Hepatitis C, Chronic
Conditions
Brief summary
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
DRUGribavirin
800 mg orally daily
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, 18-65 years of age * Chronic hepatitis C, genotype 2 or 3 * Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test) * Abdominal sonography within 3 months prior to study start
Exclusion criteria
* Previous interferon and/or pegylated interferon and ribavirin therapy * Liver cirrhosis, class B or C (Child-Pugh) * Systemic anti-neoplastic or immunomodulatory treatment \<=6 months before study drug * History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C * Decompensated liver disease * Positive for HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment | Up to Week 48 (24 weeks post completion of the treatment) | Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment. |
| Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | At Week 24 and Week 48 | Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events and Any Serious Adverse Events | Up to Week 48 | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. 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. |
| Median Hemoglobin Levels at End of Treatment | At Week 16 and Week 24 | Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was \>=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day. |
| Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | At Baseline (Week 0) and Weeks 16, 24 and 48 | Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0. |
| Percentage of Participants With Virological Response at the End of the Treatment | At Week 16 and Week 24 | Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24. |
| Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | At Baseline (Week 0) and Weeks 16, 24 and 48 | Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0. |
| Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48 | For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0. |
| Time to Viral Response | Up to Week 48 | Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 \[in days\]. Mean of number of days to viral response for overall population were reported. |
| Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | At Baseline (Week 0) and Weeks 16, 24 and 48 | The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0. |
| Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | At Week 16 and Week 24 | Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24. |
Countries
Austria
Participant flow
Recruitment details
A total of 395 participants were recruited at 20 centres in Austria in the study conducted from 20 May 2003 to 10 July 2008.
Pre-assignment details
Of the 395 participants, 380 were randomized to treatment groups. A total of 15 participants were screening failures.
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W. | 151 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W. | 144 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W. | 33 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W. | 52 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 6 | 0 | 0 |
| Overall Study | Extra exclusion criterion amended | 2 | 1 | 1 | 1 |
| Overall Study | Informed consent has been withdrawn | 2 | 2 | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 5 | 0 | 6 |
| Overall Study | Other reason | 7 | 8 | 1 | 8 |
| Overall Study | Patient is not able to attend visits | 8 | 9 | 7 | 6 |
| Overall Study | Patient´s compliance | 4 | 3 | 1 | 2 |
| Overall Study | PCR positive at week 24 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Peginterferon/Ribavirin 800 mg (24 Weeks) | Peginterferon/Ribavirin 400 mg (24 Weeks) | Peginterferon/Ribavirin 800 mg (16 Weeks) | Peginterferon/Ribavirin 400 mg (16 Weeks) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.8 Years STANDARD_DEVIATION 11.1 | 35.7 Years STANDARD_DEVIATION 10.2 | 35.8 Years STANDARD_DEVIATION 11.2 | 35.2 Years STANDARD_DEVIATION 10 | 36.1 Years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 62 Participants | 54 Participants | 14 Participants | 21 Participants | 151 Participants |
| Sex: Female, Male Male | 89 Participants | 90 Participants | 19 Participants | 31 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 133 / 144 | 128 / 141 | 27 / 30 | 38 / 48 |
| serious Total, serious adverse events | 12 / 144 | 18 / 141 | 0 / 30 | 2 / 48 |
Outcome results
Primary
Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.
Time frame: Up to Week 48 (24 weeks post completion of the treatment)
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment | 80.9 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment | 78.2 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment | 81.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment | 61.5 Percentage of participants |
95% CI: [10.5, 53.5]
95% CI: [-14, 7.6]
95% CI: [-4.7, 19.1]
95% CI: [-42.2, -0.1]
Primary
Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48
Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.
Time frame: At Week 24 and Week 48
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Positive (n=14,13,3,3) | 7.1 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Negative (n=14,13,3,3) | 92.9 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Positive (n=14,13,3,3) | 7.1 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Negative (n=14,13,3,3) | 92.9 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Positive (n=101,97,18,23) | 1.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Negative (n=101,97,18,23) | 99.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Positive (n=101,97,18,23) | 20.8 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Negative (n=101,97,18,23) | 79.2 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Negative (n=101,97,18,23) | 96.9 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Positive (n=101,97,18,23) | 3.1 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Negative (n=14,13,3,3) | 100 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Negative (n=101,97,18,23) | 78.4 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Positive (n=101,97,18,23) | 21.6 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Negative (n=14,13,3,3) | 76.9 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Positive (n=14,13,3,3) | 23.1 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Positive (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Positive (n=101,97,18,23) | 11.1 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Positive (n=14,13,3,3) | 66.7 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Negative (n=14,13,3,3) | 33.3 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Positive (n=101,97,18,23) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Negative (n=101,97,18,23) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Negative (n=101,97,18,23) | 88.9 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Positive (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Negative (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Positive (n=14,13,3,3) | 33.3 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W48, HCV-RNA Negative (n=14,13,3,3) | 66.7 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Negative (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G2, W24, HCV-RNA Positive (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Positive (n=101,97,18,23) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Negative (n=101,97,18,23) | 60.9 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W48, HCV-RNA Positive (n=101,97,18,23) | 39.1 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 | G3, W24, HCV-RNA Negative (n=101,97,18,23) | 0.0 Percentage of participants |
Secondary
Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48
For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.
Time frame: At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W12 (n=101,97,18,23) | 7.8 Score on a scale | Standard Deviation 7.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W48 (n=101,97,18,23) | 3.6 Score on a scale | Standard Deviation 4.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W4 (n=101,97,18,23) | 7.9 Score on a scale | Standard Deviation 8.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,BS (n=14,13,3,3) | 8.2 Score on a scale | Standard Deviation 4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W8 (n=101,97,18,23) | 8.2 Score on a scale | Standard Deviation 8.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W8 (n=14,13,3,3) | 10.0 Score on a scale | Standard Deviation 9.9 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W12 (n=14,13,3,3) | 8.0 Score on a scale | Standard Deviation 9.9 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W4 (n=14,13,3,3) | 10.7 Score on a scale | Standard Deviation 12.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W24 (n=101,97,18,23) | 8.0 Score on a scale | Standard Deviation 7.6 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W24 (n=14,13,3,3) | 11.5 Score on a scale | Standard Deviation 9.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W48 (n=14,13,3,3) | 3.8 Score on a scale | Standard Deviation 2.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,BS (n=101,97,18,23) | 7.1 Score on a scale | Standard Deviation 6.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W4 (n=14,13,3,3) | 8.8 Score on a scale | Standard Deviation 9.7 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,BS (n=101,97,18,23) | 8.9 Score on a scale | Standard Deviation 7.7 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W12 (n=14,13,3,3) | 8.5 Score on a scale | Standard Deviation 7.8 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W8 (n=101,97,18,23) | 12.7 Score on a scale | Standard Deviation 11.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W12 (n=101,97,18,23) | 11.4 Score on a scale | Standard Deviation 8 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W4 (n=101,97,18,23) | 10.8 Score on a scale | Standard Deviation 8.1 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,BS (n=14,13,3,3) | 5.4 Score on a scale | Standard Deviation 6.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W48 (n=14,13,3,3) | 4.0 Score on a scale | Standard Deviation 5.1 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W24 (n=14,13,3,3) | 7.6 Score on a scale | Standard Deviation 4.7 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W8 (n=14,13,3,3) | 3.0 Score on a scale | Standard Deviation 4.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W48 (n=101,97,18,23) | 6.7 Score on a scale | Standard Deviation 8 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W24 (n=101,97,18,23) | 9.0 Score on a scale | Standard Deviation 7.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W4 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,BS (n=14,13,3,3) | 9.0 Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W4 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W8 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W12 (n=14,13,3,3) | 8.0 Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W24 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W48 (n=14,13,3,3) | 4.0 Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,BS (n=101,97,18,23) | 8.0 Score on a scale | Standard Deviation 5.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W8 (n=101,97,18,23) | 20.0 Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W12 (n=101,97,18,23) | 4.8 Score on a scale | Standard Deviation 5.3 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W24 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W48 (n=101,97,18,23) | 5.4 Score on a scale | Standard Deviation 7.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W48 (n=14,13,3,3) | 1.0 Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W24 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,BS (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W12 (n=101,97,18,23) | 15.0 Score on a scale | Standard Deviation 9.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W12 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W8 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W48 (n=101,97,18,23) | 6.6 Score on a scale | Standard Deviation 7.9 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W24 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W4 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,BS (n=101,97,18,23) | 7.0 Score on a scale | Standard Deviation 3.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G2,BDI,W4 (n=14,13,3,3) | 3.0 Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 | G3,BDI,W8 (n=101,97,18,23) | NA Score on a scale | — |
Secondary
Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48
Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0.
Time frame: At Baseline (Week 0) and Weeks 16, 24 and 48
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,BS(n=101,97,18,23) | 3.3 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W12 (n=14,13,3,3) | 3.5 Score on a scale | Standard Deviation 0.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W24 (n=101,97,18,23) | 3.2 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W48 (n=14,13,3,3) | 3.4 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W24 (n=14,13,3,3) | 2.9 Score on a scale | Standard Deviation 0.6 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W4 (n=14,13,3,3) | 3.1 Score on a scale | Standard Deviation 0.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2 ,BL, BS (n=14,13,3,3) | 3.3 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W12 (n=101,97,18,23) | 3.2 Score on a scale | Standard Deviation 0.6 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W8 (n=101,97,18,23) | 3.3 Score on a scale | Standard Deviation 0.6 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W8 (n=14,13,3,3) | 3.4 Score on a scale | Standard Deviation 0.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W48 (n=101,97,18,23) | 3.6 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W4 (n=101,97,18,23) | 3.4 Score on a scale | Standard Deviation 0.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W48 (n=101,97,18,23) | 3.5 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2 ,BL, BS (n=14,13,3,3) | 3.4 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W4 (n=14,13,3,3) | 3.3 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W8 (n=14,13,3,3) | 3.6 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W12 (n=14,13,3,3) | 3.3 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W24 (n=14,13,3,3) | 3.2 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W48 (n=14,13,3,3) | 3.4 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,BS(n=101,97,18,23) | 3.3 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W4 (n=101,97,18,23) | 3.0 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W8 (n=101,97,18,23) | 3.0 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W12 (n=101,97,18,23) | 3.1 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W24 (n=101,97,18,23) | 3.2 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,BS(n=101,97,18,23) | 3.2 Score on a scale | Standard Deviation 0.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W4 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W48 (n=101,97,18,23) | 3.4 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W12 (n=101,97,18,23) | 3.2 Score on a scale | Standard Deviation 0.3 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W4 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W24 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W8 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W24 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2 ,BL, BS (n=14,13,3,3) | 3.0 Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W12 (n=14,13,3,3) | 3.0 Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W8 (n=101,97,18,23) | 2.6 Score on a scale | Standard Deviation 0.3 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W48 (n=14,13,3,3) | 3.2 Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W8 (n=101,97,18,23) | 3.7 Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W8 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,BS(n=101,97,18,23) | 3.3 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W24 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W4 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W4 (n=14,13,3,3) | 3.8 Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W48 (n=14,13,3,3) | 4.0 Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3, BL,W12 (n=101,97,18,23) | 3.0 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL, W12 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2 ,BL, BS (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G2, BL,W24 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 | G3,BL,W48 (n=101,97,18,23) | 3.3 Score on a scale | Standard Deviation 0.5 |
Secondary
Mean FSS Scores at Baseline and Weeks 16, 24 and 48
The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.
