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.
Study Type
OBSERVATIONAL
Enrollment
50
Number of Participants with Adverse Drug Reactions (ADRs)
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Time frame: Up to approximately 36 weeks
Percentage of Participants with Adverse Drug Reactions (ADRs)
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Time frame: Up to approximately 36 weeks
Number of Participants with Serious Adverse Events (SAEs)
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.
Time frame: Up to approximately 36 weeks
Percentage of Participants with Serious Adverse Events (SAEs)
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.
Time frame: Up to approximately 36 weeks
Percentage of participants achieving Sustained Virologic Response 12 (SVR12)
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Kariya Toyota General Hospital /ID# 239046
Kariya-shi, Aichi-ken, Japan
Meijo Hospital /ID# 250955
Nagoya, Aichi-ken, Japan
Nagoya University Hospital /ID# 226746
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 238745
Nagoya, Aichi-ken, Japan
Hirosaki University Hospital /ID# 262654
Hirosaki-shi, Aomori, Japan
Misawa Municipal Misawa Hospital /ID# 229544
Misawa-shi, Aomori, Japan
Chiba University Hospital /ID# 225889
Chiba, Chiba, Japan
Japanese Red Cross Narita Hospital /ID# 261349
Narita-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 239387
Matsuyama, Ehime, Japan
Shikoku Central Hospital of the Mutual Aid /ID# 230273
Shikokuchūō, Ehime, Japan
...and 44 more locations
Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug.
Time frame: At Week 12
Percentage of participants achieving Sustained Virologic Response (SVR)
SVR defined as HCV Ribonucleic acid (RNA) \< Lower limit of quantification (LLOQ).
Time frame: At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks)
Percentage of Participants with On-Treatment Virologic Failure (Breakthrough)
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).
Time frame: Up to approximately 36 weeks
Percentage of Participants with After-Treatment Virologic Failure (Relapse)
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.
Time frame: Up to approximately 36 weeks