PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)

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) 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 <5000.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: Peginterferon alfa-2a (Pegasys®)

• Study Type: Observational
• Enrollment (Actual): 4680

Contacts and Locations

Study Locations

• Austria
  • Gratwein, Austria, 8112
  • Graz, Austria, 8036
  • Innsbruck, Austria, 6020
  • Linz, Austria, 4020
  • Linz, Austria, 4010
  • Wien, Austria, 1030
  • Wien, Austria, 1100
  • Wien, Austria, 1160
  • Wien, Austria, 1090
• Brazil
  • BA
    • Salvador, BA, Brazil, 41110-170
  • GO
    • Goiania, GO, Brazil, 74535170
  • MG
    • Belo Horizonte, MG, Brazil, 31270-901
  • PA
    • Belem, PA, Brazil, 66035-080
  • PE
    • Recife, PE, Brazil, 50100-130
    • Recife, PE, Brazil, 50670-420
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20270-004
    • Rio de Janeiro, RJ, Brazil, 20529-900
    • Rio de Janeiro, RJ, Brazil, 22410002
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
    • Rio Grande, RS, Brazil, 96200-310
  • SP
    • Botucatu, SP, Brazil, 18600-400
    • Campinas, SP, Brazil, 13026-210
    • Campinas, SP, Brazil, 13081-970
    • Ribeirao Preto, SP, Brazil, 14085-410
    • Santos, SP, Brazil, 11015470
    • Sao Paulo, SP, Brazil, 04040-002
    • Sao Paulo, SP, Brazil, 01246-900
    • Sao Paulo, SP, Brazil, 01246-903
    • Sao Paulo, SP, Brazil, 1246-000
    • Sao Paulo, SP, Brazil, 1323020
    • Sao Paulo, SP, Brazil, 4029000
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 0H5
    • Edmonton, Alberta, Canada, T6G 2C8
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1T2
    • Nanaimo, British Columbia, Canada, V9R 5N9
    • New Westminster, British Columbia, Canada, V3L 3W5
    • Prince George, British Columbia, Canada, V2M 5J6
    • Vancouver, British Columbia, Canada, V6Z 2C7
    • Victoria, British Columbia, Canada, V8R 6R3
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2W 5L4
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1E 2Z1
  • Ontario
    • Barrie, Ontario, Canada, L4M 5G1
    • Brampton, Ontario, Canada, L6S 1C0
    • Etobicoke, Ontario, Canada, M9V 4B8
    • Guelph, Ontario, Canada, N1E 6Z1
    • London, Ontario, Canada, N6A 5R9
    • Newmarket, Ontario, Canada, L3Y 2P6
    • North Bay, Ontario, Canada, P1B 2H3
    • Oakville, Ontario, Canada, L6J 1X8
    • Oshawa, Ontario, Canada, L1G 2B9
    • Oshawa, Ontario, Canada, L1J 2J9
    • Ottawa, Ontario, Canada, K2B 8E8
    • Scarborough, Ontario, Canada, M1T 3V3
    • Sudbury, Ontario, Canada, P3E 1B8
    • Toronto, Ontario, Canada, M5A 1L5
    • Toronto, Ontario, Canada, M6A 3B2
    • Windsor, Ontario, Canada, N8X 5A6
  • Quebec
    • Levis, Quebec, Canada, G6V 3Z1
    • Montreal, Quebec, Canada, H2l 4P9
    • Montreal, Quebec, Canada, H2L 5B1
    • Quebec City, Quebec, Canada, G1L 3L5
    • Quebec City, Quebec, Canada, G1R 1S9
    • Quebec City, Quebec, Canada, QC G1S 4L8
    • Saint-jean Sur Richelieu, Quebec, Canada, J2X 4C7
    • St-charles Borromee, Quebec, Canada, J6E 2C3
• Croatia
  • Osijek, Croatia, 31000
  • Pula, Croatia, 52000
  • Split, Croatia, 21000
  • Zadar, Croatia, 23000
  • Zagreb, Croatia, 10000
• France
  • Agen, France, 47002
  • Aix En Provence, France, 13616
  • Albi, France, 81000
  • Amiens, France, 80054
  • Angers, France, 49033
  • Annecy, France, 74000
  • Antibes, France, 06600
  • Argenteuil, France, 95107
  • Argenteuil, France, 95100
  • Aulnay Sous Bois, France, 93602
  • Aulnay Sous Bois, France, 93600
  • Bastia, France, 20200
  • Beaumont, France, 63110
  • Beausoleil, France, 06240
  • Beauvais, France, 60021
  • Besancon, France, 25000
  • Besancon, France, 25030
  • Beziers, France, 34500
  • Beziers, France, 34525
  • Bordeaux, France, 33000
  • Bordeaux, France, 33300
  • Boulogne Billancourt, France, 92104
  • Bourgoin Jallieu, France, 38317
  • Caen, France, 14033
  • Chambery, France, 73000
  • Clermont Ferrand, France, 63023
  • Clichy, France, 92118
  • Colmar, France, 68024
  • Cornebarrieu, France, 31700
  • Creil, France, 60100
  • Creteil, France, 94010
  • Creteil, France, 94000
  • Dijon, France, 21000
  • Dijon, France, 21079
  • Druex, France, 28107
  • Evreux, France, 27000
  • Frejus, France, 83608
  • Freyming Merlebach, France, 57800
  • Grasse, France, 06130
  • Grenoble, France, 38043
  • Herouville St Clair, France, 14200
  • Hyeres, France, 83400
  • La Rochelle, France, 17100
  • La Valette du Var, France, 83160
  • Lagny Sur Marne, France, 77405
  • Le Chesnay, France, 78157
  • Le Havre, France, 76600
  • Le Kremlin Bicetre, France, 94276
  • Lille, France, 59037
  • Limoges, France, 87042
  • Lomme, France, 59160
  • Lorient, France, 56322
  • Lyon, France, 69437
  • Lyon, France, 69288
  • Lyon, France, 69009
  • Marseille, France, 13285
  • Marseille, France, 13385
  • Marseille, France, 13015
  • Marseille, France, 13013
  • Marseille, France, 13002
  • Martigues, France, 13500
  • Meaux, France, 77104
  • Melun, France, 77011
  • Menton, France, 06507
  • Metz, France, 57038
  • Metz, France, 57045
  • Monaco, France, 98012
  • Montauban, France, 82013
  • Montpellier, France, 34295
  • Montpellier, France, 34000
  • Mulhouse, France, 68070
  • Muret, France, 31607
  • Nanterre, France, 92000
  • Nantes, France, 44035
  • Nantes, France, 44000
  • Nice, France, 06000
  • Nice, France, 06202
  • Nimes, France, 30900
  • Nimes, France, 30029
  • Ollioules, France, 83190
  • Orange, France, 84100
  • Orleans, France, 45100
  • Paris, France, 75018
  • Paris, France, 75014
  • Paris, France, 75970
  • Paris, France, 75651
  • Paris, France, 75571
  • Perigueux, France, 24019
  • Perpignan, France, 66046
  • Pessac, France, 33604
  • Poissy, France, 78303
  • Poitiers, France, 86021
  • Pont a Mousson, France, 54700
  • Reims, France, 51092
  • Rennes, France, 35033
  • Rouen, France, 76031
  • Saint Laurent Du Var, France, 06700
  • Sete, France, 34207
  • St Dizier, France, 52115
  • St Jean De Verges, France, 09000
  • St Mande, France, 94163
  • Ste Maxime, France, 83120
  • Strasbourg, France, 67091
  • Tarbes, France, 65951
  • Toulon, France, 83000
  • Toulouse, France, 31059
  • Toulouse, France, 31076
  • Toulouse, France, 31077
  • Toulouse, France, 31054
  • Tourcoing, France, 59200
  • Valenciennes, France, 59322
  • Vandoeuvre-les-nancy, France, 54511
  • Villejuif, France, 94804
• Hungary
  • Ajka, Hungary, H-8400
  • Bekescsaba, Hungary, 5600
  • Budapest, Hungary, 1083
  • Budapest, Hungary, 1135
  • Budapest, Hungary, 1088
  • Budapest, Hungary, 1097
  • Budapest, Hungary, H-1125
  • Debrecen, Hungary, 4032
  • Debrecen, Hungary, H-4031
  • Eger, Hungary, 3300
  • Gyor, Hungary, 9024
  • Gyula, Hungary, 5700
  • Kaposvar, Hungary, 7400
  • Kecskemet, Hungary, 6000
  • Kistarcsa, Hungary, 2143
  • Miskolc, Hungary, 3529
  • Miskolc, Hungary, H-3501
  • Nyíregyháza, Hungary, 4400
  • Pecs, Hungary, 7623
  • Pecs, Hungary, 7654
  • Szeged, Hungary, 6720
  • Szekszard, Hungary, 7100
  • Szolnok, Hungary, 5000
  • Szombathely, Hungary, 9700
  • Székesfehérvár, Hungary, 8000
  • Tatabánya, Hungary, 2800
  • Zalaegerszeg, Hungary, 8900
  • Zalaegerszeg, Hungary, 8901
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
• Mexico
  • Chihuahua, Mexico, 31000
  • Chihuahua, Mexico, 31170
  • Culiacan, Mexico, 80230
  • Guadalajara, Mexico, 44650
  • Hermosillo, Mexico, 83150
  • Mexicali, Mexico, 21000
  • Mexico City, Mexico, 14050
  • Mexico DF, Mexico, 11649
  • Monterrey, Mexico, 64710
  • Puebla, Mexico, 72550
  • Puebla, Mexico, 72560
• Morocco
  • Casablanca, Morocco, 20100
  • Casablanca, Morocco, 20000
  • Rabat, Morocco, 504
• Poland
  • Bydgoszcz, Poland, 85-030
  • Lodz, Poland, 91-347
  • Warszawa, Poland, 01-201
  • Warszawa, Poland, 02-507
  • Wroclaw, Poland, 51-124
• Romania
  • Arad, Romania, 310037
  • Brasov, Romania, 500326
  • Brasov, Romania, 500007
  • Brasov, Romania, 500174
  • Bucharest, Romania, 021105
  • Bucharest, Romania, 022328
  • Bucharest, Romania, 010825
  • Bucharest, Romania, 030303
  • Bucharest, Romania, 020475
  • Bucharest, Romania, 21105
  • Bucharest, Romania, 005098
  • Cluj Napoca, Romania, 400015
  • Cluj-napoca, Romania, 400162
  • Constanta, Romania
  • Constanta, Romania, 8700
  • Constanta, Romania, 900900
  • Iasi, Romania, 700111
  • Iasi, Romania, 700116
  • Sector 2, Romania, 020125
  • Targu-Mures, Romania, 540136
  • Timisoara, Romania, 293406
  • Timisoara, Romania, 300310
• Serbia
  • Belgrade, Serbia, 11000
  • NIS, Serbia, 18000
  • Novi Sad, Serbia, 21000
• Slovenia
  • Celje, Slovenia, 3000
  • Ljubljana, Slovenia, 1000
  • Maribor, Slovenia, 2000
  • Novo Mesto, Slovenia, 8000
• Sweden
  • Eskilstuna, Sweden, 63188
  • Halmstad, Sweden, S301 85
  • Huddinge, Sweden, 14186
  • Linkoeping, Sweden, 58185
  • Lund, Sweden, 22185
  • Oerebro, Sweden, 70185

