Hepatitis C Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis
Conditions
Keywords
HCV Genotype 1, HCV Genotype 4, HCV Genotype 2, Cirrhotic, Interferon-Free, Compensated Cirrhosis, HCV Genotype 5, Hepatitis C, HCV Genotype 6
Brief summary
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
Interventions
DRUGABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection * Chronic HCV infection * Subject must be HCV treatment-naïve or have failed prior HCV treatment * Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease
Exclusion criteria
* Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody * HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype * Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530
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 | Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment | 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 ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. |
| Percentage of Participants With Post-treatment Relapse | From the end of treatment through 12 weeks after the last dose of 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, excluding reinfection. |
Participant flow
Pre-assignment details
This study included a 35-day screening period.
Participants by arm
| Arm | Count |
|---|---|
| ABT-493/ABT-530 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 3 |
| Overall Study | Withdrew Consent | 1 |
Baseline characteristics
| Characteristic | ABT-493/ABT-530 |
|---|---|
| Age, Continuous | 60.12 years STANDARD_DEVIATION 10.43 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 146 |
| serious Total, serious adverse events | 11 / 146 |
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: Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-493/ABT-530 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 99.3 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 ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time frame: Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment
Population: All participants who received at least 1 dose of study drug (ITT population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-493/ABT-530 | Percentage of Participants With On-treatment Virologic Failure | 0.0 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, excluding reinfection.
Time frame: From the end of treatment through 12 weeks after the last dose of study drug
Population: All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \<LLOQ at the final treatment visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-493/ABT-530 | Percentage of Participants With Post-treatment Relapse | 0.7 percentage of participants |