Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366973
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease
Hepatitis C Virus (HCV)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. Number of participants with HCV Antibodies (HCV Ab) [ Time Frame: Inclusion visit (Week 0) ]
    Number of participants with HCV Antibodies (HCV Ab).

  6. Number of participants with HCV RNA [ Time Frame: Inclusion visit (Week 0) ]
    Number of participants with HCV RNA.

  7. Time from HCV Ab to HCV RNA [ Time Frame: Inclusion visit (Week 0) ]
    Time from HCV Ab to HCV RNA.

  8. Time from HCV RNA to end of treatment [ Time Frame: Approximately 12 months ]
    Time from HCV RNA to end of treatment.

  9. Number of participants who completed treatment [ Time Frame: Approximately 12 months ]
    Number of participants who completed treatment.

  10. 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.

  11. 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.

  12. 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).

  13. Time to SVR12 [ Time Frame: Approximately 12 months ]
    Time to SVR12

  14. 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.

  15. 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.

  16. Patient Reported Quality of Life [ Time Frame: Approximately 12 months ]
    Anxiety and depression questionnaires and global assessment using visual analog scale.

  17. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants treated with glecaprevir/pibrentasvir for confirmed positive Hepatitis C Virus.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-None.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366973


Contacts
Layout table for location contacts
Contact: Yohann Gorrichon +33 660529004 yohann.gorrichon@abbvie.com

Locations
Show Show 38 study locations
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: ABBVIE INC. AbbVie
Additional Information:
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04366973    
Other Study ID Numbers: P20-127
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Keywords provided by AbbVie:
Hepatitis C Virus
HCV
glecaprevir/pibrentasvir
Maviret
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections