Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT02817594
- Lead Sponsor
- AbbVie
- Brief Summary
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in the Netherlands in a clinical practice patient population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
- If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
- Participants must voluntarily sign and date informed consent prior to inclusion into the study
- Patients participating or intending to participate in a concurrent interventional therapeutic trial.
- Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient.
- Unable to complete the questionnaires due to language incompetence.
- Unable to voluntarily sign and date the informed consent.
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 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 Achieving Virological Response at End of Treatment End of treatment (week 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.
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 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).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. Adherence to study treatment was calculated as:
Cumulative dose taken / (initial prescribed dose \* planned duration)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 Adherence to study treatment was calculated as:
Cumulative dose taken / (initial prescribed dose \* planned duration)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. Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies From first dose of study drug through 30 days after last dose (16 weeks). 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 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.Percentage of Participants With Breakthrough 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 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. 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.
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 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.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 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.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) 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);
* Premature treatment discontinuation with no on-treatment virologic failure;
* Missing SVR12 data and/or none of the above criteria.
Trial Locations
- Locations (9)
Noordwest Ziekenhuisgroep /ID# 152604
🇳🇱Alkmaar, Netherlands
Maasstad Ziekenhuis /ID# 152592
🇳🇱Rotterdam, Netherlands
Universitair Medisch Centrum Groningen /ID# 152596
🇳🇱Groningen, Netherlands
Duplicate_Onze Lieve Vrouwe Gasthuis /ID# 152600
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Utrecht /ID# 152595
🇳🇱Utrecht, Netherlands
Albert Schweitzer Ziekenhuis /ID# 152597
🇳🇱Dordrecht, Zuid-Holland, Netherlands
Radbound University Medical Ce /ID# 152598
🇳🇱Nijmegen, Netherlands
Leids Universitair Medisch Centrum /ID# 154637
🇳🇱Leiden, Netherlands
Erasmus Medisch Centrum /ID# 154635
🇳🇱Rotterdam, Netherlands