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

Chronic Hepatitis C (CHC) Clinical Trial

— EVEREST  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868163
• Other study ID #: P19-454
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: September 4, 2020

Study information

• Verified date: August 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C (CHC)
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (	Up to approximately 28 weeks
Secondary	Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status	SVR12 defined as the HCV RNA level	Up to approximately 28 weeks
Secondary	Percentage of Participants Achieving SVR12 by CHC Genotype	SVR12 defined as the HCV RNA level	Up to approximately 28 weeks
Secondary	Percentage of Participants Achieving SVR12 by Cirrhosis Status	SVR12 defined as the HCV RNA level	Up to approximately 28 weeks
Secondary	Percentage of Participants Achieving SVR12 by Previous Treatment Experience	SVR12 defined as the HCV RNA level	Up to approximately 28 weeks
Secondary	Percentage of Participants Achieving SVR12 by Patients Who Use Drugs	SVR12 defined as the HCV RNA level	Up to approximately 28 weeks
Secondary	Percentage of Elderly Participants Achieving SVR12	SVR12 defined as the HCV RNA level	Up to approximately 28 weeks
Secondary	Percentage of Patients with Commodities	Percentage of Patients with Commodities from the decision to initiate treatment.	Up to approximately 16 weeks
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis