Hepatitis C, Chronic
Conditions
Brief summary
This study will compare the efficacy and safety of 2 different treatment durations of peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is greater than (\>) 500 individuals.
Interventions
DRUGPeginterferon alfa-2a
PEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\\n
DRUGRibavirin
Ribavirin is available as 200 mg tablets
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients with chronic hepatitis C and genotype 1 (1a or 1b) or genotype 4 * Age between 18 and 70 years * Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test * Present with at least one elevated serum alanine-aminotransferase (ALT) level higher than normal in the last 6 months before therapy start including the screening period * Positive HCV-RNA level in serum * Laboratory parameters (within 35 days prior to study start): -Hepatitis A anti - IgM negativity, HIV-Ab negativity, HBsAg negativity, Hemoglobin values \> 12 g/dl in women or \> 13 g/dl in men, Leukocyte count (WBC) \> 3 000 /mcl, Platelets count \> 100 000/mcl, Creatinine not 1.5 times higher than normal, normal TSH, normal uric acid with a maximum tolerance of 15 % in patients without history of gout * Liver biopsy findings within 6 months prior to study therapy consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis. Biopsies older than 1 year are eligible only after direct communication with the principal investigator * Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. If there is no laboratory report existing, the physician should make an entry in the medical history that the pregnancy test was negative. * All fertile females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end. All fertile men with female partners must be using two forms of effective contraception during treatment and during the 7 months after treatment end. * Written informed consent obtained
Exclusion criteria
* Any IFN and / or Pegylated IFN and ribavirin therapy at any previous time * Class B or C cirrhosis as coded by Child Pugh classification * Women with ongoing pregnancy or breast feeding * Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug * Any investigational drug 6 weeks prior to the first dose of study drug * Drug addiction within 1 year prior to study start (patients participating in an official methadone program are eligible) * Diabetes mellitus in patients receiving an insulin therapy * Hemophiliac patients (due to the increased risk of requested liver biopsy) * History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) * History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease * History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease. Exception: if there is a current psychiatric report which certifies there is no contraindication to interferon therapy, patient may be included * History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.) * History or other evidence of chronic pulmonary disease associated with functional limitation * History of a severe seizure disorder or current anticonvulsant use * History of severe cardiac disease and severe coronary heart disease within the last 6 months (angina pectoris, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia). If there is clinical suspicion of coronary heart disease cardiologic workup of the patient prior to study entry is recommended. * History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease * History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study * History of major organ transplantation with an existing functional graft * Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) * Inability or unwillingness to provide informed consent or abide by the requirements of the study Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Up to Week 96 | Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (\< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (\< 600 units/milliliter \[U/ml\] and \>= 600 U/ml) is presented. |
| Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2) | Up to Week 96 | The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA \< 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96 | The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening. |
| Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96 | The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B). |
| Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Baseline (Day 1) | Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented. |
| Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Up to Week 96 | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2) | Up to Week 96 | Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (\< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1. |
| Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1) | Up to Week 72 | End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D. |
| Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2) | Up to Week 96 | The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA \< 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D. |
| Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96 | The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening. |
| Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96 | The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). |
| Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Baseline (Day 1) | Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented. |
| Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Up to Week 96 | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2) | Up to Week 72 | ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result \< 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D. |
| Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1) | Up to Week 96 | The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA \< 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D. |
Countries
Austria
Participant flow
Recruitment details
This study was conducted in 2 parts. Part 1 was conducted from 16 May 2003 to 12 September 2008 at 21 centers in Austria; Part 2 of this study was conducted from 19 October 2009 to 15 November 2013 at 15 centers in Austria.
Pre-assignment details
A total of 545 participants were enrolled in Part 1, of which 5 participants were treated but were not included in any analysis population due to a missing post-baseline safety assessment. A total of 176 participants were enrolled in Part 2 of this study.
