The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT02618928
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 735
- 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
- Participant is not participating or intending to participate in a concurrent interventional therapeutic trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen) 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. Participants with missing HCV RNA were counted as virological failure.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) Week 4 RVR 4 was defined as participants with HCV RNA \< 50 IU/mL at 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) Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.
The Core population with sufficient follow-up data regarding SVR24 included all core population participants who
* had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN
* 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 ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.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) 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 virologic failure;
* Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria
* Missing SVR12 data and/or none of the above criteria.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. Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:
Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.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. Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:
Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100Percentage 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) 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 the ABBVIE REGIMEN
* 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 the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.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 The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients.
The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impactPercentage of Participants Achieving Virological Response at End of Treatment End of treatment (week 8, 12, or 24 depending on the treatment regimen) Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
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. 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.
Percentage of Participants With Breakthrough 8, 12, or 24 weeks (depending on the treatment regimen) Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
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 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.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 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.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) 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.
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 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.
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 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.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 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).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 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.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 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.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) 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.
Trial Locations
- Locations (70)
Hopital Pitie Salpetriere /ID# 145566
🇫🇷Paris, France
CHR Orleans - Hopital de la Source /ID# 147250
🇫🇷Orleans CEDEX 2, Centre-Val De Loire, France
Hopital Universitaire Purpan /ID# 150141
🇫🇷Toulouse, Haute-Garonne, France
Clinique Amroise Pare /ID# 144924
🇫🇷Toulouse, France
Hopital Saint Joseph /ID# 144927
🇫🇷Marseille CEDEX 08, Bouches-du-Rhone, France
Hopital Saint Joseph /ID# 145560
🇫🇷Marseille CEDEX 08, Bouches-du-Rhone, France
Hopital Saint Joseph /ID# 145571
🇫🇷Marseille CEDEX 08, Bouches-du-Rhone, France
CHU Dupuytren /ID# 144920
🇫🇷Limoges CEDEX 1, Franche-Comte, France
Hopital Universitaire Purpan /ID# 145869
🇫🇷Toulouse, Haute-Garonne, France
Hopital Saint Eloi /ID# 144919
🇫🇷Montpellier CEDEX 5, Herault, France
CHU de Besancon - Jean Minjoz /ID# 145884
🇫🇷Besancon, Doubs, France
Hopital de la Timone /ID# 145574
🇫🇷Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France
C.H. du Pays d'Aix /ID# 144922
🇫🇷Aix En Provence, France
Hopital Beaujon /ID# 147923
🇫🇷Clichy, Ile-de-France, France
Hopital de la Timone /ID# 145558
🇫🇷Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France
Centre Hospitalier D'Avignon /ID# 151098
🇫🇷Avignon, France
CHU Amiens Picardie /ID# 145871
🇫🇷Amiens CEDEX 1, Somme, France
Cabinet medical /ID# 147359
🇫🇷Aix En Provence, France
CHU d'Angers /ID# 145880
🇫🇷Angers, France
Centre Hospitalier Victor Dupo /ID# 147241
🇫🇷Argenteuil, France
Centre Endo Nord Isere /ID# 148694
🇫🇷Bourgoin Jallieu, France
Cabinet Medical /ID# 147322
🇫🇷Besancon, France
Centre Hospitalier D'Avignon /ID# 151343
🇫🇷Avignon, France
Hopital Antoine Beclere /ID# 149252
🇫🇷Clamart, France
Clinique du Palais /ID# 145563
🇫🇷Grasse, France
CH de Chambery /ID# 145573
🇫🇷Chambery, France
Hopital Antoine Beclere /ID# 149251
🇫🇷Clamart, France
Centre Hospitalier Universitai /ID# 147568
🇫🇷Caen, France
Centre Hosp Intercommunal /ID# 145876
🇫🇷Creteil, France
Hospital Henri Mondor /ID# 144918
🇫🇷Creteil, France
CHU de Grenoble - Albet Michal /ID# 145881
🇫🇷Grenoble, France
CH d'Hyeres /ID# 145870
🇫🇷Hyeres, France
Ch Du Mans /Id# 147415
🇫🇷Le Mans, France
Centre Hospitalier de Libourne /ID# 145564
🇫🇷Libourne, France
Dr. Cuissard, Le Port, FR /ID# 145565
🇫🇷Le Port, France
Cabinet Medical, Boyer Darrigr /ID# 145562
🇫🇷Nanterre, France
Hopital de la Croix Rousse /ID# 149776
🇫🇷Lyon, France
CH Des Deux Vallees Longumeau /ID# 149336
🇫🇷Longjumeau, France
Ctr Consultations La Sauvegard /ID# 147236
🇫🇷Lyon, France
Ctre Hosp de Montelimar /ID# 147239
🇫🇷Montelimar, France
Hopital de la Timone /ID# 147237
🇫🇷Marseille, France
CHU de Nice /ID# 144921
🇫🇷Nice, France
Hopital Saint Antoine /ID# 148635
🇫🇷Paris, France
Cabinet Medical, Dr. Verdier, /ID# 145575
🇫🇷Nimes, France
Hopital Saint Antoine /ID# 145567
🇫🇷Paris, France
Hopital Saint Antoine /ID# 148693
🇫🇷Paris, France
Hopital Saint Antoine /ID# 152825
🇫🇷Paris, France
Cabinet Medical, Giuily /ID# 145882
🇫🇷Paris, France
Cabinet Medical /ID# 145559
🇫🇷Paris, France
Hopital Pitie Salpetriere /ID# 145556
🇫🇷Paris, France
Hopital Bichat-Claude Bernard /ID# 149246
🇫🇷Paris, France
Hopital Pitie Salpetriere /ID# 149337
🇫🇷Paris, France
Hopital Bichat Claude Bernard /ID# 145886
🇫🇷Paris, France
Hopital Tenon /ID# 145885
🇫🇷Paris, France
CHU de Reims /ID# 148477
🇫🇷Reims, France
CH Marechal Joffre /ID# 145875
🇫🇷Perpignan, France
Charles Nicolle Hosp chu rouen /ID# 145557
🇫🇷Rouen, France
CHU Jean Bernard /ID# 147414
🇫🇷Poitiers, France
Hospital Pontchaillou /ID# 145883
🇫🇷Rennes, France
Institut Arnault Tzanck /ID# 144925
🇫🇷Saint Laurent Du Var, France
CHU Strasbourg Hautepierre Hos /ID# 147246
🇫🇷Strasbourg, France
Hopital Joseph Ducuing /ID# 152832
🇫🇷Toulouse, France
Hopital Begin /ID# 145872
🇫🇷Saint Mande, France
Hopital Foch /ID# 147248
🇫🇷Suresnes, France
Cabinet Medical, Dr. Constant, /ID# 145561
🇫🇷Toulon, France
Hopital Paul Brousse /ID# 145879
🇫🇷Villejuif, France
Ctre Hospitalier de Tourcoing /ID# 145568
🇫🇷Tourcoing, France
Hopital Paul Brousse /ID# 147244
🇫🇷Villejuif, France
Cabinet Medical, Barbereau /ID# 145874
🇫🇷Tours, France
Hopital Paul Brousse /ID# 147417
🇫🇷Villejuif, France