PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: Peginterferon alfa-2a [Pegasys]; Drug: Peginterferon alfa-2b [PegIntron®]

• Study Type: Observational
• Enrollment (Actual): 1656

Contacts and Locations

Study Locations

• Puerto Rico
  • Santurce, Puerto Rico, 00909
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
    • Birmingham, Alabama, United States, 35233
    • Birmingham, Alabama, United States, 35249
    • Dothan, Alabama, United States, 36305
  • California
    • Fresno, California, United States, 93721
    • La Jolla, California, United States, 92037-1030
    • Lancaster, California, United States, 93534
    • Loma Linda, California, United States, 92354
    • Long Beach, California, United States, 90822
    • Los Angeles, California, United States, 90048
    • Los Angeles, California, United States, 90095
    • Los Angeles, California, United States, 90057
    • Sacramento, California, United States, 95817
    • San Clemente, California, United States, 92679
    • San Diego, California, United States, 92103-8465
    • San Francisco, California, United States, 94115
    • San Mateo, California, United States, 94403
    • Torrance, California, United States, 90505
  • Colorado
    • Aurora, Colorado, United States, 80045
  • Connecticut
    • Hartford, Connecticut, United States, 06106
  • Florida
    • Gainesville, Florida, United States, 32610-0214
    • Maitland, Florida, United States, 32751
    • Orlando, Florida, United States, 32806
    • Orlando, Florida, United States, 32803
  • Georgia
    • Atlanta, Georgia, United States, 30308
    • Decatur, Georgia, United States, 30033
    • Macon, Georgia, United States, 31201
    • Marietta, Georgia, United States, 30060
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
  • Illinois
    • Chicago, Illinois, United States, 60637
    • Chicago, Illinois, United States, 60612
  • Iowa
    • Iowa City, Iowa, United States, 52242
  • Kansas
    • Kansas City, Kansas, United States, 66160
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0298
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70890
    • New Orleans, Louisiana, United States, 70121
    • Opelousas, Louisiana, United States, 70520
  • Maryland
    • Annapolis, Maryland, United States, 21401
    • Baltimore, Maryland, United States, 21229
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
    • Springfield, Massachusetts, United States, 01103
    • Springfield, Massachusetts, United States, 01107-1635
    • Worcester, Massachusetts, United States, 01068
  • Michigan
    • Detroit, Michigan, United States, 48201
    • Grand Rapids, Michigan, United States, 49506
  • Mississippi
    • Jackson, Mississippi, United States, 39202
    • Tupelo, Mississippi, United States, 38801
  • Missouri
    • St Louis, Missouri, United States, 63110
    • St Louis, Missouri, United States, 63104
    • Topeka, Missouri, United States, 66606
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
  • New Jersey
    • Egg Harbour Township, New Jersey, United States, 08234
    • Hackensack, New Jersey, United States, 07601
    • Hillsborough, New Jersey, United States, 08844
    • Roseland, New Jersey, United States, 07068
    • Voorhees, New Jersey, United States, 08043
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
  • New York
    • Bayside, New York, United States, 11358
    • Catskill, New York, United States, 12414
    • Flushing, New York, United States, 11355
    • New York, New York, United States, 10016
    • New York, New York, United States, 10003
    • Poughkeepsie, New York, United States, 12601
    • Syracuse, New York, United States, 13210
  • North Carolina
    • Asheville, North Carolina, United States, 28801
    • Chapel Hill, North Carolina, United States, 27599-7584
    • Charlotte, North Carolina, United States, 28211
    • Fayetteville, North Carolina, United States, 28304
    • Rocky Mount, North Carolina, United States, 27804
    • Winston-salem, North Carolina, United States, 27103
    • Winston-salem, North Carolina, United States, 27157
  • Ohio
    • Cincinnati, Ohio, United States, 45219
    • Cleveland, Ohio, United States, 44109
    • Cleveland, Ohio, United States, 44195
    • Cleveland, Ohio, United States, 44106
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112-4481
    • Tulsa, Oklahoma, United States, 74135
  • Oregon
    • Medford, Oregon, United States, 97504
    • Portland, Oregon, United States, 97239
    • Portland, Oregon, United States, 97227
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
    • DuBois, Pennsylvania, United States, 15801
    • Pittsburgh, Pennsylvania, United States, 15213
  • Tennessee
    • Bristol, Tennessee, United States, 37620
    • Chattanooga, Tennessee, United States, 37403
    • Germantown, Tennessee, United States, 38138
    • Kingsport, Tennessee, United States, 37660
    • Nashville, Tennessee, United States, 37211
    • West Nashville, Tennessee, United States, 37205
  • Texas
    • Dallas, Texas, United States, 75203
    • Galveston, Texas, United States, 77555
    • Harlingen, Texas, United States, 78550
    • Houston, Texas, United States, 77030
    • Houston, Texas, United States, 77074
    • Houston, Texas, United States, 77090
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78234
  • Utah
    • Salt Lake City, Utah, United States, 84121
  • Virginia
    • Charlottesville, Virginia, United States, 22908
    • Fairfax, Virginia, United States, 22031
    • Norfolk, Virginia, United States, 23502
    • Richmond, Virginia, United States, 23298
  • Washington
    • Seattle, Washington, United States, 98133
  • West Virginia
    • Huntington, West Virginia, United States, 25701
  • Wyoming
    • Casper, Wyoming, United States, 82609

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients receiving peginterferon alfa treatment at a medical centre

Description

Inclusion Criteria:

• adult patients, >/= 18 years of age
• chronic hepatitis C
• HIV HCV co-infection allowed
• informed consent to data collection

Exclusion Criteria:

• co-infection with Hepatitis B Virus (HBV)
• previous treatment with peginterferon and/or ribavirin

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; Participants chronically infected with the hepatitis C virus including genotypes 1 to 6.	Drug: Peginterferon alfa-2a [Pegasys]; Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.; Drug: Peginterferon alfa-2b [PegIntron®]; Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population	Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population	Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population	Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks (Wk) after EOT
Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population	Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population	The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population	The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment	Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 12 weeks after EOT
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time	Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.	At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time	Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment	At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time	Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment	At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time	Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment	At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12	Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.	At Week 2, Week 4 and Week 12
Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12	Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.	At Week 2, Week 4 and Week 12
Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12	Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.	At Week 2, Week 4 and Week 12
Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12	Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.	At Week 2, Week 4 and Week 12
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population	The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population	The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT
Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12	Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.	At Week 4 and Week 12
Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12	RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.	During first 12 weeks of treatment
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment	Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.	24 weeks after EOT
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment	Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.	At 12 weeks after EOT
Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment	Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.	At 24 weeks after EOT

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Ferenci P, Aires R, Ancuta I, Arohnson A, Cheinquer H, Delic D, Gschwantler M, Larrey D, Tallarico L, Schmitz M, Tatsch F, Ouzan D. A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin. Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (ESTIMATE): February 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Peginterferon alfa-2a; Peginterferon alfa-2b
• Other Study ID Numbers: MV21542