Time frame: At Baseline (Week 0) and Weeks 16, 24 and 48
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W16 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3,BS(n=101,97,18,23) | 3.6 Score on a scale | Standard Deviation 1.2 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W24 (n=101,97,18,23) | 4.1 Score on a scale | Standard Deviation 1.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, BS (n=14,13,3,3) | 3.5 Score on a scale | Standard Deviation 1.2 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 (n=14,13,3,3) | 4.4 Score on a scale | Standard Deviation 1.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W48 (n=101,97,18,23) | 3.0 Score on a scale | Standard Deviation 1.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W48 (n=14,13,3,3) | 3.4 Score on a scale | Standard Deviation 1.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W48 (n=101,97,18,23) | 3.2 Score on a scale | Standard Deviation 1.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 (n=14,13,3,3) | 4.4 Score on a scale | Standard Deviation 1.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3,BS(n=101,97,18,23) | 3.8 Score on a scale | Standard Deviation 1.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W24 (n=101,97,18,23) | 4.1 Score on a scale | Standard Deviation 1.7 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W16 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W48 (n=14,13,3,3) | 3.5 Score on a scale | Standard Deviation 1.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, BS (n=14,13,3,3) | 3.4 Score on a scale | Standard Deviation 1.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, (n=101,97,18,23) | 4.0 Score on a scale | Standard Deviation 1.6 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W24 (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, BS (n=14,13,3,3) | 4.9 Score on a scale | Standard Deviation 0.3 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W48 (n=101,97,18,23) | 2.4 Score on a scale | Standard Deviation 1.6 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W48 (n=14,13,3,3) | 4.5 Score on a scale | Standard Deviation 0.4 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3,BS(n=101,97,18,23) | 3.4 Score on a scale | Standard Deviation 1.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W16 (n=14,13,3,3) | 6.2 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W48 (n=101,97,18,23) | 3.7 Score on a scale | Standard Deviation 1.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, BS (n=14,13,3,3) | 3.9 Score on a scale | Standard Deviation 2.9 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W16 (n=14,13,3,3) | 3.7 Score on a scale | Standard Deviation 1.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G2, W48 (n=14,13,3,3) | 3.2 Score on a scale | Standard Deviation 2.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3,BS(n=101,97,18,23) | 3.5 Score on a scale | Standard Deviation 1.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, (n=101,97,18,23) | 4.3 Score on a scale | Standard Deviation 1.5 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean FSS Scores at Baseline and Weeks 16, 24 and 48 | G3, W24 (n=101,97,18,23) | NA Score on a scale | — |
Secondary
Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48
Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.
Time frame: At Baseline (Week 0) and Weeks 16, 24 and 48
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Mental Health (n=101,97,18,23) | 69.2 Score on a scale | Standard Deviation 16.6 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Bodily Pain (n=14,13,3,3) | 74.0 Score on a scale | Standard Deviation 28.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Emotional (n=101,97,18,23) | 90.9 Score on a scale | Standard Deviation 23.8 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 Physical Functioning (n=14,13,3,3) | 73.5 Score on a scale | Standard Deviation 20.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Vitality (n=14,13,3,3) | 58.1 Score on a scale | Standard Deviation 19.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W48, Bodily Pain (n=14,13,3,3) | 76.1 Score on a scale | Standard Deviation 33.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Role Functioning Emotional (n=14,13,3,3) | 74.1 Score on a scale | Standard Deviation 36.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Vitality (n=14,13,3,3) | 38.5 Score on a scale | Standard Deviation 23 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Physical Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Bodily Pain (n=101,97,18,23) | 85.5 Score on a scale | Standard Deviation 22 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Physical (n=101,97,18,23) | 90.5 Score on a scale | Standard Deviation 23.9 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Vitality (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Physical Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Bodily Pain (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Mental Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS,Role Functioning Physical (n=14,13,3,3) | 72.2 Score on a scale | Standard Deviation 38.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Role Functioning Emotional (n=101,97,18,23) | 83.1 Score on a scale | Standard Deviation 29.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Bodily Pain(n=101,97,18,23) | 76.7 Score on a scale | Standard Deviation 27.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Social Functioning (n=101,97,18,23) | 86.6 Score on a scale | Standard Deviation 21 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Vitality (n=14,13,3,3) | 58.1 Score on a scale | Standard Deviation 20.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, General Health (n=101,97,18,23) | 73.9 Score on a scale | Standard Deviation 16 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48, Bodily Pain (n=101,97,18,23) | 89.5 Score on a scale | Standard Deviation 19.2 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Physical (n=101,97,18,23) | 60.4 Score on a scale | Standard Deviation 40.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, General Health (n=101,97,18,23) | 68.1 Score on a scale | Standard Deviation 18.1 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Mental Health (n=101,97,18,23) | 63.0 Score on a scale | Standard Deviation 19.9 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, General Health (n=14,13,3,3) | 60.4 Score on a scale | Standard Deviation 9.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Mental Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, General Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Physical Functioning (n=101,97,18,23) | 79.6 Score on a scale | Standard Deviation 20.8 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,General Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Social Functioning (n=101,97,18,23) | 68.8 Score on a scale | Standard Deviation 26.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Physical Functioning (n=101,97,18,23) | 91.6 Score on a scale | Standard Deviation 13.8 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Social Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, General Health (n=14,13,3,3) | 63.2 Score on a scale | Standard Deviation 12.