Chronic Hepatitis C
Conditions
Keywords
Phase 2b Dose-Ranging Study
Brief summary
The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.
Detailed description
The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 mg/day to 1400 mg/day based on subject body weight, with both drugs administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus genotype 1 infection.
Interventions
DRUGTaribavirin
Oral (200 mg) Tablet: 20mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
DRUGRibavirin
Oral (200mg)Tablet: 800 mg/day, 1000 mg/day, 1200 mg/day, or 1400 mg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
Sponsors
Bausch Health Americas, Inc.
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
Subject Inclusion Criteria To be eligible for enrollment, patients must meet all of the following criteria: 1. At least 18 years of age 2. Diagnosed with compensated chronic HCV genotype 1 infection that has not been treated with interferon, peginterferon, ribavirin or any experimental therapy for \>28 days 2a Serum HCV RNA \>2000 copies/mL (780 IU/mL) 2b Liver biopsy performed within 3 years prior to screening consistent with chronic HCV infection 2c Criteria for compensated HCV infection, including normal prothrombin time, serum albumin and bilirubin levels (unless due to non-hepatitis factors) and no history or evidence of bleeding esophageal varices, ascites, or hepatic encephalopathy 3 History of alanine aminotransferase (ALT) elevation either within 6 months prior to screening, at screening, or on retest 2 weeks after a negative screening test, or histologic evidence of HCV infection and a detectable viral load 4 Platelet count ≥90,000/mm3 5 Absolute neutrophil count ≥1200/mm3 6 Hemoglobin ≥12.0 g/dL for females or ≥13.0 g/dL for males 7 Antinuclear antibody (ANA) titer ≤1:320 8 Serum creatinine \<1.5 mg/dL 9 HbA1c ≤8.5% for diabetic patients 10 Normal or adequately controlled TSH on prescription medication 11 Alpha fetoprotein (AFP) \<20 ng/mL or hepatocellular carcinoma ruled out (ultrasound, CT or MRI scan) within 6 months prior to the study (Patients with an AFP \>20 ng/mL must have ongoing hepatocellular carcinoma screening during study as part of the patient's routine medical care) 12 All other clinical laboratory values within normal limits, unless judged not clinically significant by the investigator 13 Sterile or infertile (defined as vasectomy, tubal ligation, postmenopausal, or hysterectomy), or willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 6 months after the last dose 14 Capable of understanding instructions, adhering to study schedules and requirements, and willing to provided informed consent Subject
Exclusion criteria
Patients who have any of the following during the screening or Day 1 visit are not eligible for enrollment in this study: 1. Positive HIV or HbsAg serology 2. Severe psychiatric or neuropsychiatric disorders including severe depression, history of suicidal ideations or suicide attempt(s). (This would include patients with a history of suicidal ideations or suicide attempt(s) that occurred when the patient was a minor or many years ago; if the event occurred while under the influence of alcohol or drugs; if the suicidal ideations or suicide attempt(s) were connected to a traumatic event; if the patient was not hospitalized or treated; if the patient has obtained psychiatric clearance for treatment) 3. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic (including severe retinopathy), or immune mediated disease 4. History of thalassemia or other hemoglobinopathies (even if the hemoglobin is normal) 5. Chronic hepatic disease other than hepatitis C 6. Organ or bone marrow transplant 7. Chronic (greater than 30 days) use of immunosuppressive medications including steroids in doses equivalent to 10 mg of prednisone or higher, 30 days prior to and anytime during the course of the study 8. Female patients who are breast-feeding or have a positive pregnancy test at any time during the study 9. Males whose female partners are pregnant 10. Patients who have had a malignancy diagnosed and/or treated within the past 5 years, except for localized squamous or basal cell cancers treated by local excision 11. Patients who have participated in a clinical trial and have received an investigational drug within 30 days prior to screening 12. History of alcoholism or drug addiction 1 year prior to screening 13. The use of methadone, buprenorphine or any similar drug, regardless of the prescribed indication or the length of time the patient has been on the drug 14. Chronic (\>4 weeks duration) diarrhea, including irritable bowel disease 15. Fibrosis score F4 (cirrhosis) based on Metavir or equivalent index 16. Weight \>128 kg or \<40 kg 17. Patients infected with mixed HCV genotypes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Treatment Week 12 | The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as \<100 copies/mL serum HCV RNA. A PR is defined as \< 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24 | Treatment Week Follow-Up 24 | The primary safety endpoint will be the numbers of patients with hemoglobin \<10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed. |
| Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Treatment Week Follow-Up 24 | — |
| Relapsers at Follow-Up Visit 24 | Follow-Up Week 24 | Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug. |
Countries
United States
Participant flow
Recruitment details
Patients who met all entry criteria and signed an informed consent were randomized in a 1:1:1:1 ratio to one of the 4 arms by a central randomization schedule. A total of 51 clinical centers in the United States participated in the study. 278 patients were randomized; 275 patients who receive one dose of study drug were included in all analyses.
Pre-assignment details
Randomization was stratified by screening HCV RNA viral load less than or = to 2 or greater than (\>) 2 million copies/mL and body weight (BW) (less than or = 75 or \>75 kg). A cap of 70% was set for patients with BWs \>75 kg so that at least 30% of the patients in each group have BWs less than or = to 75 kg.
Participants by arm
| Arm | Count |
|---|---|
| Taribavirin 20 mg/kg/Day Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) | 67 |
| Taribavirin 25 mg/kg/Day Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) | 70 |
| Taribavirin 30 mg/kg/Day Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) | 68 |
| Ribavirin 800 mg/Day Oral ribavirin 800 mg/day (body weight \<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) | 70 |
| Total | 275 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 17 | 13 | 18 |
| Overall Study | Adverse Event-Diarrhea | 1 | 1 | 2 | 0 |
| Overall Study | Lack of Efficacy | 19 | 19 | 24 | 19 |
| Overall Study | Lost to Follow-up | 1 | 3 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 2 | 1 | 0 |
| Overall Study | Reason Not Completed | 3 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 1 | 3 |
Baseline characteristics
| Characteristic | Taribavirin 20 mg/kg/Day | Taribavirin 25 mg/kg/Day | Taribavirin 30 mg/kg/Day | Ribavirin 800 mg/Day | Total |
|---|---|---|---|---|---|
| Age Continuous | 48.5 years STANDARD_DEVIATION 9.39 | 47.5 years STANDARD_DEVIATION 9.42 | 49.6 years STANDARD_DEVIATION 7.24 | 49.7 years STANDARD_DEVIATION 8.3 | 48.8 years STANDARD_DEVIATION 8.63 |
| Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (log 10) | 6.6 Copies/mL STANDARD_DEVIATION 0.71 | 6.6 Copies/mL STANDARD_DEVIATION 0.78 | 6.6 Copies/mL STANDARD_DEVIATION 0.78 | 6.5 Copies/mL STANDARD_DEVIATION 0.84 | 6.6 Copies/mL STANDARD_DEVIATION 0.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 14 Participants | 13 Participants | 12 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 10 Participants | 11 Participants | 37 Participants |
| Race (NIH/OMB) White | 50 Participants | 41 Participants | 42 Participants | 45 Participants | 178 Participants |
| Sex: Female, Male Female | 35 Participants | 25 Participants | 25 Participants | 22 Participants | 107 Participants |
| Sex: Female, Male Male | 32 Participants | 45 Participants | 43 Participants | 48 Participants | 168 Participants |
| Weight | 81.5 kilograms STANDARD_DEVIATION 16.9 | 82.6 kilograms STANDARD_DEVIATION 16.8 | 82.2 kilograms STANDARD_DEVIATION 18 | 82.3 kilograms STANDARD_DEVIATION 17.1 | 82.1 kilograms STANDARD_DEVIATION 17.09 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 66 / 67 | 68 / 70 | 68 / 68 | 69 / 70 |
| serious Total, serious adverse events | 7 / 67 | 6 / 70 | 6 / 68 | 9 / 70 |
Outcome results
Primary
Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.
The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as \<100 copies/mL serum HCV RNA. A PR is defined as \< 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.
Time frame: Treatment Week 12
Population: The primary efficacy analysis was performed using the Intent-to-Treat (ITT) population and 275 patients who received at least one dose of study drug were analyzed for efficacy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Taribavirin 20 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Discontinued (Prior to TW 12) | 7 Participants |
| Taribavirin 20 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | No EVR (non-responder, Total) | 24 Participants |
| Taribavirin 20 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Detectable (greater than 100 copies/mL at TW 12) | 17 Participants |
| Taribavirin 20 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Missing (No value at TW 12) | 0 Participants |
| Taribavirin 20 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Early Virologic Response (EVR) (less than 100) | 43 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Missing (No value at TW 12) | 1 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | No EVR (non-responder, Total) | 30 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Early Virologic Response (EVR) (less than 100) | 40 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Detectable (greater than 100 copies/mL at TW 12) | 17 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Discontinued (Prior to TW 12) | 12 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Missing (No value at TW 12) | 0 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Detectable (greater than 100 copies/mL at TW 12) | 21 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Discontinued (Prior to TW 12) | 10 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Early Virologic Response (EVR) (less than 100) | 37 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | No EVR (non-responder, Total) | 31 Participants |
| Ribavirin 800 mg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Detectable (greater than 100 copies/mL at TW 12) | 19 Participants |
| Ribavirin 800 mg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | No EVR (non-responder, Total) | 34 Participants |
| Ribavirin 800 mg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Discontinued (Prior to TW 12) | 15 Participants |
| Ribavirin 800 mg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Early Virologic Response (EVR) (less than 100) | 36 Participants |
| Ribavirin 800 mg/Day | Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12. | Missing (No value at TW 12) | 0 Participants |
p-value: 0.16795% CI: [-3.65, 29.15]Fisher Exact
p-value: 0.61195% CI: [-10.76, 22.19]Fisher Exact
p-value: 0.73695% CI: [-13.67, 19.63]Fisher Exact
p-value: 0.48595% CI: [-9.28, 23.35]Fisher Exact
p-value: 0.29595% CI: [-6.72, 26.26]Fisher Exact
p-value: 0.86495% CI: [-13.84, 19.3]Fisher Exact
Secondary
Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24
The primary safety endpoint will be the numbers of patients with hemoglobin \<10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed.
Time frame: Treatment Week Follow-Up 24
Population: The secondary analysis was performed using the Safety Population and 275 patients who received at least one dose of study drug were analyzed for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Taribavirin 20 mg/kg/Day | Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24 | 11 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24 | 11 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24 | 19 Participants |
| Ribavirin 800 mg/Day | Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24 | 23 Participants |
p-value: 0.030495% CI: [2.31, 30.57]Chi-squared
p-value: 0.029395% CI: [3.22, 31.06]Chi-squared
p-value: 0.581695% CI: [-10.41, 20.24]Chi-squared
Secondary
Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24
Time frame: Treatment Week Follow-Up 24
Population: This analysis was performed using the Intent-to-Treat Population (ITT); undetectable HCV RNA defined as \<100 copies/mL;Patients with a missing value at TW 12, TW 24 were considered Non-responders (detectable); a responder is defined as a patient with undetectable HCV RNA at FW 24 after achieving EVR at TW 12 and undetectable status at TW 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Taribavirin 20 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Non-Responder Follow-Up Week 24 | 48 Participants |
| Taribavirin 20 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Detectable HCV RNA Follow-Up Week 24 | 14 Participants |
| Taribavirin 20 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Responder Follow-Up Week 24 | 19 Participants |
| Taribavirin 20 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Discontinued Week Follow-Up Week 24 | 34 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Responder Follow-Up Week 24 | 19 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Non-Responder Follow-Up Week 24 | 51 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Discontinued Week Follow-Up Week 24 | 36 Participants |
| Taribavirin 25 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Detectable HCV RNA Follow-Up Week 24 | 15 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Responder Follow-Up Week 24 | 19 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Discontinued Week Follow-Up Week 24 | 33 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Detectable HCV RNA Follow-Up Week 24 | 16 Participants |
| Taribavirin 30 mg/kg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Non-Responder Follow-Up Week 24 | 49 Participants |
| Ribavirin 800 mg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Detectable HCV RNA Follow-Up Week 24 | 14 Participants |
| Ribavirin 800 mg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Non-Responder Follow-Up Week 24 | 51 Participants |
| Ribavirin 800 mg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Discontinued Week Follow-Up Week 24 | 37 Participants |
| Ribavirin 800 mg/Day | Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24 | Responder Follow-Up Week 24 | 19 Participants |
p-value: 0.999995% CI: [-13.78, 16.22]Fisher Exact
p-value: 0.999995% CI: [-14.73, 14.73]Fisher Exact
p-value: 0.999995% CI: [-14.11, 15.71]Fisher Exact
p-value: 0.999995% CI: [-13.78, 16.22]Fisher Exact
p-value: 0.999995% CI: [-14.76, 15.59]Fisher Exact
p-value: 0.999995% CI: [-15.71, 14.11]Fisher Exact
Secondary
Relapsers at Follow-Up Visit 24
Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug.
Time frame: Follow-Up Week 24
Population: The analysis was performed using patients who had undetectable HVC RNA at their last visit on drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Taribavirin 20 mg/kg/Day | Relapsers at Follow-Up Visit 24 | 10 Participants |
| Taribavirin 25 mg/kg/Day | Relapsers at Follow-Up Visit 24 | 5 Participants |
| Taribavirin 30 mg/kg/Day | Relapsers at Follow-Up Visit 24 | 3 Participants |
| Ribavirin 800 mg/Day | Relapsers at Follow-Up Visit 24 | 5 Participants |