skin and subcutaneous tissue disorders
    Erythema nodosum 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Vascular disorders
    Hypertension 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Other (Not Including Serious) Adverse Events
    ALV 1000 mg: On-treatment AEs ALV 600 mg+RBV: On-treatment AEs ALV 800 mg+RBV: On-treatment AEs ALV 600 mg+PEG: On-treatment AEs PEG+RBV: On-treatment AEs ALV 1000 mg: Post-treatment AEs ALV 600 mg+RBV: Post-treatment AEs ALV 800 mg+RBV: Post-treatment AEs ALV 600 mg+PEG: Post-treatment AEs PEG+RBV: Post-treatment AEs
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 64/82 (78%) 69/84 (82.1%) 76/94 (80.9%) 37/39 (94.9%) 30/37 (81.1%) 10/82 (12.2%) 10/84 (11.9%) 13/94 (13.8%) 5/39 (12.8%) 2/37 (5.4%)
    Blood and lymphatic system disorders
    Anaemia 8/82 (9.8%) 11/84 (13.1%) 10/94 (10.6%) 4/39 (10.3%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Leukopenia 3/82 (3.7%) 2/84 (2.4%) 2/94 (2.1%) 2/39 (5.1%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Neutropenia 9/82 (11%) 8/84 (9.5%) 13/94 (13.8%) 10/39 (25.6%) 4/37 (10.8%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Thrombocytopenia 0/82 (0%) 5/84 (6%) 3/94 (3.2%) 6/39 (15.4%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Cardiac disorders
    Palpitations 0/82 (0%) 2/84 (2.4%) 6/94 (6.4%) 1/39 (2.6%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Tachycardia 2/82 (2.4%) 2/84 (2.4%) 4/94 (4.3%) 2/39 (5.1%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Ear and labyrinth disorders
    Motion sickness 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Vertigo 1/82 (1.2%) 1/84 (1.2%) 1/94 (1.1%) 0/39 (0%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%)
    Endocrine disorders
    Hyperthyroidism 1/82 (1.2%) 2/84 (2.4%) 1/94 (1.1%) 2/39 (5.1%) 0/37 (0%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Hypothyroidism 2/82 (2.4%) 1/84 (1.2%) 3/94 (3.2%) 4/39 (10.3%) 0/37 (0%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Eye disorders
    Abnormal sensation in eye 0/82 (0%) 0/84 (0%) 0/94 (0%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Gastrointestinal disorders
    Abdominal distension 3/82 (3.7%) 5/84 (6%) 6/94 (6.4%) 3/39 (7.7%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Abdominal pain 6/82 (7.3%) 4/84 (4.8%) 7/94 (7.4%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Abdominal pain upper 6/82 (7.3%) 6/84 (7.1%) 7/94 (7.4%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Constipation 5/82 (6.1%) 5/84 (6%) 8/94 (8.5%) 3/39 (7.7%) 0/37 (0%) 2/82 (2.4%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Diarrhoea 13/82 (15.9%) 6/84 (7.1%) 10/94 (10.6%) 9/39 (23.1%) 1/37 (2.7%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Dry mouth 3/82 (3.7%) 2/84 (2.4%) 3/94 (3.2%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Dyspepsia 7/82 (8.5%) 8/84 (9.5%) 7/94 (7.4%) 0/39 (0%) 1/37 (2.7%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Gastritis 0/82 (0%) 2/84 (2.4%) 0/94 (0%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Mouth ulceration 5/82 (6.1%) 0/84 (0%) 3/94 (3.2%) 4/39 (10.3%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Nausea 17/82 (20.7%) 15/84 (17.9%) 23/94 (24.5%) 9/39 (23.1%) 5/37 (13.5%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Vomiting 7/82 (8.5%) 7/84 (8.3%) 7/94 (7.4%) 2/39 (5.1%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    General disorders
    Asthenia 10/82 (12.2%) 7/84 (8.3%) 11/94 (11.7%) 3/39 (7.7%) 8/37 (21.6%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Chills 5/82 (6.1%) 3/84 (3.6%) 5/94 (5.3%) 4/39 (10.3%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Fatigue 21/82 (25.6%) 23/84 (27.4%) 30/94 (31.9%) 18/39 (46.2%) 10/37 (27%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Feeling cold 0/82 (0%) 0/84 (0%) 2/94 (2.1%) 0/39 (0%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Influenza like illness 8/82 (9.8%) 6/84 (7.1%) 9/94 (9.6%) 8/39 (20.5%) 4/37 (10.8%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Injection site erythema 2/82 (2.4%) 0/84 (0%) 0/94 (0%) 2/39 (5.1%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Irritability 2/82 (2.4%) 5/84 (6%) 8/94 (8.5%) 2/39 (5.1%) 2/37 (5.4%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Malaise 2/82 (2.4%) 3/84 (3.6%) 0/94 (0%) 2/39 (5.1%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Pain 3/82 (3.7%) 3/84 (3.6%) 5/94 (5.3%) 2/39 (5.1%) 1/37 (2.7%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Pyrexia 14/82 (17.1%) 16/84 (19%) 15/94 (16%) 12/39 (30.8%) 9/37 (24.3%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Hepatobiliary disorders
    Hyperbilirubinaemia 3/82 (3.7%) 2/84 (2.4%) 5/94 (5.3%) 0/39 (0%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Immune system disorders
    Hypersensitivity 0/82 (0%) 0/84 (0%) 2/94 (2.1%) 1/39 (2.6%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Infections and infestations
    Nasopharyngitis 5/82 (6.1%) 4/84 (4.8%) 5/94 (5.3%) 0/39 (0%) 0/37 (0%) 0/82 (0%) 1/84 (1.2%) 1/94 (1.1%) 1/39 (2.6%) 0/37 (0%)
    Upper respiratory tract infection 2/82 (2.4%) 3/84 (3.6%) 4/94 (4.3%) 4/39 (10.3%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%)
    Urinary tract infection 5/82 (6.1%) 1/84 (1.2%) 1/94 (1.1%) 0/39 (0%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Injury, poisoning and procedural complications
    Wound 0/82 (0%) 0/84 (0%) 0/94 (0%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Investigations
    Gamma-glutamyltransferase increased 1/82 (1.2%) 1/84 (1.2%) 1/94 (1.1%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Neutrophil count decreased 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 2/39 (5.1%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Platelet count decreased 1/82 (1.2%) 3/84 (3.6%) 2/94 (2.1%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Weight decreased 4/82 (4.9%) 2/84 (2.4%) 4/94 (4.3%) 3/39 (7.7%) 4/37 (10.8%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 15/82 (18.3%) 14/84 (16.7%) 14/94 (14.9%) 10/39 (25.6%) 9/37 (24.3%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 9/82 (11%) 2/84 (2.4%) 15/94 (16%) 10/39 (25.6%) 5/37 (13.5%) 2/82 (2.4%) 3/84 (3.6%) 2/94 (2.1%) 0/39 (0%) 0/37 (0%)
    Back pain 5/82 (6.1%) 4/84 (4.8%) 10/94 (10.6%) 4/39 (10.3%) 0/37 (0%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Muscle spasms 4/82 (4.9%) 3/84 (3.6%) 3/94 (3.2%) 2/39 (5.1%) 1/37 (2.7%) 1/82 (1.2%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Musculoskeletal pain 5/82 (6.1%) 3/84 (3.6%) 0/94 (0%) 0/39 (0%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Myalgia 10/82 (12.2%) 7/84 (8.3%) 13/94 (13.8%) 8/39 (20.5%) 8/37 (21.6%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 1/37 (2.7%)
    Nervous system disorders
    Disturbance in attention 3/82 (3.7%) 1/84 (1.2%) 4/94 (4.3%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Dizziness 6/82 (7.3%) 11/84 (13.1%) 16/94 (17%) 5/39 (12.8%) 4/37 (10.8%) 1/82 (1.2%) 0/84 (0%) 1/94 (1.1%) 1/39 (2.6%) 0/37 (0%)
    Dysgeusia 4/82 (4.9%) 3/84 (3.6%) 3/94 (3.2%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Headache 19/82 (23.2%) 18/84 (21.4%) 27/94 (28.7%) 16/39 (41%) 7/37 (18.9%) 0/82 (0%) 1/84 (1.2%) 0/94 (0%) 0/39 (0%) 1/37 (2.7%)
    Hypoaesthesia 0/82 (0%) 2/84 (2.4%) 1/94 (1.1%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Memory impairment 1/82 (1.2%) 1/84 (1.2%) 2/94 (2.1%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Paraesthesia 1/82 (1.2%) 1/84 (1.2%) 3/94 (3.2%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 1/84 (1.2%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Somnolence 2/82 (2.4%) 1/84 (1.2%) 1/94 (1.1%) 4/39 (10.3%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Syncope 0/82 (0%) 0/84 (0%) 0/94 (0%) 3/39 (7.7%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%)
    Psychiatric disorders
    Anxiety 8/82 (9.8%) 9/84 (10.7%) 5/94 (5.3%) 1/39 (2.6%) 5/37 (13.5%) 1/82 (1.2%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Depressed mood 2/82 (2.4%) 2/84 (2.4%) 3/94 (3.2%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Depression 12/82 (14.6%) 7/84 (8.3%) 9/94 (9.6%) 3/39 (7.7%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 4/94 (4.3%) 0/39 (0%) 0/37 (0%)
    Insomnia 11/82 (13.4%) 12/84 (14.3%) 14/94 (14.9%) 4/39 (10.3%) 6/37 (16.2%) 0/82 (0%) 2/84 (2.4%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Sleep disorder 2/82 (2.4%) 4/84 (4.8%) 3/94 (3.2%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 11/82 (13.4%) 13/84 (15.5%) 12/94 (12.8%) 3/39 (7.7%) 4/37 (10.8%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Dyspnoea 3/82 (3.7%) 6/84 (7.1%) 3/94 (3.2%) 2/39 (5.1%) 2/37 (5.4%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Dyspnoea exertional 1/82 (1.2%) 6/84 (7.1%) 4/94 (4.3%) 1/39 (2.6%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Oropharyngeal Pain 5/82 (6.1%) 2/84 (2.4%) 5/94 (5.3%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Productive cough 0/82 (0%) 1/84 (1.2%) 1/94 (1.1%) 2/39 (5.1%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Skin and subcutaneous tissue disorders
    Alopecia 10/82 (12.2%) 8/84 (9.5%) 4/94 (4.3%) 9/39 (23.1%) 7/37 (18.9%) 0/82 (0%) 1/84 (1.2%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Dry skin 8/82 (9.8%) 5/84 (6%) 6/94 (6.4%) 3/39 (7.7%) 3/37 (8.1%) 1/82 (1.2%) 1/84 (1.2%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)
    Eczema 2/82 (2.4%) 0/84 (0%) 2/94 (2.1%) 0/39 (0%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Erythema 0/82 (0%) 1/84 (1.2%) 2/94 (2.1%) 2/39 (5.1%) 0/37 (0%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 0/39 (0%) 0/37 (0%)
    Pruritus 14/82 (17.1%) 14/84 (16.7%) 12/94 (12.8%) 7/39 (17.9%) 6/37 (16.2%) 1/82 (1.2%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%)
    Rash 11/82 (13.4%) 9/84 (10.7%) 14/94 (14.9%) 2/39 (5.1%) 3/37 (8.1%) 0/82 (0%) 0/84 (0%) 0/94 (0%) 1/39 (2.6%) 0/37 (0%)
    Vascular disorders
    Hypertension 9/82 (11%) 10/84 (11.9%) 8/94 (8.5%) 5/39 (12.8%) 1/37 (2.7%) 0/82 (0%) 0/84 (0%) 1/94 (1.1%) 0/39 (0%) 0/37 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Results Point of Contact

    Name/Title Vice President Clinical Research & Development
    Organization Debiopharm International S.A.
    Phone 4121 321 01 11
    Email info-international@debiopharm.com
    Responsible Party:
    Debiopharm International SA
    ClinicalTrials.gov Identifier:
    NCT01215643
    Other Study ID Numbers:
    • CDEB025A2211
    • 2010-020034-26
    First Posted:
    Oct 6, 2010
    Last Update Posted:
    Aug 30, 2016
    Last Verified:
    Jul 1, 2016