Trial Outcomes & Findings for Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C (NCT NCT02640547)
NCT ID: NCT02640547
Last Updated: 2018-10-17
Results Overview
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.
Recruitment status
COMPLETED
Target enrollment
394 participants
Primary outcome timeframe
12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Results posted on
2018-10-17
Participant Flow
In this prospective, multi-center observational study a total of 394 adult patients chronically infected with hepatitis C virus (HCV) were enrolled at 17 centers in Poland.
Effectiveness analyses of clinical outcomes are reported by HCV genotype. Safety variables were analyzed by treatment regimen.
Participant milestones
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
|
|---|---|
|
Overall Study
STARTED
|
394
|
|
Overall Study
COMPLETED
|
383
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
|
|---|---|
|
Overall Study
Failure to Return
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
6
|
|
Overall Study
Miscellaneous
|
3
|
Baseline Characteristics
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=394 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Age, Customized
18 to 65 years
|
316 Participants
n=5 Participants
|
|
Age, Customized
66 to 84 years
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
394 Participants
n=5 Participants
|
|
Years Since Diagnosis of HCV Infection
|
6.6 years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
|
HCV Genotype
Genotype 1a
|
24 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a/1b
|
1 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1b
|
349 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 4
|
20 Participants
n=5 Participants
|
|
Cirrhosis Status
No cirrhosis
|
211 Participants
n=5 Participants
|
|
Cirrhosis Status
Transition to cirrhosis
|
58 Participants
n=5 Participants
|
|
Cirrhosis Status
Cirrhosis
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.
Outcome measures
| Measure |
Genotype 1 (Total)
n=374 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=349 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
|
96.8 percentage of participants
Interval 94.5 to 98.2
|
100.0 percentage of participants
Interval 86.7 to 100.0
|
96.6 percentage of participants
Interval 94.1 to 98.0
|
95.0 percentage of participants
Interval 76.4 to 99.1
|
SECONDARY outcome
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin according to standard of care and within local label recommendations for their specific disease characteristics.
Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
Outcome measures
| Measure |
Genotype 1 (Total)
n=374 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=349 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Virological Response at End of Treatment
|
95.5 percentage of participants
Interval 92.8 to 97.1
|
100.0 percentage of participants
Interval 86.7 to 100.0
|
95.1 percentage of participants
Interval 92.3 to 96.9
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
SECONDARY outcome
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.Population: Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, and with VR at actual EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70
Relapse was defined as participants with a virologic response (VR; HCV RNA \< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
Outcome measures
| Measure |
Genotype 1 (Total)
n=349 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=324 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=19 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants With Relapse
|
0.6 percentage of participants
Interval 0.2 to 2.1
|
0.0 percentage of participants
Interval 0.0 to 13.3
|
0.6 percentage of participants
Interval 0.2 to 2.2
|
0.0 percentage of participants
Interval 0.0 to 16.8
|
SECONDARY outcome
Timeframe: 12 or 24 weeks (depending on the treatment regimen)Population: Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, who had at least one undetectable HCV RNA measurement on-treatment and at least one measurement on-treatment thereafter
Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Outcome measures
| Measure |
Genotype 1 (Total)
n=17 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=1 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=16 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=5 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants With Breakthrough
|
0.0 percentage of participants
Interval 0.0 to 18.4
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 19.4
|
0.0 percentage of participants
Interval 0.0 to 43.4
|
SECONDARY outcome
Timeframe: Week 4Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA \< 50 IU/mL at week 4. Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures.
Outcome measures
| Measure |
Genotype 1 (Total)
n=374 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=349 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants With a Rapid Virological Response at Week 4
|
3.7 percentage of participants
Interval 2.2 to 6.2
|
0.0 percentage of participants
Interval 0.0 to 13.3
|
4.0 percentage of participants
Interval 2.4 to 6.6
|
5.0 percentage of participants
Interval 0.9 to 23.6
|
SECONDARY outcome
Timeframe: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.
Outcome measures
| Measure |
Genotype 1 (Total)
n=374 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=349 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24)
|
96.3 percentage of participants
Interval 93.8 to 97.8
|
100.0 percentage of participants
Interval 86.7 to 100.0
|
96.0 percentage of participants
Interval 93.4 to 97.6
|
95.0 percentage of participants
Interval 76.4 to 99.1
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)Population: The core population with sufficient follow-up data regarding SVR12
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. The core population with sufficient follow-up data regarding SVR12 included all core population participants who * had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE regimen, * or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline * or had HCV RNA \< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE regimen due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.
Outcome measures
| Measure |
Genotype 1 (Total)
n=371 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=346 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12)
|
97.6 percentage of participants
Interval 95.5 to 98.7
|
100.0 percentage of participants
Interval 86.7 to 100.0
|
97.4 percentage of participants
Interval 95.1 to 98.6
|
95.0 percentage of participants
Interval 76.4 to 99.1
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
SVR12 non-response was categorized according to the following: * Relapse, defined as HCV RNA \< 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened); * Death; * Premature treatment discontinuation with no on-treatment virological failure; * Missing SVR12 data and/or none of the above criteria.
Outcome measures
| Measure |
Genotype 1 (Total)
n=374 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=349 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Relapse
|
0.5 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Death
|
1.6 percentage of participants
|
0.0 percentage of participants
|
1.7 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Premature treatment discontinuation
|
0.3 percentage of participants
|
0.0 percentage of participants
|
0.3 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Missing SVR12 data/None of the above
|
0.8 percentage of participants
|
0.0 percentage of participants
|
0.9 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.
Outcome measures
| Measure |
Genotype 1 (Total)
n=374 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=349 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Assigned Treatment Regimen
3 DAA without RBV (12 weeks)
|
229 Participants
|
0 Participants
|
229 Participants
|
0 Participants
|
|
Assigned Treatment Regimen
2 DAA + RBV (12 weeks)
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
|
Assigned Treatment Regimen
2 DAA + RBV (24 weeks)
|
0 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
|
Assigned Treatment Regimen
3 DAA + RBV (12 weeks)
|
141 Participants
|
22 Participants
|
119 Participants
|
1 Participants
|
|
Assigned Treatment Regimen
3 DAA + RBV (24 weeks)
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimenPopulation: All enrolled participants who received at least one dose of the ABBVIE REGIMEN.
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Outcome measures
| Measure |
Genotype 1 (Total)
n=19 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=229 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=146 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 95%
|
18 Participants
|
227 Participants
|
141 Participants
|
—
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 80 % to ≤ 95%
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 50% to ≤ 80%
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
≤ 50%
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimenPopulation: All enrolled participants who received at least one dose of the ABBVIE REGIMEN that included ribavirin
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Outcome measures
| Measure |
Genotype 1 (Total)
n=19 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=146 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV
> 95%
|
14 Participants
|
—
|
105 Participants
|
—
|
|
Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV
> 80% to ≤ 95%
|
1 Participants
|
—
|
8 Participants
|
—
|
|
Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV
> 50% to ≤ 80%
|
0 Participants
|
—
|
19 Participants
|
—
|
|
Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV
≤ 50%
|
4 Participants
|
—
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
Outcome measures
| Measure |
Genotype 1 (Total)
n=374 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=25 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=349 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
n=20 Participants
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Number of Participants With Comorbidities
Any comorbidity or coinfection
|
224 Participants
|
10 Participants
|
214 Participants
|
16 Participants
|
|
Number of Participants With Comorbidities
Any coinfection
|
15 Participants
|
2 Participants
|
13 Participants
|
4 Participants
|
|
Number of Participants With Comorbidities
Coinfection with human immunodeficiency virus (HIV
|
8 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Comorbidities
Coinfection with hepatitis B virus
|
8 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimenPopulation: All enrolled participants who received at least one dose of the ABBVIE REGIMEN.
Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.
Outcome measures
| Measure |
Genotype 1 (Total)
n=19 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=229 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=146 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Number of Participants Who Received Concomitant Medications
|
10 Participants
|
103 Participants
|
64 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.Population: All enrolled participants who received at least one dose of the ABBVIE REGIMEN.
Outcome measures
| Measure |
Genotype 1 (Total)
n=19 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=229 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=146 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Any adverse event
|
8 Participants
|
19 Participants
|
42 Participants
|
—
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Serious adverse events
|
3 Participants
|
3 Participants
|
8 Participants
|
—
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Pregnancies
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.
Outcome measures
| Measure |
Genotype 1 (Total)
n=19 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=221 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=139 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
End of treatment
|
0.06 units on a scale
Interval 0.01 to 0.1
|
0.04 units on a scale
Interval 0.03 to 0.06
|
0.04 units on a scale
Interval 0.02 to 0.06
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
12 weeks post treatment
|
0.07 units on a scale
Interval 0.02 to 0.11
|
0.05 units on a scale
Interval 0.04 to 0.07
|
0.04 units on a scale
Interval 0.02 to 0.06
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
24 weeks post treatment
|
0.05 units on a scale
Interval 0.0 to 0.11
|
0.07 units on a scale
Interval 0.05 to 0.08
|
0.04 units on a scale
Interval 0.02 to 0.06
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).
Outcome measures
| Measure |
Genotype 1 (Total)
n=19 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=229 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=146 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
End of treatment
|
4.10 units on a scale
Interval -1.52 to 9.73
|
7.41 units on a scale
Interval 5.79 to 9.04
|
5.13 units on a scale
Interval 3.08 to 7.17
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
12 weeks post treatment
|
7.93 units on a scale
Interval 1.9 to 14.0
|
9.11 units on a scale
Interval 7.41 to 10.8
|
7.01 units on a scale
Interval 4.86 to 9.15
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
24 weeks post treatment
|
6.54 units on a scale
Interval 0.74 to 12.3
|
11.8 units on a scale
Interval 10.2 to 13.4
|
9.20 units on a scale
Interval 7.11 to 11.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks post treatmentPopulation: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Absenteeism indicates the percentage of work time missed due to health problems.
Outcome measures
| Measure |
Genotype 1 (Total)
n=9 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=87 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=43 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
End of treatment
|
0.0 percent impairment
Interval 0.0 to 0.0
|
0.0 percent impairment
Interval 0.0 to 0.0
|
0.0 percent impairment
Interval 0.0 to 0.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
12 weeks post treatment
|
0.0 percent impairment
Interval -11.0 to 0.0
|
0.0 percent impairment
Interval 0.0 to 0.0
|
0.0 percent impairment
Interval 0.0 to
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
24 weeks post treatment
|
0.0 percent impairment
Interval 0.0 to 0.0
|
0.0 percent impairment
Interval 0.0 to 0.0
|
0.0 percent impairment
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Presenteeism indicates the percentage of impairment while working due to health problems.
Outcome measures
| Measure |
Genotype 1 (Total)
n=9 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=88 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=44 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
End of treatment
|
-5.0 percent impairment
Interval -10.0 to 10.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -10.0 to 0.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
12 weeks post treatment
|
-5.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -10.0 to 0.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
24 weeks post treatment
|
-10.0 percent impairment
Interval -20.0 to 0.0
|
-10.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems.
Outcome measures
| Measure |
Genotype 1 (Total)
n=9 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=87 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=43 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
End of treatment
|
-5.0 percent impairment
Interval -10.0 to 10.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -10.0 to 0.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
12 weeks post treatment
|
-5.0 percent impairment
Interval -27.7 to 0.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -10.0 to 0.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
24 weeks post treatment
|
-10.0 percent impairment
Interval -20.0 to 0.0
|
-10.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.
Outcome measures
| Measure |
Genotype 1 (Total)
n=19 Participants
Participants with genotype 1 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1a
n=228 Participants
Participants with genotype 1a HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 1b
n=146 Participants
Participants with genotype 1b HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
Genotype 4
Participants with genotype 4 HCV received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
|
|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
End of treatment
|
0.0 percent impairment
Interval -10.0 to 10.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -10.0 to 10.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
12 weeks post treatment
|
0.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
0.0 percent impairment
Interval -20.0 to 0.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
24 weeks post treatment
|
-5.0 percent impairment
Interval -30.0 to 0.0
|
-10.0 percent impairment
Interval -30.0 to 0.0
|
0.0 percent impairment
Interval -30.0 to 0.0
|
—
|
Adverse Events
2 DAA + RBV
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
3 DAA Without RBV
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
3 DAA + RBV
Serious events: 8 serious events
Other events: 26 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
2 DAA + RBV
n=19 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
|
3 DAA Without RBV
n=229 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without RBV for 12 weeks.
|
3 DAA + RBV
n=146 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.44%
1/229 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.68%
1/146 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.68%
1/146 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/19 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.68%
1/146 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.00%
0/19 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.68%
1/146 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Hepatobiliary disorders
Hepatic Failure
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
1.4%
2/146 • Number of events 2 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/19 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.68%
1/146 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/19 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.44%
1/229 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/146 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellullar Carcinoma
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.68%
1/146 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.44%
1/229 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/146 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
Other adverse events
| Measure |
2 DAA + RBV
n=19 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
|
3 DAA Without RBV
n=229 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without RBV for 12 weeks.
|
3 DAA + RBV
n=146 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • Number of events 3 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
11.6%
17/146 • Number of events 17 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
General disorders
Asthenia
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.44%
1/229 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
1.4%
2/146 • Number of events 2 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
21.1%
4/19 • Number of events 4 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.44%
1/229 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
4.1%
6/146 • Number of events 6 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Number of events 1 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
0.00%
0/229 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
2.1%
3/146 • Number of events 3 • From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER