Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment, End-stage Renal Disease
Conditions
Keywords
Chronic Hepatitis C, Hepatitis C, End-stage renal disease, Hepatitis C Genotype 1, Severe Renal Impairment, renal disease, Compensated Cirrhosis, Renal impairment, dialysis, Hepatitis C Virus, cirrhosis
Brief summary
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.
Interventions
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. Positive for anti-HCV Ab (Antibody) and HCV RNA \>1,000 IU/mL at Screening. 2. Screening laboratory result indicating HCV genotype 1 infection. 3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment). 4. Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.
Exclusion criteria
1. Women who are pregnant or breastfeeding. 2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab). 3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment | 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 24 weeks | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after \< LLOQ during treatment, confirmed increase of \> 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. |
| Percentage of Participants With Post-Treatment Relapse | Within 12 weeks after the last dose of study drug | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA \< LLOQ at the end of treatment. |
Participant flow
Pre-assignment details
The intent-to-treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| 3-DAA ± RBV 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) with or ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | 3-DAA ± RBV |
|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 68 |
| serious Total, serious adverse events | 17 / 68 |
Outcome results
Primary
Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
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: All randomized participants who received at least one dose of study drug (ITT population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3-DAA ± RBV | Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment | 94.1 percentage of participants |
Secondary
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after \< LLOQ during treatment, confirmed increase of \> 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
Time frame: Up to 24 weeks
Population: All randomized participants who received at least one dose of study drug (ITT population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3-DAA ± RBV | 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 end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA \< LLOQ at the end of treatment.
Time frame: Within 12 weeks after the last dose of study drug
Population: All randomized participants who received at least one dose of study drug (ITT population) with HCV RNA \< LLOQ at the end of treatment and completed treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3-DAA ± RBV | Percentage of Participants With Post-Treatment Relapse | 1.5 percentage of participants |