Genotype 1, HCV-1, Hepatitis C, Chronic
Conditions
Brief summary
The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC), and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to standard clinical practice, on the health-related quality of life (HRQL) of a cohort of participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV).
Detailed description
As widely shown in previous reports Hepatitis C Virus (HCV) patients commonly experience fatigue, anxiety, and depression. These symptoms negatively affect patients' functional health, ability to work, self-perceived health, HRQL and well-being. Psychosocial issues and reduced HRQL are frequently experienced by HCV patients. HCV patients have more HRQL impairment than the general population. There is some evidence that HCV patients who experience greater fatigue, greater psychiatric symptoms, and poorer HRQL are more likely to discontinue treatment prematurely, with a negative impact on virological response. In addition to well-known side effects of interferon, one important determinant of HRQL during anti-viral therapy for HCV is development of RBV-induced anemia. Treatment of anemia improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic response. These issues emphasize the importance of investigating the physical and psychosocial experiences and HRQL of HCV patients. The sample size of the study must allow evaluating HRQL of HCV patients based on the SF-36 before PEG treatment and at each of the following study visits. To be able to detect differences of or over 4.2 points in the vitality dimension between the basal visit and following visits, estimating a standard deviation of 22 points, a statistical power of 80%, and a level of significance of 0.05, 216 patients will be needed. Considering a loss of follow up of 15%, a total of 238 patients are planned for this study.
Interventions
BIOLOGICALPeginterferon alfa-2b (PEG)
Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).
DRUGRibavirin (RBV)
Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with chronic hepatitis C (CHC) * Participants with HCV genotype 1 * Participants who, at the time of the study, are referred to the Hospital Pharmacy Service to begin treatment with PEG and RBV for 48 weeks * Available to understand and to give Informed Consent
Exclusion criteria
\- Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Baseline, Week 72 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. |
| Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Baseline, Week 72 | The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Clinically Important Difference (MCID) in SF-36 Scores | From Baseline Visit to Final Visit (up to 72 weeks) | SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS. |
| Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Baseline, Week 72 | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. |
| Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | From Baseline Visit to Final Visit (up to 72 weeks) | Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication. |
| MCID in CLDQ-HCV Scores | From Baseline Visit to Final Visit (up to 72 weeks) | The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score. |
| Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Baseline, Week 72 | The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. |
Participant flow
Pre-assignment details
Of 133 participants who enrolled on study, 3 participants failed screening and 130 were evaluable for this study.
Participants by arm
| Arm | Count |
|---|---|
| PEG + RBV (Standard Clinical Practice) Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation. | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | PEG + RBV (Standard Clinical Practice) |
|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 116 / 130 |
| serious Total, serious adverse events | 12 / 130 |
Outcome results
Primary
Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.
Time frame: Baseline, Week 72
Population: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Physical Function-WK72 (n=45) | 87.33 score on a scale | Standard Deviation 16.08 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Physical Function Change from BL (n=45) | -1.56 score on a scale | Standard Deviation 16.3 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Pain-WK72 (n=46) | 82.35 score on a scale | Standard Deviation 21.41 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Pain Change from BL (n=46) | -2.22 score on a scale | Standard Deviation 19.09 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | General Health-BL (n=122) | 62.22 score on a scale | Standard Deviation 18.83 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | General Health-WK72 (n=46) | 66.24 score on a scale | Standard Deviation 23.24 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | General Health Change from BL (n=46) | 1.86 score on a scale | Standard Deviation 19.52 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Social Function-WK72 (n=46) | 86.96 score on a scale | Standard Deviation 19.71 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Mental Health-BL (n=121) | 71.55 score on a scale | Standard Deviation 19.7 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Mental Health-WK72 (n=45) | 74.76 score on a scale | Standard Deviation 20.29 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Mental Health Change from BL (n=45) | 1.16 score on a scale | Standard Deviation 19.38 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | PCS-BL (n=121) | 50.40 score on a scale | Standard Deviation 7.9 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | PCS-WK72 (n=45) | 50.73 score on a scale | Standard Deviation 6.82 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | PCS Change from BL (n=45) | -0.90 score on a scale | Standard Deviation 6.38 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | MCS-WK72 (n=45) | 49.45 score on a scale | Standard Deviation 10.26 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Physical Function-BL (n=123) | 87.27 score on a scale | Standard Deviation 20.67 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Physical Role-BL (n=123) | 81.71 score on a scale | Standard Deviation 36.08 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Physical Role-WK72 (n=45) | 86.67 score on a scale | Standard Deviation 29.48 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Physical Role Change from BL (n=45) | -0.56 score on a scale | Standard Deviation 35.15 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Pain-BL (n=126) | 77.88 score on a scale | Standard Deviation 23.96 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Vitality-BL (n=121) | 67.20 score on a scale | Standard Deviation 22.23 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Vitality-WK72 (n=45) | 68.33 score on a scale | Standard Deviation 19.8 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Vitality Change from BL (n=45) | -4.30 score on a scale | Standard Deviation 21.51 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Social Function-BL (n=126) | 81.55 score on a scale | Standard Deviation 23.75 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Social Function Change from BL (n=46) | 2.17 score on a scale | Standard Deviation 22.56 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Emotional Role-BL (n=123) | 79.95 score on a scale | Standard Deviation 37.63 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Emotional Role-WK72 (n=45) | 87.41 score on a scale | Standard Deviation 30.39 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | Emotional Role Change from BL (n=45) | 1.48 score on a scale | Standard Deviation 39.54 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | MCS-BL (n=121) | 47.17 score on a scale | Standard Deviation 12.05 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores | MCS Change from BL (n=45) | 0.54 score on a scale | Standard Deviation 11.51 |
Primary
Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.
Time frame: Baseline, Week 72
Population: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Activity/Energy-BL (n=125) | 5.58 score on a scale | Standard Deviation 1.33 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Activity/Energy-WK72 (n=46) | 5.76 score on a scale | Standard Deviation 1.11 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Activity/Energy Change from BL (n=46) | -0.06 score on a scale | Standard Deviation 1.16 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Emotional Function Change from BL (n=46) | 0.10 score on a scale | Standard Deviation 0.87 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Worry-BL (n=125) | 5.26 score on a scale | Standard Deviation 1.25 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Worry-WK72 (n=46) | 5.65 score on a scale | Standard Deviation 1.46 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | CLDQ-HCV Global Change from BL (n=46) | 0.15 score on a scale | Standard Deviation 0.87 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Emotional Function-BL (n=125) | 5.19 score on a scale | Standard Deviation 1.02 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Emotional Function-WK72 (n=46) | 5.35 score on a scale | Standard Deviation 0.97 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Worry Change from BL (n=46) | 0.41 score on a scale | Standard Deviation 1.21 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Systemic Symptoms-BL (n=125) | 5.25 score on a scale | Standard Deviation 1.18 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Systemic Symptoms-WK72 (n=46) | 5.57 score on a scale | Standard Deviation 1.06 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | Systemic Symptoms Change from BL (n=46) | 0.09 score on a scale | Standard Deviation 0.8 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | CLDQ-HCV Global -BL (n=125) | 5.31 score on a scale | Standard Deviation 1.06 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) | CLDQ-HCV Global-WK72 (n=46) | 5.56 score on a scale | Standard Deviation 1.05 |
Comparison: Within-group comparison of Worry domain between BL Visit and WK72 Visitp-value: 0.027Student´s t-test for paired samples
Secondary
Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.
Time frame: Baseline, Week 72
Population: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Activity/Energy (n=38, n=8) | 0.04 score on a scale | Standard Deviation 1.17 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Emotional Function (n=38, n=8) | 0.25 score on a scale | Standard Deviation 0.83 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Worry (n=38, n=8) | 0.61 score on a scale | Standard Deviation 1.18 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | CLDQ-HCV Global (n=38, n=8) | 0.28 score on a scale | Standard Deviation 0.86 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Systemic Symptoms (n=38, n=8) | 0.15 score on a scale | Standard Deviation 0.82 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Worry (n=38, n=8) | -0.58 score on a scale | Standard Deviation 0.82 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Activity/Energy (n=38, n=8) | -0.50 score on a scale | Standard Deviation 1.07 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Systemic Symptoms (n=38, n=8) | -0.23 score on a scale | Standard Deviation 0.58 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Emotional Function (n=38, n=8) | -0.57 score on a scale | Standard Deviation 0.72 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | CLDQ-HCV Global (n=38, n=8) | -0.49 score on a scale | Standard Deviation 0.67 |
Comparison: Between-group comparison of change from baseline in Emotional Function domainp-value: 0.014Student´s t-test for paired samples
Comparison: Between-group comparison of change from baseline in Worry domainp-value: 0.009Student´s t-test for paired samples
Comparison: Between-group comparison of change from baseline in CLDQ-HCV Global domainp-value: 0.022Student´s t-test for paired samples
Secondary
Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.
Time frame: Baseline, Week 72
Population: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Physical Function (n=37, n=8) | -1.08 score on a scale | Standard Deviation 17.88 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Physical Role (n=37, n=8) | -1.35 score on a scale | Standard Deviation 38.62 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Pain (n=38, n=8) | -3.55 score on a scale | Standard Deviation 19.32 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | General Health (n=38, n=8) | 4.35 score on a scale | Standard Deviation 19.38 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Mental Health (n=37, n=8) | 3.46 score on a scale | Standard Deviation 17.41 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Vitality (n=37, n=8) | -1.98 score on a scale | Standard Deviation 21.54 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Social Function (n=38, n=8) | 4.61 score on a scale | Standard Deviation 22.4 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Emotional Role (n=37, n=8) | 4.50 score on a scale | Standard Deviation 40.19 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | PCS (n=37, n=8) | -1.23 score on a scale | Standard Deviation 6.51 |
| PEG + RBV (Standard Clinical Practice) | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | MCS (n=37, n=8) | 2.18 score on a scale | Standard Deviation 11.01 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | PCS (n=37, n=8) | 0.59 score on a scale | Standard Deviation 5.9 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | MCS (n=37, n=8) | -7.05 score on a scale | Standard Deviation 11.36 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Physical Role (n=37, n=8) | 3.13 score on a scale | Standard Deviation 8.84 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Physical Function (n=37, n=8) | -3.75 score on a scale | Standard Deviation 4.43 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Pain (n=38, n=8) | 4.13 score on a scale | Standard Deviation 17.75 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Social Function (n=38, n=8) | -9.38 score on a scale | Standard Deviation 20.86 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | General Health (n=38, n=8) | -10.00 score on a scale | Standard Deviation 16.42 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Vitality (n=37, n=8) | -15.00 score on a scale | Standard Deviation 19.09 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Emotional Role (n=37, n=8) | -12.50 score on a scale | Standard Deviation 35.36 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) | Mental Health (n=37, n=8) | -9.50 score on a scale | Standard Deviation 25.38 |
Comparison: Between-group comparison of change from baseline in MCSp-value: 0.038Student´s t-test for paired samples
Secondary
MCID in CLDQ-HCV Scores
The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score.
Time frame: From Baseline Visit to Final Visit (up to 72 weeks)
Population: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | MCID in CLDQ-HCV Scores | Emotional Function | 0.40 score on a scale | Standard Deviation 0.64 |
| PEG + RBV (Standard Clinical Practice) | MCID in CLDQ-HCV Scores | Worry | 1.00 score on a scale | Standard Deviation 0.84 |
| PEG + RBV (Standard Clinical Practice) | MCID in CLDQ-HCV Scores | Systemic Symptoms | 0.00 score on a scale | Standard Deviation 0.71 |
| PEG + RBV (Standard Clinical Practice) | MCID in CLDQ-HCV Scores | CLDQ-HCV Global | 0.40 score on a scale | Standard Deviation 0.83 |
| PEG + RBV (Standard Clinical Practice) | MCID in CLDQ-HCV Scores | Activity/Energy | 0.00 score on a scale | Standard Deviation 1.58 |
Secondary
Minimal Clinically Important Difference (MCID) in SF-36 Scores
SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS.
Time frame: From Baseline Visit to Final Visit (up to 72 weeks)
Population: All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | Physical Role | 3.57 score on a scale | Standard Deviation 50.89 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | Pain | -0.67 score on a scale | Standard Deviation 39 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | General Health | 6.86 score on a scale | Standard Deviation 13.31 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | Vitality | 4.29 score on a scale | Standard Deviation 29.64 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | Social Function | -5.36 score on a scale | Standard Deviation 17.47 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | Emotional Role | 14.29 score on a scale | Standard Deviation 37.8 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | Mental Health | 4.57 score on a scale | Standard Deviation 13.35 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | MCS | 2.73 score on a scale | Standard Deviation 9.43 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | Physical Function | 4.29 score on a scale | Standard Deviation 16.44 |
| PEG + RBV (Standard Clinical Practice) | Minimal Clinically Important Difference (MCID) in SF-36 Scores | PCS | 0.19 score on a scale | Standard Deviation 6.76 |
Secondary
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication.
Time frame: From Baseline Visit to Final Visit (up to 72 weeks)
Population: All Evaluable Participants; participants who had met the evaluation and eligibility criteria and were included in the study. Analysis Population included 53 participants who completed 48 weeks of treatment and 77 participants who did not complete 48 weeks of treatment (early end).
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| PEG + RBV (Standard Clinical Practice) | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | PEG | 98.1 percentage of participants | 1.17 |
| PEG + RBV (Standard Clinical Practice) | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | PEG + RBV | 81.1 percentage of participants | 1.18 |
| PEG + RBV (Standard Clinical Practice) | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | RBV | 81.1 percentage of participants | 0.83 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | PEG + RBV | 0 percentage of participants | 0.82 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | PEG | 0 percentage of participants | 1.07 |
| PEG + RBV (Standard Clinical Practice): Early End of Treatment | Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) | RBV | 0 percentage of participants | 0.72 |