Trial Outcomes & Findings for Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania (NCT NCT02807402)
NCT ID: NCT02807402
Last Updated: 2019-01-25
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
522 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
2019-01-25
Participant Flow
In this prospective, multi-center observational study a total of 522 adult patients chronically infected with hepatitis C virus (HCV) genotype 1 were enrolled by 22 centers in Romania.
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, and 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
|
522
|
|
Overall Study
COMPLETED
|
516
|
|
Overall Study
NOT COMPLETED
|
6
|
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, and 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
Death
|
3
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Baseline characteristics by cohort
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=522 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, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
|
|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 9.5 • n=522 Participants
|
|
Age, Customized
18-65 years
|
374 Participants
n=522 Participants
|
|
Age, Customized
66-84 years
|
147 Participants
n=522 Participants
|
|
Age, Customized
>=85 years
|
1 Participants
n=522 Participants
|
|
Sex: Female, Male
Female
|
283 Participants
n=522 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=522 Participants
|
|
Race/Ethnicity, Customized
White
|
522 Participants
n=522 Participants
|
|
Years Since Diagnosis of HCV Infection
|
6.8 years
STANDARD_DEVIATION 5.69 • n=522 Participants
|
|
HCV Genotype
Genotype 1a
|
4 Participants
n=522 Participants
|
|
HCV Genotype
Genotype 1b
|
517 Participants
n=522 Participants
|
|
HCV Genotype
Genotype 1, Subtype Unknown
|
1 Participants
n=522 Participants
|
|
Cirrhosis Status
No cirrhosis
|
9 Participants
n=522 Participants
|
|
Cirrhosis Status
Transition to cirrhosis
|
32 Participants
n=522 Participants
|
|
Cirrhosis Status
Cirrhosis
|
481 Participants
n=522 Participants
|
|
HCV RNA
|
5.87 log10 IU/mL
n=519 Participants • Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
|
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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Three participants with genotype 1 prescribed paritaprevir/r and ombitasvir instead of paritaprevir/r, ombitasvir and dasabuvir (3DAA) were excluded.
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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=519 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
|
98.1 percentage of participants
Interval 96.5 to 99.0
|
—
|
—
|
SECONDARY outcome
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)Population: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=519 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Virological Response at End of Treatment
|
99.6 percentage of participants
Interval 98.6 to 99.9
|
—
|
—
|
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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), and 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 paritaprevir/ritonavir, ombitasvir and dasabuvir * 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 paritaprevir/ritonavir, ombitasvir with dasabuvir due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=517 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment
|
98.5 percentage of participants
Interval 97.0 to 99.2
|
—
|
—
|
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: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics, and with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment and were a treatment failure between EOT and post-treatment 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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=512 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Relapse
|
0.8 percentage of participants
Interval 0.3 to 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 or 24 weeks (depending on the treatment regimen)Population: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with virological response on-treatment and with at least one on-treatment measurement (including EOT) 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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=36 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Breakthrough
|
0.00 percentage of participants
Interval 0.0 to 9.6
|
—
|
—
|
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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
SVR12 non-response was categorized according to the following: * On-treatment virologic failure (breakthrough \[at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥ 50 IU/mL\]); * 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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=519 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
On-treatment virologic failure
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Relapse
|
0.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Death
|
0.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Premature treatment discontinuation
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
None of the above criteria
|
0.2 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Treatment regimen was assigned by the physician according to local practice and label. Participants could receive three direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=519 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Assigned Treatment Regimen
3 DAA without RBV (12 weeks)
|
73 Participants
|
—
|
—
|
|
Assigned Treatment Regimen
3 DAA + RBV (12 weeks)
|
438 Participants
|
—
|
—
|
|
Assigned Treatment Regimen
3 DAA + RBV (24 weeks)
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.Population: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=519 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 105%
|
6 Participants
|
—
|
—
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 95% to ≤ 105%
|
483 Participants
|
—
|
—
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 80% to ≤ 95%
|
28 Participants
|
—
|
—
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 50% to ≤ 80%
|
1 Participants
|
—
|
—
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
≤ 50%
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimenPopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), who were prescribed ribavirin, and with available data.
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=445 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 105%
|
6 Participants
|
—
|
—
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 95% to ≤ 105%
|
349 Participants
|
—
|
—
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 80% to ≤ 95%
|
39 Participants
|
—
|
—
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 50% to ≤ 80%
|
22 Participants
|
—
|
—
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
≤ 50%
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.Population: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), who were prescribed ribavirin.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=446 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
|
94.5 percentage of days
Standard Deviation 19.12
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=519 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Number of Participants With Comorbidities
Any comorbidity or coinfection
|
335 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Any coinfection
|
9 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Coinfection with human immunodeficiency virus (HIV
|
4 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Coinfection with hepatitis B virus
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimenPopulation: Enrolled patients who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir.
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=522 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Received Concomitant Medications
|
263 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and with available data at baseline and each time point.
