Trial Outcomes & Findings for Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1. (NCT NCT00107653)

Last Updated: 2016-06-21

Results Overview

Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (\<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

569 participants

Primary outcome timeframe

At Week 72

Results posted on

2016-06-21

Participant Flow

A total of 569 participants were recruited at 52 centers in the United States in the study conducted from 26 October 2004 and 07 September 2007.

Out of 1038 screened participants, 569 were enrolled and 469 were screen failures because of eligibility criteria was not met. Of the 569 enrolled participants, 269 participants were assigned to Latino and 300 participants were assigned to non-Latino White group.

Participant milestones

Participant milestones
Measure	Latino Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Overall Study STARTED	269	300
Overall Study COMPLETED	190	224
Overall Study NOT COMPLETED	79	76

Reasons for withdrawal

Reasons for withdrawal
Measure	Latino Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Overall Study Adverse Event	24	43
Overall Study Insufficient Therapeutic Response	25	11
Overall Study Violation of Selection Criteria at Entry	1	1
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	12	13
Overall Study Lost to Follow-up	13	5
Overall Study Administrative Reasons	3	3

Baseline Characteristics

Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=300 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.	Total n=569 Participants Total of all reporting groups
Age, Continuous	45.6 Years STANDARD_DEVIATION 8.79 • n=5 Participants	48.1 Years STANDARD_DEVIATION 8.34 • n=7 Participants	46.9 Years STANDARD_DEVIATION 8.64 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	108 Participants n=7 Participants	194 Participants n=5 Participants
Sex: Female, Male Male	183 Participants n=5 Participants	192 Participants n=7 Participants	375 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 72

Population: Intent-to-Treat (ITT) Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=300 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Sustained Virologic Response at Week 72	33.5 Percentage of participants	49.3 Percentage of participants

SECONDARY outcome

Timeframe: At Weeks 4, 12, 24, 48, 60, and 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA \<28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test)

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=300 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants Achieving Virologic Response At Week 24	59.5 Percentage of participants	73.3 Percentage of participants
Percentage of Participants Achieving Virologic Response At Week 48	56.1 Percentage of participants	72.7 Percentage of participants
Percentage of Participants Achieving Virologic Response At Week 60	33.1 Percentage of participants	50.0 Percentage of participants
Percentage of Participants Achieving Virologic Response At Week 72	33.5 Percentage of participants	49.3 Percentage of participants
Percentage of Participants Achieving Virologic Response At Week 4	13.8 Percentage of participants	20.0 Percentage of participants
Percentage of Participants Achieving Virologic Response At Week 12	48.0 Percentage of participants	63.0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 4

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Percentage of participants with an early virologic response defined as an HCVRNA \>=1 log10 drop from baseline or undetectable HCV-RNA measurement at Week 4 (lower limit of detection 28 IU/mL).

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=300 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Early Virologic Response at Week 4	71.0 Percentage of participants	78.7 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Percentage of participants with an early virologic response defined as an HCV-RNA \>=2 log10 drop from baseline or undetectable HCV-RNA measurement at Week 12 (lower limit of detection 28 IU/mL).

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=300 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Early Virologic Response at Week 12	75.5 Percentage of participants	86.0 Percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.

The table below shows HCV-RNA log10 titers change from baseline values by study week and by study group. Analysis was performed for participants with a baseline and at least 1 post-baseline HCV-RNA assessment. HCV-RNA quantitation was performed using Roche High Pure System/COBAS® TaqMan® HCV Monitor Test. HCV-RNA measurement lower limit of detection was 28 IU/mL.

Outcome measures

Outcome measures
Measure	Latino n=262 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=280 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time At Week 4 (n=262, 280)	-2.3 Log10 IU/mL Standard Error 0.10	-2.9 Log10 IU/mL Standard Error 0.09
Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time At Week 12 (n=251,279)	-3.9 Log10 IU/mL Standard Error 0.10	-4.5 Log10 IU/mL Standard Error 0.09
Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time At Week 24 (n=235, 264)	-4.2 Log10 IU/mL Standard Error 0.11	-4.8 Log10 IU/mL Standard Error 0.10
Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time At Week 48 (n=207, 246)	-4.1 Log10 IU/mL Standard Error 0.11	-4.8 Log10 IU/mL Standard Error 0.10
Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time At Week 60 (n=181, 217)	-2.7 Log10 IU/mL Standard Error 0.17	-3.7 Log10 IU/mL Standard Error 0.15
Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time At Week 72 (n=174, 212)	-2.7 Log10 IU/mL Standard Error 0.17	-3.6 Log10 IU/mL Standard Error 0.16

SECONDARY outcome

Timeframe: At Weeks 4, 12, 24, 48, 60 and 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Biochemical response was defined as normal serum alanine transaminase (ALT) measurement. For ALT measurement the normal range is 5-37 IU/L.

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=300 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Biochemical Response At Week 4	42.8 Percentage of participants	57.0 Percentage of participants
Percentage of Participants With Biochemical Response At Week 12	56.1 Percentage of participants	72.0 Percentage of participants
Percentage of Participants With Biochemical Response At Week 24	53.2 Percentage of participants	68.0 Percentage of participants
Percentage of Participants With Biochemical Response At Week 48	45.7 Percentage of participants	59.7 Percentage of participants
Percentage of Participants With Biochemical Response At Week 60	35.3 Percentage of participants	53.7 Percentage of participants
Percentage of Participants With Biochemical Response At Week 72	37.5 Percentage of participants	56.7 Percentage of participants

SECONDARY outcome

Timeframe: At Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) in the ISHAK modified HAI (necroinflammatory) score at week 72. ISHAK modified HAI activity (necroinflammatory) score is a total score of periportal ± bridging (P/B) necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis grading as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5 = zone 3 multiple; 6 = panacinar necrosis and Focal necrosis grading as 0: absent; 1: \< = 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: \> 10 foci; Portal Inflammation grading: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With ISHAK Histological Activity Index Response	47.1 Percentage of participants	58.7 Percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

ISHAK modified HAI activity (necroinflammatory) score is a total score of P/B necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each Participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5= zone 3 multiple; 6= panacinar necrosis and Focal necrosis as 0: absent; 1: \<= 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: \> 10 foci; Portal Inflammation: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was tested using an analysis of covariance (ANCOVA) model with ethnicity and baseline ISHAK HAI score as the fixed effects.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72	-1.4 Score on a scale Standard Error 0.17	-2.1 Score on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.

ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) score at week 72. Baseline prognostic factors in the original model include ethnicity, sex, age, baseline ALT quotient, baseline HCV-RNA level, and ISHAK fibrosis and activity scores at baseline. ISHAK modified HAI fibrosis scale by fibrosis grading category as F0= no fibrosis; F1= some portal areas; F2= most portal areas; F3= bridging fibrosis; F4= bridging and portal to central; F5 = marked bridging; F6 = Cirrhosis; where '0' being the best and '6' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was analysed.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72 F5-F6 (n=21,11)	-1.05 Score on a scale Standard Error 0.42	-2.64 Score on a scale Standard Error 0.82
Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72 F0-F4 (n=136,190)	-1.49 Score on a scale Standard Error 0.19	-2.04 Score on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: At Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Overall ISHAK Fibrosis Score is defined as Improved: \>= 1 category decrease in fibrosis scale; Stable: no change in fibrosis scale; Worsened: \>1 category increase in fibrosis scale.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score Stable Fibrosis Score	52.9 Percentage of participants	39.8 Percentage of participants
Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score Improved Fibrosis Score	24.8 Percentage of participants	42.3 Percentage of participants
Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score Worsened Fibrosis Score	22.3 Percentage of participants	17.9 Percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

METAVIR activity scores are categorised as histological activity (A) 0 = none; A1 = mild; A2 = moderate; A3 = severe where '0' being 'No activity' and '3' being 'the sever activity'. Changes in liver inflammation defined as Improved: Participants whose METAVIR activity score at up to Month-72 decreases by 1 or more units compared to baseline; stable: Participants whose METAVIR activity score at up to Month-72 is the same as the baseline score; worsened: Participants whose METAVIR activity score at up to Month-72 increases by 1 or more units compared to baseline. METAVIR fibrosis scores are categorised as fibrosis (F) 0 = no fibrosis; F1 = without septa; F 2 = with septa; F3 = many septa; F4 = cirrhosis where; '0' being the best and '4' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in activity and fibrosis scores based on METAVIR at week 72 was analysed.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72 Activity scores based on METAVIR	-0.34 Score on a scale Standard Error 0.05	-0.51 Score on a scale Standard Error 0.05
Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72 Fibrosis scores based on METAVIR	0.04 Score on a scale Standard Error 0.07	-0.12 Score on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: At Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

METAVIR activity scale included activity defines as, Improved: \>= 1 category decrease in activity score; stable: no change in activity score; worsened: \> = 1 category increase in activity score.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score Stable Activity Score	54.1 Percentage of participants	48.8 Percentage of participants
Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score Worsened Activity Score	7.0 Percentage of participants	3.0 Percentage of participants
Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score Improved Activity Score	38.9 Percentage of participants	48.3 Percentage of participants

