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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) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.
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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/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 Type of Peginterferon and Genotype in Modified All Treated Population | Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 24 weeks (Wk) after EOT |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 24 weeks after EOT |
| Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population | Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving peginterferon alfa 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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24329937 | Derived | 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. |
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A total of 1656 participants were enrolled in this study conducted from January 2008 to August 2011 at 111 centres in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotype 1 (G1) | Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Peginterferon alfa-2b [PegIntron®] | Drug | Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks. |
|
| At 24 weeks after EOT |
| Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 24 weeks after EOT |
| Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 24 weeks after EOT |
| Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 24 weeks after EOT |
| At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
| Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
| Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
| Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
| Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | At Week 2, Week 4 and Week 12 |
| Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | At Week 2, Week 4 and Week 12 |
| Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | At Week 2, Week 4 and Week 12 |
| Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12 | Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | At Week 2, Week 4 and Week 12 |
| Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 24 weeks after EOT |
| Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 24 weeks after EOT |
| Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | At Week 4 and Week 12 |
| Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | During first 12 weeks of treatment |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment | Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | At 12 weeks after EOT |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment | Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'. | 24 weeks after EOT |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment | Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. | At 12 weeks after EOT |
| Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment | Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'. | At 24 weeks after EOT |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| Birmingham | Alabama | 35294 | United States |
| Dothan | Alabama | 36305 | United States |
| Fresno | California | 93721 | United States |
| La Jolla | California | 92037-1030 | United States |
| Lancaster | California | 93534 | United States |
| Loma Linda | California | 92354 | United States |
| Long Beach | California | 90822 | United States |
| Los Angeles | California | 90048 | United States |
| Los Angeles | California | 90057 | United States |
| Los Angeles | California | 90095 | United States |
| Sacramento | California | 95817 | United States |
| San Clemente | California | 92679 | United States |
| San Diego | California | 92103-8465 | United States |
| San Francisco | California | 94115 | United States |
| San Mateo | California | 94403 | United States |
| Torrance | California | 90505 | United States |
| Aurora | Colorado | 80045 | United States |
| Hartford | Connecticut | 06106 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Maitland | Florida | 32751 | United States |
| Orlando | Florida | 32803 | United States |
| Orlando | Florida | 32806 | United States |
| Atlanta | Georgia | 30308 | United States |
| Decatur | Georgia | 30033 | United States |
| Macon | Georgia | 31201 | United States |
| Marietta | Georgia | 30060 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60637 | United States |
| Iowa City | Iowa | 52242 | United States |
| Kansas City | Kansas | 66160 | United States |
| Lexington | Kentucky | 40536-0298 | United States |
| Baton Rouge | Louisiana | 70890 | United States |
| New Orleans | Louisiana | 70121 | United States |
| Opelousas | Louisiana | 70520 | United States |
| Annapolis | Maryland | 21401 | United States |
| Baltimore | Maryland | 21229 | United States |
| Boston | Massachusetts | 02114 | United States |
| Springfield | Massachusetts | 01103 | United States |
| Springfield | Massachusetts | 01107-1635 | United States |
| Worcester | Massachusetts | 01068 | United States |
| Detroit | Michigan | 48201 | United States |
| Grand Rapids | Michigan | 49506 | United States |
| Jackson | Mississippi | 39202 | United States |
| Tupelo | Mississippi | 38801 | United States |
| St Louis | Missouri | 63104 | United States |
| St Louis | Missouri | 63110 | United States |
| Topeka | Missouri | 66606 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Egg Harbour Township | New Jersey | 08234 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Hillsborough | New Jersey | 08844 | United States |
| Roseland | New Jersey | 07068 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Bayside | New York | 11358 | United States |
| Catskill | New York | 12414 | United States |
| Flushing | New York | 11355 | United States |
| New York | New York | 10003 | United States |
| New York | New York | 10016 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Syracuse | New York | 13210 | United States |
| Asheville | North Carolina | 28801 | United States |
| Chapel Hill | North Carolina | 27599-7584 | United States |
| Charlotte | North Carolina | 28211 | United States |
| Fayetteville | North Carolina | 28304 | United States |
| Rocky Mount | North Carolina | 27804 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44106 | United States |
| Cleveland | Ohio | 44109 | United States |
| Cleveland | Ohio | 44195 | United States |
| Oklahoma City | Oklahoma | 73112-4481 | United States |
| Tulsa | Oklahoma | 74135 | United States |
| Medford | Oregon | 97504 | United States |
| Portland | Oregon | 97227 | United States |
| Portland | Oregon | 97239 | United States |
| Camp Hill | Pennsylvania | 17011 | United States |
| DuBois | Pennsylvania | 15801 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Bristol | Tennessee | 37620 | United States |
| Chattanooga | Tennessee | 37403 | United States |
| Germantown | Tennessee | 38138 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Nashville | Tennessee | 37211 | United States |
| West Nashville | Tennessee | 37205 | United States |
| Dallas | Texas | 75203 | United States |
| Galveston | Texas | 77555 | United States |
| Harlingen | Texas | 78550 | United States |
| Houston | Texas | 77030 | United States |
| Houston | Texas | 77074 | United States |
| Houston | Texas | 77090 | United States |
| San Antonio | Texas | 78229 | United States |
| San Antonio | Texas | 78234 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Fairfax | Virginia | 22031 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23298 | United States |
| Seattle | Washington | 98133 | United States |
| Huntington | West Virginia | 25701 | United States |
