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Trial record 74 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

The Patient-Reported Outcomes Project of HCV-TARGET (PROP-UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02601820
Recruitment Status : Completed
First Posted : November 10, 2015
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Hepatitis C, Chronic
Liver Diseases
Enrollment 1601
Recruitment Details

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.

Pre-assignment Details None. Observational study included enrolled patients who completed PRO data at follow-up time periods.
Arm/Group Title Chronic HCV Patients During and After HCV Treatment
Hide Arm/Group Description 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.
Period Title: Pre-Treatment (T1)
Started 1601 [1]
Completed 1601
Not Completed 0
[1]
1601 patients were enrolled and completed Baseline PROs (T1).
Period Title: Early On-Treatment (T2)
Started 1584 [1]
Completed 1533 [2]
Not Completed 51
Reason Not Completed
Missing T2 Record             51
[1]
Of 1601, 17 were excluded at T2 due to death, withdrawal, other reason. 1584 remained in the study.
[2]
Of 1584, 51 were excluded for a missing T2 record. 1533 provided data at T2. Some outcomes missing.
Period Title: Late On-Treatment (T3)
Started 1573 [1]
Completed 1524 [2]
Not Completed 49
Reason Not Completed
missing T3 Record             49
[1]
Of 1601, 28 were excluded at T3 due to death, withdrawal, other reason. 1573 remained in the study.
[2]
Of 1573, 49 were excluded for a missing T3 record. 1524 provided data at T3. Some outcomes missing.
Period Title: 12 Weeks Post-Treatment (T4)
Started 1564 [1]
Completed 1561 [2]
Not Completed 3
Reason Not Completed
Missing T4 record             3
[1]
Of 1601, 37 were excluded at T4 due to death, withdrawal, other reason. 1564 remained in the study.
[2]
Of 1564, 3 were excluded for a missing T4 record. 1561 provided data at T4. Some outcomes missing.
Period Title: 1-Yr Post-Treatment (T5)
Started 1528 [1]
Completed 1440 [2]
Not Completed 88
Reason Not Completed
Missing T5 Record             88
[1]
Of 1601, 73 were excluded at T5 due to death, withdrawal, other reason. 1528 remained in the study.
[2]
Of 1528, 88 were excluded for a missing T5 record. 1440 provided data at T5. Some outcomes missing.
Arm/Group Title Chronic HCV Patients on Treatment
Hide Arm/Group Description All 1,601 patients with chronic HCV enrolled at baseline
Overall Number of Baseline Participants 1601
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1601 participants
57  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1601 participants
Female
714
  44.6%
Male
887
  55.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1601 participants
Hispanic or Latino
66
   4.1%
Not Hispanic or Latino
1260
  78.7%
Unknown or Not Reported
275
  17.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1601 participants
American Indian or Alaska Native
17
   1.1%
Asian
6
   0.4%
Native Hawaiian or Other Pacific Islander
5
   0.3%
Black or African American
519
  32.4%
White
975
  60.9%
More than one race
32
   2.0%
Unknown or Not Reported
47
   2.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1601 participants
1601
 100.0%
PROMIS Depression   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1598 participants
49.3  (10.5)
[1]
Measure Description: Patients completed the PROMIS Depression-8 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Depression-8a range from 38.2 - 81.3. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.Higher scores indicate worse Depression.
[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
PROMIS Anger   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1601 participants
48.9  (11.2)
[1]
Measure Description:

Patients completed the PROMIS Anger-5 item short form at baseline (T1) prior to starting HCV Treatment. Higher scores indicate worse Anger/irritability.

PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Anger-5a range from 32.9 - 82.9. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.

PROMIS Anxiety   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1591 participants
50.4  (10.2)
[1]
Measure Description:

Patients completed the PROMIS Anxiety-4 item short form at baseline (T1) prior to starting HCV Treatment.

PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Anxiety-4a range from 40.3 - 81.6. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.

Higher scores indicate worse Anxiety.

[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
PROMIS Cognitive Concerns   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1599 participants
33  (9.0)
[1]
Measure Description: Patients completed the PROMIS Applied Cognitive-General Concerns 8 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Applied Cognitive-General Concerns-8a range from 22.41 - 63.48. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.Higher scores indicate worse Cognitive Concerns.
[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
PROMIS Pain Interference   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1600 participants
53  (11)
[1]
Measure Description: Patients completed the PROMIS Pain Interference 8 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Pain Interference-8a range from 40.7 - 77.0. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Pain Interference.
[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
PROMIS Fatigue   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1599 participants
51.8  (10.8)
[1]
Measure Description: Patients completed the PROMIS Fatigue-7a item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Fatigue 7a short form range from 29.4 -83.2. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.Higher scores indicate worse Fatigue.
[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
PROMIS Sleep Disturbance   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1600 participants
51.8  (11.4)
[1]
Measure Description: Patients completed the PROMIS Sleep Disturbance-8a short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Sleep Disturbance-8a short form scores range from 28.9 - 76.5. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Sleep Disturbance.
[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
PROMIS Abdominal Pain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1600 participants
36.1  (12.9)
[1]
Measure Description: Patients completed the PROMIS Belly Pain-5 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Belly Pain-5a range from 39.3 - 80. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Belly Pain.
[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
PROMIS Diarrhea   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1584 participants
35.6  (8.7)
[1]
Measure Description: Patients completed the PROMIS Diarrhea-6 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Diarrhea-6a range from 45.9 - 75.2. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Diarrhea.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1585 participants
41.6  (8.5)
[1]
Measure Description: Patients completed the PROMIS Nausea and Vomiting-4 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Nausea/Vomit.
[2]
Measure Analysis Population Description: 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)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1577 participants
45.3  (10)
[1]
Measure Description: Patients completed the Headache Inventory Test-6 at baseline (T1) prior to starting HCV Treatment. The six items are scored on a 5-point likert scale ranging from never to always. The final score is summed and can range from 36-78, with higher scores indicate worse headaches.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1589 participants
0.6  (0.5)
[1]
Measure Description: Overall symptom burden was measured using the Memorial Symptom Assessment Scale (MSAS). The MSAS is a reliable and validated 32-item instrument used to measure change in pre-existing HCV symptoms. The MSAS evaluates 32 symptoms common in medical populations. Patients indicate the presence or absence of a symptom. If present, rate the construct on severity, frequency and distress. An overall symptom burden score is created: TMSAS (total MSAS score). The TMSAS scores range from 0 (no symptom) to 4 (present, severe, frequent, distressing). Higher scores indicate worse overall symptom burden.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1493 participants
71.7  (22.3)
[1]
Measure Description: Patients completed the HCV-PRO at baseline (T1) prior to starting HCV Treatment. The HCV-PRO is new disease specific measure. It has 16 items with responses ranging from 1-5 with the sum transformed to a 0-100 scale. Higher scores indicate better functional well-being.
[2]
Measure Analysis Population Description: 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data.
1.Primary Outcome
Title Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment
Hide Description

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.

Time Frame Baseline to up to 24 weeks of HCV Treatment
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Chronic HCV Patients on Therapy
Hide Arm/Group Description:
All enrolled patients with MSAS data available at T2 or T3 during HCV treatment
Overall Number of Participants Analyzed 1533
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change in TMSAS score from T1 to T2 Number Analyzed 1533 participants
-0.10
(-0.10 to -0.10)
Change in TMSAS score from T1 to T3 Number Analyzed 1524 participants
-0.1
(-0.10 to -0.10)
2.Secondary Outcome
Title Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Hide Description

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.

Time Frame Baseline to up to 24 weeks of HCV Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size may differ for each mean change score due to missing survey data.
Arm/Group Title Chronic HCV Patients on Therapy
Hide Arm/Group Description:
All enrolled patients with symptom data recorded at T2 or T3 during HCV treatment
Overall Number of Participants Analyzed 1533
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change in Fatigue Mean Score from T1 to T2 Number Analyzed 1527 participants
-1.1
(-1.6 to -0.6)
Change in Sleep disturbance score from T1 to T2 Number Analyzed 1526 participants
-1.6
(-2.1 to -1.1)
Change in Nausea/Vomiting mean score from T1 to T2 Number Analyzed 1499 participants
0.8
(0.3 to 1.2)
Change in Diarrhea mean score from T1 to T2 Number Analyzed 1498 participants
0.8
(0.4 to 1.3)
Change in Irritability mean score from T1 to T2 Number Analyzed 1525 participants
-1.2
(-1.8 to -0.7)
Change in Anxiety mean score from T1 to T2 Number Analyzed 1496 participants
-1.5
(-2.0 to -1.1)
Change in headache HIT-6 mean score from T1 to T2 Number Analyzed 1490 participants
0.2
(-0.3 to 0.6)
Change in Fatigue mean score from T1 to T3 Number Analyzed 1519 participants
-1.1
(-1.6 to -0.6)
Change in sleep disturbance score from T1 to T3 Number Analyzed 1522 participants
-1.8
(-2.3 to -1.3)
Change in nausea/vomiting mean score from T1 to T3 Number Analyzed 1496 participants
-0.2
(-0.6 to 0.3)
Change in Diarrhea mean score from T1 to T3 Number Analyzed 1500 participants
0.6
(0.1 to 1.1)
Change in anger mean score from T1 to T3 Number Analyzed 1522 participants
-0.8
(-1.3 to -0.2)
Change in anxiety mean score from T1 to T3 Number Analyzed 1499 participants
-1.4
(-1.9 to -0.9)
Change in headache HIT-6 mean score from T1 to T3 Number Analyzed 1479 participants
-0.1
(-0.5 to 0.4)
3.Secondary Outcome
Title Change in HCV-PRO Mean Scores From Baseline to On-Treatment
Hide Description

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.

Time Frame Baseline to up to 24 weeks of HCV Treatment
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Chronic HCV Patients on Therapy
Hide Arm/Group Description:
All enrolled patients with HCV-PRO data available at T2 or T3 during HCV treatment
Overall Number of Participants Analyzed 1533
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change in HCV-PRO mean score from T1 to T2 Number Analyzed 1346 participants
3.2
(2.3 to 4.0)
Change in HCV-PRO mean score from T1 to T3 Number Analyzed 1356 participants
3.8
(2.8 to 4.7)
4.Secondary Outcome
Title Cumulative Out of Pocket Costs During HCV Treatment
Hide Description

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.

Time Frame Up to 24 weeks of HCV Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic HCV Patients During and After HCV Treatment
Hide Arm/Group Description:
1601 patients with chronic HCV 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.
Overall Number of Participants Analyzed 1498
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
582.50
(490.60 to 674.30)
5.Secondary Outcome
Title Percentage of Participants With Nonadherence During HCV Treatment
Hide Description 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).
Time Frame Up to 24 weeks of HCV Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Patients With Baseline Mental Health Disturbance Patients Without Baseline Mental Health Disturbance Patients With Baseline Alcohol Abuse Patients Without Baseline Alcohol Abuse Patients With Baseline Substance Use Patients Without Baseline Substance Use
Hide Arm/Group Description:
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.
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.
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).
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).
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.
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.
Overall Number of Participants Analyzed 1562 1562 1562 1562 1562 1562
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Nonadherence rate (%) early on-treatment (T2) Number Analyzed 550 participants 957 participants 221 participants 1285 participants 344 participants 1163 participants
4.5
(3.1 to 6.6)
4.2
(3.1 to 5.6)
5.9
(3.5 to 9.8)
4
(3.1 to 5.3)
5.5
(3.6 to 8.5)
4.3
(3.0 to 5.2)
Nonadherence rate (%) late on-treatment (T3) Number Analyzed 546 participants 924 participants 212 participants 1257 participants 332 participants 1137 participants
9
(6.9 to 11.7)
7.6
(6.0 to 9.5)
13.7
(9.7 to 19.0)
7.2
(5.9 to 8.7)
9
(6.4 to 12.6)
7.8
(6.4 to 9.5)
6.Secondary Outcome
Title Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment
Hide Description

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.

Time Frame Baseline to 3-months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic HCV Patients Who Achieved SVR Chronic HCV Patients Who Did Not Achieve SVR
Hide Arm/Group Description:
Chronic HCV patients who achieved a sustained virologic cure (SVR) 3-months post-treatment
Chronic HCV patients who did not achieve a sustained virologic cure (SVR) 3-months post-treatment
Overall Number of Participants Analyzed 1313 58
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.2
(-0.2 to -0.2)
-0.1
(-0.2 to 0.0)
7.Secondary Outcome
Title Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Hide Description

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

Time Frame Baseline to 3-months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Chronic HCV Patients Who Achieved SVR Chronic HCV Patients Who Did Not Achieve SVR
Hide Arm/Group Description:
Chronic HCV patients who achieved a sustained virologic cure (SVR) 3-months post-treatment
Chronic HCV patients who did not achieve a sustained virologic cure (SVR) 3-months post-treatment
Overall Number of Participants Analyzed 1362 68
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Depression change score Number Analyzed 1326 participants 59 participants
-2.3
(-2.8 to -1.8)
0.2
(-1.7 to 2.1)
Anger change score Number Analyzed 1327 participants 59 participants
-2.1
(-2.7 to -1.5)
0.7
(-1.9 to 3.4)
Anxiety change score Number Analyzed 1310 participants 58 participants
-1.7
(-2.2 to -1.2)
-0.7
(-3.0 to 1.5)
Cognitive Concerns change score Number Analyzed 1326 participants 59 participants
-1.4
(-1.8 to -0.9)
0
(-1.7 to 1.8)
Pain Interference change score Number Analyzed 1327 participants 59 participants
-2.3
(-2.8 to -1.8)
-1.7
(-4.1 to 0.7)
Fatigue change score Number Analyzed 1329 participants 58 participants
-4.1
(-4.6 to -3.5)
-2.9
(-5.4 to -0.4)
Sleep change score Number Analyzed 1327 participants 59 participants
-3.1
(-3.6 to -2.5)
-0.9
(-3.3 to 1.4)
Belly Pain change score Number Analyzed 1326 participants 58 participants
-2.3
(-2.9 to -1.6)
0.9
(-1.9 to 3.6)
Diarrhea change score Number Analyzed 1308 participants 58 participants
-0.1
(-0.6 to 0.4)
0.7
(-2.1 to 3.5)
Nausea change score Number Analyzed 1308 participants 59 participants
-1.5
(-1.9 to -1.0)
-0.3
(-2.1 to 1.6)
Headache change score Number Analyzed 1297 participants 55 participants
-1.5
(-1.9 to -1.0)
-1.1
(-3.1 to 0.9)
8.Secondary Outcome
Title Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment
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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.

Time Frame Baseline to 3-months post-treatment
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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.
Arm/Group Title Chronic HCV Patients Who Achieved SVR Chronic HCV Patients Who Did Not Achieve SVR
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Chronic HCV patients who achieved a sustained virologic cure (SVR) 3-months post-treatment
Chronic HCV patients who did not achieve a sustained virologic cure (SVR) 3-months post-treatment
Overall Number of Participants Analyzed 1172 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
6.5
(5.5 to 7.5)
2.0
(-7.1 to 3.1)
9.Secondary Outcome
Title Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment
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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

Time Frame Baseline to 1 year post-treatment
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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)
Arm/Group Title Chronic HCV Patients Who Achieved SVR Chronic HCV Patients Who Did Not Achieve SVR
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Chronic HCV patients who achieved a sustained virologic cure (SVR) and completed PRO data one-year post-treatment (T5)
Chronic HCV patients who did not achieve a sustained virologic cure (SVR) and completed data one-year post-treatment (T5)
Overall Number of Participants Analyzed 1269 51
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.2
(-0.2 to -0.1)
0
(-0.2 to 0.1)
10.Secondary Outcome
Title Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
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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

Time Frame Baseline to 1 year post-treatment
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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.
Arm/Group Title Chronic HCV Patients Who Achieved SVR Chronic HCV Patients Who Did Not Achieve SVR
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Chronic HCV patients who achieved a sustained virologic cure (SVR) and completed PRO data one-year post-treatment (T5)
Chronic HCV patients who did not achieve a sustained virologic cure (SVR) and completed data one-year post-treatment (T5)
Overall Number of Participants Analyzed 1285 52
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Depression change score Number Analyzed 1277 participants 52 participants
-2.2
(-2.7 to -1.7)
-0.9
(-2.8 to 1.0)
Anger change score Number Analyzed 1276 participants 52 participants
-2.2
(-2.8 to -1.6)
-0.3
(-3.2 to 2.6)
Anxiety change score Number Analyzed 1264 participants 51 participants
-2.0
(-2.5 to -1.4)
-0.4
(-2.3 to 1.6)
Cognitive Concern change score Number Analyzed 1277 participants 52 participants
-1.7
(-2.1 to -1.3)
0.3
(-1.7 to 2.3)
Pain Interference change score Number Analyzed 1278 participants 52 participants
-1.9
(-2.5 to -1.4)
-0.8
(-3.4 to 1.9)
Fatigue change score Number Analyzed 1278 participants 52 participants
-3.6
(-4.2 to -3.1)
-0.6
(-3.1 to 1.8)
Sleep Disturbance change score Number Analyzed 1278 participants 52 participants
-3.1
(-3.7 to -2.5)
-1.3
(-4.2 to 1.6)
Belly Pain change score Number Analyzed 1276 participants 52 participants
-2.6
(-3.3 to -1.9)
-3.7
(-7.5 to 0.0)
Diarrhea change score Number Analyzed 1261 participants 52 participants
-0.3
(-0.8 to 0.2)
-0.1
(-2.8 to 2.6)
Nausea change score Number Analyzed 1260 participants 52 participants
-1.4
(-1.9 to -1.0)
-0.1
(-2.4 to 2.2)
Headache HIT-6 Change score Number Analyzed 1250 participants 48 participants
-1.5
(-2.0 to -1.1)
-0.7
(-2.2 to 0.9)
11.Secondary Outcome
Title Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment
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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.

Time Frame Baseline to 1 year post-treatment
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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)
Arm/Group Title Chronic HCV Patients Who Achieved SVR Chronic HCV Patients Who Did Not Achieve SVR
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Chronic HCV patients who achieved a sustained virologic cure (SVR) and completed PRO data one-year post-treatment (T5)
Chronic HCV patients who did not achieve a sustained virologic cure (SVR) and completed data one-year post-treatment (T5)
Overall Number of Participants Analyzed 1132 49
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.0
(6.0 to 8.0)
0.6
(-4.7 to 5.9)
Time Frame Up to 1.5 years from time of patient enrollment.
Adverse Event Reporting Description This observational, non-interventional survey study did not systematically track NON-study related deaths, SAEs, or OAEs. Per protocol, only study-related deaths, SAEs, and OAEs were reportable and none occurred. All deaths observed were learned about inadvertently and via non-systematic methods during data collection processes. While possibly incomplete, the number reported represents all known observable deaths during the study. Other SAEs and OAEs were not monitored/assessed.
 
Arm/Group Title Chronic HCV Patients During and After HCV Treatment
Hide Arm/Group Description 1601 patients with chronic HCV 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.
All-Cause Mortality
Chronic HCV Patients During and After HCV Treatment
Affected / at Risk (%)
Total   34/1601 (2.12%) 
Show Serious Adverse Events Hide Serious Adverse Events
Chronic HCV Patients During and After HCV Treatment
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chronic HCV Patients During and After HCV Treatment
Affected / at Risk (%)
Total   0/0 
The secondary outcome - cumulative out of pocket costs- may include less reliable data at the upper limit. Patient reporting of cumulative costs at 3 time points likely led to erroneous inflation affecting the upper limit.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Donna Evon, PhD
Organization: University of North Carolina at Chapel Hill
Phone: 919-260-4062
EMail: donna_evon@med.unc.edu
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02601820     History of Changes
Other Study ID Numbers: 15-1633
First Submitted: November 3, 2015
First Posted: November 10, 2015
Results First Submitted: January 16, 2019
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019