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

简要总结

主要结局

次要结局

• Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)(Week 4)
• Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)(24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen))
• Number of Participants in Each Non-response Category 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen))
• Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category(From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.)
• Percentage of Participants With Adherence to Ribavirin by Adherence Category(From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.)
• Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen))
• Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies(From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.)
• Change From Baseline in Fatigue Impact Scale Total Score(Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Percentage of Participants Achieving Virological Response at End of Treatment(End of treatment (week 8, 12, or 24 depending on the treatment regimen))
• Percentage of Participants With Relapse(End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.)
• Percentage of Participants With Breakthrough(8, 12, or 24 weeks (depending on the treatment regimen))
• Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days(From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.)
• Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism(Baseline, end of treatment (week 8, 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): Presenteeism(Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)(Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen))
• Number of Participants Who Received Concomitant Medications(From first dose of study drug to end of treatment, 8 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 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score(Baseline, end of treatment (week 8, 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 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Number of Participants With Hospitalizations Due to Liver Disease by Category(From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.)
• Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment(Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
• Number of Participants With Outpatient Consultations Due to Liver Disease by Category(From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.)
• Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)(Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen))
• Change From Baseline in Patient Activation Measure 13 (PAM-13)(Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen))