Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Romania

简要总结

主要结局

次要结局

• Percentage of Participants Achieving Virological Response at End of Treatment(End of treatment (week 12 or 24 depending on the treatment regimen))
• Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen))
• Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen))
• Number of Participants Who Received Concomitant Medications(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
• Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Percentage of Participants With Relapse(End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.)
• Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.)
• Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
• Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Percentage of Participants With Breakthrough(12 or 24 weeks (depending on the treatment regimen))
• Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.)
• Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Assigned Treatment Regimen(Baseline)
• Number of Participants With Comorbidities(Baseline)
• Change From Baseline in Patient Activation Measure 13 (PAM-13)(Baseline and end of treatment (week 12 or 24 depending on the treatment regimen))
• Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies(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.)
• Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)(Baseline and end of treatment (week 12 or 24 depending on the treatment regimen))