An observational study in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 272 sites in 27 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-30.
Sponsored by Hoffmann-La Roche · Observational
This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.
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Chronic hepatitis C (CHC) participants (naïve or treatment experienced, including HIV HCV co-infected) receiving combination therapy with pegylated interferons plus ribavirin or treatment regimens containing direct-acting antivirals.
Exclusion Criteria:
Participants with chronic hepatitis C (CHC) receiving dual therapy (pegylated interferon alfa-2a \[peg-IFN Alfa-2a\] along with ribavirin according to standard of care and in line with local labeling) were followed up for the duration of their treatment and for up to 24 weeks after therapy.
Drug: Peg-IFN Alfa-2a · Drug: Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b \[peg-IFN Alfa-2b\] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Drug: Peg-IFN Alfa-2b · Drug: Ribavirin
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Drug: Peg-IFN Alfa-2a · Drug: Ribavirin · Drug: Boceprevir
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Drug: Peg-IFN Alfa-2b · Drug: Ribavirin · Drug: Boceprevir
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Drug: Peg-IFN Alfa-2a · Drug: Ribavirin · Drug: Telaprevir
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Drug: Peg-IFN Alfa-2b · Drug: Ribavirin · Drug: Telaprevir
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Ribavirin according to standard of care and in line with local labeling.
Boceprevir according to standard of care and in line with local labeling.
Telaprevir according to standard of care and in line with local labeling.
Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 24 weeks post completion of the treatment period.
Time frame: 24 weeks after end of treatment (up to 118 weeks)
Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 12 weeks post completion of the treatment period.
Time frame: 12 weeks after end of treatment (up to 118 weeks)
Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
Virological response (VR) for dual therapy participants is defined as HCV RNA \<50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) \<=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) \<=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ \>50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection \<=50 IU/mL (UVR). Results of HCV RNA tests with an LLD \>50 IU/mL were considered as non-response for triple therapy participants.
Time frame: Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
Virological Relapse After End of Treatment
Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA \>=50 IU/mL).
Time frame: Up to 24 weeks after EOT (up to 118 weeks)
Virological Breakthrough
Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by \>=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
Time frame: Up to EOT (up to 118 weeks)
Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be \<=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
Time frame: Up to first 12 weeks of treatment
Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks
Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
Time frame: Up to 12 weeks
Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
Time frame: Up to 98 weeks
Duration of Overall Treatment
Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
Time frame: Up to 118 weeks
Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
Time frame: Up to 118 weeks
Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
Participants who prolonged the treatment period from 72 weeks were not reported.
Time frame: Up to 72 weeks of treatment
Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
Time frame: Up to 72 weeks of treatment
Percentage of Participants With Concomitant Medical Condition at Baseline
Time frame: Baseline
Percentage of Participants With Adverse Events (AE)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Time frame: Up to 118 weeks
A total of 4442 participants were enrolled in the study, one participant had double enrollment. Out of 4442 participants, analyses were restricted to only core population, which included 4100 participants.
| Milestone | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Started | 2312 | 496 | 292 | 93 | 821 | 86 |
| Completed | 1590 | 331 | 192 | 60 | 610 | 54 |
| Not completed | 722 | 165 | 100 | 33 | 211 | 32 |
| Withdrew: Death | 6 | 3 | 2 | 1 | 7 | 0 |
| Withdrew: Adverse event | 3 | 0 | 1 | 0 | 2 | 0 |
| Withdrew: Failure to return/consent withdrawn | 357 | 78 | 31 | 7 | 69 | 9 |
| Withdrew: Insuff. vr/trt too short to expect vr | 300 | 71 | 52 | 21 | 92 | 14 |
| Withdrew: Administrative/other | 34 | 9 | 10 | 2 | 33 | 4 |
| Withdrew: Svr12 assessment | 13 | 1 | 2 | 1 | 5 | 5 |
| Withdrew: New treatment started | 8 | 2 | 1 | 0 | 2 | 0 |
| Withdrew: Reason not specified | 1 | 1 | 1 | 1 | 1 | 0 |
SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 24 weeks post completion of the treatment period.
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | 52.1 (50.1 to 54.2) | 49.4 (44.9 to 53.9) | 46.6 (40.7 to 52.5) | 50.5 (40.0 to 61.1) | 57.7 (54.3 to 61.1) | 47.7 (36.8 to 58.7) |
SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 12 weeks post completion of the treatment period.
