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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Participants chronically infected with the hepatitis C virus including Genotypes 1 to 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a (Pegasys®) | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving peginterferon alfa-2a treatment at a medical centre
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gratwein | 8112 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26158171 | Derived | 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. | |
| 24329937 |
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A total of 4680 participants were enrolled into the study conducted from June 2007 to July 2011 at 332 centers in 14 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotype 1 | Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| 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 |
| Graz |
| 8036 |
| Austria |
| Innsbruck | 6020 | Austria |
| Linz | 4010 | Austria |
| Linz | 4020 | Austria |
| Vienna | 1030 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1100 | Austria |
| Vienna | 1160 | Austria |
| Salvador | Estado de Bahia | 41110-170 | Brazil |
| Goiânia | Goiás | 74535170 | Brazil |
| Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
| Belém | Pará | 66035-080 | Brazil |
| Recife | Pernambuco | 50100-130 | Brazil |
| Recife | Pernambuco | 50670-420 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20270-004 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20529-900 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 22410002 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Rio Grande | Rio Grande do Sul | 96200-310 | Brazil |
| Botucatu | São Paulo | 18600-400 | Brazil |
| Campinas | São Paulo | 13026-210 | Brazil |
| Campinas | São Paulo | 13081-970 | Brazil |
| Ribeirão Preto | São Paulo | 14085-410 | Brazil |
| Santos | São Paulo | 11015470 | Brazil |
| São Paulo | São Paulo | 01246-900 | Brazil |
| São Paulo | São Paulo | 01246-903 | Brazil |
| São Paulo | São Paulo | 04040-002 | Brazil |
| São Paulo | São Paulo | 1246-000 | Brazil |
| São Paulo | São Paulo | 1323020 | Brazil |
| São Paulo | São Paulo | 4029000 | Brazil |
| Calgary | Alberta | T2G 0H5 | Canada |
| Edmonton | Alberta | T6G 2C8 | Canada |
| Kelowna | British Columbia | V1Y 1T2 | Canada |
| Nanaimo | British Columbia | V9R 5N9 | Canada |
| New Westminster | British Columbia | V3L 3W5 | Canada |
| Prince George | British Columbia | V2M 5J6 | Canada |
| Vancouver | British Columbia | V6Z 2C7 | Canada |
| Victoria | British Columbia | V8R 6R3 | Canada |
| Winnipeg | Manitoba | R2W 5L4 | Canada |
| St. John's | Newfoundland and Labrador | A1E 2Z1 | Canada |
| Barrie | Ontario | L4M 5G1 | Canada |
| Brampton | Ontario | L6S 1C0 | Canada |
| Etobicoke | Ontario | M9V 4B8 | Canada |
| Greater Sudbury | Ontario | P3E 1B8 | Canada |
| Guelph | Ontario | N1E 6Z1 | Canada |
| London | Ontario | N6A 5R9 | Canada |
| Newmarket | Ontario | L3Y 2P6 | Canada |
| North Bay | Ontario | P1B 2H3 | Canada |
| Oakville | Ontario | L6J 1X8 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Oshawa | Ontario | L1J 2J9 | Canada |
| Ottawa | Ontario | K2B 8E8 | Canada |
| Scarborough Village | Ontario | M1T 3V3 | Canada |
| Toronto | Ontario | M5A 1L5 | Canada |
| Toronto | Ontario | M6A 3B2 | Canada |
| Windsor | Ontario | N8X 5A6 | Canada |
| Lévis | Quebec | G6V 3Z1 | Canada |
| Montreal | Quebec | H2L 4P9 | Canada |
| Montreal | Quebec | H2L 5B1 | Canada |
| Québec | Quebec | G1L 3L5 | Canada |
| Québec | Quebec | G1R 1S9 | Canada |
| Québec | Quebec | QC G1S 4L8 | Canada |
| Saint-Charles-Borromée | Quebec | J6E 2C3 | Canada |
| Saint-Jean-sur-Richelieu | Quebec | J2X 4C7 | Canada |
| Osijek | 31000 | Croatia |
| Pula | 52000 | Croatia |
| Split | 21000 | Croatia |
| Zadar | 23000 | Croatia |
| Zagreb | 10000 | Croatia |
| Agen | 47002 | France |
| Aix-en-Provence | 13616 | France |
| Albi | 81000 | France |
| Amiens | 80054 | France |
| Angers | 49033 | France |
| Annecy | 74000 | France |
| Antibes | 06600 | France |
| Argenteuil | 95100 | France |
| Argenteuil | 95107 | France |
| Aulnay-sous-Bois | 93600 | France |
| Aulnay-sous-Bois | 93602 | France |
| Bastia | 20200 | France |
| Beaumont | 63110 | France |
| Beausoleil | 06240 | France |
| Beauvais | 60021 | France |
| Besançon | 25000 | France |
| Besançon | 25030 | France |
| Béziers | 34500 | France |
| Béziers | 34525 | France |
| Bordeaux | 33000 | France |
| Bordeaux | 33300 | France |
| Boulogne-Billancourt | 92104 | France |
