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

AbbVie99 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C Virus (HCV)

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (8)

Dagestan State Medical University /ID# 218500

Makhachkala, Dagestan, Respublika, Russia

A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498

Kazan', Tatarstan, Respublika, Russia

South-Ural Medical State University /ID# 218501

Chelyabinsk, Russia

Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252

Irkutsk, Russia

Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590

Moscow, Russia

Infectious Clinical Hosp #1 /ID# 218497

Moscow, Russia

Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499

Samara, Russia

Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253

Yekaterinburg, Russia

Outcomes

Primary Outcomes

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.

Time frame: At Week 12

Secondary Outcomes

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.

Time frame: At Week 12

Number of Participants With Co-morbidities

Number and percentage of participants with co-morbidities will be analyzed.

Time frame: At Baseline Visit (Week 0)

Number of Participants Taking Concomitant Medications

Number and percentage of participants taking concomitant medications will be analyzed.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Up to approximately 28 weeks