A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01591460
Collaborator
(none)
165
32
2
22
5.2
0.2
Study Details
Study Description
Brief Summary
This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
165 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An International, Multicenter, Open-Label Study Evaluating Sustained Virological Response and Safety With Boceprevir in Triple Combination Therapy With Peginterferon Alfa-2a (40KD) and Ribavirin in Treatment-Naïve Patients With Genotype 1 Chronic Hepatitis C
Study Start Date
:
Aug 1, 2012
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dual Combination Therapy
|
Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 4 weeks
Drug: ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 4 weeks
|
| Experimental: Triple Combination Therapy
|
Drug: boceprevir
800 mg three times daily for 24, 32 or 44 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously once a week for 24, 32 or 44 weeks
Drug: ribavirin (Copegus]
1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) [At 12 weeks after EOT (up to 60 weeks)]
SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100.
Secondary Outcome Measures
- Percentage of Participants With SVR at 24 Weeks After EOT [At 24 weeks after EOT (up to 72 weeks)]
SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100.
- HCV RNA Levels [At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)]
HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL.
- Percentage of Participants With Virological Response [At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)]
HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100.
- Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA [At Weeks 2, 4, 6, 8, 12, 16, 24, and 28]
HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100.
- Percentage of Participants With Virological Relapse Following EOT Response [Up to 72 weeks (at 12 and 24 weeks after EOT)]
Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.
- Percentage of Participants With Virological Breakthrough Following On-Treatment Response [Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)]
Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.
- Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA [Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)]
Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.
- Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA [At 12 and 24 weeks]
Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100.
- Duration of Treatment With PEG-IFN, RBV, and Boceprevir [Up to 48 weeks (from Baseline until EOT)]
The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks.
- Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason [Up to 48 weeks (from Baseline until EOT)]
Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.
- Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir [Up to 48 weeks (from Baseline until EOT)]
The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100.
- Number of Participants With a Safety-Related Dose Modification [Up to 48 weeks (from Baseline until EOT)]
Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.
- Time to Safety-Related Dose Modification [Up to 48 weeks (from Baseline until EOT)]
Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks.
- Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up [Up to 72 weeks (from Baseline until 24 weeks after EOT)]
Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100.
- Percentage of Participants With a Concomitant Disease Prior to or During the Study [Up to 76 weeks (from Screening until 24 weeks after EOT)]
The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here.
- Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up [Up to 72 weeks (from Baseline until 24 weeks after EOT)]
Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adult patients >/=18 years of age
-
Chronic liver disease consistent with chronic hepatitis C, genotype 1 infection
-
Serum HCV RNA quantifiable at screening
-
Patients who have not been previously treated with pegylated interferon (IFN), standard IFN, RBV or any direct acting anti-viral agent
-
Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score </=6)
-
Negative urine or blood pregnancy test (for women of childbearing potential)
Exclusion Criteria:
-
Women with ongoing pregnancy or breast feeding
-
Male partners of women who are pregnant
-
Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment </=6 months prior to the first dose of study drug
-
Any investigational drug </=6 weeks prior to the first dose of study drug
-
History or other evidence of decompensated liver disease
-
History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
-
Signs or symptoms of hepatocellular carcinoma
-
Co-infection with HCV genotypes other than genotype 1
-
Co-infection with hepatitis A, hepatitis B, and/or human immunodeficiency virus (HIV)
-
Any patient with an increased risk for anemia
-
History of severe psychiatric disease
-
History of immunologically mediated, chronic pulmonary, or severe cardiac disease
-
Current diseases that are not adequately controlled
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Graz | Austria | 8036 | ||
| 2 | Innsbruck | Austria | 6020 | ||
| 3 | Linz | Austria | 4010 | ||
| 4 | Wien | Austria | 1090 | ||
| 5 | Wien | Austria | 1100 | ||
| 6 | Wien | Austria | 1160 | ||
| 7 | Dortmund | Germany | 44263 | ||
| 8 | Frankfurt am Main | Germany | 60594 | ||
| 9 | Hamburg | Germany | 20099 | ||
| 10 | Hannover | Germany | 30625 | ||
| 11 | Oberhausen | Germany | 46145 | ||
| 12 | Budapest | Hungary | 1088 | ||
| 13 | Budapest | Hungary | 1097 | ||
| 14 | Budapest | Hungary | 1126 | ||
| 15 | Debrecen | Hungary | 4032 | ||
| 16 | Kaposvar | Hungary | 7400 | ||
| 17 | Pecs | Hungary | 7624 | ||
| 18 | Bialystok | Poland | 15-540 | ||
| 19 | Bydgoszcz | Poland | 85-030 | ||
| 20 | Chorzow | Poland | 41-500 | ||
| 21 | Lublin | Poland | 20-081 | ||
| 22 | Wrocław | Poland | 50-349 | ||
| 23 | Łodz | Poland | 91-347 | ||
| 24 | Bucharest | Romania | 021105 | ||
| 25 | Bucharest | Romania | 022328 | ||
| 26 | Bucharest | Romania | 030303 | ||
| 27 | Constanta | Romania | 900635 | ||
| 28 | Timisoara | Romania | 300167 | ||
| 29 | Vigo | Pontevedra | Spain | 36200 | |
| 30 | Baracaldo | Vizcaya | Spain | 48903 | |
| 31 | Granada | Spain | 18012 | ||
| 32 | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01591460
Other Study ID Numbers:
- MV28073
- 2011-004810-41
First Posted:
May 4, 2012
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. |
| Period Title: Overall Study | |
| STARTED | 165 |
| COMPLETED | 139 |
| NOT COMPLETED | 26 |
Baseline Characteristics
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. |
| Overall Participants | 165 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
45.8
(12.53)
|
| Gender (Count of Participants) | |
| Female |
83
50.3%
|
| Male |
82
49.7%
|
Outcome Measures
| Title | Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) |
|---|---|
| Description | SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | At 12 weeks after EOT (up to 60 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| Number (95% Confidence Interval) [percentage of participants] |
81
49.1%
|
70
NaN
|
75
NaN
|
88
NaN
|
95
NaN
|
32
NaN
|
| Title | Percentage of Participants With SVR at 24 Weeks After EOT |
|---|---|
| Description | SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | At 24 weeks after EOT (up to 72 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| Number (95% Confidence Interval) [percentage of participants] |
80
48.5%
|
70
NaN
|
71
NaN
|
88
NaN
|
95
NaN
|
32
NaN
|
| Title | HCV RNA Levels |
|---|---|
| Description | HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL. |
| Time Frame | At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population; number (n) = number of participants who provided evaluable data at the respective visit. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| Baseline (n=165,20,24,24,78,19) |
6.29
(0.722)
|
6.34
(0.710)
|
6.40
(0.592)
|
6.46
(0.530)
|
6.18
(0.796)
|
6.34
(0.762)
|
| Week 2 (n=159,18,24,23,76,18) |
4.86
(1.418)
|
5.06
(1.288)
|
6.07
(0.610)
|
5.38
(0.767)
|
4.27
(1.441)
|
4.90
(1.597)
|
| Week 4 (n=158,20,24,22,75,17) |
4.06
(1.525)
|
4.30
(1.533)
|
5.78
(0.550)
|
4.60
(0.874)
|
3.25
(1.289)
|
4.24
(1.689)
|
| Week 6 (n=151,18,24,21,73,15) |
1.75
(0.882)
|
2.01
(1.002)
|
2.70
(0.972)
|
1.91
(0.570)
|
1.25
(0.154)
|
2.18
(1.337)
|
| Week 8 (n=160,20,24,24,77,15) |
1.47
(0.638)
|
1.69
(0.650)
|
1.95
(0.874)
|
1.52
(0.329)
|
1.18
(0.000)
|
1.84
(1.236)
|
| Week 12 (n=160,20,24,24,77,15) |
1.35
(0.682)
|
1.41
(0.393)
|
1.69
(1.316)
|
1.25
(0.107)
|
1.18
(0.000)
|
1.74
(1.292)
|
| Week 16 (n=156,19,22,24,78,13) |
1.25
(0.405)
|
1.34
(0.459)
|
1.46
(0.906)
|
1.19
(0.045)
|
1.18
(0.000)
|
1.32
(0.458)
|
| Week 24 (n=152,17,23,24,78,10) |
1.41
(1.042)
|
1.80
(1.753)
|
1.83
(1.696)
|
1.18
(0.000)
|
1.18
(0.000)
|
2.21
(1.916)
|
| Week 28 (n=143,15,19,23,76,10) |
1.23
(0.480)
|
1.18
(0.000)
|
1.45
(1.173)
|
1.18
(0.000)
|
1.18
(0.025)
|
1.48
(0.822)
|
| Week 36 (n=71,16,21,24,3,7) |
1.69
(1.563)
|
1.54
(1.412)
|
2.00
(2.069)
|
1.33
(0.745)
|
2.60
(2.466)
|
1.91
(1.930)
|
| EOT (n=162,20,24,23,78,17) |
1.52
(1.120)
|
1.58
(1.167)
|
1.87
(1.563)
|
1.38
(0.996)
|
1.18
(0.025)
|
2.73
(1.943)
|
| 12 weeks after EOT (n=152,19,24,23,74,12) |
1.92
(1.792)
|
2.53
(2.340)
|
2.48
(2.345)
|
1.48
(1.087)
|
1.40
(0.946)
|
3.83
(2.789)
|
| 24 weeks after EOT (n=159,20,23,24,78,14) |
2.00
(1.874)
|
2.66
(2.351)
|
2.39
(2.327)
|
1.77
(1.605)
|
1.42
(1.053)
|
4.05
(2.592)
|
| Title | Percentage of Participants With Virological Response |
|---|---|
| Description | HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| Week 2 |
4
2.4%
|
0
NaN
|
0
NaN
|
0
NaN
|
6
NaN
|
5
NaN
|
| Week 4 |
7
4.2%
|
0
NaN
|
0
NaN
|
0
NaN
|
14
NaN
|
5
NaN
|
| Week 6 |
41
24.8%
|
35
NaN
|
0
NaN
|
4
NaN
|
71
NaN
|
26
NaN
|
| Week 8 |
61
37%
|
45
NaN
|
13
NaN
|
0
NaN
|
100
NaN
|
53
NaN
|
| Week 12 |
82
49.7%
|
65
NaN
|
75
NaN
|
67
NaN
|
100
NaN
|
53
NaN
|
| Week 16 |
87
52.7%
|
70
NaN
|
71
NaN
|
96
NaN
|
100
NaN
|
58
NaN
|
| Week 24 |
88
53.3%
|
80
NaN
|
79
NaN
|
100
NaN
|
100
NaN
|
42
NaN
|
| Week 28 |
87
52.7%
|
80
NaN
|
79
NaN
|
96
NaN
|
99
NaN
|
42
NaN
|
| Week 36 |
83
50.3%
|
75
NaN
|
75
NaN
|
96
NaN
|
95
NaN
|
37
NaN
|
| EOT |
87
52.7%
|
80
NaN
|
79
NaN
|
96
NaN
|
99
NaN
|
47
NaN
|
| Title | Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA |
|---|---|
| Description | HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | At Weeks 2, 4, 6, 8, 12, 16, 24, and 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| 3-log, Week 2 |
12
7.3%
|
5
NaN
|
0
NaN
|
0
NaN
|
19
NaN
|
16
NaN
|
| 3-log, Week 4 |
29
17.6%
|
20
NaN
|
0
NaN
|
8
NaN
|
47
NaN
|
26
NaN
|
| 3-log, Week 6 |
88
53.3%
|
85
NaN
|
75
NaN
|
92
NaN
|
97
NaN
|
63
NaN
|
| 3-log, Week 8 |
93
56.4%
|
95
NaN
|
83
NaN
|
100
NaN
|
100
NaN
|
68
NaN
|
| 3-log, Week 12 |
95
57.6%
|
100
NaN
|
88
NaN
|
100
NaN
|
100
NaN
|
74
NaN
|
| 3-log, Week 16 |
94
57%
|
95
NaN
|
88
NaN
|
100
NaN
|
100
NaN
|
