Trial Outcomes & Findings for The Patient-Reported Outcomes Project of HCV-TARGET (NCT NCT02601820)
NCT ID: NCT02601820
Last Updated: 2019-09-16
Results Overview
Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score. Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores \> +/- 0.3 were considered clinically meaningful.
COMPLETED
1601 participants
Baseline to up to 24 weeks of HCV Treatment
2019-09-16
Participant Flow
11 liver or gastroenterology centers in the United States: 9 academic medical centers, 2 private gastroenterology centers. 1601 patients officially enrolled who provided informed consent, completed baseline patient-reported outcome (PRO) surveys and were prescribed one of five direct acting antiviral treatment regimens for chronic hepatitis C.
None. Observational study included enrolled patients who completed PRO data at follow-up time periods.
Participant milestones
| Measure |
Chronic HCV Patients During and After HCV Treatment
1601 patients with chronic hepatitis C were enrolled. Criteria for enrollment included: providing consent, completing baseline patient-reported outcome (PRO) measures, and initiating one of five direct acting antiviral (DAAs) therapy.
|
|---|---|
|
Pre-Treatment (T1)
STARTED
|
1601
|
|
Pre-Treatment (T1)
COMPLETED
|
1601
|
|
Pre-Treatment (T1)
NOT COMPLETED
|
0
|
|
Early On-Treatment (T2)
STARTED
|
1584
|
|
Early On-Treatment (T2)
COMPLETED
|
1533
|
|
Early On-Treatment (T2)
NOT COMPLETED
|
51
|
|
Late On-Treatment (T3)
STARTED
|
1573
|
|
Late On-Treatment (T3)
COMPLETED
|
1524
|
|
Late On-Treatment (T3)
NOT COMPLETED
|
49
|
|
12 Weeks Post-Treatment (T4)
STARTED
|
1564
|
|
12 Weeks Post-Treatment (T4)
COMPLETED
|
1561
|
|
12 Weeks Post-Treatment (T4)
NOT COMPLETED
|
3
|
|
1-Yr Post-Treatment (T5)
STARTED
|
1528
|
|
1-Yr Post-Treatment (T5)
COMPLETED
|
1440
|
|
1-Yr Post-Treatment (T5)
NOT COMPLETED
|
88
|
Reasons for withdrawal
| Measure |
Chronic HCV Patients During and After HCV Treatment
1601 patients with chronic hepatitis C were enrolled. Criteria for enrollment included: providing consent, completing baseline patient-reported outcome (PRO) measures, and initiating one of five direct acting antiviral (DAAs) therapy.
|
|---|---|
|
Early On-Treatment (T2)
Missing T2 Record
|
51
|
|
Late On-Treatment (T3)
missing T3 Record
|
49
|
|
12 Weeks Post-Treatment (T4)
Missing T4 record
|
3
|
|
1-Yr Post-Treatment (T5)
Missing T5 Record
|
88
|
Baseline Characteristics
1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
Baseline characteristics by cohort
| Measure |
Chronic HCV Patients on Treatment
n=1601 Participants
All 1,601 patients with chronic HCV enrolled at baseline
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 11 • n=1601 Participants
|
|
Sex: Female, Male
Female
|
714 Participants
n=1601 Participants
|
|
Sex: Female, Male
Male
|
887 Participants
n=1601 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
66 Participants
n=1601 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1260 Participants
n=1601 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
275 Participants
n=1601 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
17 Participants
n=1601 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=1601 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=1601 Participants
|
|
Race (NIH/OMB)
Black or African American
|
519 Participants
n=1601 Participants
|
|
Race (NIH/OMB)
White
|
975 Participants
n=1601 Participants
|
|
Race (NIH/OMB)
More than one race
|
32 Participants
n=1601 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
47 Participants
n=1601 Participants
|
|
Region of Enrollment
United States
|
1601 Participants
n=1601 Participants
|
|
PROMIS Depression
|
49.3 units on a scale
STANDARD_DEVIATION 10.5 • n=1598 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Anger
|
48.9 units on a scale
STANDARD_DEVIATION 11.2 • n=1601 Participants
|
|
PROMIS Anxiety
|
50.4 units on a scale
STANDARD_DEVIATION 10.2 • n=1591 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Cognitive Concerns
|
33 units on a scale
STANDARD_DEVIATION 9.0 • n=1599 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Pain Interference
|
53 units on a scale
STANDARD_DEVIATION 11 • n=1600 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Fatigue
|
51.8 units on a scale
STANDARD_DEVIATION 10.8 • n=1599 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Sleep Disturbance
|
51.8 units on a scale
STANDARD_DEVIATION 11.4 • n=1600 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Abdominal Pain
|
36.1 units on a scale
STANDARD_DEVIATION 12.9 • n=1600 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Diarrhea
|
35.6 units on a scale
STANDARD_DEVIATION 8.7 • n=1584 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
PROMIS Nausea and Vomiting
|
41.6 units on a scale
STANDARD_DEVIATION 8.5 • n=1585 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
Headache Impact Test (HIT-6)
|
45.3 units on a scale
STANDARD_DEVIATION 10 • n=1577 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
TMSAS Overall Symptom Burden
|
0.6 units on a scale
STANDARD_DEVIATION 0.5 • n=1589 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
|
HCV-PRO Functional Well-Being
|
71.7 units on a scale
STANDARD_DEVIATION 22.3 • n=1493 Participants • 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
|
PRIMARY outcome
Timeframe: Baseline to up to 24 weeks of HCV TreatmentPopulation: Of 1533 patients with complete record at T2, 1517 provided sufficient TMSAS data to calculate change score. Of 1524 patients with complete record at T3, 1513 provided sufficient TMSAS data to calculate change score. Discrepancies due to missing TMSAS data at T2 or T3.
Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score. Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores \> +/- 0.3 were considered clinically meaningful.
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1533 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment
Change in TMSAS score from T1 to T2
|
-0.10 units on a scale
Interval -0.1 to -0.1
|
—
|
—
|
—
|
—
|
—
|
|
Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment
Change in TMSAS score from T1 to T3
|
-0.1 units on a scale
Interval -0.1 to -0.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to up to 24 weeks of HCV TreatmentPopulation: Sample size may differ for each mean change score due to missing survey data.
Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved. 1. PROMIS Fatigue-7 mean change score range = +/- 53.9 2. PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1 3. PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0 4. PROMIS Diarrhea-6 mean change score range = +/- 42.8 5. PROMIS Anger-5 mean change score range = +/- 50.5. 6. PROMIS Anxiety-4 mean change score range = +/- 41.4 7. HIT-6 mean change score range = +/- 42 To aid in interpretation of clinical significance, a 5% change from baseline is considered a "minimally important change (MIC)." The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points.
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1533 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Fatigue Mean Score from T1 to T2
|
-1.1 units on a scale
Interval -1.6 to -0.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Sleep disturbance score from T1 to T2
|
-1.6 units on a scale
Interval -2.1 to -1.1
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Nausea/Vomiting mean score from T1 to T2
|
0.8 units on a scale
Interval 0.3 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Diarrhea mean score from T1 to T2
|
0.8 units on a scale
Interval 0.4 to 1.3
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Irritability mean score from T1 to T2
|
-1.2 units on a scale
Interval -1.8 to -0.7
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Anxiety mean score from T1 to T2
|
-1.5 units on a scale
Interval -2.0 to -1.1
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in headache HIT-6 mean score from T1 to T2
|
0.2 units on a scale
Interval -0.3 to 0.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Fatigue mean score from T1 to T3
|
-1.1 units on a scale
Interval -1.6 to -0.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in sleep disturbance score from T1 to T3
|
-1.8 units on a scale
Interval -2.3 to -1.3
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in nausea/vomiting mean score from T1 to T3
|
-0.2 units on a scale
Interval -0.6 to 0.3
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Diarrhea mean score from T1 to T3
|
0.6 units on a scale
Interval 0.1 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in anger mean score from T1 to T3
|
-0.8 units on a scale
Interval -1.3 to -0.2
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in anxiety mean score from T1 to T3
|
-1.4 units on a scale
Interval -1.9 to -0.9
|
—
|
—
|
—
|
—
|
—
|
|
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in headache HIT-6 mean score from T1 to T3
|
-0.1 units on a scale
Interval -0.5 to 0.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to up to 24 weeks of HCV TreatmentPopulation: Of 1533 patients with data records at T2, 1346 had analyzable HCV-PRO data at T2. Of 1524 patients with data records at T3, 1356 had analyzable HCV-PRO data at T3. Discrepancies due to missing HCV-PRO data.
HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life. The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score. HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores \> +/- 4.0 were considered clinically meaningful.
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1533 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in HCV-PRO Mean Scores From Baseline to On-Treatment
Change in HCV-PRO mean score from T1 to T2
|
3.2 units on a scale
Interval 2.3 to 4.0
|
—
|
—
|
—
|
—
|
—
|
|
Change in HCV-PRO Mean Scores From Baseline to On-Treatment
Change in HCV-PRO mean score from T1 to T3
|
3.8 units on a scale
Interval 2.8 to 4.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks of HCV TreatmentPopulation: Of 1601 patients enrolled, OOP cost data was recorded by 1578 patients. Due to unreliable data, especially at the upper limit, 40 cases (2.53%) were eliminated from each tail (lower and upper limit), totaling 80 cases (5.06%) of the 1578 sample. OOP dollar amount below based on 1498 cases.
Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended. The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4.
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1498 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Cumulative Out of Pocket Costs During HCV Treatment
|
582.50 units on a scale
Interval 490.6 to 674.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks of HCV TreatmentPopulation: Of 1601 enrolled patients, 1562 had VMAS adherence data at either early treatment (T2) or late treatment (T3). 1513 patients had adherence data at T2. 1476 patients had adherence data at T3.
Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or \<100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3).
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1562 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
n=1562 Participants
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
n=1562 Participants
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
n=1562 Participants
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
n=1562 Participants
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
n=1562 Participants
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Nonadherence During HCV Treatment
Nonadherence rate (%) early on-treatment (T2)
|
4.5 percentage of participants
Interval 3.1 to 6.6
|
4.2 percentage of participants
Interval 3.1 to 5.6
|
5.9 percentage of participants
Interval 3.5 to 9.8
|
4 percentage of participants
Interval 3.1 to 5.3
|
5.5 percentage of participants
Interval 3.6 to 8.5
|
4.3 percentage of participants
Interval 3.0 to 5.2
|
|
Percentage of Participants With Nonadherence During HCV Treatment
Nonadherence rate (%) late on-treatment (T3)
|
9 percentage of participants
Interval 6.9 to 11.7
|
7.6 percentage of participants
Interval 6.0 to 9.5
|
13.7 percentage of participants
Interval 9.7 to 19.0
|
7.2 percentage of participants
Interval 5.9 to 8.7
|
9 percentage of participants
Interval 6.4 to 12.6
|
7.8 percentage of participants
Interval 6.4 to 9.5
|
SECONDARY outcome
Timeframe: Baseline to 3-months post-treatmentPopulation: Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Additional missing numbers (from 1362 to 1313 and 68 to 58) were due to missing MSAS survey data at 3-months post-treatment.
Change in "Overall Symptom Burden" from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score. Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores \> +/- 0.3 were considered clinically meaningful.
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1313 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
n=58 Participants
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment
|
-0.2 units on a scale
Interval -0.2 to -0.2
|
-0.1 units on a scale
Interval -0.2 to 0.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3-months post-treatmentPopulation: Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Missing numbers below are due to missing PRO survey data at T4.
Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved 1. PROMIS Fatigue mean change score range = +/- 53.9 2. PROMIS Sleep Disturbance mean change score range = +/- 47.1 3. PROMIS Nausea mean change score range = +/- 44.0 4. PROMIS Diarrhea mean change score range = +/- 42.8 5. PROMIS Anger mean change score range = +/- 50.5. 6. PROMIS Anxiety mean change score range = +/- 41.4 7. PROMIS Depression mean change score range = +/- 43.1 8. PROMIS Cognitive Concern mean change score range = +/- 39.5 9. PROMIS Pain mean change score range = +/- 36.4 10. PROMIS Belly Pain mean change score range = +/- 50.2 11. Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically "minimally important change" (MIC). The 5% MIC = +/- 2.5 points. Change scores were calculated for two subgroups: Patients who did and did not achieve SVR
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1362 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
n=68 Participants
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Depression change score
|
-2.3 units on a scale
Interval -2.8 to -1.8
|
0.2 units on a scale
Interval -1.7 to 2.1
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Anger change score
|
-2.1 units on a scale
Interval -2.7 to -1.5
|
0.7 units on a scale
Interval -1.9 to 3.4
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Anxiety change score
|
-1.7 units on a scale
Interval -2.2 to -1.2
|
-0.7 units on a scale
Interval -3.0 to 1.5
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Cognitive Concerns change score
|
-1.4 units on a scale
Interval -1.8 to -0.9
|
0 units on a scale
Interval -1.7 to 1.8
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Pain Interference change score
|
-2.3 units on a scale
Interval -2.8 to -1.8
|
-1.7 units on a scale
Interval -4.1 to 0.7
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Fatigue change score
|
-4.1 units on a scale
Interval -4.6 to -3.5
|
-2.9 units on a scale
Interval -5.4 to -0.4
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Sleep change score
|
-3.1 units on a scale
Interval -3.6 to -2.5
|
-0.9 units on a scale
Interval -3.3 to 1.4
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Belly Pain change score
|
-2.3 units on a scale
Interval -2.9 to -1.6
|
0.9 units on a scale
Interval -1.9 to 3.6
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Diarrhea change score
|
-0.1 units on a scale
Interval -0.6 to 0.4
|
0.7 units on a scale
Interval -2.1 to 3.5
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Nausea change score
|
-1.5 units on a scale
Interval -1.9 to -1.0
|
-0.3 units on a scale
Interval -2.1 to 1.6
|
—
|
—
|
—
|
—
|
|
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Headache change score
|
-1.5 units on a scale
Interval -1.9 to -1.0
|
-1.1 units on a scale
Interval -3.1 to 0.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3-months post-treatmentPopulation: Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Additional missing numbers due to missing HCV-PRO survey data at 3-months post-treatment.
HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores \> +/- 4.0 were considered clinically meaningful.
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1172 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
n=54 Participants
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment
|
6.5 units on a scale
Interval 5.5 to 7.5
|
2.0 units on a scale
Interval -7.1 to 3.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-treatmentPopulation: 1430 of 1601 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. Of 1430, T5 records were missing for 93 cases (1337 remaining). Of the remaining 1337 records, TMSAS data were missing for 17 patients (1320 remaining: 1269 with SVR, 51 with no SVR)
Change in "Overall Symptom Burden" from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score. Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores \> +/- 0.3 were considered clinically meaningful
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1269 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
n=51 Participants
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment
|
-0.2 units on a scale
Interval -0.2 to -0.1
|
0 units on a scale
Interval -0.2 to 0.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-treatmentPopulation: 1430 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. T5 records were missing for 93 cases. Discrepancies from 1362 and 68 due to missing survey data at T5 for specific measure.
Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved 1. PROMIS Fatigue mean change score range = +/- 53.9 2. PROMIS Sleep Disturbance mean change score range = +/- 47.1 3. PROMIS Nausea mean change score range = +/- 44.0 4. PROMIS Diarrhea mean change score range = +/- 42.8 5. PROMIS Anger mean change score range = +/- 50.5. 6. PROMIS Anxiety mean change score range = +/- 41.4 7. PROMIS Depression mean change score range = +/- 43.1 8. PROMIS Cognitive Concern mean change score range = +/- 39.5 9. PROMIS Pain mean change score range = +/- 36.4 10. PROMIS Belly Pain mean change score range = +/- 50.2 11. Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically "minimally important change" (MIC). The 5% MIC = +/- 2.5 points. Change scores were calculated for two subgroups: Patients who did and did not achieve SVR
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1285 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
n=52 Participants
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Depression change score
|
-2.2 units on a scale
Interval -2.7 to -1.7
|
-0.9 units on a scale
Interval -2.8 to 1.0
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Anger change score
|
-2.2 units on a scale
Interval -2.8 to -1.6
|
-0.3 units on a scale
Interval -3.2 to 2.6
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Anxiety change score
|
-2.0 units on a scale
Interval -2.5 to -1.4
|
-0.4 units on a scale
Interval -2.3 to 1.6
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Cognitive Concern change score
|
-1.7 units on a scale
Interval -2.1 to -1.3
|
0.3 units on a scale
Interval -1.7 to 2.3
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Pain Interference change score
|
-1.9 units on a scale
Interval -2.5 to -1.4
|
-0.8 units on a scale
Interval -3.4 to 1.9
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Fatigue change score
|
-3.6 units on a scale
Interval -4.2 to -3.1
|
-0.6 units on a scale
Interval -3.1 to 1.8
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Sleep Disturbance change score
|
-3.1 units on a scale
Interval -3.7 to -2.5
|
-1.3 units on a scale
Interval -4.2 to 1.6
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Belly Pain change score
|
-2.6 units on a scale
Interval -3.3 to -1.9
|
-3.7 units on a scale
Interval -7.5 to 0.0
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Diarrhea change score
|
-0.3 units on a scale
Interval -0.8 to 0.2
|
-0.1 units on a scale
Interval -2.8 to 2.6
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Nausea change score
|
-1.4 units on a scale
Interval -1.9 to -1.0
|
-0.1 units on a scale
Interval -2.4 to 2.2
|
—
|
—
|
—
|
—
|
|
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Headache HIT-6 Change score
|
-1.5 units on a scale
Interval -2.0 to -1.1
|
-0.7 units on a scale
Interval -2.2 to 0.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-treatmentPopulation: 1430 of 1601 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. Of 1430, T5 records were missing for 93 cases (1337 remaining). Of the remaining 1337 records, HCV-PRO data were missing for 156 patients (1181 remaining: 1132 with SVR, 49 with no SVR)
HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life. The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a \>5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores \> +/- 4.0 were considered clinically meaningful.
Outcome measures
| Measure |
Chronic HCV Patients on Therapy
n=1132 Participants
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
|
Patients Without Baseline Mental Health Disturbance
n=49 Participants
For this analysis, participants were classified as having mental health disturbances if they reported taking psychiatric medications for psychiatric conditions at enrollment or had ever been hospitalized for a psychiatric condition.
|
Patients With Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients Without Baseline Alcohol Abuse
for this analysis, current alcohol abuse was evaluated using a score of greater than or equal to 5 on the Substance Abuse Mental Illness Symptom Screener (SAMISS), using questions similar to the Alcohol Use Disorders Identification Test (AUDIT).
|
Patients With Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS screener.
|
Patients Without Baseline Substance Use
For this analysis, substance abuse was classified as self-reported use of prescription drugs to either get high or change the way a patient feels, or use of nonprescription street drugs within the year prior to enrollment using the SAMISS Screener.
|
|---|---|---|---|---|---|---|
|
Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment
|
7.0 units on a scale
Interval 6.0 to 8.0
|
0.6 units on a scale
Interval -4.7 to 5.9
|
—
|
—
|
—
|
—
|
Adverse Events
Chronic HCV Patients During and After HCV Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Donna Evon, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place