Chronic Hepatitis C, Cirrhosis, Hepatitis C Virus
Conditions
Keywords
Chronic Hepatitis C, Interferon-Free, Hepatitis C Genotype 1, Hepatitis C Virus, Hepatitis C, Cirrhosis
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.
Interventions
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
DRUGRibavirin
Tablet
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
* US military veteran currently receiving healthcare through the Veterans Health Administration * Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection * Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA \> 1,000 IU/mL at the time of Screening or HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)
Exclusion criteria
* Women who are pregnant or breastfeeding * Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab) * Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir * Any current or past clinical evidence of Child-Pugh B or C classification * Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis
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. Participants with missing data after backwards imputation were imputed as nonresponders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virologic Failure During Treatment | up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end 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. |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders | 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. Participants with missing data after backwards imputation were imputed as nonresponders. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3-DAA ± RBV for 12 or 24 Weeks 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis. | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Other | 1 |
| Overall Study | Withdrew Consent | 2 |
Baseline characteristics
| Characteristic | 3-DAA ± RBV for 12 or 24 Weeks |
|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 5.9 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 99 |
| serious Total, serious adverse events | 7 / 99 |
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. Participants with missing data after backwards imputation were imputed as nonresponders.
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3-DAA ± RBV for 12 or 24 Weeks | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 93.9 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: 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) |
|---|---|---|
| 3-DAA ± RBV for 12 or 24 Weeks | Percentage of Participants With Post-treatment Relapse | 2.2 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders
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. Participants with missing data after backwards imputation were imputed as nonresponders.
Time frame: 12 weeks after the last actual dose of study drug
Population: All participants who received at least 1 dose of study drug (ITT population) and with ongoing psychiatric disorders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3-DAA ± RBV for 12 or 24 Weeks | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders | 95.8 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure During Treatment
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.
Time frame: up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group
Population: Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3-DAA ± RBV for 12 or 24 Weeks | Percentage of Participants With Virologic Failure During Treatment | 1.0 percentage of participants |