| Bourgoin | 38317 | France |
| Caen | 14033 | France |
| Chambéry | 73000 | France |
| Clermont-Ferrand | 63023 | France |
| Clichy | 92118 | France |
| Colmar | 68024 | France |
| Cornebarrieu | 31700 | France |
| Creil | 60100 | France |
| Créteil | 94000 | France |
| Créteil | 94010 | France |
| Dijon | 21000 | France |
| Dijon | 21079 | France |
| Druex | 28107 | France |
| Évreux | 27000 | France |
| Freyming-Merlebach | 57800 | France |
| Fréjus | 83608 | France |
| Grasse | 06130 | France |
| Grenoble | 38043 | France |
| Hérouville-Saint-Clair | 14200 | France |
| Hyères | 83400 | France |
| La Rochelle | 17100 | France |
| La Valette-du-Var | 83160 | France |
| Lagny-sur-Marne | 77405 | France |
| Le Chesnay | 78157 | France |
| Le Havre | 76600 | France |
| Le Kremlin-Bicêtre | 94276 | France |
| Lille | 59037 | France |
| Limoges | 87042 | France |
| Lomme | 59160 | France |
| Lorient | 56322 | France |
| Lyon | 69009 | France |
| Lyon | 69288 | France |
| Lyon | 69437 | France |
| Marseille | 13002 | France |
| Marseille | 13013 | France |
| Marseille | 13015 | France |
| Marseille | 13285 | France |
| Marseille | 13385 | France |
| Martigues | 13500 | France |
| Meaux | 77104 | France |
| Melun | 77011 | France |
| Menton | 06507 | France |
| Metz | 57038 | France |
| Metz | 57045 | France |
| Monaco | 98012 | France |
| Montauban | 82013 | France |
| Montpellier | 34000 | France |
| Montpellier | 34295 | France |
| Mulhouse | 68070 | France |
| Muret | 31607 | France |
| Nanterre | 92000 | France |
| Nantes | 44000 | France |
| Nantes | 44035 | France |
| Nice | 06000 | France |
| Nice | 06202 | France |
| Nîmes | 30029 | France |
| Nîmes | 30900 | France |
| Ollioules | 83190 | France |
| Orange | 84100 | France |
| Orléans | 45100 | France |
| Paris | 75014 | France |
| Paris | 75018 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Paris | 75970 | France |
| Perpignan | 66046 | France |
| Pessac | 33604 | France |
| Périgueux | 24019 | France |
| Poissy | 78303 | France |
| Poitiers | 86021 | France |
| Pont-Ã -Mousson | 54700 | France |
| Reims | 51092 | France |
| Rennes | 35033 | France |
| Rouen | 76031 | France |
| Saint-Dizier | 52115 | France |
| Saint-Jean-de-Verges | 09000 | France |
| Saint-Laurent-du-Var | 06700 | France |
| Saint-Mandé | 94163 | France |
| Sète | 34207 | France |
| Ste Maxime | 83120 | France |
| Strasbourg | 67091 | France |
| Tarbes | 65951 | France |
| Toulon | 83000 | France |
| Toulouse | 31054 | France |
| Toulouse | 31059 | France |
| Toulouse | 31076 | France |
| Toulouse | 31077 | France |
| Tourcoing | 59200 | France |
| Valenciennes | 59322 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Villejuif | 94804 | France |
| Ajka | H-8400 | Hungary |
| Békéscsaba | 5600 | Hungary |
| Budapest | 1083 | Hungary |
| Budapest | 1088 | Hungary |
| Budapest | 1097 | Hungary |
| Budapest | 1135 | Hungary |
| Budapest | H-1125 | Hungary |
| Debrecen | 4032 | Hungary |
| Debrecen | H-4031 | Hungary |
| Eger | 3300 | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Kaposvár | 7400 | Hungary |
| Kecskemét | 6000 | Hungary |
| Kistarcsa | 2143 | Hungary |
| Miskolc | 3529 | Hungary |
| Miskolc | H-3501 | Hungary |
| NyÃregyháza | 4400 | Hungary |
| Pécs | 7623 | Hungary |
| Pécs | 7654 | Hungary |
| Szeged | 6720 | Hungary |
| Szekszárd | 7100 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szolnok | 5000 | Hungary |
| Szombathely | 9700 | Hungary |
| Tatabánya | 2800 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Zalaegerszeg | 8901 | Hungary |
| Chihuahua City | 31000 | Mexico |
| Chihuahua City | 31170 | Mexico |
| Culiacán | 80230 | Mexico |
| Guadalajara | 44650 | Mexico |
| Hermosillo | 83150 | Mexico |
| Mexicali | 21000 | Mexico |
| Mexico City | 11649 | Mexico |
| Mexico City | 14050 | Mexico |
| Monterrey | 64710 | Mexico |
| Puebla City | 72550 | Mexico |
| Puebla City | 72560 | Mexico |
| Casablanca | 20000 | Morocco |
| Casablanca | 20100 | Morocco |
| Rabat | 504 | Morocco |
| Skopje | 1000 | North Macedonia |
| Bydgoszcz | 85-030 | Poland |
| Lodz | 91-347 | Poland |
| Warsaw | 01-201 | Poland |
| Warsaw | 02-507 | Poland |
| Wroclaw | 51-124 | Poland |
| Arad | 310037 | Romania |
| Brasov | 500007 | Romania |
| Brasov | 500174 | Romania |
| Brasov | 500326 | Romania |
| Bucharest | 005098 | Romania |
| Bucharest | 010825 | Romania |
| Bucharest | 020475 | Romania |
| Bucharest | 021105 | Romania |
| Bucharest | 022328 | Romania |
| Bucharest | 030303 | Romania |
| Bucharest | 21105 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Cluj-Napoca | 400162 | Romania |
