Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program. (NCT NCT00087594)

Last Updated: 2016-03-04

Results Overview

TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or \>= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a \< 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

Up to 24 weeks for G2/3; up to 48 weeks for G1

Results posted on

2016-03-04

Participant Flow

A total of 48 participants were screened at 6 study sites in the United States (U.S) between 20 November 2003 and 25 September 2006.

Participant milestones

Participant milestones
Measure	Direct Observed Therapy Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Study STARTED	24	24
Overall Study COMPLETED	16	12
Overall Study NOT COMPLETED	8	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Direct Observed Therapy Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Overall Study Adverse Event	2	3
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	4	2
Overall Study Lack of Efficacy	2	5

Baseline Characteristics

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Total n=48 Participants Total of all reporting groups
Age, Continuous	47.9 years STANDARD_DEVIATION 10.50 • n=5 Participants	46.8 years STANDARD_DEVIATION 9.45 • n=7 Participants	47.4 years STANDARD_DEVIATION 9.90 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks for G2/3; up to 48 weeks for G1

Population: Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Treatment Completion Rate (TCR) G1 (n = 13, 16)	9 participants	10 participants
Number of Participants With Treatment Completion Rate (TCR) G1, 2 log drop at Week 12 (n = 4, 9)	4 participants	5 participants
Number of Participants With Treatment Completion Rate (TCR) G1, non 2 log drop at Week 12 (n = 4, 4)	4 participants	4 participants
Number of Participants With Treatment Completion Rate (TCR) G1, missing HCV-RNA at Week 12 (n = 5, 3)	1 participants	1 participants
Number of Participants With Treatment Completion Rate (TCR) G2/3 (n = 11, 8)	11 participants	7 participants

SECONDARY outcome

Timeframe: Week 48 for G2/3 and Week 72 for G1

Population: ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.

SVR is defined as the number of participants with undetectable HCV-RNA (\< 10 international unit per milliliter \[IU/mL\]) at 24 weeks post treatment completion.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1) G1 (n = 13, 16)	4 participants	5 participants
Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1) G2/3 (n = 11, 8)	10 participants	2 participants

SECONDARY outcome

Timeframe: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)

Population: ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.

Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (\< 10 IU/mL). Treatment completion (end of treatment \[EOT\]) for G1 was Week 48 and for G2 or 3 was Week 24.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion Week 12 (G1), (n = 13, 16)	3 participants	5 participants
Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion Week 24 (G1), (n = 13, 16)	5 participants	8 participants
Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion Week 48 (EOT) (G1), (n = 13, 16)	5 participants	8 participants
Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion 12 weeks after EOT (G1), (n = 13, 16)	5 participants	4 participants
Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion Week 12 (G2/3), (n = 11, 8)	11 participants	8 participants
Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion Week 24 (EOT) (G2/3), (n = 11, 8)	11 participants	7 participants
Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion 12 Weeks after EOT (G2/3), (n = 11, 8)	9 participants	3 participants

SECONDARY outcome

Timeframe: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)

Population: ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.

Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT \< 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion Week 12 (G1), (n = 13, 16)	3 participants	13 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion Week 24 (G1), (n = 13, 16)	5 participants	13 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion Week 48/EOT (G1), (n = 13, 16)	4 participants	5 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion 12 Weeks after EOT (G1), (n = 13, 16)	6 participants	8 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion 24 Weeks after EOT (G1), (n = 13, 16)	4 participants	7 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion Week 12 (G2/3), (n = 11, 8)	10 participants	2 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion Week 24/EOT (G2/3), (n = 11, 8)	10 participants	4 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion 12 Weeks after EOT (G2/3), (n = 11, 8)	10 participants	4 participants
Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion 24 Weeks after EOT (G2/3), (n = 11, 8)	11 participants	3 participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12 Week 12 (G1), (n = 13, 16)	4 participants	9 participants
Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12 Week 12 (G2/3), (n = 11, 8)	11 participants	8 participants

SECONDARY outcome

Timeframe: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).

BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (\>= 29). Higher scores reflective of greater severity (worse outcome).