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Mental Health (n=101,97,18,23) | 70.5 Score on a scale | Standard Deviation 15.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, General Health (n=101,97,18,23) | 67.2 Score on a scale | Standard Deviation 18.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, General Health (n=14,13,3,3) | 76.3 Score on a scale | Standard Deviation 13.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Emotional (n=101,97,18,23) | 61.0 Score on a scale | Standard Deviation 41 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Role Functioning Physical (n=14,13,3,3) | 56.3 Score on a scale | Standard Deviation 47.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Physical Functioning (n=14,13,3,3) | 87.8 Score on a scale | Standard Deviation 22.1 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS,Reported Health Transition (n=14,13,3,3) | 2.7 Score on a scale | Standard Deviation 0.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Physical Functioning, (n=14,13,3,3) | 80.6 Score on a scale | Standard Deviation 30.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Social Functioning (n=101,97,18,23) | 83.8 Score on a scale | Standard Deviation 19.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Bodily Pain (n=14,13,3,3) | 78.6 Score on a scale | Standard Deviation 29 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Reported Health Transition (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Physical (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Social Functioning (n=14,13,3,3) | 89.1 Score on a scale | Standard Deviation 15.6 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Mental Health (n=14,13,3,3) | 59.2 Score on a scale | Standard Deviation 22.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Reported Health Transition (n=14,13,3,3) | 2.6 Score on a scale | Standard Deviation 1 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Emotional (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Social Functioning (n=14,13,3,3) | 63.8 Score on a scale | Standard Deviation 32 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Social Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Reported Health Transition (n=14,13,3,3) | 1.8 Score on a scale | Standard Deviation 0.9 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Role Functioning Emotional (n=14,13,3,3) | 60.4 Score on a scale | Standard Deviation 37.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Role Functioning Physical (n=14,13,3,3) | 57.5 Score on a scale | Standard Deviation 31.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Physical Functioning (n=101,97,18,23) | 90.6 Score on a scale | Standard Deviation 13.9 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Reported Health Transition (n=101,97,18,23) | 2.8 Score on a scale | Standard Deviation 1.1 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Role Functioning Emotional (n=14,13,3,3) | 56.7 Score on a scale | Standard Deviation 38.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Social Functioning (n=14,13,3,3) | 80.6 Score on a scale | Standard Deviation 21.8 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Bodily Pain (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Reported Health Transition (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Mental Health (n=14,13,3,3) | 66.3 Score on a scale | Standard Deviation 19.2 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Vitality (n=101,97,18,23) | 63.4 Score on a scale | Standard Deviation 19.1 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, Mental Health (n=14,13,3,3) | 66.5 Score on a scale | Standard Deviation 13.5 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Reported Health Transition (n=101,97,18,23) | 3.0 Score on a scale | Standard Deviation 1.3 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Role Functioning Emotional (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Vitality (n=101,97,18,23) | 46.9 Score on a scale | Standard Deviation 24.4 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Vitality (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Reported Health Transition (n=101,97,18,23) | 1.7 Score on a scale | Standard Deviation 0.9 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS,Role Functioning Physical (n=101,97,18,23) | 81.2 Score on a scale | Standard Deviation 30.7 |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Role Functioning Physical (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Vitality (n=101,97,18,23) | 55.8 Score on a scale | Standard Deviation 21.1 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Physical (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Emotional (n=101,97,18,23) | 57.4 Score on a scale | Standard Deviation 44.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Emotional (n=101,97,18,23) | 84.2 Score on a scale | Standard Deviation 33.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Physical Functioning, (n=14,13,3,3) | 81.0 Score on a scale | Standard Deviation 20.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, Mental Health (n=14,13,3,3) | 73.2 Score on a scale | Standard Deviation 14.9 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Mental Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Physical (n=101,97,18,23) | 63.6 Score on a scale | Standard Deviation 39.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Mental Health (n=14,13,3,3) | 64.8 Score on a scale | Standard Deviation 21.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Mental Health (n=14,13,3,3) | 76.1 Score on a scale | Standard Deviation 14.3 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Mental Health (n=101,97,18,23) | 67.8 Score on a scale | Standard Deviation 17.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Mental Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Physical (n=101,97,18,23) | 85.5 Score on a scale | Standard Deviation 30.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Mental Health (n=101,97,18,23) | 63.2 Score on a scale | Standard Deviation 21 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Mental Health (n=101,97,18,23) | 68.8 Score on a scale | Standard Deviation 20.9 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS,Reported Health Transition (n=14,13,3,3) | 3.0 Score on a scale | Standard Deviation 0.8 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Reported Health Transition (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Bodily Pain (n=14,13,3,3) | 83.0 Score on a scale | Standard Deviation 24.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Reported Health Transition (n=14,13,3,3) | 3.7 Score on a scale | Standard Deviation 0.8 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Reported Health Transition (n=14,13,3,3) | 1.9 Score on a scale | Standard Deviation 0.8 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Reported Health Transition (n=101,97,18,23) | 2.9 Score on a scale | Standard Deviation 1 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Reported Health Transition (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Bodily Pain (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Reported Health Transition (n=101,97,18,23) | 2.7 Score on a scale | Standard Deviation 1.