Participants by arm
| Arm | Count |
|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks. | 142 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks. | 152 |
| PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (\< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (\>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks. | 78 |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks. | 156 |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment. | 12 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks. | 36 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks. | 25 |
| PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without a \> 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks. | 20 |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (\< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks. | 42 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (\>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks. | 45 |
| PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2) Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment. | 8 |
| Total | 716 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 8 | 2 | 2 | 5 | 1 | 5 | 0 | 1 | 1 | 5 |
| Overall Study | Baseline viral load unavailable | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Blood could not be drawn | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Exclusion criterion during screening | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Financial problems | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Inclusion criteria not fulfilled | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 5 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Missing PCR result at Week 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Negative PCR result | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | No 2 Log drop at Week 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Non-response Week 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | No PCR at baseline | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Participant cannot be reached | 4 | 4 | 0 | 8 | 2 | 1 | 0 | 1 | 0 | 2 | 1 |
| Overall Study | Participant's compliance | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 1 |
| Overall Study | Participant showed relapse | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Participant showed weight reduction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Participant's PCR high | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Participant stopped study/treatment | 1 | 3 | 1 | 0 | 0 | 1 | 2 | 0 | 1 | 0 | 0 |
| Overall Study | Participant treated after Week 24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Participant unable to attend study visit | 4 | 10 | 1 | 2 | 5 | 1 | 1 | 1 | 0 | 2 | 0 |
| Overall Study | Participation in sili rescue study | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | PCR not performed at Week 12 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | PCR positive | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | PCR positive at follow up 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | PCR positive at Week 24 | 15 | 21 | 62 | 0 | 0 | 6 | 3 | 8 | 0 | 1 | 0 |
| Overall Study | PCR positive at Week 28 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | PCR positive at Week 48 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | PCR positive at Week 68 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | PCR sample for Week 4 not drawn | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Source data not found | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Therapy stopped due to misunderstanding | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal of informed consent | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1) | PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2) | PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2) | PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2) | PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2) | PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 10.7 | 44.2 years STANDARD_DEVIATION 10.2 | 46.6 years STANDARD_DEVIATION 9 | 40.5 years STANDARD_DEVIATION 11.7 | 46.5 years STANDARD_DEVIATION 9.5 | 44.6 years STANDARD_DEVIATION 9.1 | 47.3 years STANDARD_DEVIATION 9.8 | 46.6 years STANDARD_DEVIATION 8.7 | 37.8 years STANDARD_DEVIATION 11.1 | 41.1 years STANDARD_DEVIATION 10.2 | 43.6 years STANDARD_DEVIATION 15.4 | 43.5 years STANDARD_DEVIATION 10.78 |
| Sex: Female, Male Female | 50 Participants | 53 Participants | 21 Participants | 57 Participants | 4 Participants | 8 Participants | 8 Participants | 5 Participants | 17 Participants | 20 Participants | 3 Participants | 246 Participants |
| Sex: Female, Male Male | 92 Participants | 99 Participants | 57 Participants | 99 Participants | 8 Participants | 28 Participants | 17 Participants | 15 Participants | 25 Participants | 25 Participants | 5 Participants | 470 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 139 / 142 | 147 / 152 | 76 / 78 | 150 / 156 | 9 / 12 | 36 / 36 | 25 / 25 | 19 / 20 | 40 / 42 | 42 / 45 | 6 / 8 |
| serious Total, serious adverse events | 22 / 142 | 28 / 152 | 8 / 78 | 14 / 156 | 2 / 12 | 1 / 36 | 3 / 25 | 2 / 20 | 5 / 42 | 7 / 45 | 1 / 8 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA \< 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.
Time frame: Up to Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2) | Genotype I, n = 33, 23, 39 | 30.3 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2) | Genotype IV, n = 3, 2, 6 | 33.3 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2) | Genotype I, n = 33, 23, 39 | 34.8 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2) | Genotype IV, n = 3, 2, 6 | 0.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2) | Genotype I, n = 33, 23, 39 | 64.1 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2) | Genotype IV, n = 3, 2, 6 | 50.0 Percentage of participants |
Comparison: Comparison of Groups A1+B1 versus group E stratified by genotype I.p-value: 0.0021Cochran-Mantel-Haenszel
Comparison: Comparison of Groups A1+B1 versus group E stratified by genotype IVp-value: 0.3031Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (\< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (\< 600 units/milliliter \[U/ml\] and \>= 600 U/ml) is presented.
