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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glecaprevir plus Pibrentasvir | Participants in this observational study will receive treatment with glecaprevir and pibrentasvir for up to 16 weeks for treatment of chronic hepatis C (CHC) genotypes 1, 2, 3, 4, 5, or 6. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice, international guidelines and/or label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 (\ | Up to approximately 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status | SVR12 defined as the HCV RNA level \ | Up to approximately 28 weeks |
| Percentage of Participants Achieving SVR12 by CHC Genotype |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CHC in a real world clinical practice setting.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLC Medical Company Hepatolog /ID# 212384 | Samara | Samara Oblast | 443063 | Russia | ||
| Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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SVR12 defined as the HCV RNA level \ |
| Up to approximately 28 weeks |
| Percentage of Participants Achieving SVR12 by Cirrhosis Status | SVR12 defined as the HCV RNA level \ | Up to approximately 28 weeks |
| Percentage of Participants Achieving SVR12 by Previous Treatment Experience | SVR12 defined as the HCV RNA level \ | Up to approximately 28 weeks |
| Percentage of Participants Achieving SVR12 by Patients Who Use Drugs | SVR12 defined as the HCV RNA level \ | Up to approximately 28 weeks |
| Percentage of Elderly Participants Achieving SVR12 | SVR12 defined as the HCV RNA level \ | Up to approximately 28 weeks |
| Percentage of Patients with Commodities | Percentage of Patients with Commodities from the decision to initiate treatment. | Up to approximately 16 weeks |
| Percentage of Participants Taking Concomitant Medications | The percentage of participants taking concomitant medications from the decision to initiate treatment through up to 12 weeks after the last dose of GLE/PBR | Up to approximately 28 weeks |
| Percentage of GLE/PIB Dose Taken | Percentage of GLE/PIB dose taken by patient report in relation to the prescribed target dose (that is, the number of pills taken out of the number that should have been taken). | Up to approximately 16 weeks |
| Number of Health Care Resource Utilization (HCRU) | Health Care Resource Utilization (HCRU) for a patient will be the 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. | Up to approximately 28 weeks |
| Stavropol |
| Stavropol Kray |
| 355035 |
| Russia |
| A. F. Agafonov Republican Clin /ID# 212381 | Kazan' | Tatarstan, Respublika | 420140 | Russia |
| South Ural State Medical univ /ID# 212020 | Chelyabinsk | 454052 | Russia |
| Clinical Inf. Dis Hospital 1 /ID# 217033 | Novosibirsk | 630099 | Russia |
| SIH Orlovskiy region city hospital named after S.P. Botkin /ID# 212383 | Oryol | 302038 | Russia |
| Perm Regional Center of Cepato /ID# 213992 | Perm | 614000 | Russia |
| Saint-Petersburg AIDS Center /ID# 212380 | Saint Petersburg | 190103 | Russia |
| Samara State Medical Universit /ID# 217029 | Samara | 443099 | Russia |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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