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Completed

NCT Number: NCT04366973

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

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.

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Key information

Conditions

Hepatitis C Virus (HCV) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682, Nice, Alpes-Maritimes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-None.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France

Acronym: NeoVie

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2020
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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