Chronic Hepatitis C Virus Infection
Conditions
Keywords
Hepatitis C Virus, Genotype 2, Chronic Hepatitis C, Genotype 3, Non-cirrhotic, Cirrhotic
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.
Interventions
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic HCV infection prior to study enrollment. 2. Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype). 3. Absence OR presence of cirrhosis. 4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)
Exclusion criteria
1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody 2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse. 3. Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267). 4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis. 5. Abnormal lab tests. 6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 12 weeks after the last actual dose of study drug | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With On-treatment Virologic Failure | Up to Week 12 | On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment. |
| Percentage of Participants With Post-treatment Relapse | Up to 12 weeks after the last actual dose of active study drug | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment. |
Participant flow
Pre-assignment details
The study included a 35-day screening period.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks. | 9 |
| Arm B (GT3, Noncirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks. | 11 |
| Arm C (GT2, Noncirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks. | 10 |
| Arm D (GT2, Noncirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks. | 9 |
| Arm E (GT3, Cirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks. | 21 |
| Arm F (GT3, Noncirrhotic) OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks. | 10 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Subject enrolled in new study. | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Arm A (Genotype [GT]3, Noncirrhotic) | Arm B (GT3, Noncirrhotic) | Arm C (GT2, Noncirrhotic) | Arm D (GT2, Noncirrhotic) | Arm E (GT3, Cirrhotic) | Arm F (GT3, Noncirrhotic) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 9.17 | 53.5 years STANDARD_DEVIATION 8.26 | 56.6 years STANDARD_DEVIATION 6.7 | 61.6 years STANDARD_DEVIATION 5.9 | 53.8 years STANDARD_DEVIATION 6.56 | 48.9 years STANDARD_DEVIATION 7.52 | 54.2 years STANDARD_DEVIATION 7.88 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 11 Participants | 10 Participants | 7 Participants | 17 Participants | 9 Participants | 61 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 5 Participants | 3 Participants | 9 Participants | 2 Participants | 27 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 5 Participants | 6 Participants | 12 Participants | 8 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 | 0 / 10 | 0 / 9 | 0 / 21 | 0 / 10 |
| other Total, other adverse events | 8 / 9 | 10 / 11 | 10 / 10 | 9 / 9 | 20 / 21 | 8 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 | 1 / 10 | 0 / 9 | 2 / 21 | 0 / 10 |
Outcome results
Primary
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 100 percentage of participants |
| Arm B (GT3, Noncirrhotic) | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 90.9 percentage of participants |
| Arm C (GT2, Noncirrhotic) | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 90.0 percentage of participants |
| Arm D (GT2, Noncirrhotic) | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 44.4 percentage of participants |
| Arm E (GT3, Cirrhotic) | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 100 percentage of participants |
| Arm F (GT3, Noncirrhotic) | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 100 percentage of participants |
Secondary
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
Time frame: Up to Week 12
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm B (GT3, Noncirrhotic) | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm C (GT2, Noncirrhotic) | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm D (GT2, Noncirrhotic) | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm E (GT3, Cirrhotic) | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm F (GT3, Noncirrhotic) | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
Secondary
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.
Time frame: Up to 12 weeks after the last actual dose of active study drug
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) | Percentage of Participants With Post-treatment Relapse | 0 percentage of participants |
| Arm B (GT3, Noncirrhotic) | Percentage of Participants With Post-treatment Relapse | 0 percentage of participants |
| Arm C (GT2, Noncirrhotic) | Percentage of Participants With Post-treatment Relapse | 10.0 percentage of participants |
| Arm D (GT2, Noncirrhotic) | Percentage of Participants With Post-treatment Relapse | 55.6 percentage of participants |
| Arm E (GT3, Cirrhotic) | Percentage of Participants With Post-treatment Relapse | 0 percentage of participants |
| Arm F (GT3, Noncirrhotic) | Percentage of Participants With Post-treatment Relapse | 0 percentage of participants |