68
NaN
|
| 3-log, Week 24 |
90
54.5%
|
80
NaN
|
83
NaN
|
100
NaN
|
100
NaN
|
53
NaN
|
| 3-log, Week 28 |
88
53.3%
|
80
NaN
|
79
NaN
|
96
NaN
|
100
NaN
|
53
NaN
|
| 2-log, Week 2 |
27
16.4%
|
20
NaN
|
0
NaN
|
8
NaN
|
42
NaN
|
26
NaN
|
| 2-log, Week 4 |
51
30.9%
|
50
NaN
|
0
NaN
|
33
NaN
|
76
NaN
|
37
NaN
|
| 2-log, Week 6 |
95
57.6%
|
95
NaN
|
96
NaN
|
96
NaN
|
99
NaN
|
74
NaN
|
| 2-log, Week 8 |
97
58.8%
|
100
NaN
|
100
NaN
|
100
NaN
|
100
NaN
|
74
NaN
|
| 2-log, Week 12 |
95
57.6%
|
100
NaN
|
88
NaN
|
100
NaN
|
100
NaN
|
74
NaN
|
| 2-log, Week 16 |
94
57%
|
95
NaN
|
88
NaN
|
100
NaN
|
100
NaN
|
68
NaN
|
| 2-log, Week 24 |
90
54.5%
|
80
NaN
|
83
NaN
|
100
NaN
|
100
NaN
|
53
NaN
|
| 2-log, Week 28 |
88
53.3%
|
80
NaN
|
79
NaN
|
96
NaN
|
100
NaN
|
53
NaN
|
| 1-log, Week 2 |
55
33.3%
|
60
NaN
|
0
NaN
|
54
NaN
|
73
NaN
|
42
NaN
|
| 1-log, Week 4 |
81
49.1%
|
75
NaN
|
0
NaN
|
100
NaN
|
100
NaN
|
84
NaN
|
| 1-log, Week 6 |
98
59.4%
|
95
NaN
|
100
NaN
|
100
NaN
|
100
NaN
|
84
NaN
|
| 1-log, Week 8 |
98
59.4%
|
100
NaN
|
100
NaN
|
100
NaN
|
100
NaN
|
84
NaN
|
| 1-log, Week 12 |
96
58.2%
|
100
NaN
|
96
NaN
|
100
NaN
|
100
NaN
|
74
NaN
|
| 1-log, Week 16 |
94
57%
|
95
NaN
|
88
NaN
|
100
NaN
|
100
NaN
|
68
NaN
|
| 1-log, Week 24 |
91
55.2%
|
80
NaN
|
88
NaN
|
100
NaN
|
100
NaN
|
58
NaN
|
| 1-log, Week 28 |
88
53.3%
|
80
NaN
|
79
NaN
|
96
NaN
|
100
NaN
|
53
NaN
|
| Title | Percentage of Participants With Virological Relapse Following EOT Response |
|---|---|
| Description | Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | Up to 72 weeks (at 12 and 24 weeks after EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population; only participants with a previous EOT virological response were included in the analysis. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 143 | 16 | 19 | 23 | 77 | 8 |
| Number (95% Confidence Interval) [percentage of participants] |
7
4.2%
|
13
NaN
|
5
NaN
|
9
NaN
|
4
NaN
|
25
NaN
|
| Title | Percentage of Participants With Virological Breakthrough Following On-Treatment Response |
|---|---|
| Description | Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population; only participants with a previous on-treatment virological response were included in the analysis. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 151 | 17 | 19 | 24 | 78 | 13 |
| Number (95% Confidence Interval) [percentage of participants] |
3
1.8%
|
0
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
23
NaN
|
| Title | Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA |
|---|---|
| Description | Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population; only participants with a previous on-treatment decline in HCV RNA were included in the analysis. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 164 | 20 | 24 | 24 | 78 | 18 |
| Number (95% Confidence Interval) [percentage of participants] |
6
3.6%
|
5
NaN
|
17
NaN
|
4
NaN
|
0
NaN
|
22
NaN
|
| Title | Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA |
|---|---|
| Description | Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | At 12 and 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Treated Population. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| Week 12 |
4
2.4%
|
10
NaN
|
13
NaN
|
0
NaN
|
0
NaN
|
11
NaN
|
| Week 24 |
3
1.8%
|
5
NaN
|
8
NaN
|
0
NaN
|
0
NaN
|
11
NaN
|
| Title | Duration of Treatment With PEG-IFN, RBV, and Boceprevir |
|---|---|
| Description | The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks. |
| Time Frame | Up to 48 weeks (from Baseline until EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment; n = number of participants who received the respective study medication. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| PEG-IFN (n=165,20,24,24,78,19) |
