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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C (CHC)

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454052
    • South Ural State Medical univ /ID# 212020
  • Novosibirsk, Russian Federation, 630099
    • Clinical Inf. Dis Hospital 1 /ID# 217033
  • Oryol, Russian Federation, 302038
    • SIH Orlovskiy region city hospital named after S.P. Botkin /ID# 212383
  • Perm, Russian Federation, 614000
    • Perm Regional Center of Cepato /ID# 213992
  • Samara, Russian Federation, 443099
    • Samara State Medical Universit /ID# 217029
  • St. Petersburg, Russian Federation, 190103
    • Saint-Petersburg AIDS Center /ID# 212380
  • Samarskaya Oblast
    • Samara, Samarskaya Oblast, Russian Federation, 443063
      • LLC Medical Company Hepatolog /ID# 212384
  • Stavropol Skiy Kray
    • Stavropol, Stavropol Skiy Kray, Russian Federation, 355035
      • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420140
      • A. F. Agafonov Republican Clin /ID# 212381

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with CHC in a real world clinical practice setting.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Glecaprevir plus Pibrentasvir; Participants in this observational study will receive treatment with glecaprevir and pibrentasvir for up to 16 weeks for treatment of chronic hepatis C (CHC) genotypes 1, 2, 3, 4, 5, or 6. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice, international guidelines and/or label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	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.	Up to approximately 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status	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.	Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by CHC Genotype	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.	Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Cirrhosis Status	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	Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Previous Treatment Experience	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.	Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Patients Who Use Drugs	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.	Up to approximately 28 weeks
Percentage of Elderly Participants Achieving SVR12	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.	Up to approximately 28 weeks
Percentage of Patients with Commodities	Percentage of Patients with Commodities from the decision to initiate treatment.	Up to approximately 16 weeks
Percentage of Participants Taking Concomitant Medications	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	Up to approximately 28 weeks
Percentage of GLE/PIB Dose Taken	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).	Up to approximately 16 weeks
Number of Health Care Resource Utilization (HCRU)	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.	Up to approximately 28 weeks

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): September 4, 2020
• Study Completion (Actual): September 4, 2020

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: glecaprevir; pibrentasvir; Observational Study; Chronic Hepatitis C; Hepatitis C; Hepatitis; real world setting
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic
• Other Study ID Numbers: P19-454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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