A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation (DETI-2)

Real World EviDEnce of the EffecTIveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents 12 to <18 Years of Age With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation (DETI-2)

The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus (HCV)

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • South-Ural Medical State University /ID# 218501
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253
  • Irkutsk, Russian Federation, 664035
    • Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252
  • Moscow, Russian Federation, 115093
    • Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590
  • Moscow, Russian Federation, 125310
    • Infectious Clinical Hosp #1 /ID# 218497
  • Samara, Russian Federation, 443029
    • Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499
  • Dagestan, Respublika
    • Makhachkala, Dagestan, Respublika, Russian Federation, 367000
      • Dagestan State Medical University /ID# 218500
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420140
      • A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescent participants 12 to <18 years of age with chronic hepatitis C (CHC) being treated with glecaprevir/pibrentasvir (GLE/PIB) in clinical practice in Russian Federation.

Description

Inclusion Criteria:

• Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis
• Treatment naive or treatment experienced participants
• Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label
• Participant and his/her legal representative voluntarily signs and dates an informed consent form
• Must not be participating or intending to participant 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
Participants Treated with GLE/PIB; Participants treated with all oral glecaprevir/pibrentasvir (GLE/PIB) and the decision to treat with GLE/PIB is made before the decision to offer an opportunity to join this study. Prescription of the treatment regimen is at the discretion of the physician and in accordance with local clinical practice and label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)	Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the site 12 weeks after the last actual dose of GLE/PIB.	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site	Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the stie 12 weeks after the last actual dose of GLE/PIB.	At Week 12
Number of Participants With Co-morbidities	Number and percentage of participants with co-morbidities will be analyzed.	At Baseline Visit (Week 0)
Number of Participants Taking Concomitant Medications	Number and percentage of participants taking concomitant medications will be analyzed.	Up to approximately 28 weeks
Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose	Percentage of GLE/PIB pills taken out of the number that was prescribed.	Up to approximately 16 weeks
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.	Up to approximately 28 weeks
Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU)	Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call ) with a health care provider or designee in relation to their HCV infection during the study as recorded on an electronic case report form (eCRF).	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 17, 2020
• Primary Completion (Actual): June 24, 2021
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Hepatitis C Virus (HCV); Chronic Hepatitis C (C); Maviret
• 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: P20-105

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