Hepatitis C Virus (HCV)
Conditions
Keywords
Hepatitis C Virus (HCV), Chronic Hepatitis C (CHC), Maviret, Mavyret
Brief summary
This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret * Enrolled after Maviret treatment begins * Prior treatment with Maviret
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Serious Adverse Events (SAEs) | Up to approximately 36 weeks | 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 judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. |
| Number of Participants with Adverse Drug Reactions (ADRs) | Up to approximately 36 weeks | Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out. |
| Percentage of Participants with Adverse Drug Reactions (ADRs) | Up to approximately 36 weeks | Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out. |
| Number of Participants with Serious Adverse Events (SAEs) | Up to approximately 36 weeks | 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 judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving Sustained Virologic Response 12 (SVR12) | At Week 12 | Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug. |
| Percentage of participants achieving Sustained Virologic Response (SVR) | At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks) | SVR defined as HCV Ribonucleic acid (RNA) \< Lower limit of quantification (LLOQ). |
| Percentage of Participants with On-Treatment Virologic Failure (Breakthrough) | Up to approximately 36 weeks | On-treatment virologic failure (breakthrough) defined as at least 1 documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value ≥ 50 IU/mL). |
| Percentage of Participants with After-Treatment Virologic Failure (Relapse) | Up to approximately 36 weeks | After-treatment virologic failure (relapse) is defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment. |
Countries
Japan
Outcome results
None listed