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The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Treated with GLE/PIB | Participants treated with all oral glecaprevir/pibrentasvir (GLE/PIB) and the decision to treat with GLE/PIB is made before the decision to offer an opportunity to join this study. Prescription of the treatment regimen is at the discretion of the physician and in accordance with local clinical practice and label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) | Defined as HCV RNA <50 IU/mL or \ | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site | Defined as HCV RNA <50 IU/mL or \ | At Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
None
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Adolescent participants 12 to <18 years of age with chronic hepatitis C (CHC) being treated with glecaprevir/pibrentasvir (GLE/PIB) in clinical practice in Russian Federation.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dagestan State Medical University /ID# 218500 | Makhachkala | Dagestan, Respublika | 367000 | Russia | ||
| A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498 |
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| Number of Participants With Co-morbidities |
Number and percentage of participants with co-morbidities will be analyzed. |
| At Baseline Visit (Week 0) |
| Number of Participants Taking Concomitant Medications | Number and percentage of participants taking concomitant medications will be analyzed. | Up to approximately 28 weeks |
| Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose | Percentage of GLE/PIB pills taken out of the number that was prescribed. | Up to approximately 16 weeks |
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Up to approximately 28 weeks |
| Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU) | Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call ) with a health care provider or designee in relation to their HCV infection during the study as recorded on an electronic case report form (eCRF). | Up to approximately 28 weeks |
| Kazan' |
| Tatarstan, Respublika |
| 420140 |
| Russia |
| South-Ural Medical State University /ID# 218501 | Chelyabinsk | 454048 | Russia |
| Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252 | