Chronic Hepatitis C Virus (HCV Infection Genotype 1)
Conditions
Keywords
Treatment naive, Hepatitis C Genotype 1
Brief summary
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis
Interventions
DRUGombitasvir/paritaprevir/ritonavir, dasabuvir
tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
DRUGsofosbuvir (SOF)
tablet
DRUGribavirin (RBV)
tablet
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female at least 18 years of age at time of screening 2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment 3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only 4. Absence of cirrhosis and advanced bridging fibrosis
Exclusion criteria
1. Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay 2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator 3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score \> 2 or an Ishak score \> 3 4. Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration 5. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 12 weeks after the last actual dose of study drug | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With On-treatment Virologic Failure | 6 weeks | Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment). |
| Percentage of Subjects With Post-treatment Relapse | Up to 12 weeks after last actual dose of active study drug | Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment |
Participant flow
Recruitment details
A total 10 participants were enrolled in the first arm (ombitasvir/paritaprevir/r, dasabuvir, and SOF plus RBV for 6 weeks); based on inadequate efficacy in the first arm, subsequent arms (4 weeks of treatment; with or without RBV) were not enrolled per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
Time frame: 12 weeks after the last actual dose of study drug
Population: Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 80 percentage of participants |
Secondary
Percentage of Subjects With On-treatment Virologic Failure
Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).
Time frame: 6 weeks
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | Percentage of Subjects With On-treatment Virologic Failure | 0 percentage of participants |
Secondary
Percentage of Subjects With Post-treatment Relapse
Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment
Time frame: Up to 12 weeks after last actual dose of active study drug
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | Percentage of Subjects With Post-treatment Relapse | 20 percentage of participants |