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Reported Health Transition (n=101,97,18,23) | 1.9 Score on a scale | Standard Deviation 1.1 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Physical Functioning (n=101,97,18,23) | 85.9 Score on a scale | Standard Deviation 18.3 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Bodily Pain (n=14,13,3,3) | 55.5 Score on a scale | Standard Deviation 33.3 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W48, Bodily Pain (n=14,13,3,3) | 84.0 Score on a scale | Standard Deviation 15.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Bodily Pain (n=101,97,18,23) | 82.9 Score on a scale | Standard Deviation 19.7 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Bodily Pain (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Physical Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Bodily Pain(n=101,97,18,23) | 71.5 Score on a scale | Standard Deviation 25.9 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48, Bodily Pain (n=101,97,18,23) | 87.7 Score on a scale | Standard Deviation 23 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Physical Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, General Health (n=14,13,3,3) | 66.3 Score on a scale | Standard Deviation 17.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,General Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Physical Functioning (n=101,97,18,23) | 79.8 Score on a scale | Standard Deviation 22.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, General Health (n=14,13,3,3) | 67.2 Score on a scale | Standard Deviation 20.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, General Health (n=14,13,3,3) | 76.0 Score on a scale | Standard Deviation 14.9 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, General Health (n=101,97,18,23) | 61.7 Score on a scale | Standard Deviation 19.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, General Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Physical Functioning (n=101,97,18,23) | 89.7 Score on a scale | Standard Deviation 18.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, General Health (n=101,97,18,23) | 59.5 Score on a scale | Standard Deviation 21.3 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, General Health (n=101,97,18,23) | 70.5 Score on a scale | Standard Deviation 21.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Physical Functioning (n=14,13,3,3) | 87.9 Score on a scale | Standard Deviation 12.9 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Vitality (n=14,13,3,3) | 62.2 Score on a scale | Standard Deviation 11.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Vitality (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS,Role Functioning Physical (n=14,13,3,3) | 88.9 Score on a scale | Standard Deviation 22 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Vitality (n=14,13,3,3) | 39.5 Score on a scale | Standard Deviation 22 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Vitality (n=14,13,3,3) | 63.9 Score on a scale | Standard Deviation 15 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Vitality (n=101,97,18,23) | 51.9 Score on a scale | Standard Deviation 21.4 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Vitality (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Role Functioning Physical (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Vitality (n=101,97,18,23) | 45.5 Score on a scale | Standard Deviation 23.8 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Vitality (n=101,97,18,23) | 58.7 Score on a scale | Standard Deviation 20.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 Physical Functioning (n=14,13,3,3) | 79.0 Score on a scale | Standard Deviation 17.9 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Social Functioning (n=14,13,3,3) | 93.8 Score on a scale | Standard Deviation 10.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Social Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Role Functioning Physical (n=14,13,3,3) | 50.0 Score on a scale | Standard Deviation 37.3 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Social Functioning (n=14,13,3,3) | 76.3 Score on a scale | Standard Deviation 28.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Social Functioning (n=14,13,3,3) | 86.1 Score on a scale | Standard Deviation 15.9 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Social Functioning (n=101,97,18,23) | 77.2 Score on a scale | Standard Deviation 23.5 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Social Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Role Functioning Physical (n=14,13,3,3) | 88.9 Score on a scale | Standard Deviation 18.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Social Functioning (n=101,97,18,23) | 72.1 Score on a scale | Standard Deviation 26.3 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Social Functioning (n=101,97,18,23) | 81.6 Score on a scale | Standard Deviation 27 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Role Functioning Emotional (n=14,13,3,3) | 88.9 Score on a scale | Standard Deviation 23.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Role Functioning Emotional (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS,Role Functioning Physical (n=101,97,18,23) | 73.9 Score on a scale | Standard Deviation 33 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Role Functioning Emotional (n=14,13,3,3) | 43.3 Score on a scale | Standard Deviation 38.7 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Role Functioning Emotional (n=14,13,3,3) | 85.2 Score on a scale | Standard Deviation 24.2 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Role Functioning Emotional (n=101,97,18,23) | 73.2 Score on a scale | Standard Deviation 36.1 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Emotional (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Bodily Pain (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Role Functioning Emotional (n=14,13,3,3) | 100.0 Score on a scale | Standard Deviation 0 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Mental Health (n=101,97,18,23) | 63.6 Score on a scale | Standard Deviation 17.4 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Vitality (n=101,97,18,23) | 51.7 Score on a scale | Standard Deviation 24.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Reported Health Transition (n=101,97,18,23) | 2.3 Score on a scale | Standard Deviation 1.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Bodily Pain (n=14,13,3,3) | 61.3 Score on a scale | Standard Deviation 39 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Emotional (n=101,97,18,23) | 63.0 Score on a scale | Standard Deviation 35.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Vitality (n=101,97,18,23) | 46.1 Score on a scale | Standard Deviation 19.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Role Functioning Emotional (n=14,13,3,3) | 77.8 Score on a scale | Standard Deviation 19.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Reported Health Transition (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Physical Functioning, (n=14,13,3,3) | 82.5 Score on a scale | Standard Deviation 17.7 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Vitality (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Role Functioning Physical (n=14,13,3,3) | 16.7 Score on a scale | Standard Deviation 28.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Reported Health Transition (n=101,97,18,23) | 3.3 Score on a scale | Standard Deviation 1.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Mental Health (n=14,13,3,3) | 58.5 Score on a scale | Standard Deviation 37.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Vitality (n=101,97,18,23) | 70.6 Score on a scale | Standard Deviation 15.7 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Role Functioning Emotional (n=101,97,18,23) | 70.4 Score on a scale | Standard Deviation 35.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Reported Health Transition (n=101,97,18,23) | 2.9 Score on a scale | Standard Deviation 0.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Role Functioning Emotional (n=14,13,3,3) | 33.3 Score on a scale | Standard Deviation 33.3 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Social Functioning (n=14,13,3,3) | 75.0 Score on a scale | Standard Deviation 12.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Reported Health Transition (n=14,13,3,3) | 2.0 Score on a scale | Standard Deviation 0 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Bodily Pain (n=14,13,3,3) | 71.0 Score on a scale | Standard Deviation 25.7 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Emotional (n=101,97,18,23) | 88.9 Score on a scale | Standard Deviation 23.6 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Social Functioning (n=14,13,3,3) | 50.0 Score on a scale | Standard Deviation 43.3 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Physical (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Reported Health Transition (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Physical (n=101,97,18,23) | 61.1 Score on a scale | Standard Deviation 35.6 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Social Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Role Functioning Physical (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Reported Health Transition (n=14,13,3,3) | 4.0 Score on a scale | Standard Deviation 1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Role Functioning Emotional (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Social Functioning (n=14,13,3,3) | 81.3 Score on a scale | Standard Deviation 26.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 Physical Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS,Reported Health Transition (n=14,13,3,3) | 3.7 Score on a scale | Standard Deviation 0.6 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS,Role Functioning Physical (n=101,97,18,23) | 83.3 Score on a scale | Standard Deviation 28 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Social Functioning (n=101,97,18,23) | 86.1 Score on a scale | Standard Deviation 20.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Mental Health (n=101,97,18,23) | 68.0 Score on a scale | Standard Deviation 20.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Physical Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Physical (n=101,97,18,23) | 91.7 Score on a scale | Standard Deviation 17.7 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, General Health (n=14,13,3,3) | 53.5 Score on a scale | Standard Deviation 26.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Physical Functioning (n=14,13,3,3) | 63.3 Score on a scale | Standard Deviation 20.8 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, General Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Mental Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, General Health (n=101,97,18,23) | 56.9 Score on a scale | Standard Deviation 12.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,General Health (n=14,13,3,3) | 42.3 Score on a scale | Standard Deviation 27.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, General Health (n=14,13,3,3) | 62.3 Score on a scale | Standard Deviation 21.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Social Functioning (n=101,97,18,23) | 63.9 Score on a scale | Standard Deviation 20.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, General Health (n=101,97,18,23) | 58.3 Score on a scale | Standard Deviation 20.4 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Emotional (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48, Bodily Pain (n=101,97,18,23) | 84.1 Score on a scale | Standard Deviation 18.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Mental Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, General Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Physical Functioning (n=101,97,18,23) | 88.9 Score on a scale | Standard Deviation 12.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Physical Functioning (n=101,97,18,23) | 81.1 Score on a scale | Standard Deviation 14.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Mental Health (n=14,13,3,3) | 42.7 Score on a scale | Standard Deviation 20.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, General Health (n=101,97,18,23) | 70.2 Score on a scale | Standard Deviation 19.5 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Social Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Bodily Pain(n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Role Functioning Physical (n=14,13,3,3) | 87.5 Score on a scale | Standard Deviation 17.7 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Vitality (n=14,13,3,3) | 43.3 Score on a scale | Standard Deviation 18.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Bodily Pain (n=101,97,18,23) | 69.6 Score on a scale | Standard Deviation 19.4 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Bodily Pain (n=101,97,18,23) | 73.0 Score on a scale | Standard Deviation 26.1 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Mental Health (n=101,97,18,23) | 56.4 Score on a scale | Standard Deviation 15 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Vitality (n=14,13,3,3) | 25.0 Score on a scale | Standard Deviation 21.8 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, Mental Health (n=14,13,3,3) | 57.3 Score on a scale | Standard Deviation 18 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W48, Bodily Pain (n=14,13,3,3) | 81.0 Score on a scale | Standard Deviation 26.9 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Social Functioning (n=101,97,18,23) | 87.5 Score on a scale | Standard Deviation 18.8 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Vitality (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS,Role Functioning Physical (n=14,13,3,3) | 75.0 Score on a scale | Standard Deviation 25 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Physical Functioning (n=101,97,18,23) | 87.2 Score on a scale | Standard Deviation 15.2 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Physical Functioning (n=14,13,3,3) | 76.7 Score on a scale | Standard Deviation 10.4 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Vitality (n=14,13,3,3) | 57.5 Score on a scale | Standard Deviation 24.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Reported Health Transition (n=101,97,18,23) | 2.2 Score on a scale | Standard Deviation 0.9 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Physical Functioning (n=14,13,3,3) | 69.4 Score on a scale | Standard Deviation 43.2 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Physical Functioning (n=14,13,3,3) | 63.3 Score on a scale | Standard Deviation 31.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24 Physical Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Physical Functioning, (n=14,13,3,3) | 85.0 Score on a scale | Standard Deviation 21.2 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Physical Functioning (n=101,97,18,23) | 77.9 Score on a scale | Standard Deviation 26.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Physical Functioning (n=101,97,18,23) | 69.8 Score on a scale | Standard Deviation 28.1 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Physical Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Physical Functioning (n=101,97,18,23) | 87.9 Score on a scale | Standard Deviation 12.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS,Role Functioning Physical (n=14,13,3,3) | 50.0 Score on a scale | Standard Deviation 70.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Role Functioning Physical (n=14,13,3,3) | 41.7 Score on a scale | Standard Deviation 52 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Role Functioning Physical (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Role Functioning Physical (n=14,13,3,3) | 87.5 Score on a scale | Standard Deviation 17.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS,Role Functioning Physical (n=101,97,18,23) | 75.0 Score on a scale | Standard Deviation 34.3 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Physical (n=101,97,18,23) | 61.8 Score on a scale | Standard Deviation 40.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Physical (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Physical (n=101,97,18,23) | 81.3 Score on a scale | Standard Deviation 31 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Bodily Pain (n=14,13,3,3) | 61.0 Score on a scale | Standard Deviation 55.2 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Bodily Pain (n=14,13,3,3) | 54.3 Score on a scale | Standard Deviation 40.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Bodily Pain (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W48, Bodily Pain (n=14,13,3,3) | 81.0 Score on a scale | Standard Deviation 26.9 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, Bodily Pain (n=101,97,18,23) | 83.6 Score on a scale | Standard Deviation 30.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Bodily Pain (n=101,97,18,23) | 70.2 Score on a scale | Standard Deviation 31.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, Bodily Pain(n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48, Bodily Pain (n=101,97,18,23) | 81.9 Score on a scale | Standard Deviation 33.3 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, General Health (n=14,13,3,3) | 51.0 Score on a scale | Standard Deviation 36.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,General Health (n=14,13,3,3) | 49.0 Score on a scale | Standard Deviation 21.3 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, General Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, General Health (n=14,13,3,3) | 43.5 Score on a scale | Standard Deviation 26.2 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, BS, General Health (n=101,97,18,23) | 61.1 Score on a scale | Standard Deviation 23.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, General Health (n=101,97,18,23) | 63.6 Score on a scale | Standard Deviation 19.9 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W24, General Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, General Health (n=101,97,18,23) | 63.0 Score on a scale | Standard Deviation 26 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Vitality (n=14,13,3,3) | 35.0 Score on a scale | Standard Deviation 49.5 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Vitality (n=14,13,3,3) | 30.6 Score on a scale | Standard Deviation 14.2 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W24, Vitality (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Vitality (n=14,13,3,3) | 45.0 Score on a scale | Standard Deviation 35.4 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Vitality (n=101,97,18,23) | 49.4 Score on a scale | Standard Deviation 24.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Vitality (n=101,97,18,23) | 43.5 Score on a scale | Standard Deviation 18.1 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Vitality (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Vitality (n=101,97,18,23) | 60.1 Score on a scale | Standard Deviation 18.9 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Social Functioning (n=14,13,3,3) | 56.3 Score on a scale | Standard Deviation 44.2 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, W16, Social Functioning (n=14,13,3,3) | 58.3 Score on a scale | Standard Deviation 26 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Social Functioning (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Social Functioning (n=14,13,3,3) | 81.3 Score on a scale | Standard Deviation 26.5 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Social Functioning (n=101,97,18,23) | 84.7 Score on a scale | Standard Deviation 20.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W16, Social Functioning (n=101,97,18,23) | 66.9 Score on a scale | Standard Deviation 30.3 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Social Functioning (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Social Functioning (n=101,97,18,23) | 78.7 Score on a scale | Standard Deviation 26.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2, BS, Role Functioning Emotional (n=14,13,3,3) | 50.0 Score on a scale | Standard Deviation 70.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Role Functioning Emotional (n=14,13,3,3) | 44.4 Score on a scale | Standard Deviation 50.9 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Role Functioning Emotional (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Role Functioning Emotional (n=14,13,3,3) | 83.3 Score on a scale | Standard Deviation 23.6 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Role Functioning Emotional (n=101,97,18,23) | 68.5 Score on a scale | Standard Deviation 40.4 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Role Functioning Emotional (n=101,97,18,23) | 60.8 Score on a scale | Standard Deviation 41.2 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Role Functioning Emotional (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W48,Role Functioning Emotional (n=101,97,18,23) | 79.2 Score on a scale | Standard Deviation 36.3 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS, Mental Health (n=14,13,3,3) | 58.0 Score on a scale | Standard Deviation 48.1 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16, Mental Health (n=14,13,3,3) | 49.3 Score on a scale | Standard Deviation 19.