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | 54.3 (52.2 to 56.3) | 51.0 (46.5 to 55.5) | 50.0 (44.1 to 55.9) | 53.8 (43.1 to 64.2) | 62.0 (58.6 to 65.3) | 57.0 (45.8 to 67.6) |
Virological response (VR) for dual therapy participants is defined as HCV RNA \<50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) \<=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) \<=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ \>50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection \<=50 IU/mL (UVR). Results of HCV RNA tests with an LLD \>50 IU/mL were considered as non-response for triple therapy participants.
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| VR by Week 4 | 39.5 (37.5 to 41.5) | 40.1 (35.8 to 44.6) | 9.9 (6.8 to 14.0) | 9.7 (4.5 to 17.6) | 49.8 (46.3 to 53.3) | 51.2 (40.1 to 62.1) |
| VR by Week 12 | 71.3 (69.4 to 73.2) | 67.7 (63.4 to 71.8) | 56.8 (51.0 to 62.6) | 59.1 (48.5 to 69.2) | 80.8 (77.9 to 83.4) | 73.3 (62.6 to 82.2) |
| VR by EOT | 73.6 (71.7 to 75.4) | 70.6 (66.3 to 74.5) | 67.1 (61.4 to 72.5) | 72.0 (61.8 to 80.9) | 74.9 (71.8 to 77.8) | 66.3 (55.3 to 76.1) |
Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA \>=50 IU/mL).
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Virological Relapse After End of Treatment | 18.4 (16.5 to 20.4) | 19.7 (15.5 to 24.6) | 21.0 (15.3 to 27.7) | 20.6 (11.5 to 32.7) | 13.8 (11.1 to 16.8) | 7.5 (2.1 to 18.2) |
Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by \>=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Virological Breakthrough | 5.4 (4.5 to 6.4) | 4.8 (3.0 to 7.3) | 8.7 (5.7 to 12.7) | 15.9 (9.0 to 25.2) | 15.0 (12.6 to 17.7) | 21.6 (12.9 to 32.7) |
SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be \<=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| SVR at Week 12 After EOT | 37.1 (28.3 to 46.5) | 27.3 (13.3 to 45.5) | 20.7 (8.0 to 39.7) | 14.3 (0.4 to 57.9) | 35.4 (25.0 to 47.0) | 44.4 (13.7 to 78.8) |
| SVR at Week 24 EOT | 35.3 (26.7 to 44.8) | 24.2 (11.1 to 42.3) | 17.2 (5.8 to 35.8) | 14.3 (0.4 to 57.9) | 34.2 (23.9 to 45.7) | 44.4 (13.7 to 78.8) |
Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
No measurements were reported for this outcome.
Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
| percentage of participants | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|
| Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) | 37.7 (32.1 to 43.5) | 32.3 (22.9 to 42.7) | 45.6 (42.1 to 49.0) | 47.7 (36.8 to 58.7) |
Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
| Weeks | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Duration of Overall Treatment | 34.2 ± 16.04 | 31.3 ± 15.73 | 35.2 ± 17.48 | 35.3 ± 15.27 | 33.2 ± 15.03 | 31.2 ± 15.95 |
No measurements were reported for this outcome.
Participants who prolonged the treatment period from 72 weeks were not reported.
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Discontinued PEG-IFN During Week 1 to Week 12 | 5.7 | 8.3 | 9.2 | 9.7 | 9.9 | 11.6 |
| Discontinued RBV During Week 1 to Week 12 | 6.3 | 9.1 | 9.6 | 10.8 | 10.8 | 12.8 |
| Discontinued PEG-IFN During Week 13 to Week 24 | 13.5 | 17.1 | 16.8 | 14.0 | 10.2 | 12.8 |
| Discontinued RBV During Week 13 to Week 24 | 22.1 | 22.4 | 17.1 | 16.1 | 13.9 | 19.8 |
| Discontinued PEG-IFN During Week 25 to Week 48 | 41.7 | 41.3 | 30.1 | 29.0 | 41.0 | 43.0 |
| Discontinued RBV During Week 25 to Week 48 | 43.0 | 46.6 | 41.1 | 41.9 | 44.9 | 41.9 |
| Discontinued PEG-IFN During Week 49 to Week 72 | 36.2 | 32.1 | 41.1 | 47.3 | 38.9 | 32.6 |
| Discontinued RBV During Week 49 to Week 72 | 26.6 | 21.0 | 29.1 | 31.2 | 30.3 | 25.6 |
Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
| percentage of participants | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|
| Discontinued DAA During Week 1 to Week 2 | 6.8 | 7.5 | 1.7 | 4.7 |
