Trial Outcomes & Findings for Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) (NCT NCT00078403)

Last Updated: 2021-11-08

Results Overview

SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

333 participants

Primary outcome timeframe

Baseline and at week 72 or premature discontinuation

Results posted on

2021-11-08

Participant Flow

People with hepatitis C virus (HCV)/HIV coinfection were recruited for participation in this study.

330 participants were to receive 12 weeks of PEG+RBV to determine EVR status. Of the 330, 33 discontinued prior to week 12; 113 were non-EVRs, 80 of whom were randomized between Arms A and B; and 184 achieved EVR, 170 of whom were eligible to continue. 169 of the 170 were assigned to Arm C and one was inadvertently randomized between Arms A and B.

Participant milestones

Participant milestones
Measure	Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Overall Study STARTED	44	42	169
Overall Study COMPLETED	26	26	141
Overall Study NOT COMPLETED	18	16	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.	Total n=255 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	42 Participants n=7 Participants	169 Participants n=5 Participants	255 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	48.8 years STANDARD_DEVIATION 6.7 • n=5 Participants	48.1 years STANDARD_DEVIATION 5.8 • n=7 Participants	47.2 years STANDARD_DEVIATION 7.1 • n=5 Participants	47.6 years STANDARD_DEVIATION 6.8 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	30 Participants n=7 Participants	150 Participants n=5 Participants	212 Participants n=4 Participants
Region of Enrollment United States	41 participants n=5 Participants	40 participants n=7 Participants	168 participants n=5 Participants	249 participants n=4 Participants
Region of Enrollment Puerto Rico	3 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	6 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and at week 72 or premature discontinuation

Population: 62 Arm A and B participants who had follow-up liver biopsy performed or those who had Week 72 potential as of May 2, 2007 but no follow-up liver biopsy. In the unadjusted ITT analysis, the participants without SCMFS available were assigned the highest SCMFS (+2).

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=33 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=29 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)	0 Metavir units per one year (52 weeks) Interval 0.0 to 1.37	0 Metavir units per one year (52 weeks) Interval 0.0 to 2.0	—

SECONDARY outcome

Timeframe: Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84

Population: All Arm A, B and C participants

Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 0--Number of participants with HCV RNA data	44 Participant	42 Participant	164 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 0--Number of participants with detectable HCV	42 Participant	42 Participant	53 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 12--Number of participants with HCV RNA data	42 Participant	34 Participant	158 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 12-Number of participants with detectable HCV	40 Participant	34 Participant	31 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 24--Number of participants with HCV RNA data	36 Participant	35 Participant	163 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 24-Number of participants with detectable HCV	35 Participant	35 Participant	39 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 36--Number of participants with HCV RNA data	0 Participant	0 Participant	158 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 36-Number of participants with detectable HCV	NA Participant Test not specified in protocol at this time point.	NA Participant Test not specified in protocol at this time point.	41 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 48--Number of participants with HCV RNA data	31 Participant	28 Participant	0 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 48-Number of participants with detectable HCV	31 Participant	28 Participant	NA Participant Test not specified in protocol at this time point.
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 60--Number of participants with HCV RNA data	0 Participant	0 Participant	137 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 60-Number of participants with detectable HCV	NA Participant Test not specified in protocol at this time point.	NA Participant Test not specified in protocol at this time point.	34 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 72--Number of participants with HCV RNA data	27 Participant	22 Participant	135 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 72-Number of participants with detectable HCV	27 Participant	22 Participant	51 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 84--Number of participants with HCV RNA data	0 Participant	0 Participant	137 Participant
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) Week 84-Number of participants with detectable HCV	NA Participant Test not specified in protocol at this time point.	NA Participant Test not specified in protocol at this time point.	50 Participant

SECONDARY outcome

Timeframe: Baseline and at week 72 or premature discontinuation

Population: All participants with SCIIS available (Complete Cases)

Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)	0 Ishak units per one year (52 weeks) Interval -0.75 to 1.79	1.31 Ishak units per one year (52 weeks) Interval 0.0 to 2.1	—

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: All Arm A, B and C participants

Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Anemia Anemia >= Grade 2	1 Participant	0 Participant	6 Participant
Number of Participants With Anemia Grade 2	0 Participant	0 Participant	3 Participant
Number of Participants With Anemia Grade 3	0 Participant	0 Participant	1 Participant
Number of Participants With Anemia Grade 4	1 Participant	0 Participant	2 Participant

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: All Arm A, B and C participants