28.0
|
48.0
|
48.0
|
48.0
|
28.0
|
26.0
|
| RBV (n=165,20,24,24,78,19) |
28.0
|
48.0
|
48.0
|
48.0
|
28.0
|
27.0
|
| Boceprevir (n=164,20,24,24,78,18) |
24.0
|
44.0
|
44.0
|
32.0
|
24.0
|
10.0
|
| Title | Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason |
|---|---|
| Description | Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | Up to 48 weeks (from Baseline until EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population; n = number of participants who received the respective study medication. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders | Others |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy. |
| Measure Participants | 165 | 20 | 24 | 24 | 78 | 19 |
| PEG-IFN, Any reason (n=165,20,24,24,78,19) |
52
31.5%
|
60
NaN
|
54
NaN
|
46
NaN
|
42
NaN
|
84
NaN
|
| PEG-IFN, Anemia (n=165,20,24,24,78,19) |
1
0.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
5
NaN
|
| PEG-IFN, Asthenia (n=165,20,24,24,78,19) |
1
0.6%
|
0
NaN
|
4
NaN
|
4
NaN
|
0
NaN
|
0
NaN
|
| PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19) |
0.6
0.4%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
| PEG-IFN, Neutropenia (n=165,20,24,24,78,19) |
36
21.8%
|
30
NaN
|
38
NaN
|
33
NaN
|
36
NaN
|
47
NaN
|
| PEG-IFN, Rash (n=165,20,24,24,78,19) |
0.6
0.4%
|
5
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19) |
5
3%
|
35
NaN
|
4
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
| PEG-IFN, Safety/other (n=165,20,24,24,78,19) |
4
2.4%
|
10
NaN
|
4
NaN
|
13
NaN
|
0
NaN
|
0
NaN
|
| PEG-IFN, Poor efficacy (n=165,20,24,24,78,19) |
8
4.8%
|
15
NaN
|
21
NaN
|
4
NaN
|
0
NaN
|
21
NaN
|
| PEG-IFN, Not specified (n=165,20,24,24,78,19) |
12
7.3%
|
0
NaN
|
8
NaN
|
13
NaN
|
8
NaN
|
42
NaN
|
| RBV, Any reason (n=165,20,24,24,78,19) |
64
38.8%
|
65
NaN
|
67
NaN
|
46
NaN
|
62
NaN
|
89
NaN
|
| RBV, Anemia (n=165,20,24,24,78,19) |
46
27.9%
|
50
NaN
|
46
NaN
|
38
NaN
|
53
NaN
|
26
NaN
|
| RBV, Asthenia (n=165,20,24,24,78,19) |
0.6
0.4%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
| RBV, Nausea/vomiting (n=165,20,24,24,78,19) |
1
0.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
11
NaN
|
| RBV, Neutropenia (n=165,20,24,24,78,19) |
3
1.8%
|
0
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
21
NaN
|
| RBV, Rash (n=165,20,24,24,78,19) |
1
0.6%
|
5
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
5
NaN
|
| RBV, Safety/other (n=165,20,24,24,78,19) |
8
4.8%
|
15
NaN
|
8
NaN
|
13
NaN
|
3
NaN
|
16
NaN
|
| RBV, Poor efficacy (n=165,20,24,24,78,19) |
8
4.8%
|
15
NaN
|
21
NaN
|
4
NaN
|
0
NaN
|
21
NaN
|
| RBV, Not specified (n=165,20,24,24,78,19) |
11
6.7%
|
0
NaN
|
8
NaN
|
8
NaN
|
8
NaN
|
42
NaN
|
| Boceprevir, Any reason (n=164,20,24,24,78,18) |
28
17%
|
45
NaN
|
29
NaN
|
21
NaN
|
12
NaN
|
89
NaN
|
| Boceprevir, Anemia (n=164,20,24,24,78,18) |
2
1.2%
|
10
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
0
NaN
|
| Boceprevir, Asthenia (n=164,20,24,24,78,18) |
0.6
0.4%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
| Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18) |
1
0.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
11
NaN
|
| Boceprevir, Neutropenia (n=164,20,24,24,78,18) |
4
2.4%
|
0
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
28
NaN
|
| Boceprevir, Rash (n=164,20,24,24,78,18) |
1
0.6%
|
5
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
6
NaN
|
| Boceprevir, Safety/other (n=164,20,24,24,78,18) |
4
2.4%
|
10
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
17
NaN
|
| Boceprevir, Poor efficacy (n=164,20,24,24,78,18) |
7
4.2%
|
15
NaN
|
21
NaN
|
0
NaN
|
0
NaN
|
17
NaN
|
| Boceprevir, Not specified (n=164,20,24,24,78,18) |
