Hepatitis C, HIV Infections, Liver Disease
Conditions
Keywords
Treatment Experienced
Brief summary
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.
Detailed description
Rapid progression of liver disease to liver failure has been observed in people coinfected with HIV and HCV. This observation appears to be directly related to an increase in the rate of fibrotic progression in the liver compared to people infected with HCV alone. PEG-IFN and ribavirin are used in standard treatment of HCV. This study tested the effectiveness of using PEG-IFN in reducing the rate of liver fibrosis progression in participants coinfected with HIV and HCV who could not lower their HCV viral load to undetectable or who could not maintain their HCV viral load at undetectable on PEG-IFN and ribavirin treatment. Participants entered Step 1 (initial run-in period) to receive 12 weeks of 180 mcg PEG-IFN subcutaneously once weekly plus 1 to 1.2 g/day ribavirin based on body weight. At week 12, HCV RNA testing was performed. Participants with early virologic response (EVR), defined as \>=2 log10 drop in HCV RNA from baseline or undetectable HCV RNA (\<600 IU/ml with quantitative assay used in Step 1) at Week 12, who had tolerated Step 1 treatment, entered into Step 3 to continue receiving the Step 1 treatment for a total of 72 weeks (Arm C). Participants who did not meet the criteria for entry into Step 3 were discontinued from the study. In Step 3, participants were followed for an additional 24 weeks after treatment discontinuation to determine sustained virologic response (SVR). Initially, Step 3 participants who had a detectable HCV viral load (\>=60 IU/ml with the qualitative assay used in Step 3) at Week 36 were eligible to enroll in Step 2. After early closure of Step 2, such participants remained in Step 3 until study completion. Participants with \<2 log10 drop in HCV RNA from baseline and detectable HCV RNA at Week 12 (non-EVR) discontinued Step 1 treatment. Non-EVRs who met the Step 2 eligibility criteria, were enrolled in Step 2 and randomized to receive 180 mcg PEG-IFN subcutaneously weekly for 72 weeks (Arm A) or observation for 72 weeks (Arm B). Participants who did not meet the criteria for entry into Step 2 were discontinued from the study. Step 2 of the study was closed prematurely in May 2007 due to lower than expected progression rates among the participants in the observation arm such that the primary objective could not be reached. There were no safety concerns. Liver biopsies were conducted at study screening, and at Step 2 entry and exit until the early closure of Step 2. Medical history assessment, physical exams, and blood collection were conducted every 4-12 weeks for participants in Steps 1, 2, and 3. Participants were followed for up to 18 weeks in Step 1, followed by a total of 72 in Step 2 or by up to a total of 84 weeks in Step 3.
Interventions
DRUGPeginterferon alfa-2a
180 mcg PEG-IFN subcutaneously
DRUGRibavirin
One tablet or capsule containing ribavirin 200 mg
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Step 1: * HIV infected * Stable antiretroviral therapy for at least 8 weeks prior to study entry OR have not received any antiretroviral therapy for at least 4 weeks prior to entry * HIV viral load less than 50,000 copies/ml within 6 weeks prior to study entry * CD4 count greater than 200 cells/mm\^3 within 6 weeks prior to study entry * Hepatitis C virus (HCV) infected * Either HCV treatment naive OR previously treated with interferon (IFN), PEG-IFN, IFN and ribavirin, or PEG-IFN and ribavirin for at least 12 weeks and HCV RNA positive following their last course of HCV treatment * Chronic liver disease consistent with chronic viral hepatitis * At least stage I fibrosis on a liver biopsy obtained within 104 weeks of study entry * If at stage VI fibrosis, Child-Pugh-Turcotte (CPT) score of 5 or less and no more than Child-Pugh Class A * Liver enzyme (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase) levels 10 times or less than upper limit of normal * Agree to use acceptable methods of contraception Inclusion Criteria for Step 2: * Currently enrolled in Step 1 or received 12 weeks of PEG-IFN plus ribavirin outside this study * Detectable HCV viral load and \<2 log10 decrease from baseline in plasma/serum HCV viral load at Week 12. * On Step 1 study treatment for no longer than 18 weeks Inclusion Criteria for Step 3: * Currently enrolled in Step 1 * Undetectable HCV RNA or a 2-log or greater decrease in plasma/serum HCV viral load. * On Step 1 study treatment for no longer than 18 weeks
Exclusion criteria
for Steps 1 and 3: * Have received HCV treatment within 4 weeks of study entry. Participants currently receiving treatment for HCV, if non-EVRs, were considered for direct entry into Step 2, without the run-in period in Step 1. * Could not tolerate treatment with PEG-IFN, defined as missing 3 or more consecutive PEG-IFN doses during the first 12 weeks or a total of 5 doses prior to Step 3 entry. Participants who have missed doses of ribavirin will not be excluded from Step 3 entry. * Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry * Alpha feto protein level 400 ng/ml or greater within 24 weeks prior to study entry, or alpha feto protein level greater than 50 ng/ml and less than 400 ng/ml (unless computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] shows no evidence of hepatic tumor) within 24 weeks prior to study entry * Decompensated liver disease, including presence or history of ascites, variceal bleeding, and brain or nervous system damage as a result of liver damage * Other causes of significant liver disease, including hepatitis A or B, excess iron deposits in the liver (hemochromatosis), or homozygote alpha-1 antitrypsin deficiency * Use of systemic corticosteroids, interferon gamma, TNF-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 2 weeks prior to study entry * Known allergy/sensitivity to PEG-IFN alfa-2a or ribavirin or their formulations * History of uncontrolled seizure disorders * Clinically active thyroid disease. Thyroid hormone replacement therapy is permitted, but thyroid-stimulating hormone (TSH) and free thyroxine index (FTI) must be in normal range. * History of autoimmune processes, including Crohn's disease, ulcerative colitis, severe psoriasis, and rheumatoid arthritis, that may be made worse by interferon use * Any systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry * Malignancy * Active coronary artery disease within 24 weeks prior to study entry * Acute or active AIDS-defining opportunistic infections within 12 weeks of study entry * Hemoglobin abnormalities (e.g., thalassemia) or any other cause of or tendency to break down red blood cells (hemolysis) * History of major organ transplantation with an existing functional graft * Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with study adherence * Uncontrolled or active depression or other psychiatric disorder, such as untreated Grade 3 psychiatric disorder, medically untreatable Grade 3 disorder, or any hospitalization within 52 weeks of study entry that, in the opinion of the investigator, may interfere with study requirements * Other serious illness or chronic medical condition that, in the opinion of the investigator, may have prevented participant's completion of the study * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS) | Baseline and at week 72 or premature discontinuation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-scaled Change in Ishak Liver Inflammation Score (SCIIS) | Baseline and at week 72 or premature discontinuation | 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. |
| Number of Participants With Anemia | Up to 96 weeks | 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. |
| Number of Participants With Neutropenia | Up to 96 weeks | 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. |
| Number of Participants With Thrombocytopenia | Up to 96 weeks | 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. |
| Number of Participants With Depression and/or Other Psychological Events | Up to 96 weeks | 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. |
| Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Up to 96 Weeks | 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. |
| Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations | Up to 96 Weeks | 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. |
| Number of Participants Adherent to Study Medications | Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60. | 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. |
| Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84 | 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. |
| HCV-specific Immune Response in Intrahepatic Lymphocytes | Entry and week 72 (Arms A and B only). | Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. |
| Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84 | 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. |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 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. | 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. |
| Sustained Virologic Response | 24 weeks after end of treatment | Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (\<60 IU/ml) 24 weeks after treatment discontinuation. |
| Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol | Up to 96 weeks | Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment. |
| Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF) | At any time after pre-assignment | 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 |
| Weight | 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. | Participant weight in kilograms. |
| HCV Polymorphisms | Entry and week 72 (Arms A and B only). | Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
People with hepatitis C virus (HCV)/HIV coinfection were recruited for participation in this study.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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). | 42 |
| 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. | 169 |
| Total | 255 |
Baseline characteristics
| Characteristic | Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | OL (PEG-IFN, RBV) Then OL Randomized (Observation) | OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 42 Participants | 169 Participants | 255 Participants |
| Age, Continuous | 48.8 years STANDARD_DEVIATION 6.7 | 48.1 years STANDARD_DEVIATION 5.8 | 47.2 years STANDARD_DEVIATION 7.1 | 47.6 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment Puerto Rico | 3 participants | 2 participants | 1 participants | 6 participants |
| Region of Enrollment United States | 41 participants | 40 participants | 168 participants | 249 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 19 Participants | 43 Participants |
| Sex: Female, Male Male | 32 Participants | 30 Participants | 150 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 44 | 41 / 42 | 166 / 169 |
| serious Total, serious adverse events | 6 / 44 | 2 / 42 | 37 / 169 |
Outcome results
Primary
Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)
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).
