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

Completed

• Conditions: Chronic Hepatitis C (CHC)

• Registration Number: NCT03868163
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-28
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-08
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

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Exclusion Criteria

• None.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	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 Outcome Measures

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

Trial Locations

Locations (9)

LLC Medical Company Hepatolog /ID# 212384; 🇷🇺 Samara, Samarskaya Oblast, Russian Federation

A. F. Agafonov Republican Clin /ID# 212381; 🇷🇺 Kazan, Tatarstan, Respublika, Russian Federation

Clinical Inf. Dis Hospital 1 /ID# 217033; 🇷🇺 Novosibirsk, Russian Federation

Perm Regional Center of Cepato /ID# 213992; 🇷🇺 Perm, Russian Federation

Saint-Petersburg AIDS Center /ID# 212380; 🇷🇺 St. Petersburg, Russian Federation

South Ural State Medical univ /ID# 212020; 🇷🇺 Chelyabinsk, Russian Federation

SIH Orlovskiy region city hospital named after S.P. Botkin /ID# 212383; 🇷🇺 Oryol, Russian Federation

Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035; 🇷🇺 Stavropol, Stavropol Skiy Kray, Russian Federation

Samara State Medical Universit /ID# 217029; 🇷🇺 Samara, Russian Federation