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

AbbVie161 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

161

Conditions

Chronic Hepatitis C (CHC)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

LLC Medical Company Hepatolog /ID# 212384

Samara, Samara Oblast, Russia

Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035

Stavropol, Stavropol Kray, Russia

A. F. Agafonov Republican Clin /ID# 212381

Kazan', Tatarstan, Respublika, Russia

Outcomes

Primary Outcomes

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.