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS) | 0 Metavir units per one year (52 weeks) |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS) | 0 Metavir units per one year (52 weeks) |
Comparison: Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.p-value: 0.58Exact Wilcoxon rank sum test
Secondary
HCV Polymorphisms
Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.
Time frame: 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.
Secondary
HCV-specific Immune Response in Intrahepatic Lymphocytes
Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.
Time frame: 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.
Secondary
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | 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 |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 12: HOMA-IR (N=72 in C) | NA mg/dL x uIU/mL |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | 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 |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 36: HOMA-IR (N=66 in C) | NA mg/dL x uIU/mL |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | 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 |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 72: HOMA-IR (N=67 in C) | 4.79 mg/dL x uIU/mL |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 84: HOMA-IR (N=63 in C) | NA mg/dL x uIU/mL |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 96: HOMA-IR (N=65 in C) | NA mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 24: HOMA-IR (N=34 in A, 30 in B, 73 in C) | 4.78 mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 84: HOMA-IR (N=63 in C) | NA mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 36: HOMA-IR (N=66 in C) | NA mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 48: HOMA-IR (N=30 in A, 24 in B, 74 in C) | 2.84 mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 72: HOMA-IR (N=67 in C) | 4.82 mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 0: HOMA-IR (N=32 in A, 32 in B, 72 in C) | 2.49 mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 12: HOMA-IR (N=72 in C) | NA mg/dL x uIU/mL |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 96: HOMA-IR (N=65 in C) | NA mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 24: HOMA-IR (N=34 in A, 30 in B, 73 in C) | 2.58 mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 12: HOMA-IR (N=72 in C) | 2.47 mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 0: HOMA-IR (N=32 in A, 32 in B, 72 in C) | 2.37 mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 36: HOMA-IR (N=66 in C) | 2.41 mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 84: HOMA-IR (N=63 in C) | 2.99 mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 72: HOMA-IR (N=67 in C) | 2.69 mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 48: HOMA-IR (N=30 in A, 24 in B, 74 in C) | 3.25 mg/dL x uIU/mL |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Week 96: HOMA-IR (N=65 in C) | 2.30 mg/dL x uIU/mL |
Secondary
Number of Participants Adherent to Study Medications
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 0: Number of participants with adherence data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 0: Number of participants adherent to meds | NA Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 12:Number of participants with adherence data | 37 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 12:Number of participants adherent to meds | 32 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 24:Number of participants with adherence data | 32 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 24:Number of participants adherent to meds | 28 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 48:Number of participants with adherence data | 22 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 48:Number of participants adherent to meds | 19 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 60:Number of participants with adherence data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 60:Number of participants adherent to meds | NA Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 72:Number of participants with adherence data | 8 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Adherent to Study Medications | Week 72:Number of participants adherent to meds | 7 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 72:Number of participants with adherence data | 0 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 0: Number of participants with adherence data | 158 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 48:Number of participants with adherence data | 120 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 0: Number of participants adherent to meds | 132 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 60:Number of participants adherent to meds | 79 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 12:Number of participants with adherence data | 150 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 48:Number of participants adherent to meds | 95 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 12:Number of participants adherent to meds | 125 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 72:Number of participants adherent to meds | NA Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 24:Number of participants with adherence data | 145 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 60:Number of participants with adherence data | 91 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Adherent to Study Medications | Week 24:Number of participants adherent to meds | 118 Participant |
Secondary
Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol
Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.
Time frame: Up to 96 weeks
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol | Number of participants who used megestrol | 2 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol | Number of participants who used dronabinol | 4 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol | Number of participants who used megestrol | 1 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol | Number of participants who used dronabinol | 4 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol | Number of participants who used megestrol | 6 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol | Number of participants who used dronabinol | 22 Participant |
Secondary
Number of Participants With Anemia
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.
Time frame: Up to 96 weeks
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Anemia | Anemia >= Grade 2 | 1 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Anemia | Grade 2 | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Anemia | Grade 3 | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Anemia | Grade 4 | 1 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Anemia | Grade 4 | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Anemia | Anemia >= Grade 2 | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Anemia | Grade 3 | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Anemia | Grade 2 | 0 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Anemia | Grade 4 | 2 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Anemia | Grade 2 | 3 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Anemia | Grade 3 | 1 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Anemia | Anemia >= Grade 2 | 6 Participant |
Secondary
Number of Participants With Depression and/or Other Psychological Events
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.
Time frame: Up to 96 weeks
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Depression and/or Other Psychological Events | Grade 4 | 1 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Depression and/or Other Psychological Events | Grade 3 | 2 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Depression and/or Other Psychological Events | Any psychological | 3 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Depression and/or Other Psychological Events | Grade 4 | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Depression and/or Other Psychological Events | Any psychological | 1 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Depression and/or Other Psychological Events | Grade 3 | 1 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Depression and/or Other Psychological Events | Grade 4 | 1 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Depression and/or Other Psychological Events | Grade 3 | 18 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Depression and/or Other Psychological Events | Any psychological | 19 Participant |
Secondary
Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 24--Number of participants with HCV RNA data | 36 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 0--Number of participants with detectable HCV | 42 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 12--Number of participants with HCV RNA data | 42 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 12-Number of participants with detectable HCV | 40 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 0--Number of participants with HCV RNA data | 44 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 24-Number of participants with detectable HCV | 35 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 36--Number of participants with HCV RNA data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 36-Number of participants with detectable HCV | NA Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 48--Number of participants with HCV RNA data | 31 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 48-Number of participants with detectable HCV | 31 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 60--Number of participants with HCV RNA data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 60-Number of participants with detectable HCV | NA Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 72--Number of participants with HCV RNA data | 27 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 72-Number of participants with detectable HCV | 27 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 84--Number of participants with HCV RNA data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 84-Number of participants with detectable HCV | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 24-Number of participants with detectable HCV | 35 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 36--Number of participants with HCV RNA data | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 84-Number of participants with detectable HCV | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 36-Number of participants with detectable HCV | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 72-Number of participants with detectable HCV | 22 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 48--Number of participants with HCV RNA data | 28 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 48-Number of participants with detectable HCV | 28 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 60--Number of participants with HCV RNA data | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 0--Number of participants with HCV RNA data | 42 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 84--Number of participants with HCV RNA data | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 0--Number of participants with detectable HCV | 42 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 60-Number of participants with detectable HCV | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 12--Number of participants with HCV RNA data | 34 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 12-Number of participants with detectable HCV | 34 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 24--Number of participants with HCV RNA data | 35 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 72--Number of participants with HCV RNA data | 22 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 60--Number of participants with HCV RNA data | 137 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 24-Number of participants with detectable HCV | 39 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 72--Number of participants with HCV RNA data | 135 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 12--Number of participants with HCV RNA data | 158 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 36--Number of participants with HCV RNA data | 158 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 0--Number of participants with HCV RNA data | 164 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 60-Number of participants with detectable HCV | 34 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 36-Number of participants with detectable HCV | 41 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 24--Number of participants with HCV RNA data | 163 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 0--Number of participants with detectable HCV | 53 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 48--Number of participants with HCV RNA data | 0 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 72-Number of participants with detectable HCV | 51 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 12-Number of participants with detectable HCV | 31 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 48-Number of participants with detectable HCV | NA Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 84-Number of participants with detectable HCV | 50 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL) | Week 84--Number of participants with HCV RNA data | 137 Participant |
Secondary
Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations
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.
Time frame: Up to 96 Weeks
Population: All Arm A and C participants. Arm B participants did not receive treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations | Premature treatment discontinuation | 16 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations | Temporarily off treatment | 7 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations | Reduced dose | 2 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations | Premature treatment discontinuation | 57 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations | Temporarily off treatment | 29 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations | Reduced dose | 33 Participant |
Secondary
Number of Participants With High-grade Signs and Symptoms or Laboratory Values
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.
Time frame: Up to 96 Weeks
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Grade 3 | 15 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Any Grade 3 or higher | 22 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Grade 4 | 7 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Grade 3 | 15 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Any Grade 3 or higher | 20 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Grade 4 | 5 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Any Grade 3 or higher | 84 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Grade 4 | 11 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With High-grade Signs and Symptoms or Laboratory Values | Grade 3 | 73 Participant |
Secondary
Number of Participants With Neutropenia
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.
Time frame: Up to 96 weeks
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Neutropenia | Grade 3 | 10 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Neutropenia | Grade 4 | 3 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Neutropenia | Neutropenia >= Grade 2 | 20 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Neutropenia | Grade 2 | 7 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Neutropenia | Grade 2 | 4 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Neutropenia | Grade 3 | 5 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Neutropenia | Neutropenia >= Grade 2 | 10 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Neutropenia | Grade 4 | 1 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Neutropenia | Grade 2 | 38 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Neutropenia | Grade 4 | 21 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Neutropenia | Neutropenia >= Grade 2 | 96 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Neutropenia | Grade 3 | 37 Participant |
Secondary
Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)
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
Time frame: At any time after pre-assignment
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | 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 |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | 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 |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | 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 |
| B: OL (PEG-IFN, RBV) Then OL Randomized (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 GCSF | 8 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (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 | 13 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (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 GM-CSF | 0 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | 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 | 70 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | 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 |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | 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 | 60 Participant |
Secondary
Number of Participants With Thrombocytopenia
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.
Time frame: Up to 96 weeks
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Thrombocytopenia | Thrombocytopenia >= Grade 2 | 14 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Thrombocytopenia | Grade 2 | 10 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Thrombocytopenia | Grade 3 | 4 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Thrombocytopenia | Grade 4 | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Thrombocytopenia | Grade 4 | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Thrombocytopenia | Thrombocytopenia >= Grade 2 | 4 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Thrombocytopenia | Grade 3 | 1 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Thrombocytopenia | Grade 2 | 3 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Thrombocytopenia | Grade 4 | 1 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Thrombocytopenia | Grade 2 | 25 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Thrombocytopenia | Grade 3 | 5 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Thrombocytopenia | Thrombocytopenia >= Grade 2 | 31 Participant |
Secondary
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 24: Number of participants with HIV RNA data | 39 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 0: No. of participants with undetectable VL | 32 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 12: Number of participants with HIV RNA data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 12: No. of participants with undetectable VL | NA Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 0: Number of participants with HIV RNA data | 44 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 24: No. of participants with undetectable VL | 25 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 36: Number of participants with HIV RNA data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 36: No. of participants with undetectable VL | NA Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 48: Number of participants with HIV RNA data | 35 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 48: No. of participants with undetectable VL | 24 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 60: Number of participants with HIV RNA data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 60: No. of participants with undetectable VL | NA Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 72: Number of participants with HIV RNA data | 27 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 72: No. of participants with undetectable VL | 19 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 84: Number of participants with HIV RNA data | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 84: No. of participants with undetectable VL | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 84: Number of participants with HIV RNA data | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 24: No. of participants with undetectable VL | 25 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 84: No. of participants with undetectable VL | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 36: Number of participants with HIV RNA data | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 72: Number of participants with HIV RNA data | 27 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 36: No. of participants with undetectable VL | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 48: Number of participants with HIV RNA data | 33 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 48: No. of participants with undetectable VL | 25 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 72: No. of participants with undetectable VL | 20 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 0: Number of participants with HIV RNA data | 42 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 60: Number of participants with HIV RNA data | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 0: No. of participants with undetectable VL | 34 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 12: Number of participants with HIV RNA data | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 12: No. of participants with undetectable VL | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 60: No. of participants with undetectable VL | NA Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 24: Number of participants with HIV RNA data | 39 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 12: Number of participants with HIV RNA data | 164 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 72: No. of participants with undetectable VL | 107 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 24: No. of participants with undetectable VL | 141 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 0: Number of participants with HIV RNA data | 169 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 60: No. of participants with undetectable VL | 113 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 36: Number of participants with HIV RNA data | 160 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 12: No. of participants with undetectable VL | 138 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 0: No. of participants with undetectable VL | 146 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 36: No. of participants with undetectable VL | 134 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 72: Number of participants with HIV RNA data | 140 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 60: Number of participants with HIV RNA data | 140 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 48: Number of participants with HIV RNA data | 150 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 84: No. of participants with undetectable VL | 108 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 24: Number of participants with HIV RNA data | 165 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 84: Number of participants with HIV RNA data | 136 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL) | Week 48: No. of participants with undetectable VL | 125 Participant |
Secondary
Sustained Virologic Response
Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (\<60 IU/ml) 24 weeks after treatment discontinuation.
Time frame: 24 weeks after end of treatment
Population: All Arm A, B and C participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Sustained Virologic Response | Yes | 0 Participant |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Sustained Virologic Response | No | 44 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Sustained Virologic Response | Yes | 0 Participant |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Sustained Virologic Response | No | 42 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Sustained Virologic Response | Yes | 88 Participant |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Sustained Virologic Response | No | 81 Participant |
Secondary
Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)
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.
Time frame: Baseline and at week 72 or premature discontinuation
Population: All participants with SCIIS available (Complete Cases)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Time-scaled Change in Ishak Liver Inflammation Score (SCIIS) | 0 Ishak units per one year (52 weeks) |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Time-scaled Change in Ishak Liver Inflammation Score (SCIIS) | 1.31 Ishak units per one year (52 weeks) |
Secondary
Weight
Participant weight in kilograms.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 64: Weight (N=26 in A, 24 in B) | 78.5 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 4: Weight (N=43 in A, 35 in B, 161 in C) | 74.7 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 24: Weight (N=39 in A, 36 in B, 165 in C) | 75.5 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 56: Weight (N=31 in A, 24 in B) | 79.7 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 12: Weight (N=42 in A, 30 in B, 157 in C) | 76.3 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 32: Weight (N=37 in A, 35 in B) | 76.5 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 84: Weight (N=140 in C) | NA kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 0: Weight (N=43 in A, 42 in B, 169 in C) | 74.9 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 36: Weight (N=162 in C) | NA kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 96: Weight (N=138) | NA kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 8: Weight (N=39 in A, 34 in B, 162 in C) | 74.9 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 40: Weight (N=32 in A, 29 in B) | 75.7 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 72: Weight (N=26 in A, 27 in B, 141 in C) | 81.6 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 16: Weight (N=39 in A, 35 in B, 164 in C) | 77.4 kilograms |
| A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) | Weight | Week 48: Weight (N=33 in A, 31 in B, 153 in C) | 78.2 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 16: Weight (N=39 in A, 35 in B, 164 in C) | 79.9 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 56: Weight (N=31 in A, 24 in B) | 81.6 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 0: Weight (N=43 in A, 42 in B, 169 in C) | 79.8 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 64: Weight (N=26 in A, 24 in B) | 84.0 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 72: Weight (N=26 in A, 27 in B, 141 in C) | 85.4 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 12: Weight (N=42 in A, 30 in B, 157 in C) | 81.1 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 84: Weight (N=140 in C) | NA kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 96: Weight (N=138) | NA kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 48: Weight (N=33 in A, 31 in B, 153 in C) | 80.4 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 24: Weight (N=39 in A, 36 in B, 165 in C) | 79.4 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 4: Weight (N=43 in A, 35 in B, 161 in C) | 80.4 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 32: Weight (N=37 in A, 35 in B) | 80.4 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 36: Weight (N=162 in C) | NA kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 40: Weight (N=32 in A, 29 in B) | 83.1 kilograms |
| B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) | Weight | Week 8: Weight (N=39 in A, 34 in B, 162 in C) | 80.8 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 96: Weight (N=138) | 78.4 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 0: Weight (N=43 in A, 42 in B, 169 in C) | 75.8 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 4: Weight (N=43 in A, 35 in B, 161 in C) | 75.8 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 8: Weight (N=39 in A, 34 in B, 162 in C) | 75.8 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 12: Weight (N=42 in A, 30 in B, 157 in C) | 76.3 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 16: Weight (N=39 in A, 35 in B, 164 in C) | 76.3 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 24: Weight (N=39 in A, 36 in B, 165 in C) | 75.8 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 32: Weight (N=37 in A, 35 in B) | NA kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 36: Weight (N=162 in C) | 75.0 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 40: Weight (N=32 in A, 29 in B) | NA kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 56: Weight (N=31 in A, 24 in B) | NA kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 64: Weight (N=26 in A, 24 in B) | NA kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 72: Weight (N=26 in A, 27 in B, 141 in C) | 75.6 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 84: Weight (N=140 in C) | 77.0 kilograms |
| C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) | Weight | Week 48: Weight (N=33 in A, 31 in B, 153 in C) | 75.1 kilograms |