Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis

AbbVie99 enrolled

Overview

Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV. GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation. Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C Virus (HCV)

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label. * Participants may be enrolled up to 4 weeks after treatment initiation. Exclusion Criteria: * Participating or intending to participate in a concurrent interventional therapeutic trial.

Locations (6)

South Ural State Medical University /ID# 225501

Chelyabinsk, Russia

Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499

Irkutsk, Russia

S. P. Botkin City Hospital /ID# 225500

Oryol, Russia

Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582

Samara, Russia

Stavropol State Medical University /ID# 226589

Stavropol, Russia

Medical center Academy /ID# 226587

Ulyanovsk, Russia

Outcomes

Primary Outcomes

Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12)

SVR12 is defined as Hepatitis C Virus (HCV) RNA \< 50 IU/ml or \< lower limit of quantification/detection (LLoQ/D) available at the site 12 weeks (i.e.,\>=70 days) after the last actual dose.

Time frame: At Week 20

Secondary Outcomes

Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest

SVR12 is defined as HCV RNA \< lower limit of quantification/detection (LLoQ/D) 12 weeks (i.e., \>=70 days) after the last actual dose of GLE/PIB with a sensitive polymerase chain reaction (PCR) available in the clinical site in the settings of the Russian Federation in subgroups of interest.

Time frame: At Week 20

Number Of Participants With Co-morbidities

Participants who have other existing medical conditions.

Time frame: At Week 20

Number Of Participants Taking Concomitant Medication

Participants who take other medications along with Glecaprevir/Pibrentasvir (GLE/PIB).

Time frame: At Week 20

Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose

Percentage of GLE/PIB dose taken by participant report in relation to the prescribed target dose (number of pills taken out of the number that should have been taken).

Time frame: At Week 20

Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. 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.

Time frame: Baseline (Week 0) To 30 days post last dose

Percentage of Participants With Shifts in Clinical Laboratory Values

Percentage of participants with clinically significant change in laboratory parameters of interest (hematology, biochemistry, virology, coagulation, and urinalysis), post-baseline during treatment, will be summarized.

Time frame: Baseline (Week 0) to Week 20

Number Of Health Care Resource Utilization (HCRU) Over Time Overall And By Subpopulations Of Interest

HCRU for a participant will be the total number of visits/touchpoints (face to face or phone call) with a Health Care Professional (HCP) or designee in relation to their Hepatitic C Virus (HCV) infection during the study.

Time frame: At Week 20