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II) Baseline, (n = 24, 24)	8.7 units on a scale Standard Error 1.2	8.6 units on a scale Standard Error 0.9
Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II) EOT (Week 24/48), (n = 18, 13)	13.6 units on a scale Standard Error 2.4	22.8 units on a scale Standard Error 3.0
Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II) EOS (Week 48/72), (n = 22, 19)	8.6 units on a scale Standard Error 2.0	13.4 units on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits EOT (Week 24/48), (n = 18, 13)	6.1 units on a scale Standard Error 2.2	13.5 units on a scale Standard Error 3.2
Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits EOS (Week 48/72), (n = 22, 19)	0.4 units on a scale Standard Error 1.8	4.5 units on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: Up to Week 72

Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (\>= 29). Higher scores reflective of greater severity (worse outcome).

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Baseline, none-mild	22 participants	24 participants
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Baseline, moderate	2 participants	0 participants
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Highest post-baseline, none-mild	16 participants	9 participants
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Highest post-baseline, moderate	5 participants	11 participants
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Highest post-baseline, severe	3 participants	3 participants
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Last post-baseline, none-mild	20 participants	18 participants
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Last post-baseline, moderate	3 participants	3 participants
Number of Participants With Degrees of Depression as Defined by the BDI-II Score Last post-baseline, severe	1 participants	2 participants

SECONDARY outcome

Timeframe: Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)

The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being \[PWB\] and health distress \[HD\]) and two hepatitis-specific scales (limitations because of chronic hepatitis C \[HLIM\] and health distress because of chronic hepatitis C \[HHD\]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HHD at Baseline (n = 23, 23)	62.8 units on a scale Standard Error 5.5	69.8 units on a scale Standard Error 5.7
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HLIM at EOT, (n = 15, 12)	59.1 units on a scale Standard Error 7.4	40.0 units on a scale Standard Error 8.7
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HLIM at 24 Weeks after EOT, (n = 16, 15)	84.2 units on a scale Standard Error 5.6	68.9 units on a scale Standard Error 9.6
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HHD at EOT, (n = 15, 12)	58.7 units on a scale Standard Error 8.2	50.4 units on a scale Standard Error 7.4
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HHD at 24 Weeks after EOT, (n = 16, 15)	81.6 units on a scale Standard Error 6.0	67.3 units on a scale Standard Error 7.3
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit SF at Baseline (n = 23, 24)	70.7 units on a scale Standard Error 4.1	75.5 units on a scale Standard Error 5.2
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit SF at EOT, (n = 15, 12)	50.0 units on a scale Standard Error 7.0	35.4 units on a scale Standard Error 8.9
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit SF at 24 Weeks after EOT, (n = 17, 15)	72.8 units on a scale Standard Error 6.8	59.2 units on a scale Standard Error 8.4
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit RE at Baseline (n = 23, 24)	55.1 units on a scale Standard Error 9.0	75.0 units on a scale Standard Error 7.0
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit RE at EOT, (n = 14, 12)	47.6 units on a scale Standard Error 12.0	36.1 units on a scale Standard Error 12.6
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit RE at 24 Weeks after EOT, (n = 17, 15)	74.5 units on a scale Standard Error 9.7	62.2 units on a scale Standard Error 11.7
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit MH at Baseline (n = 23, 24)	63.7 units on a scale Standard Error 3.4	73.5 units on a scale Standard Error 3.6
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit MH at EOT, (n = 15, 12)	53.6 units on a scale Standard Error 5.9	51.7 units on a scale Standard Error 5.6
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit MH at 24 Weeks after EOT, (n = 17, 15)	67.5 units on a scale Standard Error 6.1	57.9 units on a scale Standard Error 4.7
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit PF at Baseline (n = 23, 24)	74.6 units on a scale Standard Error 4.9	80.0 units on a scale Standard Error 4.6
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit PF at EOT, (n = 15, 12)	59.0 units on a scale Standard Error 8.4	52.9 units on a scale Standard Error 8.3
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit PF at 24 Weeks after EOT, (n = 17, 14)	75.9 units on a scale Standard Error 6.0	62.9 units on a scale Standard Error 8.8
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit RP at Baseline (n = 23, 24)	62.0 units on a scale Standard Error 8.1	59.4 units on a scale Standard Error 8.8
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit RP at EOT, (n = 15, 12)	26.7 units on a scale Standard Error 9.6	16.7 units on a scale Standard Error 7.1
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit RP at 24 Weeks after EOT, (n = 17, 14)	66.2 units on a scale Standard Error 9.3	55.4 units on a scale Standard Error 11.5
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit BP at Baseline (n = 23, 24)	67.0 units on a scale Standard Error 4.6	72.2 units on a scale Standard Error 4.1
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit BP at EOT, (n = 14, 12)	55.9 units on a scale Standard Error 5.6	47.8 units on a scale Standard Error 6.9
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit BP at 24 Weeks after EOT, (n = 17, 15)	66.7 units on a scale Standard Error 6.0	68.1 units on a scale Standard Error 7.3
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit GH at Baseline (n = 23, 24)	56.3 units on a scale Standard Error 2.8	60.8 units on a scale Standard Error 4.0
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit GH at EOT, (n = 15, 12)	54.0 units on a scale Standard Error 5.3	37.2 units on a scale Standard Error 4.4
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit GH at 24 Weeks after EOT, (n = 17, 15)	58.7 units on a scale Standard Error 6.5	46.6 units on a scale Standard Error 5.4
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit VT at Baseline (n = 23, 24)	48.0 units on a scale Standard Error 4.2	52.7 units on a scale Standard Error 3.8
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit VT at EOT, (n = 15, 12)	29.0 units on a scale Standard Error 4.6	20.0 units on a scale Standard Error 4.8
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit VT at 24 Weeks after EOT, (n = 17, 15)	54.4 units on a scale Standard Error 6.9	41.3 units on a scale Standard Error 5.9
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HD at Baseline (n = 23, 24)	65.7 units on a scale Standard Error 4.9	76.9 units on a scale Standard Error 4.5
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HD at EOT, (n = 15, 12)	62.3 units on a scale Standard Error 5.7	43.3 units on a scale Standard Error 7.8
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HD at 24 Weeks after EOT, (n = 17, 15)	73.8 units on a scale Standard Error 6.8	52.7 units on a scale Standard Error 7.3
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit PWB at Baseline (n = 23, 24)	50.0 units on a scale Standard Error 4.4	40.2 units on a scale Standard Error 4.3
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit PWB at EOT, (n = 15, 12)	65.3 units on a scale Standard Error 5.5	63.8 units on a scale Standard Error 5.6
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit PWB at 24 Weeks after EOT, (n = 17, 15)	45.3 units on a scale Standard Error 6.7	47.0 units on a scale Standard Error 6.6
Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit HLIM at Baseline (n = 23, 23)	74.5 units on a scale Standard Error 6.0	76.8 units on a scale Standard Error 6.1