Number of participants with neutropenia by grade (defined by absolute neutrophil count \[ANC\] per cubic millimeter; mm\^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm\^3; Grade 2 = 750 to 999 /mm\^3; Grade 3 = 500 to 749 /mm\^3; Grade 4 = below 500 /mm\^3.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Neutropenia Neutropenia >= Grade 2	20 Participant	10 Participant	96 Participant
Number of Participants With Neutropenia Grade 2	7 Participant	4 Participant	38 Participant
Number of Participants With Neutropenia Grade 3	10 Participant	5 Participant	37 Participant
Number of Participants With Neutropenia Grade 4	3 Participant	1 Participant	21 Participant

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: All Arm A, B and C participants

Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm\^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm\^3; Grade 2 = 50,000 to 74,999 /mm\^3; Grade 3 = 20,000 to 49,999 /mm\^3; Grade 4 = below 20,000 /mm\^3.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Thrombocytopenia Thrombocytopenia >= Grade 2	14 Participant	4 Participant	31 Participant
Number of Participants With Thrombocytopenia Grade 2	10 Participant	3 Participant	25 Participant
Number of Participants With Thrombocytopenia Grade 3	4 Participant	1 Participant	5 Participant
Number of Participants With Thrombocytopenia Grade 4	0 Participant	0 Participant	1 Participant

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: All Arm A, B and C participants

Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Depression and/or Other Psychological Events Grade 4	1 Participant	0 Participant	1 Participant
Number of Participants With Depression and/or Other Psychological Events Any psychological	3 Participant	1 Participant	19 Participant
Number of Participants With Depression and/or Other Psychological Events Grade 3	2 Participant	1 Participant	18 Participant

SECONDARY outcome

Timeframe: Up to 96 Weeks

Population: All Arm A, B and C participants

Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With High-grade Signs and Symptoms or Laboratory Values Any Grade 3 or higher	22 Participant	20 Participant	84 Participant
Number of Participants With High-grade Signs and Symptoms or Laboratory Values Grade 3	15 Participant	15 Participant	73 Participant
Number of Participants With High-grade Signs and Symptoms or Laboratory Values Grade 4	7 Participant	5 Participant	11 Participant

SECONDARY outcome

Timeframe: Up to 96 Weeks

Population: All Arm A and C participants. Arm B participants did not receive treatment.

3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations Premature treatment discontinuation	16 Participant	—	57 Participant
Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations Temporarily off treatment	7 Participant	—	29 Participant
Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations Reduced dose	2 Participant	—	33 Participant

SECONDARY outcome

Timeframe: Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.

Population: All Arm A and Arm C participants. Arm B participants did not receive treatment.

A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=159 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants Adherent to Study Medications Week 0: Number of participants with adherence data	0 Participant	—	158 Participant
Number of Participants Adherent to Study Medications Week 0: Number of participants adherent to meds	NA Participant Evaluation not specified in protocol at this timepoint.	—	132 Participant
Number of Participants Adherent to Study Medications Week 12:Number of participants with adherence data	37 Participant	—	150 Participant
Number of Participants Adherent to Study Medications Week 12:Number of participants adherent to meds	32 Participant	—	125 Participant
Number of Participants Adherent to Study Medications Week 24:Number of participants with adherence data	32 Participant	—	145 Participant
Number of Participants Adherent to Study Medications Week 24:Number of participants adherent to meds	28 Participant	—	118 Participant
Number of Participants Adherent to Study Medications Week 48:Number of participants with adherence data	22 Participant	—	120 Participant
Number of Participants Adherent to Study Medications Week 48:Number of participants adherent to meds	19 Participant	—	95 Participant
Number of Participants Adherent to Study Medications Week 60:Number of participants with adherence data	0 Participant	—	91 Participant
Number of Participants Adherent to Study Medications Week 60:Number of participants adherent to meds	NA Participant Evaluation not specified in protocol at this timepoint.	—	79 Participant
Number of Participants Adherent to Study Medications Week 72:Number of participants with adherence data	8 Participant	—	0 Participant
Number of Participants Adherent to Study Medications Week 72:Number of participants adherent to meds	7 Participant	—	NA Participant Evaluation not specified in protocol at this timepoint.

SECONDARY outcome

Timeframe: Entry and week 72 (Arms A and B only).

Population: Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.

Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Entry and week 72 (Arms A and B only).

Population: Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.

Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84

Population: All Arm A, B, and C participants

A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as \<50 copies/mL (undetectable) or \>=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 0: Number of participants with HIV RNA data	44 Participant	42 Participant	169 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 0: No. of participants with undetectable VL	32 Participant	34 Participant	146 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 12: Number of participants with HIV RNA data	0 Participant	0 Participant	164 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 12: No. of participants with undetectable VL	NA Participant Test not specified in protocol at this timepoint.	NA Participant Test not specified in protocol at this timepoint.	138 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 24: Number of participants with HIV RNA data	39 Participant	39 Participant	165 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 24: No. of participants with undetectable VL	25 Participant	25 Participant	141 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 36: Number of participants with HIV RNA data	0 Participant	0 Participant	160 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 36: No. of participants with undetectable VL	NA Participant Test not specified in protocol at this timepoint.	NA Participant Test not specified in protocol at this timepoint.	134 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 48: Number of participants with HIV RNA data	35 Participant	33 Participant	150 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 48: No. of participants with undetectable VL	24 Participant	25 Participant	125 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 60: Number of participants with HIV RNA data	0 Participant	0 Participant	140 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 60: No. of participants with undetectable VL	NA Participant Test not specified in protocol at this timepoint.	NA Participant Test not specified in protocol at this timepoint.	113 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 72: Number of participants with HIV RNA data	27 Participant	27 Participant	140 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 72: No. of participants with undetectable VL	19 Participant	20 Participant	107 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 84: Number of participants with HIV RNA data	0 Participant	0 Participant	136 Participant
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) Week 84: No. of participants with undetectable VL	NA Participant Test not specified in protocol at this timepoint.	NA Participant Test not specified in protocol at this timepoint.	108 Participant

SECONDARY outcome

Timeframe: Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.

Population: All Arm A, B and C participants who had HOMA-IR result available. In Arm C, metabolic testing was only performed on participants who enrolled under protocol version 1.0. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.

Insulin resistance was evaluated by HOMA-IR, calculated as \[fasting glucose (mg/dL) x fasting insulin (uIU/mL)\]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=98 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 72: HOMA-IR (N=67 in C)	4.79 mg/dL x uIU/mL Interval 3.41 to 7.83	4.82 mg/dL x uIU/mL Interval 2.46 to 9.12	2.69 mg/dL x uIU/mL Interval 1.66 to 5.47
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 0: HOMA-IR (N=32 in A, 32 in B, 72 in C)	3.84 mg/dL x uIU/mL Interval 2.77 to 9.03	2.49 mg/dL x uIU/mL Interval 1.83 to 4.48	2.37 mg/dL x uIU/mL Interval 1.5 to 5.36
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 12: HOMA-IR (N=72 in C)	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 12 in Arms A and B.	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 12 in Arms A and B.	2.47 mg/dL x uIU/mL Interval 1.63 to 4.22
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 24: HOMA-IR (N=34 in A, 30 in B, 73 in C)	3.08 mg/dL x uIU/mL Interval 1.68 to 5.59	4.78 mg/dL x uIU/mL Interval 1.78 to 6.13	2.58 mg/dL x uIU/mL Interval 1.35 to 4.44
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 36: HOMA-IR (N=66 in C)	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 36 in Arms A and B.	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 36 in Arms A and B.	2.41 mg/dL x uIU/mL Interval 1.44 to 4.58
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 48: HOMA-IR (N=30 in A, 24 in B, 74 in C)	3.53 mg/dL x uIU/mL Interval 1.72 to 6.65	2.84 mg/dL x uIU/mL Interval 1.78 to 6.38	3.25 mg/dL x uIU/mL Interval 1.73 to 5.01
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 84: HOMA-IR (N=63 in C)	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 84 in Arms A and B.	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 84 in Arms A and B.	2.99 mg/dL x uIU/mL Interval 1.66 to 4.98
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Week 96: HOMA-IR (N=65 in C)	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 96 in Arms A and B.	NA mg/dL x uIU/mL HOMA-IR was not collected at Week 96 in Arms A and B.	2.30 mg/dL x uIU/mL Interval 1.63 to 4.15

SECONDARY outcome

Timeframe: 24 weeks after end of treatment

Population: All Arm A, B and C participants

Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (\<60 IU/ml) 24 weeks after treatment discontinuation.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Sustained Virologic Response Yes	0 Participant	0 Participant	88 Participant
Sustained Virologic Response No	44 Participant	42 Participant	81 Participant

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: All Arm A, B and C participants

Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol Number of participants who used megestrol	2 Participant	1 Participant	6 Participant
Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol Number of participants who used dronabinol	4 Participant	4 Participant	22 Participant

SECONDARY outcome

Timeframe: At any time after pre-assignment

Population: All Arm A, B and C participants

Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF) Number of participants who used EPO	14 Participant	13 Participant	70 Participant
Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF) Number of participants who used GCSF	17 Participant	8 Participant	60 Participant
Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF) Number of participants who used GM-CSF	0 Participant	0 Participant	0 Participant

SECONDARY outcome

Timeframe: Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.

