Trial Outcomes & Findings for Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336) (NCT NCT00863109)

Last Updated: 2017-04-07

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

133 participants

Primary outcome timeframe

Baseline, Week 72

Results posted on

2017-04-07

Participant Flow

Of 133 participants who enrolled on study, 3 participants failed screening and 130 were evaluable for this study.

Participant milestones

Participant milestones
Measure	PEG + RBV (Standard Clinical Practice) Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
Treatment Period STARTED	130
Treatment Period COMPLETED	53
Treatment Period NOT COMPLETED	77
Follow-up Period STARTED	59
Follow-up Period COMPLETED	48
Follow-up Period NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG + RBV (Standard Clinical Practice) n=130 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
Age, Continuous	47.4 years STANDARD_DEVIATION 10.7 • n=93 Participants
Sex: Female, Male Female	63 Participants n=93 Participants
Sex: Female, Male Male	67 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PEG + RBV (Standard Clinical Practice) n=126 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.	PEG + RBV (Standard Clinical Practice): Early End of Treatment Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
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	—
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	—
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 16.30	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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 19.80	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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 19.70	—
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	—
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	—
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 7.90	—
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	—
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	—
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	—
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	—
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PEG + RBV (Standard Clinical Practice) n=125 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.	PEG + RBV (Standard Clinical Practice): Early End of Treatment Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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 0.80	—
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	—
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	—
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	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	PEG + RBV (Standard Clinical Practice) n=38 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.	PEG + RBV (Standard Clinical Practice): Early End of Treatment n=8 Participants Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
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	-3.75 score on a scale Standard Deviation 4.43
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	3.13 score on a scale Standard Deviation 8.84
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	4.13 score on a scale Standard Deviation 17.75
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	-10.00 score on a scale Standard Deviation 16.42
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	-15.00 score on a scale Standard Deviation 19.09
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 22.40	-9.38 score on a scale Standard Deviation 20.86
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	-12.50 score on a scale Standard Deviation 35.36
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	-9.50 score on a scale Standard Deviation 25.38
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	0.59 score on a scale Standard Deviation 5.90
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	-7.05 score on a scale Standard Deviation 11.36

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	PEG + RBV (Standard Clinical Practice) n=38 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.	PEG + RBV (Standard Clinical Practice): Early End of Treatment n=8 Participants Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
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	-0.57 score on a scale Standard Deviation 0.72
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	-0.50 score on a scale Standard Deviation 1.07
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	-0.58 score on a scale Standard Deviation 0.82
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	-0.23 score on a scale Standard Deviation 0.58
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	-0.49 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PEG + RBV (Standard Clinical Practice) n=7 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.	PEG + RBV (Standard Clinical Practice): Early End of Treatment Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
Minimal Clinically Important Difference (MCID) in SF-36 Scores Physical Function	4.29 score on a scale Standard Deviation 16.44	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores Physical Role	3.57 score on a scale Standard Deviation 50.89	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores Pain	-0.67 score on a scale Standard Deviation 39.00	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores General Health	6.86 score on a scale Standard Deviation 13.31	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores Vitality	4.29 score on a scale Standard Deviation 29.64	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores Social Function	-5.36 score on a scale Standard Deviation 17.47	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores Emotional Role	14.29 score on a scale Standard Deviation 37.80	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores Mental Health	4.57 score on a scale Standard Deviation 13.35	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores PCS	0.19 score on a scale Standard Deviation 6.76	—
Minimal Clinically Important Difference (MCID) in SF-36 Scores MCS	2.73 score on a scale Standard Deviation 9.43	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PEG + RBV (Standard Clinical Practice) n=7 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.	PEG + RBV (Standard Clinical Practice): Early End of Treatment Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
MCID in CLDQ-HCV Scores Activity/Energy	0.00 score on a scale Standard Deviation 1.58	—
MCID in CLDQ-HCV Scores Emotional Function	0.40 score on a scale Standard Deviation 0.64	—
MCID in CLDQ-HCV Scores Worry	1.00 score on a scale Standard Deviation 0.84	—
MCID in CLDQ-HCV Scores Systemic Symptoms	0.00 score on a scale Standard Deviation 0.71	—
MCID in CLDQ-HCV Scores CLDQ-HCV Global	0.40 score on a scale Standard Deviation 0.83	—

SECONDARY outcome

Timeframe: 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).

Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication.

Outcome measures

Outcome measures
Measure	PEG + RBV (Standard Clinical Practice) n=53 Participants Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.	PEG + RBV (Standard Clinical Practice): Early End of Treatment n=77 Participants Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) PEG	98.1 percentage of participants 1.17	0 percentage of participants 1.07
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) RBV	81.1 percentage of participants 0.83	0 percentage of participants 0.72
Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) PEG + RBV	81.1 percentage of participants 1.18	0 percentage of participants 0.82

Adverse Events

PEG + RBV (Standard Clinical Practice)

Serious events: 12 serious events

Other events: 116 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PEG + RBV (Standard Clinical Practice) n=130 participants at risk Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
Blood and lymphatic system disorders ANAEMIA	3.1% 4/130 • Number of events 4 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Blood and lymphatic system disorders APLASIA PURE RED CELL	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Blood and lymphatic system disorders BONE MARROW FAILURE	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Blood and lymphatic system disorders LYMPHOCYTIC INFILTRATION	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Ear and labyrinth disorders TINNITUS	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.77% 1/130 • Number of events 2 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Gastrointestinal disorders DIARRHOEA	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Gastrointestinal disorders VOMITING	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
General disorders ASTHENIA	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Investigations HAEMOGLOBIN DECREASED	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Investigations PLATELET COUNT DECREASED	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Metabolism and nutrition disorders DECREASED APPETITE	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Metabolism and nutrition disorders DEHYDRATION	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	1.5% 2/130 • Number of events 2 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Psychiatric disorders ACUTE PSYCHOSIS	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Psychiatric disorders DEPRESSED MOOD	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Renal and urinary disorders RENAL FAILURE	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Respiratory, thoracic and mediastinal disorders COUGH	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Skin and subcutaneous tissue disorders ALOPECIA	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Skin and subcutaneous tissue disorders ECZEMA	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Skin and subcutaneous tissue disorders URTICARIA	0.77% 1/130 • Number of events 1 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.

Other adverse events

Other adverse events
Measure	PEG + RBV (Standard Clinical Practice) n=130 participants at risk Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
Blood and lymphatic system disorders ANAEMIA	5.4% 7/130 • Number of events 14 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Gastrointestinal disorders NAUSEA	34.6% 45/130 • Number of events 70 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
General disorders ASTHENIA	14.6% 19/130 • Number of events 25 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
General disorders FATIGUE	26.2% 34/130 • Number of events 63 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
General disorders INJECTION SITE REACTION	46.9% 61/130 • Number of events 116 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
General disorders PYREXIA	14.6% 19/130 • Number of events 22 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Investigations WEIGHT DECREASED	58.5% 76/130 • Number of events 140 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Metabolism and nutrition disorders DECREASED APPETITE	7.7% 10/130 • Number of events 10 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Musculoskeletal and connective tissue disorders MYALGIA	58.5% 76/130 • Number of events 153 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Nervous system disorders HEADACHE	56.9% 74/130 • Number of events 146 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Psychiatric disorders DEPRESSION	5.4% 7/130 • Number of events 9 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Psychiatric disorders EMOTIONAL DISORDER	12.3% 16/130 • Number of events 18 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Psychiatric disorders INSOMNIA	12.3% 16/130 • Number of events 18 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Psychiatric disorders MENTAL DISORDER	19.2% 25/130 • Number of events 35 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Skin and subcutaneous tissue disorders ALOPECIA	33.8% 44/130 • Number of events 73 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Skin and subcutaneous tissue disorders DRY SKIN	10.0% 13/130 • Number of events 14 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.
Skin and subcutaneous tissue disorders PRURITUS	6.9% 9/130 • Number of events 11 • From Baseline visit to Final Visit (up to 72 weeks) Of 133 enrolled participants, AEs were collected for the 130 evaluable participants. 3 enrolled participants who failed screening did not have AEs reported.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The study data/results may not be published or disseminated without prior consent from the study sponsor. All publications arising from the study will cite all the participating researchers.
Publication restrictions are in place

Restriction type: OTHER