Time frame: Up to Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype IV, Week 4 response < 600 U/ml, n =12, 16 | 0.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype I, Week 4 response < 600 U/ml,n= 130, 136 | 22.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype IV, Week 4 response >=600 U/ml, n =12, 16 | 80.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype I,Week 4 response >=600 U/ml, n =130, 136 | 52.7 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype IV, Week 4 response >=600 U/ml, n =12, 16 | 80.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype I, Week 4 response < 600 U/ml,n= 130, 136 | 8.3 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype IV, Week 4 response < 600 U/ml, n =12, 16 | 42.9 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) | Genotype I,Week 4 response >=600 U/ml, n =130, 136 | 30.0 Percentage of participants |
Comparison: For Genotype I, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.p-value: 0.1002Chi-squared
Comparison: For Genotype I, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.p-value: 0.0184Chi-squared
Comparison: For Genotype IV, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.p-value: 0.091Chi-squared
Comparison: For Genotype IV, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.p-value: 1Chi-squared
Secondary
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).
Time frame: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed for a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 72, n = 8, 7, 1 | 3.9 scores on a scale | Standard Deviation 1.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 48, n = 11, 7, 0 | 4.0 scores on a scale | Standard Deviation 1.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Baseline, n = 22, 17, 15 | 3.7 scores on a scale | Standard Deviation 1.6 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 24, n = 17, 15, 9 | 4.2 scores on a scale | Standard Deviation 1.7 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 96, n = 0, 7, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 48, n = 11, 7, 0 | 4.5 scores on a scale | Standard Deviation 1.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Baseline, n = 22, 17, 15 | 3.8 scores on a scale | Standard Deviation 2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 24, n = 17, 15, 9 | 4.9 scores on a scale | Standard Deviation 1.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 72, n = 8, 7, 1 | 3.8 scores on a scale | Standard Deviation 2.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 96, n = 0, 7, 0 | 4.5 scores on a scale | Standard Deviation 1.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 96, n = 0, 7, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 72, n = 8, 7, 1 | 5.3 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Baseline, n = 22, 17, 15 | 3.9 scores on a scale | Standard Deviation 1.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 48, n = 11, 7, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2) | Week 24, n = 17, 15, 9 | 4.8 scores on a scale | Standard Deviation 1.6 |
Secondary
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).
Time frame: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 24, n = 69, 77 | 4.5 scores on a scale | Standard Deviation 1.7 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 72, n = 58, 62 | 3.0 scores on a scale | Standard Deviation 1.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 48, n = 59, 63 | 4.7 scores on a scale | Standard Deviation 1.6 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 96, n = 0, 57 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Baseline, n = 104, 114 | 3.6 scores on a scale | Standard Deviation 1.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 96, n = 0, 57 | 3.4 scores on a scale | Standard Deviation 1.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Baseline, n = 104, 114 | 3.4 scores on a scale | Standard Deviation 1.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 24, n = 69, 77 | 4.7 scores on a scale | Standard Deviation 1.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 48, n = 59, 63 | 4.7 scores on a scale | Standard Deviation 1.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1) | Week 72, n = 58, 62 | 4.3 scores on a scale | Standard Deviation 1.8 |
Secondary
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.
Time frame: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 24, n = 17, 13, 9 | 61.8 scores on a scale | Standard Deviation 25.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 48, n = 13, 8, 0 | 62.5 scores on a scale | Standard Deviation 27.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 24, n = 17, 13, 8 | 64.7 scores on a scale | Standard Deviation 26.6 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 72, n = 10, 7, 1 | 77.5 scores on a scale | Standard Deviation 20.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning -Emotional,Baseline,n =22, 18, 15 | 71.2 scores on a scale | Standard Deviation 38.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning-Emotional, Week 24, n=17, 13, 8 | 43.1 scores on a scale | Standard Deviation 43.7 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 48, n= 13, 8, 0 | 43.6 scores on a scale | Standard Deviation 39.4 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 72, n= 10, 7, 1 | 56.7 scores on a scale | Standard Deviation 49.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 96, n = 0, 5, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Baseline, n = 22, 18, 15 | 82.5 scores on a scale | Standard Deviation 22.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 48, n = 13, 8, 0 | 66.5 scores on a scale | Standard Deviation 22.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 72, n = 10, 7, 1 | 77.0 scores on a scale | Standard Deviation 18.4 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Baseline, n = 21, 18, 15 | 71.6 scores on a scale | Standard Deviation 18.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning- Physical, Baseline,n =22, 18, 15 | 75.0 scores on a scale | Standard Deviation 33.6 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 24, n= 17, 13, 8 | 41.2 scores on a scale | Standard Deviation 44.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 48, n = 13, 8, 0 | 41.0 scores on a scale | Standard Deviation 41.3 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 24, n = 17, 11, 8 | 58.8 scores on a scale | Standard Deviation 21.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical,, Week 72, n= 10, 7,1 | 60.0 scores on a scale | Standard Deviation 47.4 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 96, n = 0, 5, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Baseline, n = 21, 19, 15 | 75.3 scores on a scale | Standard Deviation 26.7 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 48, n = 13, 8, 0 | 57.4 scores on a scale | Standard Deviation 24 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 24, n = 17, 13, 8 | 57.9 scores on a scale | Standard Deviation 28.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 48, n = 13, 8, 0 | 66.4 scores on a scale | Standard Deviation 31.6 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 72, n = 9, 7, 1 | 66.7 scores on a scale | Standard Deviation 24 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 72, n = 10, 7, 1 | 71.1 scores on a scale | Standard Deviation 30.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition,Baseline, n =22, 19, 15 | 3.0 scores on a scale | Standard Deviation 1.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Baseline, n = 22, 16, 14 | 61.8 scores on a scale | Standard Deviation 18.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 24, n = 17, 11, 8 | 52.8 scores on a scale | Standard Deviation 23.6 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 48, n = 12, 8, 0 | 54.4 scores on a scale | Standard Deviation 21 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 72, n = 10, 7, 1 | 55.0 scores on a scale | Standard Deviation 21.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Baseline, n = 21, 18, 15 | 54.0 scores on a scale | Standard Deviation 21.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 24, n = 17, 11, 8 | 37.8 scores on a scale | Standard Deviation 13.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 48, n = 13, 8, 0 | 43.2 scores on a scale | Standard Deviation 22.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 72, n = 9, 7, 1 | 47.2 scores on a scale | Standard Deviation 23.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Baseline, n = 22, 19, 15 | 84.7 scores on a scale | Standard Deviation 18.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 24, 17, 13, 9 | 3.8 scores on a scale | Standard Deviation 1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 48, n = 13, 8, 0 | 2.9 scores on a scale | Standard Deviation 1.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 72, n = 10, 7, 1 | 2.8 scores on a scale | Standard Deviation 1.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 48, n = 13, 8, 0 | 48.1 scores on a scale | Standard Deviation 17.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Baseline, n = 21, 18, 15 | 62.9 scores on a scale | Standard Deviation 22 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning- Physical, Baseline,n =22, 18, 15 | 62.0 scores on a scale | Standard Deviation 42.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Baseline, n = 21, 18, 15 | 52.5 scores on a scale | Standard Deviation 19.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 24, n= 17, 13, 8 | 15.4 scores on a scale | Standard Deviation 33.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 48, n = 13, 8, 0 | 56.3 scores on a scale | Standard Deviation 39.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 24, n = 17, 11, 8 | 31.2 scores on a scale | Standard Deviation 21.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical,, Week 72, n= 10, 7,1 | 82.1 scores on a scale | Standard Deviation 37.4 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 24, n = 17, 11, 8 | 46.2 scores on a scale | Standard Deviation 18.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 96, n = 0, 5, 0 | 70.0 scores on a scale | Standard Deviation 32.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 48, n = 13, 8, 0 | 2.9 scores on a scale | Standard Deviation 1.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Baseline, n = 21, 19, 15 | 76.3 scores on a scale | Standard Deviation 25.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 24, n = 17, 13, 8 | 45.9 scores on a scale | Standard Deviation 27.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 72, n = 9, 7, 1 | 60.2 scores on a scale | Standard Deviation 16.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 72, n = 9, 7, 1 | 66.9 scores on a scale | Standard Deviation 17.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 96, n = 0, 6, 0 | 58.3 scores on a scale | Standard Deviation 15.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 48, n = 13, 8, 0 | 54.6 scores on a scale | Standard Deviation 19.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 96, n = 0, 6, 0 | 2.0 scores on a scale | Standard Deviation 0.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 72, n = 10, 7, 1 | 70.4 scores on a scale | Standard Deviation 15 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 96, n = 0, 6, 0 | 56.9 scores on a scale | Standard Deviation 15.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 96, n = 0, 6, 0 | 74.5 scores on a scale | Standard Deviation 19.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 72, n = 10, 7, 1 | 2.6 scores on a scale | Standard Deviation 1.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 24, n = 17, 13, 9 | 51.2 scores on a scale | Standard Deviation 25.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Baseline, n = 22, 16, 14 | 56.7 scores on a scale | Standard Deviation 21.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 48, n = 13, 8, 0 | 61.0 scores on a scale | Standard Deviation 16.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Baseline, n = 22, 19, 15 | 78.9 scores on a scale | Standard Deviation 25 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 24, n = 17, 13, 8 | 56.7 scores on a scale | Standard Deviation 23.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 48, n = 13, 8, 0 | 78.1 scores on a scale | Standard Deviation 27.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition,Baseline, n =22, 19, 15 | 2.9 scores on a scale | Standard Deviation 0.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 72, n = 10, 7, 1 | 78.6 scores on a scale | Standard Deviation 15.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 24, n = 17, 11, 8 | 37.1 scores on a scale | Standard Deviation 14.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 96, n = 0, 6, 0 | 83.3 scores on a scale | Standard Deviation 17.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning -Emotional,Baseline,n =22, 18, 15 | 62.0 scores on a scale | Standard Deviation 42.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning-Emotional, Week 24, n=17, 13, 8 | 20.5 scores on a scale | Standard Deviation 37.4 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 48, n = 12, 8, 0 | 56.3 scores on a scale | Standard Deviation 23.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 48, n= 13, 8, 0 | 54.2 scores on a scale | Standard Deviation 46.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 72, n= 10, 7, 1 | 81.0 scores on a scale | Standard Deviation 37.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 96, n = 0, 5, 0 | 60.0 scores on a scale | Standard Deviation 43.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 72, n = 10, 7, 1 | 59.9 scores on a scale | Standard Deviation 16.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Baseline, n = 22, 18, 15 | 83.1 scores on a scale | Standard Deviation 17.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 48, n = 13, 8, 0 | 76.3 scores on a scale | Standard Deviation 19.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 24, 17, 13, 9 | 3.5 scores on a scale | Standard Deviation 1.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 72, n = 10, 7, 1 | 80.7 scores on a scale | Standard Deviation 9.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 96, n = 0, 6, 0 | 52.8 scores on a scale | Standard Deviation 18.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 96, n = 0, 6, 0 | 85.8 scores on a scale | Standard Deviation 17.7 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 72, n = 10, 7, 1 | 45.0 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 24, 17, 13, 9 | 3.2 scores on a scale | Standard Deviation 1.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning-Emotional, Week 24, n=17, 13, 8 | 45.8 scores on a scale | Standard Deviation 50.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Baseline, n = 21, 18, 15 | 62.1 scores on a scale | Standard Deviation 20.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Baseline, n = 22, 18, 15 | 78.5 scores on a scale | Standard Deviation 28.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning- Physical, Baseline,n =22, 18, 15 | 53.3 scores on a scale | Standard Deviation 41 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 24, n = 17, 13, 9 | 72.2 scores on a scale | Standard Deviation 24.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 48, n= 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 24, n= 17, 13, 8 | 43.8 scores on a scale | Standard Deviation 43.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Baseline, n = 21, 18, 15 | 45.0 scores on a scale | Standard Deviation 16 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Baseline, n = 22, 19, 15 | 72.5 scores on a scale | Standard Deviation 33.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 48, n = 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Baseline, n = 22, 16, 14 | 53.4 scores on a scale | Standard Deviation 19.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 48, n = 12, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical,, Week 72, n= 10, 7,1 | 0.0 scores on a scale | Standard Deviation 0 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 24, n = 17, 13, 8 | 65.6 scores on a scale | Standard Deviation 23.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 24, n = 17, 11, 8 | 62.0 scores on a scale | Standard Deviation 19.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 24, n = 17, 11, 8 | 43.1 scores on a scale | Standard Deviation 17.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 72, n = 10, 7, 1 | 35.0 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Physical, Week 96, n = 0, 5, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 48, n = 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 72, n= 10, 7, 1 | 0.0 scores on a scale | Standard Deviation 0 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 48, n = 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Baseline, n = 21, 19, 15 | 66.5 scores on a scale | Standard Deviation 31.7 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 48, n = 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 72, n = 10, 7, 1 | 4.0 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 24, n = 17, 13, 8 | 54.9 scores on a scale | Standard Deviation 17.