Hepatitis C, Chronic
Conditions
Brief summary
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
180 micrograms/week sc for 24 weeks
800mg po daily for 24 weeks
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * positive serum HCV RNA.
Exclusion criteria
* co-infection with HIV or HBV (patients with a positive HBsAg); * previous treatment with interferon, or peginterferon and/or ribavirin; * severe hepatic dysfunction or decompensated cirrhosis of liver.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virological Response at Week 48 | At Week 48 | Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virological Response at Week 24 | At Week 24 | Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24). |
| Percentage of Participants With Virological Relapse | At week 48 | Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR. |
| Percentage of Participants With Positive Predictive Value | At Week 48 | Positive predictive value is defined as participants with RVR who did not achieve SVR. |
| Percentage of Participants With Rapid Virological Response at Week 4 | At Week 4 | Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR. |
| Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48 | Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets. |
| Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Baseline, Week 4, Week 12, Week 24 and Week 48 | Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of \>3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance. |
| Number of Participants With Any Adverse Events and Any Serious Adverse Events | Up to 48 weeks | An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. |
Countries
Brazil
Participant flow
Recruitment details
A total of 262 participants were enrolled from 13 centers in Brazil. This study was conducted between 26 November 2008 and 19 November 2010.
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a + Ribavirin Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed. | 262 |
| Total | 262 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Detectable HCV RNA after Week 4 | 82 |
| Overall Study | HCV RNA not detected at baseline and SAE | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Refused Treatment | 2 |
| Overall Study | Treatment never started | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a + Ribavirin |
|---|---|
| Age, Continuous | 49.7 Years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 179 / 262 |
| serious Total, serious adverse events | 13 / 262 |
Outcome results
Primary
Percentage of Participants With Sustained Virological Response at Week 48
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
Time frame: At Week 48
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Sustained Virological Response at Week 48 | 52.7 Percentage of participants |
Secondary
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of \>3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 48
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | ALT, Week 4 ( n = 257) | -28.5 Percent change | Standard Error 4.8 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | ALT, Week 12 (n = 159) | -30.4 Percent change | Standard Error 5.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | ALT, Week 24 (n = 156) | -30 Percent change | Standard Error 8.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | ALT, Week 48 (n = 125) | -61.8 Percent change | Standard Error 3.1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | AST, Week 4 ( n = 256) | -19.6 Percent change | Standard Error 2.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | AST, Week 12 (n = 159) | -10.2 Percent change | Standard Error 4.9 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | AST, Week 24 (n = 156) | -7.6 Percent change | Standard Error 8.4 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | AST, Week 48 (n = 125) | -47.2 Percent change | Standard Error 2.9 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Gamma-GT, Week 4 ( n = 243) | 11.8 Percent change | Standard Error 3.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Gamma-GT, Week 12 (n = 151) | 32.5 Percent change | Standard Error 7.9 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Gamma-GT, Week 24 (n = 149) | 69.2 Percent change | Standard Error 25.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Gamma-GT, Week 48 (n = 121) | -33.4 Percent change | Standard Error 3.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting cholesterol, Week 4 ( n = 214) | -1 Percent change | Standard Error 1.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting cholesterol, Week 12 (n = 130) | -1.4 Percent change | Standard Error 2.4 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting cholesterol, Week 24 (n = 123) | 0.6 Percent change | Standard Error 2.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting cholesterol, Week 48 (n = 97) | 15.6 Percent change | Standard Error 2.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting blood glucose, Week 4 ( n = 229) | -3.5 Percent change | Standard Error 1.1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting blood glucose, Week 12 (n = 135) | -1.8 Percent change | Standard Error 2.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting blood glucose, Week 24 (n = 136) | 1.3 Percent change | Standard Error 2.4 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting blood glucose, Week 48 (n = 111) | -1.2 Percent change | Standard Error 2.1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting insulin, Week 4 ( n = 131) | 22.9 Percent change | Standard Error 11.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting insulin, Week 12 (n = 79) | 11.1 Percent change | Standard Error 11.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting insulin, Week 24 (n = 74) | -12.2 Percent change | Standard Error 5.8 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting insulin, Week 48 (n = 68) | 18.3 Percent change | Standard Error 16.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Total bilirubin, Week 4 ( n = 234) | 32.8 Percent change | Standard Error 4.4 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Total bilirubin, Week 12 (n = 148) | 19.3 Percent change | Standard Error 5.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Total bilirubin, Week 24 (n = 123) | 0 Percent change | Standard Error 3.9 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Total bilirubin, Week 48 (n = 108) | -1.7 Percent change | Standard Error 4.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Creatinine, Week 4 ( n = 239) | -1.82 Percent change | Standard Error 0.99 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Creatinine, Week 12 (n = 138) | -2.71 Percent change | Standard Error 1.43 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Creatinine, Week 24 (n = 133) | -3.55 Percent change | Standard Error 1.55 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Creatinine, Week 48 (n = 116) | 5.89 Percent change | Standard Error 1.78 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting triglycerides, Week 4 ( n = 212) | 44.7 Percent change | Standard Error 4.8 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting triglycerides, Week 12 (n = 128) | 56 Percent change | Standard Error 7.2 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting triglycerides, Week 24 (n = 121) | 58.1 Percent change | Standard Error 7.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Fasting triglycerides, Week 48 (n = 92) | 22 Percent change | Standard Error 6.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | HOMA score, Week 4 ( n = 46) | 12.6 Percent change | Standard Error 23.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | HOMA score, Week 12 (n = 37) | 10.3 Percent change | Standard Error 20.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | HOMA score, Week 24 (n = 28) | -14.6 Percent change | Standard Error 11.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | HOMA score, Week 48 (n = 20) | 10.9 Percent change | Standard Error 19.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | PT, Week 4 ( n = 55) | -1.9 Percent change | Standard Error 0.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | PT, Week 12 (n = 31) | -2.6 Percent change | Standard Error 1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | PT, Week 24 (n = 26) | -3.5 Percent change | Standard Error 1.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | PT, Week 48 (n = 30) | -4.1 Percent change | Standard Error 1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | INR, Week 4 ( n = 151) | 0.1 Percent change | Standard Error 1.3 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | INR, Week 12 (n = 73) | -1.1 Percent change | Standard Error 0.8 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | INR, Week 24 (n = 73) | -1.5 Percent change | Standard Error 1.1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | INR, Week 48 (n = 71) | -3.2 Percent change | Standard Error 0.8 |
Secondary
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
Time frame: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematocrit, Week 12 (n = 156) | -17.7 Percent change | Standard Error 0.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hemoglobin, Week 2 ( n =257) | -8.4 Percent change | Standard Error 0.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hemoglobin, Week 4 (n=259) | -15.7 Percent change | Standard Error 0.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hemoglobin, Week 12 (n=157) | -19.6 Percent change | Standard Error 0.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hemoglobin, Week 24 (n=156) | -20.7 Percent change | Standard Error 0.8 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hemoglobin, Week 48 (n=110) | -2.2 Percent change | Standard Error 0.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematocrit, Week 2 ( n = 255) | -8.1 Percent change | Standard Error 0.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematocrit, Week 4 (n = 257) | -14.5 Percent change | Standard Error 0.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematocrit, Week 24 (n = 155) | -17.9 Percent change | Standard Error 0.8 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematocrit, Week 48 (n=110) | -2.3 Percent change | Standard Error 0.6 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Leukocytes, Week 2 ( n = 256) | -33.2 Percent change | Standard Error 1.2 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Leukocytes, Week 4 (n = 258) | -43.4 Percent change | Standard Error 1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Leukocytes, Week 12 (n = 157) | -48.1 Percent change | Standard Error 2.1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Leukocytes, Week 24 (n = 156) | -52.1 Percent change | Standard Error 1.4 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Leukocytes, Week 48 (n = 110) | 0.3 Percent change | Standard Error 2.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Neutrophils, Week 2 ( n = 256) | -42.9 Percent change | Standard Error 2.4 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Neutrophils, Week 4 (n = 258) | -48 Percent change | Standard Error 2.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Neutrophils, Week 12 (n = 157) | -47.3 Percent change | Standard Error 4.1 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Neutrophils, Week 24 (n = 156) | -53.6 Percent change | Standard Error 2 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Neutrophils, Week 48 (n = 110) | 4.5 Percent change | Standard Error 3.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Platelets, Week 2 ( n = 257) | -18.3 Percent change | Standard Error 1.7 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Platelets, Week 4 (n = 259) | -20.4 Percent change | Standard Error 1.5 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Platelets, Week 12 (n = 157) | -26.7 Percent change | Standard Error 2.4 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Platelets, Week 24 (n = 155) | -27.6 Percent change | Standard Error 1.9 |
| Peginterferon Alfa-2a + Ribavirin | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Platelets, Week 48 (n = 110) | 4 Percent change | Standard Error 4.3 |
Secondary
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time frame: Up to 48 weeks
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any AEs | 196 participants |
| Peginterferon Alfa-2a + Ribavirin | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any SAEs | 13 participants |
Secondary
Percentage of Participants With Positive Predictive Value
Positive predictive value is defined as participants with RVR who did not achieve SVR.
Time frame: At Week 48
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Positive Predictive Value | 85.2 percentage of participants |
Secondary
Percentage of Participants With Rapid Virological Response at Week 4
Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.
Time frame: At Week 4
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Rapid Virological Response at Week 4 | 56.9 Percentage of participants |
Secondary
Percentage of Participants With Virological Relapse
Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
Time frame: At week 48
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virological Relapse | 9.4 Percentage of participants |
Secondary
Percentage of Participants With Virological Response at Week 24
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
Time frame: At Week 24
Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Percentage of Participants With Virological Response at Week 24 | 56.9 Percentage of participants |