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

Chronic Hepatitis C Clinical Trial

— VERITAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636608
• Other study ID #: P15-709
• Secondary ID: HU15-01
• Status: Completed
• Start date: November 27, 2015
• Est. completion date: May 23, 2018

Study information

• Verified date: January 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: May 23, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.

• If RBV is co-administered with the PTV/r+OBV±DSV±RBV, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).

• Patients must voluntarily sign and date Subject Information Form and Informed Consent Form prior to inclusion into the study.

• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.

• Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	IST GmbH, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	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.	12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Secondary	Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)	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.	24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
Secondary	Percentage of Participants Achieving Virological Response at End of Treatment	Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.	End of treatment (week 12 or 24 depending on the treatment regimen)
Secondary	Percentage of Participants With Relapse	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.	End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
Secondary	Number of Participants With Breakthrough	Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA = 50 IU/mL during treatment.	12 or 24 weeks (depending on the treatment regimen)
Secondary	Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment	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; None of the above criteria or missing SVR12 data	12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Secondary	Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category	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.	From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
Secondary	Percentage of Participants With Adherence to Ribavirin by Adherence Category	Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100	From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Secondary	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, 12 to 24 weeks depending on the treatment regimen.
Secondary	Number of Participants Who Received Concomitant Medications	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.	From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Secondary	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)
Secondary	Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score	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).; The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status.	Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Secondary	Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score	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.	Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism	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.	Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism	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.	Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)	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.	Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment	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.	Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Secondary	Change From Baseline in Patient Activation Measure 13 (PAM-13)	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 that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health.	Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)
Secondary	Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)		Up to post treatment week 24
Secondary	Utilization of the AbbVie Patient Support Program (PSP) Components	At the end of treatment visit participants were asked to indicate which of the following PSP services they had used: Personal support (e.g., Care Coach); Printed educational material; Online educational materials; Web-portal; App	End of treatment (week 12 or 24 depending on the treatment regimen)
Secondary	Satisfaction With the AbbVie Patient Support Program (PSP) Components	At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used.	End of treatment (weeks 12 or 24 depending on treatment regimen)

External Links

•   Link