Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania
Source: ClinicalTrials.gov NCT02807402 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
98.1 | — |
| SECONDARY Percentage of Participants Achieving Virological Response at End of Treatment |
99.6 | — |
| SECONDARY 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 | — |
| SECONDARY Percentage of Participants With Relapse |
0.8 | — |
| SECONDARY Percentage of Participants With Breakthrough |
0.00 | — |
| SECONDARY Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment |
0.2; 0.8; 0.6; 0.2; 0.2 | — |
| SECONDARY Assigned Treatment Regimen |
73; 438; 8 | — |
| SECONDARY Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA |
6; 483; 28; 1; 1 | — |
| SECONDARY Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin |
6; 349; 39; 22; 29 | — |
| SECONDARY Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days |
94.5 | — |
| SECONDARY Number of Participants With Comorbidities |
335; 9; 4; 6 | — |
| SECONDARY Number of Participants Who Received Concomitant Medications |
263 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score |
0.07; 0.04; 0.09; 0.08; 0.09; 0.10 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score |
10.9; 8.36; 13.9; 12.7; 18.8; 15.2 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism |
-1.3; -1.4; -15.4; -3.8; -7.5; -8.7 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism |
-23.3; -8.5; -16.7; -10.4; -70.0; -9.3 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) |
-18.5; -8.7; -17.0; -11.5; -72.3; -20.7 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment |
-2.9; -10.4; -9.5; -10.5; -8.9; -11.5 | — |
| SECONDARY Change From Baseline in Patient Activation Measure 13 (PAM-13) |
-3.94; -4.00 | — |
| SECONDARY Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) |
-0.26; 0.06; -0.07; -0.21; 0.01; 0.01 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies |
0; 6; 82; 0; 3; 17 | — |
Eligibility Criteria
Inclusion Criteria
Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± RBV according to standard of care and in line with the current local label
If RBV is co-administered with the paritaprevir/ritonavir and ombitasvir with dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT02807402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.