12
7.3%
|
10
NaN
|
8
NaN
|
8
NaN
|
10
NaN
|
28
NaN
|
| Title | Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir |
|---|---|
| Description | The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | Up to 48 weeks (from Baseline until EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population; only participants providing evaluable data were included in the analysis. Arms were not mutually exclusive. |
| Arm/Group Title | Total Population | Cirrhotics | Poor Responders | Late Responders | Early Responders |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28. |
| Measure Participants | 146 | 20 | 24 | 24 | 78 |
| PEG-IFN, <60% |
8
4.8%
|
25
NaN
|
25
NaN
|
0
NaN
|
0
NaN
|
| PEG-IFN, 60 to <80% |
0.7
0.4%
|
0
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
| PEG-IFN, 80 to <95% |
5
3%
|
5
NaN
|
0
NaN
|
17
NaN
|
4
NaN
|
| PEG-IFN, 95% or more |
86
52.1%
|
70
NaN
|
75
NaN
|
79
NaN
|
96
NaN
|
| RBV, <60% |
9
5.5%
|
25
NaN
|
25
NaN
|
4
NaN
|
1
NaN
|
| RBV, 60 to <80% |
0.7
0.4%
|
0
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
| RBV, 80 to <95% |
5
3%
|
10
NaN
|
0
NaN
|
8
NaN
|
4
NaN
|
| RBV, 95% or more |
86
52.1%
|
65
NaN
|
75
NaN
|
83
NaN
|
95
NaN
|
| Boceprevir, <60% |
10
6.1%
|
30
NaN
|
25
NaN
|
8
NaN
|
1
NaN
|
| Boceprevir, 60 to <80% |
0.7
0.4%
|
5
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Boceprevir, 80 to <95% |
3
1.8%
|
5
NaN
|
0
NaN
|
4
NaN
|
3
NaN
|
| Boceprevir, 95% or more |
86
52.1%
|
60
NaN
|
75
NaN
|
88
NaN
|
96
NaN
|
| Title | Number of Participants With a Safety-Related Dose Modification |
|---|---|
| Description | Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | Up to 48 weeks (from Baseline until EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. |
| Measure Participants | 165 |
| Number [participants] |
113
68.5%
|
| Title | Time to Safety-Related Dose Modification |
|---|---|
| Description | Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks. |
| Time Frame | Up to 48 weeks (from Baseline until EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. |
| Measure Participants | 165 |
| Median (95% Confidence Interval) [weeks] |
12.1
|
| Title | Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up |
|---|---|
| Description | Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. |
| Time Frame | Up to 72 weeks (from Baseline until 24 weeks after EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. |
| Measure Participants | 165 |
| Number [percentage of participants] |
6
3.6%
|
| Title | Percentage of Participants With a Concomitant Disease Prior to or During the Study |
|---|---|
| Description | The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here. |
| Time Frame | Up to 76 weeks (from Screening until 24 weeks after EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. |
| Measure Participants | 165 |
| Any disease |
53
32.1%
|
| Hypertension |
18
10.9%
|
| Diabetes mellitus |
8
4.8%
|
| Hypothyroidism |
6
3.6%
|
| Vitamin D deficiency |
5
3%
|
| Title | Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up |
|---|---|
| Description | Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here. |
| Time Frame | Up to 72 weeks (from Baseline until 24 weeks after EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. |
| Measure Participants | 165 |
| Any medication |
79
47.9%
|
| Analgesics |
29
17.6%
|
| NSAIDs |
22
13.3%
|
| Antihistamines |
19
11.5%
|
| Corticosteroids |
19
11.5%
|
| Proton pump inhibitors |
17
10.3%
|
| Vitamins and minerals |
12
7.3%
|
| Beta-adrenoceptor blocking agents |
11
6.7%
|
Adverse Events
| Time Frame | Up to 72 weeks (from Baseline until 24 weeks after EOT) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria. | |||