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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=55 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=319 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
End of Treatment
|
0.07 units on a scale
Interval 0.04 to 0.1
|
0.04 units on a scale
Interval 0.03 to 0.06
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
12 weeks post treatment
|
0.09 units on a scale
Interval 0.06 to 0.13
|
0.08 units on a scale
Interval 0.07 to 0.1
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
24 weeks post treatment
|
0.09 units on a scale
Interval 0.01 to 0.16
|
0.10 units on a scale
Interval 0.08 to 0.11
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and with available data at baseline and each time point.
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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=56 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=332 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
End of Treatment
|
10.9 units on a scale
Interval 6.4 to 15.3
|
8.36 units on a scale
Interval 6.55 to 10.2
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
12 weeks post treatment
|
13.9 units on a scale
Interval 9.71 to 18.0
|
12.7 units on a scale
Interval 11.1 to 14.4
|
—
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
24 weeks post treatment
|
18.8 units on a scale
Interval 9.45 to 28.1
|
15.2 units on a scale
Interval 13.2 to 17.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). 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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=10 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=67 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
End of Treatment
|
-1.3 percent impairment
Standard Deviation 3.1
|
-1.4 percent impairment
Standard Deviation 11.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
12 weeks post treatment
|
-15.4 percent impairment
Standard Deviation 37.4
|
-3.8 percent impairment
Standard Deviation 29.0
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
24 weeks post treatment
|
-7.5 percent impairment
Standard Deviation NA
Could not be calculated for one participant
|
-8.7 percent impairment
Standard Deviation 34.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). 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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=9 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=68 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
24 weeks post treatment
|
-70.0 percent impairment
Standard Deviation NA
Could not be calculated for one participant
|
-9.3 percent impairment
Standard Deviation 21.4
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
End of Treatment
|
-23.3 percent impairment
Standard Deviation 29.4
|
-8.5 percent impairment
Standard Deviation 27.1
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
12 weeks post treatment
|
-16.7 percent impairment
Standard Deviation 30.1
|
-10.4 percent impairment
Standard Deviation 31.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). 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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=10 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=63 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
End of Treatment
|
-18.5 percent impairment
Standard Deviation 30.5
|
-8.7 percent impairment
Standard Deviation 25.4
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
12 weeks post treatment
|
-17.0 percent impairment
Standard Deviation 30.6
|
-11.5 percent impairment
Standard Deviation 39.4
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
24 weeks post treatment
|
-72.3 percent impairment
Standard Deviation NA
Could not be calculated for one participant
|
-20.7 percent impairment
Standard Deviation 31.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with available data at baseline and each time point.
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 |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=54 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=320 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
24 weeks post treatment
|
-8.9 percent impairment
Standard Deviation 49.9
|
-11.5 percent impairment
Standard Deviation 37.7
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
End of Treatment
|
-2.9 percent impairment
Standard Deviation 29.7
|
-10.4 percent impairment
Standard Deviation 33.7
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
12 weeks post treatment
|
-9.5 percent impairment
Standard Deviation 31.0
|
-10.5 percent impairment
Standard Deviation 36.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)Population: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with available data at baseline and end of treatment.
PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=29 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=184 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Patient Activation Measure 13 (PAM-13)
|
-3.94 units on a scale
Interval -8.77 to 0.89
|
-4.00 units on a scale
Interval -5.92 to -2.08
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)Population: Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with available data at baseline and end of treatment.
The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=54 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=312 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
Specific Concerns
|
-0.26 units on a scale
Interval -0.49 to -0.03
|
0.06 units on a scale
Interval -0.03 to 0.16
|
—
|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
Specific Necessity
|
-0.07 units on a scale
Interval -0.26 to 0.12
|
-0.21 units on a scale
Interval -0.28 to -0.13
|
—
|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
General Overuse
|
0.01 units on a scale
Interval -0.2 to 0.23
|
0.01 units on a scale
Interval -0.08 to 0.1
|
—
|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
General Harm
|
-0.02 units on a scale
Interval -0.21 to 0.18
|
0.10 units on a scale
Interval 0.02 to 0.19
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days.Population: All enrolled participants who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin
n=3 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with 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.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=73 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=446 Participants
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Any adverse event
|
0 Participants
|
6 Participants
|
82 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Serious adverse events
|
0 Participants
|
3 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Pregnancies
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Paritaprevir/Ritonavir + Ombitasvir With RBV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With R+ RBV
Serious events: 17 serious events
Other events: 44 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Paritaprevir/Ritonavir + Ombitasvir With RBV
n=3 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV
n=73 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With R+ RBV
n=446 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
1.3%
6/446 • Number of events 6 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
1.4%
1/73 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/446 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Gastrointestinal disorders
GASTRIC VARICES HAEMORRHAGE
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.90%
4/446 • Number of events 4 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
1.4%
1/73 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/446 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
1.4%
1/73 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/446 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Infections and infestations
PYONEPHROSIS
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
1.4%
1/73 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/446 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.22%
1/446 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
Other adverse events
| Measure |
Paritaprevir/Ritonavir + Ombitasvir With RBV
n=3 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV
n=73 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With R+ RBV
n=446 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/3 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
0.00%
0/73 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
9.9%
44/446 • Number of events 44 • From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
|
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