Chronic Hepatitis C (CHC)
Conditions
Keywords
Chronic Hepatitis C, Hepatitis C, Hepatitis, glecaprevir, pibrentasvir, real world setting, Observational Study
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
Russia
Outcome results
None listed