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Completed

NCT Number: NCT03868163

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation

This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.

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Key information

Conditions

Chronic Hepatitis C (CHC) Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LLC Medical Company Hepatolog /ID# 212384, Samara, Samara Oblast, Russia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
  • May be enrolled up to 4 weeks after treatment initiation.
  • Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
  • Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

    Time frame: Up to approximately 28 weeks

    SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification/detection (<LLOQ/D) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir (GLE/PIB).with a sensitive polymerase chain reaction [PCR] test with an LLoQ/D of <50 IU/mL or as described in a validated assay.

Secondary outcomes

  1. Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status

    Time frame: Up to approximately 28 weeks

    SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB.with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.

  2. Percentage of Participants Achieving SVR12 by CHC Genotype

    Time frame: Up to approximately 28 weeks

    SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB.with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.

  3. Percentage of Participants Achieving SVR12 by Cirrhosis Status

    Time frame: Up to approximately 28 weeks

    SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay

  4. Percentage of Participants Achieving SVR12 by Previous Treatment Experience

    Time frame: Up to approximately 28 weeks

    SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.

  5. Percentage of Participants Achieving SVR12 by Patients Who Use Drugs

    Time frame: Up to approximately 28 weeks

    SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.

  6. Percentage of Elderly Participants Achieving SVR12

    Time frame: Up to approximately 28 weeks

    SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.

  7. Percentage of Patients with Commodities

    Time frame: Up to approximately 16 weeks

    Percentage of Patients with Commodities from the decision to initiate treatment.

  8. Percentage of Participants Taking Concomitant Medications

    Time frame: Up to approximately 28 weeks

    The percentage of participants taking concomitant medications from the decision to initiate treatment through up to 12 weeks after the last dose of GLE/PBR

  9. Percentage of GLE/PIB Dose Taken

    Time frame: Up to approximately 16 weeks

    Percentage of GLE/PIB dose taken by patient report in relation to the prescribed target dose (that is, the number of pills taken out of the number that should have been taken).

  10. Number of Health Care Resource Utilization (HCRU)

    Time frame: Up to approximately 28 weeks

    Health Care Resource Utilization (HCRU) for a patient will be the total number of visits/touchpoints (face to face or phone call) with a Health Care Provider (HCP) or designee in relation to their HCV infection during the study.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation

Acronym: EVEREST

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Aug 30, 2021

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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