Clinical trial NCT02618928: The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: HCV
Chronic Hepatitis C
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 735
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites.

Brief summary: This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.


Eligibility criteria: Inclusion Criteria:

* Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4
* Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label
* RBV prescribed in line with the current local label

Exclusion Criteria:

* Participant is not participating or intending to participate in a concurrent interventional therapeutic trial

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
Secondary outcomes:
measure: Percentage of Participants Achieving Virological Response at End of Treatment
timeFrame: End of treatment (week 8, 12, or 24 depending on the treatment regimen)
measure: Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment
timeFrame: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
measure: Percentage of Participants With Relapse
timeFrame: End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
measure: Percentage of Participants With Breakthrough
timeFrame: 8, 12, or 24 weeks (depending on the treatment regimen)
measure: Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
timeFrame: Week 4
measure: Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)
timeFrame: 24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)
measure: Number of Participants in Each Non-response Category 12 Weeks Post-treatment
timeFrame: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
measure: Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
timeFrame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.
measure: Percentage of Participants With Adherence to Ribavirin by Adherence Category
timeFrame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.
measure: Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
timeFrame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.
measure: Number of Participants Who Received Concomitant Medications
timeFrame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen
measure: Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
timeFrame: 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.
measure: Change From Baseline in Fatigue Impact Scale Total Score
timeFrame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
timeFrame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
timeFrame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
timeFrame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
timeFrame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
timeFrame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
timeFrame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
timeFrame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
measure: Change From Baseline in Patient Activation Measure 13 (PAM-13)
timeFrame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
measure: Number of Participants With Outpatient Consultations Due to Liver Disease by Category
timeFrame: 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.
measure: Number of Participants With Hospitalizations Due to Liver Disease by Category
timeFrame: 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.
measure: Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
Other outcomes:
Locations:
city: Marseille CEDEX 08
country: France
facility: Hopital Saint Joseph /ID# 144927
state: Bouches-du-Rhone
city: Marseille CEDEX 08
country: France
facility: Hopital Saint Joseph /ID# 145560
state: Bouches-du-Rhone
city: Marseille CEDEX 08
country: France
facility: Hopital Saint Joseph /ID# 145571
state: Bouches-du-Rhone
city: Orleans CEDEX 2
country: France
facility: CHR Orleans - Hopital de la Source /ID# 147250
state: Centre-Val De Loire
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 145884
state: Doubs
city: Limoges CEDEX 1
country: France
facility: CHU Dupuytren /ID# 144920
state: Franche-Comte
city: Toulouse
country: France
facility: Hopital Universitaire Purpan /ID# 145869
state: Haute-Garonne
city: Toulouse
country: France
facility: Hopital Universitaire Purpan /ID# 150141
state: Haute-Garonne
city: Montpellier CEDEX 5
country: France
facility: Hopital Saint Eloi /ID# 144919
state: Herault
city: Clichy
country: France
facility: Hopital Beaujon /ID# 147923
state: Ile-de-France
city: Marseille CEDEX 05
country: France
facility: Hopital de la Timone /ID# 145558
state: Provence-Alpes-Cote-d Azur