SECONDARY outcome

Timeframe: Up to Week 24 for G 2/3; up to Week 48 for G1

Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48\*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24\*7) for G2/3.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Compliance to the Prescribed Treatment Regimen Peginterferon alfa-2a, 0-60%	8 participants	8 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Peginterferon alfa-2a, >60-80%	0 participants	1 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Peginterferon alfa-2a, >80-97%	1 participants	4 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Peginterferon alfa-2a, >97%	15 participants	11 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Ribavirin, 0-60%	8 participants	10 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Ribavirin, >60-80%	4 participants	1 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Ribavirin, >80-97%	5 participants	7 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Ribavirin, >97%	7 participants	6 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Total Treatment Duration, 0-60%	8 participants	8 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Total Treatment Duration, >60-80%	0 participants	1 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Total Treatment Duration, >80-97%	1 participants	3 participants
Number of Participants With Compliance to the Prescribed Treatment Regimen Total Treatment Duration, >97%	15 participants	12 participants

SECONDARY outcome

Timeframe: Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)

Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as \< 85 mm Hg or \> 180 mm Hg with a change from baseline of \> 20%; DBP as \> 110 mm Hg with a change from baseline of \> 20%; and PR as \< 50 bpm and \> 120 bpm with a change from baseline of \> 20%.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Abnormal Vital Signs SBP - High	1 participants	0 participants
Number of Participants With Abnormal Vital Signs SBP - Low	1 participants	0 participants
Number of Participants With Abnormal Vital Signs DBP - High	2 participants	0 participants
Number of Participants With Abnormal Vital Signs PR - Low	1 participants	1 participants

SECONDARY outcome

Timeframe: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's "International Guideline for the Handling and Reporting of Laboratory Data", and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Marked Laboratory Abnormalities (Hematology) Hemoglobin - Low (n = 24, 24)	10 participants	16 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) Platelets - Low (n = 24, 24)	11 participants	10 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) RBC - Low (n = 24, 24)	14 participants	18 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) PTT - High (n = 22, 23)	2 participants	3 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) PT INR (ratio) - High (n = 22, 23)	0 participants	2 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) Hematocrit (fraction) - Low (n = 24, 24)	10 participants	11 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) WBC - High (n = 24, 24)	0 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) WBC - Low (n = 24, 24)	18 participants	19 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) Eosinophils - High (n = 24, 24)	0 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) Lymphocytes - Low (n = 24, 24)	8 participants	10 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) Monocytes - High (n = 24, 24)	0 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) Neutrophils - High (n = 24, 24)	0 participants	4 participants
Number of Participants With Marked Laboratory Abnormalities (Hematology) Neutrophils - Low (n = 24, 24)	19 participants	20 participants

SECONDARY outcome

Timeframe: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

Laboratory values falling outside the marked reference range as defined by Roche's "International Guideline for the Handling and Reporting of Laboratory Data", and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Albumin - Low (n = 24, 24)	0 participants	4 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Aspartate aminotransferase - High (n = 24, 24)	2 participants	8 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Alanine aminotransferase - High (n = 24, 24)	2 participants	4 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Total protein - High (n = 24, 24)	1 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Total protein - Low (n = 24, 24)	0 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Chloride - Low (n = 24, 24)	2 participants	3 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Sodium - Low (n = 24, 24)	3 participants	2 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Calcium - Low (n = 24, 24)	0 participants	5 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Phosphate - High (n = 24, 24)	1 participants	2 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Phosphate - Low (n = 24, 24)	6 participants	7 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Glucose random - High (n = 24, 24)	1 participants	2 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Triglycerides - High (n = 24, 24)	9 participants	6 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Thyroxine (T4) - High (n = 22, 22)	4 participants	2 participants
Number of Participants With Marked Laboratory Abnormalities (Biochemistry) Thyroid-Stimulating Hormone - High (n = 22, 22)	0 participants	3 participants

SECONDARY outcome

Timeframe: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded.

Outcome measures

Outcome measures
Measure	Direct Observed Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 Participants Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation Any AEs	24 participants	24 participants
Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation Any SAEs	3 participants	3 participants
Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation AEs	2 participants	3 participants
Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation Study discontinuation due to Insufficient Response	2 participants	5 participants
Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation Study discontinuation due to Refused Treatment	4 participants	2 participants
Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation Study discontinuation due to Failure to Return	0 participants	2 participants

Adverse Events

Direct Observed Therapy

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Self-Administration Therapy

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Direct Observed Therapy n=24 participants at risk Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 participants at risk Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Psychiatric disorders Psychotic disorder	4.2% 1/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Psychiatric disorders Suicidal ideation	4.2% 1/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Asthma	4.2% 1/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Injury, poisoning and procedural complications Heat stroke	0.00% 0/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Injury, poisoning and procedural complications Overdose	0.00% 0/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Gastrointestinal disorders Abdominal pain	0.00% 0/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
General disorders Drug withdrawal syndrome	0.00% 0/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Hepatobiliary disorders Bile duct stone	0.00% 0/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Infections and infestations Cellulitis	0.00% 0/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72

Other adverse events

Other adverse events
Measure	Direct Observed Therapy n=24 participants at risk Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.	Self-Administration Therapy n=24 participants at risk Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
General disorders Fatigue	66.7% 16/24 • From baseline to Week 72	79.2% 19/24 • From baseline to Week 72
General disorders Irritability	33.3% 8/24 • From baseline to Week 72	37.5% 9/24 • From baseline to Week 72
General disorders Chills	25.0% 6/24 • From baseline to Week 72	29.2% 7/24 • From baseline to Week 72
General disorders Pyrexia	20.8% 5/24 • From baseline to Week 72	33.3% 8/24 • From baseline to Week 72
General disorders Injection site erythema	16.7% 4/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
General disorders Asthenia	12.5% 3/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
General disorders Influenza like illness	4.2% 1/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Gastrointestinal disorders Nausea	54.2% 13/24 • From baseline to Week 72	58.3% 14/24 • From baseline to Week 72
Gastrointestinal disorders Vomiting	25.0% 6/24 • From baseline to Week 72	37.5% 9/24 • From baseline to Week 72
Gastrointestinal disorders Dry mouth	12.5% 3/24 • From baseline to Week 72	20.8% 5/24 • From baseline to Week 72
Gastrointestinal disorders Abdominal pain upper	12.5% 3/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Gastrointestinal disorders Constipation	12.5% 3/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Gastrointestinal disorders Abdominal pain	8.3% 2/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Gastrointestinal disorders Diarrhoea	8.3% 2/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Gastrointestinal disorders Stomatitis	8.3% 2/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Gastrointestinal disorders Toothache	8.3% 2/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Gastrointestinal disorders Gastritis	0.00% 0/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Psychiatric disorders Depression	37.5% 9/24 • From baseline to Week 72	41.7% 10/24 • From baseline to Week 72
Psychiatric disorders Insomnia	33.3% 8/24 • From baseline to Week 72	41.7% 10/24 • From baseline to Week 72
Psychiatric disorders Anxiety	12.5% 3/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Psychiatric disorders Confusional state	8.3% 2/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Psychiatric disorders Agitation	8.3% 2/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Skin and subcutaneous tissue disorders Rash	50.0% 12/24 • From baseline to Week 72	25.0% 6/24 • From baseline to Week 72
Skin and subcutaneous tissue disorders Dry skin	20.8% 5/24 • From baseline to Week 72	16.7% 4/24 • From baseline to Week 72
Skin and subcutaneous tissue disorders Alopecia	12.5% 3/24 • From baseline to Week 72	25.0% 6/24 • From baseline to Week 72
Skin and subcutaneous tissue disorders Rash papular	8.3% 2/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Nervous system disorders Headache	37.5% 9/24 • From baseline to Week 72	41.7% 10/24 • From baseline to Week 72
Nervous system disorders Dysgeusia	12.5% 3/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Nervous system disorders Dizziness	12.5% 3/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Nervous system disorders Hypoaesthesia	8.3% 2/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Nervous system disorders Lethargy	4.2% 1/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Nervous system disorders Mental impairment	8.3% 2/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Nervous system disorders Paraesthesia	0.00% 0/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Musculoskeletal and connective tissue disorders Arthralgia	37.5% 9/24 • From baseline to Week 72	37.5% 9/24 • From baseline to Week 72
Musculoskeletal and connective tissue disorders Myalgia	16.7% 4/24 • From baseline to Week 72	33.3% 8/24 • From baseline to Week 72
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 3/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Musculoskeletal and connective tissue disorders Back pain	12.5% 3/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Blood and lymphatic system disorders Neutropenia	33.3% 8/24 • From baseline to Week 72	33.3% 8/24 • From baseline to Week 72
Blood and lymphatic system disorders Anaemia	16.7% 4/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Blood and lymphatic system disorders Thrombocytopenia	16.7% 4/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Cough	12.5% 3/24 • From baseline to Week 72	16.7% 4/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 3/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/24 • From baseline to Week 72	16.7% 4/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Epistaxis	4.2% 1/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 2/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Infections and infestations Upper respiratory tract infection	12.5% 3/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Infections and infestations Bronchitis	8.3% 2/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Infections and infestations Urinary tract infection	4.2% 1/24 • From baseline to Week 72	12.5% 3/24 • From baseline to Week 72
Infections and infestations Nasopharyngitis	4.2% 1/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Infections and infestations Rhinitis	8.3% 2/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Infections and infestations Cellulitis	4.2% 1/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Metabolism and nutrition disorders Decreased appetite	20.8% 5/24 • From baseline to Week 72	41.7% 10/24 • From baseline to Week 72
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Injury, poisoning and procedural complications Excoriation	8.3% 2/24 • From baseline to Week 72	4.2% 1/24 • From baseline to Week 72
Injury, poisoning and procedural complications Joint sprain	0.00% 0/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Eye disorders Vision blurred	0.00% 0/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Surgical and medical procedures Tooth extraction	0.00% 0/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72
Investigations Blood pressure increased	8.3% 2/24 • From baseline to Week 72	0.00% 0/24 • From baseline to Week 72
Investigations Drug screen positive	29.2% 7/24 • From baseline to Week 72	16.7% 4/24 • From baseline to Week 72
Investigations Haemoglobin decreased	8.3% 2/24 • From baseline to Week 72	8.3% 2/24 • From baseline to Week 72

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 61 6878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER