EVEREST: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [Up to approximately 28 weeks]
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.
Secondary Outcome Measures
- Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status [Up to approximately 28 weeks]
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB.with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
- Percentage of Participants Achieving SVR12 by CHC Genotype [Up to approximately 28 weeks]
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB.with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
- Percentage of Participants Achieving SVR12 by Cirrhosis Status [Up to approximately 28 weeks]
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay
- Percentage of Participants Achieving SVR12 by Previous Treatment Experience [Up to approximately 28 weeks]
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
- Percentage of Participants Achieving SVR12 by Patients Who Use Drugs [Up to approximately 28 weeks]
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
- Percentage of Elderly Participants Achieving SVR12 [Up to approximately 28 weeks]
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
- Percentage of Patients with Commodities [Up to approximately 16 weeks]
Percentage of Patients with Commodities from the decision to initiate treatment.
- Percentage of Participants Taking Concomitant Medications [Up to approximately 28 weeks]
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
- Percentage of GLE/PIB Dose Taken [Up to approximately 16 weeks]
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).
- Number of Health Care Resource Utilization (HCRU) [Up to approximately 28 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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May be enrolled up to 4 weeks after treatment initiation.
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Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
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Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
Exclusion Criteria:
- None.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LLC Medical Company Hepatolog /ID# 212384 | Samara | Samarskaya Oblast | Russian Federation | 443063 |
| 2 | Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035 | Stavropol | Stavropol Skiy Kray | Russian Federation | 355035 |
| 3 | A. F. Agafonov Republican Clin /ID# 212381 | Kazan | Tatarstan, Respublika | Russian Federation | 420140 |
| 4 | South Ural State Medical univ /ID# 212020 | Chelyabinsk | Russian Federation | 454052 | |
| 5 | Clinical Inf. Dis Hospital 1 /ID# 217033 | Novosibirsk | Russian Federation | 630099 | |
| 6 | SIH Orlovskiy region city hospital named after S.P. Botkin /ID# 212383 | Oryol | Russian Federation | 302038 | |
| 7 | Perm Regional Center of Cepato /ID# 213992 | Perm | Russian Federation | 614000 | |
| 8 | Samara State Medical Universit /ID# 217029 | Samara | Russian Federation | 443099 | |
| 9 | Saint-Petersburg AIDS Center /ID# 212380 | St. Petersburg | Russian Federation | 190103 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P19-454