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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)

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ClinicalTrials.gov Identifier: NCT04366973
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : December 13, 2021
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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