SECONDARY outcome

Timeframe: At Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

METAVIR fibrosis score is categorized as, Improved: \>= 1 category decrease in activity score; stable: no change in activity score; worsened: \>= 1 category increase in activity score.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score Stable Fibrosis Score	71.3 Percentage of participants	66.2 Percentage of participants
Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score Worsened Fibrosis Score	15.3 Percentage of participants	11.4 Percentage of participants
Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score Improved Fibrosis Score	13.4 Percentage of participants	22.4 Percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Grading categories for the fat scale were as follows: 1 = \<5% hepatocytes; 2 = 6 - 33% hepatocytes; 3 = 34 - 66% hepatocytes; 4 = 67 - 100% hepatocytes.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Mean Change From Baseline in Fat Score at Week 72	-0.15 Score on a scale Standard Error 0.07	-0.25 Score on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Fat scores are categorised as Improved: \> 1 category decrease in fat scale; stable: no change in fat scale; worsened: \>= 1 category increase in fat scale.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72 Stable Fat Score	47.8 Percentage of participants	51.2 Percentage of participants
Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72 Worsened Fat Score	20.4 Percentage of participants	16.4 Percentage of participants
Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72 Improved Fat Score	31.8 Percentage of participants	32.3 Percentage of participants

SECONDARY outcome

Timeframe: At Week 72

Population: ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

The Nonalcoholic Steatohepatitis (NASH) included an assessment of sinusoidal fibrosis, Mallory bodies, and hepatocyte ballooning (HB). Grading categories for the NASH scales were as: Sinusoidal fibrosis: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules, without diffuse interstitial sinusoidal collagen deposition; 3 = Involvement of most or all lobules;, with diffuse interstitial fibrosis involving some or most of the lobules Mallory bodies: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules; and Hepatocyte ballooning: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules.

Outcome measures

Outcome measures
Measure	Latino n=157 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=201 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score Mallory Bodies Non-zero NASH Score at Week 72	3.2 Percentage of participants	2.0 Percentage of participants
Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score Sinusoidal Fibrosis Non-zero NASH Score at Week 72	19.1 Percentage of participants	18.4 Percentage of participants
Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score HB Non-zero NASH Score at Week 72	19.7 Percentage of participants	9.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 48 and Week 72

The Fatigue Severity Scale (FSS) is a 10-item self-report questionnaire designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 weeks by marking on a visual analogue scale (VAS) labelled at one end with "no fatigue" ('0' being the best) and at the other end with "greater fatigue" ('100' being the worst). Longer distance on the scale from "no fatigue" indicated "greater fatigue". FSS values are presented based on questionnaire and visual analog scale. FSS values at week 48 and 72 are presented based on questionnaire and visual analog scale.

Outcome measures

Outcome measures
Measure	Latino n=180 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=224 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72 FSS Score,From Baseline At Week 48 (n=180,224)	0.9 Score on a scale Standard Error 0.15	1.5 Score on a scale Standard Error 0.13
Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72 FSS Score,From Baseline At Week 72 (n=174,214)	-0.1 Score on a scale Standard Error 0.15	0.1 Score on a scale Standard Error 0.11
Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72 FSS VAS Score,From Baseline At Week 48 (n=177,221)	14.8 Score on a scale Standard Error 2.84	25.4 Score on a scale Standard Error 2.09
Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72 FSS VAS Score,From Baseline At Week72 (n=173,212)	1.9 Score on a scale Standard Error 2.75	-2.7 Score on a scale Standard Error 1.57

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 48 and Week 72

The 36-item Short Form Health Survey (SF-36) is a 36-item self-report questionnaire that includes 8 domain scales The 8 domains are incorporated into 2 components: mental and physical. The mental component (MC) includes social functioning, role limitations-emotional, mental health, and vitality. The physical component (PC) includes physical functioning, role limitations-physical, bodily pain, and general health perception. Raw domain scores are transformed to a 0 to 100 scale, \[0=worst score (or quality of life) and 100=best score\]. Two summary scale scores were computed based on weighted combinations of the 8 domain scores (Physical and the Mental Component) where no minimum or maximum score; higher score indicate better health status. The difference between study groups in change from baseline in SF-36 score at week 48 and 72 was analysed.

Outcome measures

Outcome measures
Measure	Latino n=178 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=224 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72 Standardized PC, At Week 48 (n=178,224)	-4.3 Score on a scale Standard Error 0.75	-8.4 Score on a scale Standard Error 0.60
Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72 Standardized PC, At Week 72 (n=172,213)	-1.4 Score on a scale Standard Error 0.71	-1.8 Score on a scale Standard Error 0.53
Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72 Standardized MC, At Week 48 (n=178,224)	-6.1 Score on a scale Standard Error 0.77	-6.3 Score on a scale Standard Error 0.68
Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72 Standardized MC, At Week 72 (n=172,213)	-1.6 Score on a scale Standard Error 0.73	-0.7 Score on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Up to Week 72

Population: The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An adverse event could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as adverse events. A serious adverse event (SAE) was any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=299 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Number of Participants With Any Adverse Events and Serious Adverse Events Any AEs	264 Participants	292 Participants
Number of Participants With Any Adverse Events and Serious Adverse Events Any SAEs	42 Participants	48 Participants

SECONDARY outcome

Timeframe: Up to Week 72

Population: The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment. 'n'=number of evaluable participants available at specified time point.

The below table includes participants with marked abnormal lab parameters. Standard reference ranges include: Hematocrit: (fraction) 0.37 - 0.49, Hemoglobin 130 - 180 g/L, Platelets 150 - 350 10\^9/L, White Blood Cell (WBC) 4.5 - 11.0 10\^9/L, Lymphocytes 1.00 - 4.80 10\^9/L, Neutrophils 1.80 - 7.70 10\^9/L, Aspartate aminotransferase (AST) 0-40 U/L, ALT 0 - 55 U/L, Total bilirubin 0 - 17 μmol/L, Thyroxine T4 58 - 140 nmol/L, Thyroid Stimulating Hormone (TSH) 0.0 - 5.0 million units (mU)/L, Albumin 35.0 - 55.0 g/L, Chloride 100 - 108 mmol/L, Calcium 2.10 - 2.60 mmol/L, Phosphate 0.84 - 1.45 mmol/L, Uric acid 214 - 506 μmol/L.

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=299 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Number of Participants With Marked Abnormal Laboratory Parameters Hematocrit low (n=269,298)	49 Participants	67 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Hemoglobin low (n=269,298)	99 Participants	126 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Platelets, low (n=269,298)	78 Participants	103 Participants
Number of Participants With Marked Abnormal Laboratory Parameters WBC, high (n=269,298)	2 Participants	7 Participants
Number of Participants With Marked Abnormal Laboratory Parameters WBC low (n=269,298)	192 Participants	253 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Lymphocytes low (n=269,298)	80 Participants	159 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Neutrophils, high (n=269,298)	7 Participants	15 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Neutrophils, low (n=269,298)	208 Participants	261 Participants
Number of Participants With Marked Abnormal Laboratory Parameters AST, high (n=269,296)	51 Participants	47 Participants
Number of Participants With Marked Abnormal Laboratory Parameters ALT, high (n=269,296)	46 Participants	47 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Total bilirubin, high (n=269,296)	4 Participants	6 Participants
Number of Participants With Marked Abnormal Laboratory Parameters T4, high (n=17,16)	2 Participants	2 Participants
Number of Participants With Marked Abnormal Laboratory Parameters T4, low (n=17,16)	8 Participants	4 Participants
Number of Participants With Marked Abnormal Laboratory Parameters TSH, high (n=64,65)	6 Participants	11 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Albumin, low (n=269,296)	2 Participants	5 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Chloride, low (n=269,296)	0 Participants	6 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Calcium, low (n=269,296)	4 Participants	16 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Phosphate, high (n=269,296)	16 Participants	18 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Phosphate, low (n=269,296)	51 Participants	50 Participants
Number of Participants With Marked Abnormal Laboratory Parameters Uric acid, high (n=269,296)	12 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to Week 72

Population: The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.

The table below includes participants with premature withdrawals due to adverse events or laboratory abnormalities.

Outcome measures

Outcome measures
Measure	Latino n=269 Participants Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Non-Latino White n=299 Participants Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Psychiatric disorders	8 Participants	12 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities General disorders	4 Participants	5 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Blood and lymphatic system disorders	3 Participants	6 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Gastrointestinal disorders	2 Participants	4 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Nervous system disorders	3 Participants	3 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Respiratory, thoracic and mediastinal disorders	2 Participants	3 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Skin and subcutaneous tissue disorders	1 Participants	3 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Eye disorders	0 Participants	4 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Musculoskeletal and connective tissue disorders	1 Participants	2 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Investigations	3 Participants	0 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Infections and infestations	1 Participants	1 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Injury, poisoning and procedural complications	0 Participants	2 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Social circumstances	0 Participants	2 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Cardiac disorders	1 Participants	0 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Endocrine disorders	1 Participants	0 Participants
Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities Vascular disorders	0 Participants	1 Participants

Adverse Events

Non-Latino White

Serious events: 48 serious events

Other events: 290 other events

Deaths: 0 deaths

Latino

Serious events: 42 serious events

Other events: 256 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

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