city: Marseille CEDEX 05
country: France
facility: Hopital de la Timone /ID# 145574
state: Provence-Alpes-Cote-d Azur
city: Amiens CEDEX 1
country: France
facility: CHU Amiens Picardie /ID# 145871
state: Somme
city: Aix En Provence
country: France
facility: C.H. du Pays d'Aix /ID# 144922
city: Aix En Provence
country: France
facility: Cabinet medical /ID# 147359
city: Angers
country: France
facility: CHU d'Angers /ID# 145880
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupo /ID# 147241
city: Avignon
country: France
facility: Centre Hospitalier D'Avignon /ID# 151098
city: Avignon
country: France
facility: Centre Hospitalier D'Avignon /ID# 151343
city: Besancon
country: France
facility: Cabinet Medical /ID# 147322
city: Bourgoin Jallieu
country: France
facility: Centre Endo Nord Isere /ID# 148694
city: Caen
country: France
facility: Centre Hospitalier Universitai /ID# 147568
city: Chambery
country: France
facility: CH de Chambery /ID# 145573
city: Clamart
country: France
facility: Hopital Antoine Beclere /ID# 149251
city: Clamart
country: France
facility: Hopital Antoine Beclere /ID# 149252
city: Creteil
country: France
facility: Centre Hosp Intercommunal /ID# 145876
city: Creteil
country: France
facility: Hospital Henri Mondor /ID# 144918
city: Grasse
country: France
facility: Clinique du Palais /ID# 145563
city: Grenoble
country: France
facility: CHU de Grenoble - Albet Michal /ID# 145881
city: Hyeres
country: France
facility: CH d'Hyeres /ID# 145870
city: Le Mans
country: France
facility: Ch Du Mans /Id# 147415
city: Le Port
country: France
facility: Dr. Cuissard, Le Port, FR /ID# 145565
city: Libourne
country: France
facility: Centre Hospitalier de Libourne /ID# 145564
city: Longjumeau
country: France
facility: CH Des Deux Vallees Longumeau /ID# 149336
city: Lyon
country: France
facility: Hopital de la Croix Rousse /ID# 149776
city: Lyon
country: France
facility: Ctr Consultations La Sauvegard /ID# 147236
city: Marseille
country: France
facility: Hopital de la Timone /ID# 147237
city: Montelimar
country: France
facility: Ctre Hosp de Montelimar /ID# 147239
city: Nanterre
country: France
facility: Cabinet Medical, Boyer Darrigr /ID# 145562
city: Nice
country: France
facility: CHU de Nice /ID# 144921
city: Nimes
country: France
facility: Cabinet Medical, Dr. Verdier, /ID# 145575
city: Paris
country: France
facility: Hopital Saint Antoine /ID# 145567
city: Paris
country: France
facility: Hopital Saint Antoine /ID# 148635
city: Paris
country: France
facility: Hopital Saint Antoine /ID# 148693
city: Paris
country: France
facility: Hopital Saint Antoine /ID# 152825
city: Paris
country: France
facility: Cabinet Medical, Giuily /ID# 145882
city: Paris
country: France
facility: Hopital Bichat-Claude Bernard /ID# 149246
city: Paris
country: France
facility: Cabinet Medical /ID# 145559
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 145556
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 145566
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 149337
city: Paris
country: France
facility: Hopital Bichat Claude Bernard /ID# 145886
city: Paris
country: France
facility: Hopital Tenon /ID# 145885
city: Perpignan
country: France
facility: CH Marechal Joffre /ID# 145875
city: Poitiers
country: France
facility: CHU Jean Bernard /ID# 147414
city: Reims
country: France
facility: CHU de Reims /ID# 148477
city: Rennes
country: France
facility: Hospital Pontchaillou /ID# 145883
city: Rouen
country: France
facility: Charles Nicolle Hosp chu rouen /ID# 145557
city: Saint Laurent Du Var
country: France
facility: Institut Arnault Tzanck /ID# 144925
city: Saint Mande
country: France
facility: Hopital Begin /ID# 145872
city: Strasbourg
country: France
facility: CHU Strasbourg Hautepierre Hos /ID# 147246
city: Suresnes
country: France
facility: Hopital Foch /ID# 147248
city: Toulon
country: France
facility: Cabinet Medical, Dr. Constant, /ID# 145561
city: Toulouse
country: France
facility: Clinique Amroise Pare /ID# 144924
city: Toulouse
country: France
facility: Hopital Joseph Ducuing /ID# 152832
city: Tourcoing
country: France
facility: Ctre Hospitalier de Tourcoing /ID# 145568
city: Tours
country: France
facility: Cabinet Medical, Barbereau /ID# 145874
city: Villejuif
country: France
facility: Hopital Paul Brousse /ID# 145879
city: Villejuif
country: France
facility: Hopital Paul Brousse /ID# 147244
city: Villejuif
country: France
facility: Hopital Paul Brousse /ID# 147417
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.