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), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response. GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation. Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study. 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
42
South Ural State Medical University /ID# 226555
Chelyabinsk, Russia
LLC Center of Targeted Therapy /ID# 239529
Domodedovo, Russia
Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509
Irkutsk, Russia
Specialized Clinical Infectious Diseases Hospital /ID# 229814
Krasnodar, Russia
Infectious Clinical Hosp #1 /ID# 225063
Moscow, Russia
Infectious Clinical Hospita l#2 /ID# 243217
Nizhny Novgorod, Russia
S. P. Botkin City Hospital /ID# 229510
Oryol, Russia
Saint-Petersburg AIDS Center /ID# 239357
Saint Petersburg, Russia
Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 226591
Samara, Russia
Stavropol State Medical University /ID# 243216
Stavropol, Russia
Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< 50 IU/ml or lower limit of quantification/detection (LLoQ/D) available at the site at Week 12 after the last actual dose.
Time frame: Week 12 after the end of treatment
Percentage of Participants Achieving SVR12
SVR12 is defined as HCV RNA \< LLoQ/D 12 weeks 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: Week 12 after the end of treatment
Number of Participants With Co-morbidities and Taking Concomitant Medication
Number of participants with co-morbidities and taking concomitant medication of interest report will be calculated.
Time frame: Up to Week 12 after the end of treatment
Health Care Resource Utilization (HCRU)
HCRU will be 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 as recorded overall and by subpopulations of interest.
Time frame: Up to Week 12 after the end of treatment
Percent of Glecaprevir/Pibrentasvir 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 will be calculated.
Time frame: Up to Week 12 after the end of treatment
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient 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 overall and in subgroups of interest. 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: Up to Week 12 after the end of treatment
Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values
Percentage of participants who experience post-baseline shifts during treatment in clinical laboratory values will be summarized overall and in subgroups of interest.
Time frame: Up to Week 12 after the end of treatment
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