| Arm/Group Title | Cirrhotics (Safety) | Noncirrhotics (Safety) | ||
| Arm/Group Description | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis. | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis. | ||
All Cause Mortality |
||||
| Cirrhotics (Safety) | Noncirrhotics (Safety) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Cirrhotics (Safety) | Noncirrhotics (Safety) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/21 (33.3%) | 8/144 (5.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/21 (9.5%) | 2/144 (1.4%) | ||
| Granulocytopenia | 0/21 (0%) | 1/144 (0.7%) | ||
| Neutropenia | 0/21 (0%) | 1/144 (0.7%) | ||
| Thrombocytopenia | 1/21 (4.8%) | 0/144 (0%) | ||
| General disorders | ||||
| Fatigue | 0/21 (0%) | 1/144 (0.7%) | ||
| Hepatobiliary disorders | ||||
| Hepatic failure | 2/21 (9.5%) | 0/144 (0%) | ||
| Immune system disorders | ||||
| Drug hypersensitivity | 0/21 (0%) | 1/144 (0.7%) | ||
| Infections and infestations | ||||
| Epididymitis | 0/21 (0%) | 1/144 (0.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Overdose | 0/21 (0%) | 1/144 (0.7%) | ||
| Road traffic accident | 0/21 (0%) | 1/144 (0.7%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Hepatic neoplasm | 1/21 (4.8%) | 0/144 (0%) | ||
| Hepatocellular carcinoma | 1/21 (4.8%) | 0/144 (0%) | ||
| Psychiatric disorders | ||||
| Depression | 0/21 (0%) | 1/144 (0.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Psoriasis | 1/21 (4.8%) | 0/144 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Cirrhotics (Safety) | Noncirrhotics (Safety) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/21 (100%) | 135/144 (93.8%) | ||
| Blood and lymphatic system disorders | ||||
| Neutropenia | 5/21 (23.8%) | 47/144 (32.6%) | ||
| Anaemia | 7/21 (33.3%) | 57/144 (39.6%) | ||
| Thrombocytopenia | 6/21 (28.6%) | 13/144 (9%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 3/21 (14.3%) | 23/144 (16%) | ||
| Diarrhoea | 4/21 (19%) | 15/144 (10.4%) | ||
| Dyspepsia | 3/21 (14.3%) | 11/144 (7.6%) | ||
| Vomiting | 1/21 (4.8%) | 8/144 (5.6%) | ||
| Abdominal pain | 0/21 (0%) | 9/144 (6.3%) | ||
| Gastritis | 2/21 (9.5%) | 2/144 (1.4%) | ||
| Stomatitis | 2/21 (9.5%) | 2/144 (1.4%) | ||
| General disorders | ||||
| Asthenia | 7/21 (33.3%) | 40/144 (27.8%) | ||
| Influenza like illness | 6/21 (28.6%) | 34/144 (23.6%) | ||
| Fatigue | 4/21 (19%) | 31/144 (21.5%) | ||
| Pyrexia | 0/21 (0%) | 26/144 (18.1%) | ||
| Investigations | ||||
| Weight decreased | 2/21 (9.5%) | 8/144 (5.6%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1/21 (4.8%) | 13/144 (9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 1/21 (4.8%) | 13/144 (9%) | ||
| Arthralgia | 1/21 (4.8%) | 13/144 (9%) | ||
| Nervous system disorders | ||||
| Dysgeusia | 6/21 (28.6%) | 45/144 (31.3%) | ||
| Headache | 2/21 (9.5%) | 32/144 (22.2%) | ||
| Dizziness | 1/21 (4.8%) | 13/144 (9%) | ||
| Somnolence | 2/21 (9.5%) | 4/144 (2.8%) | ||
| Psychiatric disorders | ||||
| Insomnia | 3/21 (14.3%) | 17/144 (11.8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 3/21 (14.3%) | 31/144 (21.5%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 4/21 (19%) | 30/144 (20.8%) | ||
| Rash | 3/21 (14.3%) | 19/144 (13.2%) | ||
| Alopecia | 1/21 (4.8%) | 19/144 (13.2%) | ||
| Dry skin | 0/21 (0%) | 8/144 (5.6%) | ||
| Erythema | 2/21 (9.5%) | 5/144 (3.5%) | ||
| Vascular disorders | ||||
| Hypertension | 2/21 (9.5%) | 4/144 (2.8%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-LaRoche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01591460
Other Study ID Numbers:
- MV28073
- 2011-004810-41
First Posted:
May 4, 2012
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016