A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers (NeoVie)

• ClinicalTrials.gov Identifier: NCT04366973
• Recruitment Status: Recruiting
• First Posted: April 29, 2020
• Last Update Posted: December 13, 2021
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: April 28, 2020
• First Posted Date: April 29, 2020
• Last Update Posted Date: December 13, 2021
• Actual Study Start Date: May 26, 2020
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2020)

Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit. [ Time Frame: Inclusion visit (Week 0) ]

Percentage of participants with and without HCV treatment prescribed at end of the inclusion visit. Criteria for treatment choice and reasons for treatment refusal will be described.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 28, 2020)

• Health Care Resources and Utilization [ Time Frame: Inclusion visit (Week 0) ]
  HCRU in the addiction centers will be described on the basis of declarative questionnaires completed at time of the study implementation (yearly number of people followed, health resources, staffing, formation of center team, capabilities regarding HCV screening, specialized consultations in hepatology, and liver fibrosis tests).
• Level of HCV infection knowledge [ Time Frame: Inclusion visit (Week 0) ]
  The level of knowledge of both patients and providers on HCV infection will be described on the basis of declarative questionnaires. For patients, analysis will be performed in the TP population and according to patient subgroups (with and without HCV treatment).
• Determinants associated with initiation of HCV treatment [ Time Frame: Inclusion visit (Week 0) ]
  Criteria for treatment choice or no treatment uptake assessed by physician, patient, and disease characteristics.
• Data and disease characteristics from patients with and without HCV treatment [ Time Frame: Inclusion visit (Week 0) ]
  Data and disease characteristics from patients with and without HCV treatment.
• Number of participants with HCV Antibodies (HCV Ab) [ Time Frame: Inclusion visit (Week 0) ]
  Number of participants with HCV Antibodies (HCV Ab).
• Number of participants with HCV RNA [ Time Frame: Inclusion visit (Week 0) ]
  Number of participants with HCV RNA.
• Time from HCV Ab to HCV RNA [ Time Frame: Inclusion visit (Week 0) ]
  Time from HCV Ab to HCV RNA.
• Time from HCV RNA to end of treatment [ Time Frame: Approximately 12 months ]
  Time from HCV RNA to end of treatment.
• Number of participants who completed treatment [ Time Frame: Approximately 12 months ]
  Number of participants who completed treatment.
• Percentage of participants achieving SVR12 [ Time Frame: Approximately 12 months ]
  SVR12 defined as HCV RNA under the lower limit of quantification (LLOQ) 12 weeks after the last dose of treatment with a sensitive polymerase chain reaction (PCR) test.
• Percentage of cured participants willing to share their experience with other substance abuse patients. [ Time Frame: Approximately 12 months ]
  Percentage of cured participants willing to share their experience with other substance abuse patients at the SVR12 visit and up to 6 months after the SVR12 visit.
• Number of participants achieving sustained viral response at 12 weeks (SVR12) [ Time Frame: Approximately 12 months ]
  Number of participants achieving sustained viral response at 12 weeks (SVR12).
• Time to SVR12 [ Time Frame: Approximately 12 months ]
  Time to SVR12
• Number of people in charge of patient follow-up [ Time Frame: Approximately 12 months ]
  Number of people in charge of patient follow-up including physicians, nurses, social workers.
• Percentage of participants with treatment adherence [ Time Frame: Approximately 12 months ]
  Defined as the percentage of participants who have taken the target dose according to participant reporting.
• Patient Reported Quality of Life [ Time Frame: Approximately 12 months ]
  Anxiety and depression questionnaires and global assessment using visual analog scale.
• Number of participants with addictive behaviors [ Time Frame: Approximately 12 months ]
  Addictive behaviors of participants (alcohol and drug consumption) will be assessed by participant-completed questionnaires.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers
• Official Title: New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France

Brief Summary

Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest.

Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France.

All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months.

All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adult participants treated with glecaprevir/pibrentasvir for confirmed positive Hepatitis C Virus.
• Condition: Hepatitis C Virus (HCV)
• Intervention: Not Provided

Study Groups/Cohorts

Participants with Hepatitis C Virus With or Without Treatment

This study includes 3 populations for analysis:

Target Population (TP): Defined as all participants enrolled in the study regardless of whether treated for HCV or not.

Core Population (CP): Defined as all participants of the TP who have been prescribed glecaprevir/pibrentasvir (G/P) and started treatment.

Safety Population (SP): Defined as all participants who received at least one dose of G/P.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 28, 2020): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Followed in an addiction center.
• Confirmed positive for HCV ribonucleic acid (RNA).

Exclusion Criteria:

-None.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Yohann Gorrichon; +33 660529004; yohann.gorrichon@abbvie.com

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04366973
• Other Study ID Numbers: P20-127
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: AbbVie
• Study Sponsor: AbbVie
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: December 2021