Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

Real World Evidence (RWE) of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Poland (HCV RWE PMOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640547
• Other study ID #: P15-767
• Secondary ID: PLHCVRWE01
• Status: Completed
• Start date: November 26, 2015
• Est. completion date: March 29, 2017

Study information

• Verified date: March 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• 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 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).

• Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study.

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

Exclusion Criteria:

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.	12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Secondary	Percentage of Participants Achieving Virological Response at End of Treatment	Virologic response is 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	Percentage 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 With a Rapid Virological Response at Week 4	Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA < 50 IU/mL at week 4.; Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures.	Week 4
Secondary	Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24)	Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.	24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
Secondary	Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved 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.; 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.	12 weeks after the last dose of study drug (week 24 or 36 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: 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 virological failure; Missing SVR12 data and/or none of the above criteria.	12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Secondary	Assigned Treatment Regimen	Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.	Baseline
Secondary	Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA	Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration)	From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Secondary	Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV	Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration)	From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Secondary	Number of Participants With Comorbidities		Baseline
Secondary	Number of Participants Who Received Concomitant Medications	Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN 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. The median duration of treatment was 84 days.
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, and at 12 and 24 weeks after end of treatment
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. 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).	Baseline, end of treatment, 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, and at 12 and 24 weeks post 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, 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, 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, and at 12 and 24 weeks after end of treatment

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