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition, Week 48, n = 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 72, n = 10, 7, 1 | 25.0 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 72, n = 9, 7, 1 | 36.0 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 72, n = 9, 7, 1 | 40.0 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning - Emotional, Week 96, n = 0, 5, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Mental Health, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Social Functioning, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 48, n = 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | General Health, Week 24, n = 17, 11, 8 | 57.1 scores on a scale | Standard Deviation 24.4 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Physical functioning, Week 48, n = 13, 8, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 72, n = 10, 7, 1 | 62.0 scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Role Functioning -Emotional,Baseline,n =22, 18, 15 | 53.3 scores on a scale | Standard Deviation 45.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Vitality, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Reported Health Transition,Baseline, n =22, 19, 15 | 3.3 scores on a scale | Standard Deviation 1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2) | Bodily Pain, Week 96, n = 0, 6, 0 | NA scores on a scale | — |
Secondary
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.
Time frame: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 24, n = 76, 91 | 68.2 scores on a scale | Standard Deviation 31.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 72, n = 63, 67 | 66.9 scores on a scale | Standard Deviation 18.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Baseline, n = 106, 121 | 86.9 scores on a scale | Standard Deviation 15.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 96, n = 0, 59 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 48, n = 67, 77 | 69.5 scores on a scale | Standard Deviation 28.6 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Baseline, n = 105, 121 | 79.8 scores on a scale | Standard Deviation 21.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 24, n = 77, 88 | 39.0 scores on a scale | Standard Deviation 43 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 24, n = 77, 91 | 64.4 scores on a scale | Standard Deviation 28.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 72, n = 64, 70 | 85.4 scores on a scale | Standard Deviation 23.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 48, n = 67, 78 | 71.6 scores on a scale | Standard Deviation 24 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 48, n = 67, 77 | 66.1 scores on a scale | Standard Deviation 26.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 72, n = 65, 70 | 86.3 scores on a scale | Standard Deviation 22.3 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 96, n = 0, 61 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 96, n = 0, 61 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 48, n = 66, 76 | 40.7 scores on a scale | Standard Deviation 39.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional,Baseline,n = 104, 120 | 71.5 scores on a scale | Standard Deviation 39.3 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Baseline, n = 102, 119 | 64.5 scores on a scale | Standard Deviation 17.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 24, n = 76, 88 | 36.8 scores on a scale | Standard Deviation 42.4 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Baseline,n = 105, 120 | 74.7 scores on a scale | Standard Deviation 36.3 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 48, n = 66, 74 | 41.7 scores on a scale | Standard Deviation 41 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 24, n = 75, 83 | 58.9 scores on a scale | Standard Deviation 19 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 72, n = 65, 66 | 80.5 scores on a scale | Standard Deviation 32.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 72, n = 65, 67 | 81.5 scores on a scale | Standard Deviation 32.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 96, n = 0, 58 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 48, n = 63, 74 | 58.1 scores on a scale | Standard Deviation 20.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Baseline, n = 103, 115 | 69.6 scores on a scale | Standard Deviation 18.7 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 72, n = 65, 68 | 89.8 scores on a scale | Standard Deviation 14.1 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 24, n = 76, 88 | 60.7 scores on a scale | Standard Deviation 19.3 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 72, n = 65, 62 | 71.7 scores on a scale | Standard Deviation 18.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 48, n = 66, 77 | 62.6 scores on a scale | Standard Deviation 19.8 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 96, n = 0, 58 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 72, n = 63, 67 | 76.3 scores on a scale | Standard Deviation 16.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 96, n = 0, 59 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 96, n = 0, 59 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 24, n = 77, 90 | 61.8 scores on a scale | Standard Deviation 28.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Baseline, n = 105, 123 | 3.1 scores on a scale | Standard Deviation 0.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Baseline, n = 103, 116 | 56.8 scores on a scale | Standard Deviation 20.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 24, n = 77, 90 | 3.5 scores on a scale | Standard Deviation 1.2 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Baseline, n = 103, 120 | 82.3 scores on a scale | Standard Deviation 22.5 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 48, n = 67, 77 | 3.2 scores on a scale | Standard Deviation 1.3 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 24, n = 75, 88 | 40.3 scores on a scale | Standard Deviation 24 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 72, n = 65, 69 | 1.6 scores on a scale | Standard Deviation 0.9 |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 96, n = 0, 59 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 96, n = 0, 61 | NA scores on a scale | — |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 48, n = 66, 77 | 40.6 scores on a scale | Standard Deviation 23.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 96, n = 0, 61 | 1.3 scores on a scale | Standard Deviation 0.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Baseline, n = 106, 121 | 87.0 scores on a scale | Standard Deviation 17.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 24, n = 77, 90 | 69.2 scores on a scale | Standard Deviation 22.