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24, Mental Health (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48, Mental Health (n=14,13,3,3) | 70.0 Score on a scale | Standard Deviation 31.1 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS, Mental Health (n=101,97,18,23) | 59.6 Score on a scale | Standard Deviation 25.4 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16, Mental Health (n=101,97,18,23) | 55.5 Score on a scale | Standard Deviation 19.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24, Mental Health (n=101,97,18,23) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3, W48, Mental Health (n=101,97,18,23) | 64.1 Score on a scale | Standard Deviation 19.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,BS,Reported Health Transition (n=14,13,3,3) | 3.0 Score on a scale | Standard Deviation 2.8 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W16,Reported Health Transition (n=14,13,3,3) | 3.0 Score on a scale | Standard Deviation 1 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W24,Reported Health Transition (n=14,13,3,3) | NA Score on a scale | — |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G2,W48,Reported Health Transition (n=14,13,3,3) | 2.5 Score on a scale | Standard Deviation 0.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,BS,Reported Health Transition (n=101,97,18,23) | 2.8 Score on a scale | Standard Deviation 1.1 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W16,Reported Health Transition (n=101,97,18,23) | 2.9 Score on a scale | Standard Deviation 1.5 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 | G3,W24,Reported Health Transition (n=101,97,18,23) | NA Score on a scale | — |
Secondary
Median Hemoglobin Levels at End of Treatment
Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was \>=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.
Time frame: At Week 16 and Week 24
Population: The Safety analysis population was defined to include only participant who received at least one dose of (either) study medication and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 16 | 123.00 g/L |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 24 | 124.00 g/L |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 24 | 130.00 g/L |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 16 | 131.00 g/L |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 16 | 129.50 g/L |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 24 | NA g/L |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 16 | 131.00 g/L |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Median Hemoglobin Levels at End of Treatment | At Week 24 | NA g/L |
Secondary
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. 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 48
Population: The Safety analysis population was defined to include only participants who received at least one dose of (either) study medication and had at least one post-baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any AE | 139 Number of Participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any SAE | 12 Number of Participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any SAE | 18 Number of Participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any AE | 138 Number of Participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any AE | 29 Number of Participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any SAE | 0 Number of Participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any AE | 45 Number of Participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Number of Participants With Any Adverse Events and Any Serious Adverse Events | Any SAE | 2 Number of Participants |
Secondary
Percentage of Participants With Virological Response at the End of the Treatment
Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.
Time frame: At Week 16 and Week 24
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Virological Response at the End of the Treatment | 98.3 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Virological Response at the End of the Treatment | 97.3 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Virological Response at the End of the Treatment | 95.2 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Virological Response at the End of the Treatment | 100 Percentage of participants |
95% CI: [-1, 0.2]
95% CI: [-6.4, 1.3]
95% CI: [-1.4, 1.4]
95% CI: [-0.5, 1.7]
Secondary
Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment
Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.
Time frame: At Week 16 and Week 24
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W16, Virologic Response (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W24, Virologic Response (n=14,13,3,3) | 92.9 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W16,Virologic Response (n=101,97,18,23) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W24,Virologic Response (n=101,97,18,23) | 99.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W24, Virologic Response (n=14,13,3,3) | 100 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W16,Virologic Response (n=101,97,18,23) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W24,Virologic Response (n=101,97,18,23) | 96.9 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W16, Virologic Response (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W16,Virologic Response (n=101,97,18,23) | 100 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W24, Virologic Response (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W24,Virologic Response (n=101,97,18,23) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W16, Virologic Response (n=14,13,3,3) | 66.7 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W24,Virologic Response (n=101,97,18,23) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W24, Virologic Response (n=14,13,3,3) | 0.0 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G2, W16, Virologic Response (n=14,13,3,3) | 100 Percentage of participants |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment | G3, W16,Virologic Response (n=101,97,18,23) | 100 Percentage of participants |
Secondary
Time to Viral Response
Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 \[in days\]. Mean of number of days to viral response for overall population were reported.
Time frame: Up to Week 48
Population: Standard analysis population includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peginterferon/Ribavirin 800 mg (24 Weeks) | Time to Viral Response | 165.1 Days | Standard Deviation 73.6 |
| Peginterferon/Ribavirin 400 mg (24 Weeks) | Time to Viral Response | 165.0 Days | Standard Deviation 78.8 |
| Peginterferon/Ribavirin 800 mg (16 Weeks) | Time to Viral Response | 114.5 Days | Standard Deviation 76.7 |
| Peginterferon/Ribavirin 400 mg (16 Weeks) | Time to Viral Response | 122.8 Days | Standard Deviation 56.4 |
p-value: 0.2667Regression, Cox
p-value: 0.9999Regression, Cox
p-value: 0.9891Regression, Cox