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-2a treatment at a medical centre

Description

Inclusion Criteria:

• adult patients, >/= 18 years of age
• chronic hepatitis C
• informed consent to data collection

Exclusion Criteria:

• co-infection with HIV or 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 (PEG-IFN) alfa-2a 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 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 hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. 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 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. 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 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 who received PEG-IFN alfa-2a. 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 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. 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 Week 12 on Modified Sustained Virological Response by Genotype 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. 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 by Genotype 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. 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 Virological Response by Genotype in Modified All-Treated Population Over Time	Virological response 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 mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time	Virological response 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. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time	Modified virological response 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. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time	Modified virological response 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. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype 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.	At Week 2, Week 4, and Week 12
Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype 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.	Week 2, Week 4, and Week 12
Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype 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.	Week 2, Week 4, and Week 12
Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype 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.	Week 2, Week 4, and Week 12
Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12	Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 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, Week 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 Week 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.	Week 4 and Week 12
Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12	RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 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 Week 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 Week 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.	At Week 4 and Week 12
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 percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 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 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 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 percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 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 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 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 percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 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 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 percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. 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 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population	The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 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 was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. 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 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population	The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 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 are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.	At 24 weeks after EOT

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Ascione A, Bruno S, Coppola C, Mangia A, Orlandini A, Schmitz M, Deodato B, Puoti M. Treatment Outcomes and Predictors of Response in Treatment-Naive HCV Patients Treated with Peginterferon Alfa/Ribavirin in Real-World Italian Clinics: Sub-Analysis from the PROPHESYS Cohort. Hepatogastroenterology. 2014 Jun;61(132):1094-106.
• 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: June 1, 2007
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 17, 2010
• First Posted (Estimate): February 18, 2010

Study Record Updates

• Last Update Posted (Estimate): June 15, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: May 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
• Other Study ID Numbers: MV21012