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 48, n = 67, 77 | 66.8 scores on a scale | Standard Deviation 23.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 72, n = 65, 68 | 70.3 scores on a scale | Standard Deviation 24.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Baseline,n = 105, 120 | 76.2 scores on a scale | Standard Deviation 36.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 24, n = 77, 88 | 45.7 scores on a scale | Standard Deviation 41.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 48, n = 66, 76 | 42.2 scores on a scale | Standard Deviation 44 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 72, n = 65, 67 | 47.4 scores on a scale | Standard Deviation 43.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Physical, Week 96, n = 0, 58 | 84.5 scores on a scale | Standard Deviation 29.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Baseline, n = 103, 120 | 83.5 scores on a scale | Standard Deviation 22.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 24, n = 76, 91 | 70.0 scores on a scale | Standard Deviation 29.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 48, n = 67, 77 | 66.8 scores on a scale | Standard Deviation 30.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 72, n = 64, 70 | 67.3 scores on a scale | Standard Deviation 29.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Bodily Pain, Week 96, n = 0, 61 | 90.2 scores on a scale | Standard Deviation 19.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Baseline, n = 102, 119 | 66.3 scores on a scale | Standard Deviation 19.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 24, n = 75, 83 | 55.1 scores on a scale | Standard Deviation 22.8 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 48, n = 63, 74 | 56.3 scores on a scale | Standard Deviation 19.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 72, n = 65, 62 | 60.1 scores on a scale | Standard Deviation 19.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | General Health, Week 96, n = 0, 59 | 70.3 scores on a scale | Standard Deviation 18.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Baseline, n = 103, 116 | 58.9 scores on a scale | Standard Deviation 22.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 24, n = 75, 88 | 40.6 scores on a scale | Standard Deviation 23.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 48, n = 66, 77 | 41.2 scores on a scale | Standard Deviation 21.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 72, n = 63, 67 | 43.5 scores on a scale | Standard Deviation 22.4 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Vitality, Week 96, n = 0, 59 | 62.9 scores on a scale | Standard Deviation 21.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Baseline, n = 105, 121 | 81.6 scores on a scale | Standard Deviation 22 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 24, n = 77, 91 | 64.1 scores on a scale | Standard Deviation 30.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 48, n = 67, 78 | 57.2 scores on a scale | Standard Deviation 27.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 72, n = 65, 70 | 63.8 scores on a scale | Standard Deviation 29.4 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Social Functioning, Week 96, n = 0, 61 | 83.4 scores on a scale | Standard Deviation 23.4 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional,Baseline,n = 104, 120 | 75.8 scores on a scale | Standard Deviation 36.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 24, n = 76, 88 | 43.9 scores on a scale | Standard Deviation 43.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 48, n = 66, 74 | 42.8 scores on a scale | Standard Deviation 42.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 72, n = 65, 66 | 43.4 scores on a scale | Standard Deviation 43.4 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Role Functioning - Emotional, Week 96, n = 0, 58 | 84.5 scores on a scale | Standard Deviation 31.4 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Baseline, n = 103, 115 | 71.9 scores on a scale | Standard Deviation 19.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 24, n = 76, 88 | 57.9 scores on a scale | Standard Deviation 21.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 48, n = 66, 77 | 59.6 scores on a scale | Standard Deviation 20.7 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 72, n = 63, 67 | 60.8 scores on a scale | Standard Deviation 18.5 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Mental Health, Week 96, n = 0, 59 | 72.3 scores on a scale | Standard Deviation 14.6 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Baseline, n = 105, 123 | 3.0 scores on a scale | Standard Deviation 0.9 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 24, n = 77, 90 | 3.2 scores on a scale | Standard Deviation 1.2 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 48, n = 67, 77 | 3.0 scores on a scale | Standard Deviation 1.3 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Reported Health Transition, Week 72, n = 65, 69 | 2.3 scores on a scale | Standard Deviation 1.1 |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1) | Physical Functioning, Week 96, n = 0, 59 | 87.0 scores on a scale | Standard Deviation 20.4 |
Secondary
Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to Week 96
Population: The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any AE | 140 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any SAE | 22 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any AE | 149 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any SAE | 28 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any AE | 76 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any SAE | 8 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any SAE | 14 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any AE | 153 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any AE | 10 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 1) | Number of participants with any SAE | 2 Number of participants |
Secondary
Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to Week 96
Population: The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any AE | 36 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any SAE | 1 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any AE | 25 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any SAE | 3 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any AE | 19 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any SAE | 2 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any AE | 40 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any SAE | 5 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any AE | 43 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any SAE | 7 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any AE | 7 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2) | Number of Participants With Adverse Events and Serious Adverse Events (Part 2) | Number of participants with any SAE | 1 Number of participants |