| Discontinued DAA During Week 3 to Week 4 | 2.1 | 1.1 | 1.5 | 4.7 |
| Discontinued DAA During Week 5 to Week 12 | 13.4 | 8.6 | 24.7 | 22.1 |
| Discontinued DAA During Week 13 to Week 24 | 16.1 | 18.3 | 71.7 | 68.6 |
| Discontinued DAA During Week 25 to Week 48 | 59.2 | 64.5 | 0.4 | 0.0 |
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Percentage of Participants With Concomitant Medical Condition at Baseline | 48.1 | 50.4 | 65.8 | 68.8 | 67.2 | 41.9 |
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
| percentage of participants | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AE) | 60.3 | 65.7 | 76.7 | 88.2 | 90.7 | 87.2 |
Collected over Up to 118 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | — | 148/2,312 (6.4%) | 1,225/2,312 (53%) |
| Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | — | 33/496 (6.7%) | 287/496 (57.9%) |
| Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | — | 43/292 (14.7%) | 207/292 (70.9%) |
| Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | — | 9/93 (9.7%) | 79/93 (84.9%) |
| Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | — | 163/821 (19.9%) | 709/821 (86.4%) |
| Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin | — | 4/86 (4.7%) | 72/86 (83.7%) |
| Event | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 25/2312 | 2/496 | 9/292 | 3/93 | 57/821 | 1/86 |
| NeutropeniaBlood and lymphatic system disorders | 12/2312 | 1/496 | 4/292 | 0/93 | 2/821 | 0/86 |
| DiarrhoeaGastrointestinal disorders | 0/2312 | 0/496 | 1/292 | 0/93 | 1/821 | 1/86 |
| VomitingGastrointestinal disorders | 0/2312 | 1/496 | 2/292 | 0/93 | 3/821 | 1/86 |
| AstheniaGeneral disorders | 1/2312 | 0/496 | 0/292 | 0/93 | 1/821 | 1/86 |
| Optic neuritisNervous system disorders | 0/2312 | 0/496 | 0/292 | 0/93 | 0/821 | 1/86 |
| Renal failureRenal and urinary disorders | 1/2312 | 0/496 | 0/292 | 0/93 | 3/821 | 1/86 |
| RashSkin and subcutaneous tissue disorders | 1/2312 | 0/496 | 2/292 | 0/93 | 6/821 | 1/86 |
| PancytopeniaBlood and lymphatic system disorders | 5/2312 | 0/496 | 0/292 | 1/93 | 5/821 | 0/86 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/2312 | 2/496 | 2/292 | 1/93 | 4/821 | 0/86 |
| Event | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin |
|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 435/2312 | 141/496 | 112/292 | 42/93 | 351/821 | 43/86 |
| LeukopeniaBlood and lymphatic system disorders | 129/2312 | 47/496 | 8/292 | 6/93 | 59/821 | 31/86 |
| AstheniaGeneral disorders | 236/2312 | 72/496 | 53/292 | 23/93 | 245/821 | 8/86 |
| PruritusSkin and subcutaneous tissue disorders | 160/2312 | 55/496 | 37/292 | 16/93 | 240/821 | 10/86 |
| NeutropeniaBlood and lymphatic system disorders | 258/2312 | 64/496 | 35/292 | 25/93 | 84/821 | 24/86 |
| ThrombocytopeniaBlood and lymphatic system disorders | 138/2312 | 26/496 | 31/292 | 5/93 | 94/821 | 23/86 |
| NauseaGastrointestinal disorders | 85/2312 | 30/496 | 36/292 | 24/93 | 134/821 | 11/86 |
| FatigueGeneral disorders | 244/2312 | 53/496 | 68/292 | 23/93 | 170/821 | 13/86 |
| RashSkin and subcutaneous tissue disorders | 85/2312 | 25/496 | 24/292 | 9/93 | 155/821 | 9/86 |
| Influenza like illnessGeneral disorders | 167/2312 | 38/496 | 31/292 | 17/93 | 97/821 | 7/86 |
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
| Age, Customized(participants) | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin | Total |
|---|---|---|---|---|---|---|---|
| Less Than or Equal to (<=) 45 Years | 987 | 178 | 73 | 21 | 184 | 14 | 1457 |
| Greater (>) 45 years | 1325 | 318 | 219 | 72 | 637 | 72 | 2643 |
| Sex: Female, Male(Participants) | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin | Total |
|---|---|---|---|---|---|---|---|
| Female | 910 | 250 | 108 | 37 | 331 | 43 | 1679 |
| Male | 1402 | 246 | 184 | 56 | 490 | 43 | 2421 |
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Hoffmann-La Roche