| Casper | Wyoming | 82609 | United States |
| Santurce | 00909 | Puerto Rico |
| FG001 |
| Genotype 2 (G2) |
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| FG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| FG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| FG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| FG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The All Patient Enrolled Population included every participant of whom there was any data in the PROPHESYS database.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Genotype 1 (G1) | Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| BG001 | Genotype 2 (G2) | Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| BG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| BG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| BG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| BG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling 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: Female, Male | Count of Participants | 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 Type of Peginterferon and Genotype in Modified All Treated Population | Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks (Wk) after EOT |
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| Primary | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The per-protocol (PP) population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Primary | Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population | Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 international units per millilitre (IU/mL) were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Primary | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Primary | Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Primary | Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Secondary | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
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| Secondary | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
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| Secondary | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
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| Secondary | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT |
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| Secondary | Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4 and Week 12 |
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| Secondary | Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 | Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | Th PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4 and Week 12 |
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| Secondary | Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 | Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4 and Week 12 |
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| Secondary | Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12 | Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 2, Week 4 and Week 12 |
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| Secondary | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Secondary | Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Secondary | Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 | Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | participants | At Week 4 and Week 12 |
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| Secondary | Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 | RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | participants | During first 12 weeks of treatment |
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| 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 number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | Percentage of Participants | At 12 weeks after EOT |
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| 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 modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'. | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | Posted | Number | Percentage of Participants | 24 weeks after EOT |
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| 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 the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | Percentage of Participants | At 12 weeks after EOT |
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| 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 modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'. | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | Posted | Number | Percentage of Participants | At 24 weeks after EOT |
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Up to 3 years and 8 months
An Adverse events (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The safety population included all participants who received at least one dose of either PEG-IFN or ribavirin.
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 | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. | 130 | 1,441 | 841 | 1,441 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Escherichia sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Lung abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Peritonitis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia staphylococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Acute psychosis | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Bicytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate Control | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Phlebitis superficial | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Laboratory test interference | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Scleritis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug rehabilitation | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| Fanconi Syndrome | Congenital, familial and genetic disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Ovarian mass | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Substance use | Social circumstances | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
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 | F. 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 |
| C417083 | peginterferon alfa-2b |
Not provided
Not provided
Not provided
| Male |
|
| Peg IFN Alfa 2b (n=106,46,29,2,1,1) |
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
|
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 |
| Genotype 3 (G3) |
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 |
| Genotype 3 (G3) |
Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
|
|
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
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| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
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| OG001 | Genotype 2 (G2) | Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
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| OG001 | Genotype 2 (G2) | Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
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Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
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| Genotype 2 (G2) |
Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG002 | Genotype 3 (G3) | Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG003 | Genotype 4 (G4) | Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG004 | Genotype 5/6 (G5/6) | Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
| OG005 | Genotype Unknown (UNK) | Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed. |
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