| Constanța | 8700 | Romania |
| Constanța | 900900 | Romania |
| Constanța | Romania |
| Iași | 700111 | Romania |
| Iași | 700116 | Romania |
| Sector 2 | 020125 | Romania |
| Târgu Mureş | 540136 | Romania |
| Timișoara | 293406 | Romania |
| Timișoara | 300310 | Romania |
| Belgrade | 11000 | Serbia |
| Niš | 18000 | Serbia |
| Novi Sad | 21000 | Serbia |
| Celje | 3000 | Slovenia |
| Ljubljana | 1000 | Slovenia |
| Maribor | 2000 | Slovenia |
| Novo Mesto | 8000 | Slovenia |
| Eskilstuna | 63188 | Sweden |
| Halmstad | S301 85 | Sweden |
| Huddinge | 14186 | Sweden |
| Linköping | 58185 | Sweden |
| Lund | 22185 | Sweden |
| Örebro | 70185 | Sweden |
| 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. |
| Genotype 2 |
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labelling were observed for up to 72 weeks. |
| FG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks. |
| FG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks. |
| FG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| FG005 | Genotype Unknown | Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled population included every participant for whom there was any data available in the PROPHESYS 1 database.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Genotype 1 | Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| BG001 | Genotype 2 | Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| BG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| BG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| BG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| BG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The mTRT population included all participants who received at least one dose of peginterferon alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 2, Week 4, and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population. | Posted | Number | Participants | Week 4 and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | Participants | At Week 4 and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | Percentage of participants | At 12 Weeks after EOT |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | Percentage of Participants | At 12 weeks after EOT |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | Percentage of participants | At 24 weeks after EOT |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | Percentage of participants | At 24 weeks after EOT |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PP population included all participants who met the inclusion/exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 weeks after EOT |
|
Up to 24 Weeks after EOT. The EOT is 12, 24, 48 or 72 weeks after initiation of treatment.
Documentation of adverse event/serious adverse event was not within scope of this study. Serious Adverse Drug Reactions (SADRs) were to be reported spontaneously through spontaneous reporting system for marketed drugs. In most SADRs, the study number was missing on form; thus it could not be assigned to study and no data was available for reporting
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genotype 1 | Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 0 | 0 | 0 | 0 | ||
| EG001 | Genotype 2 | Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 0 | 0 | 0 | 0 | ||
| EG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 0 | 0 | 0 | 0 | ||
| EG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 0 | 0 | 0 | 0 | ||
| EG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 0 | 0 | 0 | 0 | ||
| EG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. | 0 | 0 | 0 | 0 |
Not provided
Not provided
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
Not provided
Not provided
Not provided
| Male |
|
| Unknown |
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
|
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| Genotype 3 |
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 |
| Genotype 3 |
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG001 |
| Genotype 2 |
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| Genotype 2 |
Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| OG002 | Genotype 3 | Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
|
| Genotype 3 |
Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG003 | Genotype 4 | Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG004 | Genotype 5/6 | Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
| OG005 | Genotype Unknown | Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed. |
|
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