Secondary
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.
Time frame: Baseline (Day 1)
Population: The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 2 | 64 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 1 | 38 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 0 | 11 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 3 | 18 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 4 | 11 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 2 | 68 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 0 | 15 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 1 | 40 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 3 | 13 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 4 | 16 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 4 | 11 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 0 | 8 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 2 | 23 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 3 | 15 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 1 | 20 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 1 | 57 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 0 | 17 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 2 | 58 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 4 | 14 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 3 | 10 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 3 | 3 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 4 | 0 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 2 | 6 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 0 | 1 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1) | Grade 1 | 1 Number of participants |
Secondary
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.
Time frame: Baseline (Day 1)
Population: The ITT population included all participants randomized and allocated to receive treatments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 3 | 5 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 0 | 5 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 4 | 5 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 1 | 6 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 2 | 4 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 3 | 2 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 2 | 4 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 1 | 3 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 4 | 4 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 0 | 4 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 2 | 6 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 0 | 1 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 1 | 2 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 3 | 5 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 4 | 1 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 4 | 0 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 0 | 4 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 3 | 1 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 2 | 10 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 1 | 8 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 2 | 8 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 3 | 1 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 0 | 3 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 4 | 5 Number of participants |
| PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1) | Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2) | Grade 1 | 9 Number of participants |
Secondary
Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)
The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA \< 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.
Time frame: Up to Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1) | 45.1 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1) | 48.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1) | 6.4 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1) | 73.7 Percentage of participants |
Secondary
Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)
The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA \< 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.
Time frame: Up to Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2) | 0.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2) | 73.8 Percentage of participants |
Secondary
Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)
Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (\< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.
Time frame: Up to Week 96
Population: The ITT population included all participants randomized and allocated to receive treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2) | 41.2 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2) | 38.5 Percentage of participants |
Secondary
Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)
End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.
Time frame: Up to Week 72
Population: The ITT population included all participants randomized and allocated to receive treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1) | 74.6 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1) | 64.5 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1) | 9.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1) | 92.3 Percentage of participants |
Secondary
Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)
ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result \< 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.
Time frame: Up to Week 72
Population: The ITT population included all participants randomized and allocated to receive treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) | Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2) | 47.2 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) | Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2) | 52.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) | Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2) | 5.0 Percentage of participants |
| PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1) | Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2) | 90.5 Percentage of participants |