Population: All Arm A, B and C participants who had weight available. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.

Participant weight in kilograms.

Outcome measures

Outcome measures
Measure	A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) n=44 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.	B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) n=42 Participants At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).	C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) n=169 Participants At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA \<600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly \& RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA \>=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
Weight Week 96: Weight (N=138)	NA kilograms Weight was not collected at Week 96 in Arms A and B.	NA kilograms Weight was not collected at Week 96 in Arms A and B.	78.4 kilograms Interval 69.6 to 88.0
Weight Week 0: Weight (N=43 in A, 42 in B, 169 in C)	74.9 kilograms Interval 67.6 to 86.8	79.8 kilograms Interval 69.7 to 88.3	75.8 kilograms Interval 68.6 to 84.4
Weight Week 4: Weight (N=43 in A, 35 in B, 161 in C)	74.7 kilograms Interval 68.6 to 87.4	80.4 kilograms Interval 70.5 to 88.5	75.8 kilograms Interval 68.3 to 83.5
Weight Week 8: Weight (N=39 in A, 34 in B, 162 in C)	74.9 kilograms Interval 66.7 to 87.3	80.8 kilograms Interval 71.8 to 90.9	75.8 kilograms Interval 67.6 to 84.9
Weight Week 12: Weight (N=42 in A, 30 in B, 157 in C)	76.3 kilograms Interval 67.2 to 87.9	81.1 kilograms Interval 69.9 to 89.9	76.3 kilograms Interval 67.4 to 83.0
Weight Week 16: Weight (N=39 in A, 35 in B, 164 in C)	77.4 kilograms Interval 67.9 to 89.5	79.9 kilograms Interval 70.0 to 90.4	76.3 kilograms Interval 66.3 to 83.2
Weight Week 24: Weight (N=39 in A, 36 in B, 165 in C)	75.5 kilograms Interval 66.3 to 89.0	79.4 kilograms Interval 72.5 to 91.0	75.8 kilograms Interval 65.9 to 82.6
Weight Week 32: Weight (N=37 in A, 35 in B)	76.5 kilograms Interval 69.0 to 88.1	80.4 kilograms Interval 70.8 to 87.7	NA kilograms Weight was not collected at Week 32 in Arm C.
Weight Week 36: Weight (N=162 in C)	NA kilograms Weight was not collected at Week 36 in Arms A and B.	NA kilograms Weight was not collected at Week 36 in Arms A and B.	75.0 kilograms Interval 65.9 to 84.0
Weight Week 40: Weight (N=32 in A, 29 in B)	75.7 kilograms Interval 67.7 to 86.4	83.1 kilograms Interval 70.9 to 91.0	NA kilograms Weight was not collected at Week 40 in Arm C.
Weight Week 48: Weight (N=33 in A, 31 in B, 153 in C)	78.2 kilograms Interval 68.8 to 88.7	80.4 kilograms Interval 68.1 to 93.3	75.1 kilograms Interval 66.3 to 84.4
Weight Week 56: Weight (N=31 in A, 24 in B)	79.7 kilograms Interval 69.4 to 92.7	81.6 kilograms Interval 68.8 to 90.9	NA kilograms Weight was not collected at Week 56 in Arm C.
Weight Week 64: Weight (N=26 in A, 24 in B)	78.5 kilograms Interval 69.3 to 87.7	84.0 kilograms Interval 72.8 to 91.9	NA kilograms Weight was not collected at Week 64 in Arm C.
Weight Week 72: Weight (N=26 in A, 27 in B, 141 in C)	81.6 kilograms Interval 68.6 to 89.6	85.4 kilograms Interval 71.7 to 94.0	75.6 kilograms Interval 65.5 to 84.6
Weight Week 84: Weight (N=140 in C)	NA kilograms Weight was not collected at Week 84 in Arms A and B.	NA kilograms Weight was not collected at Week 84 in Arms A and B.	77.0 kilograms Interval 67.6 to 87.6

Adverse Events

Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)

Serious events: 6 serious events

Other events: 43 other events

Deaths: 0 deaths

OL (PEG-IFN, RBV) Then OL Randomized (Observation)

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)

Serious events: 37 serious events

Other events: 166 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

ACTG Clinicaltrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

Phone: (301) 628-3313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve US or foreign patent or other intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER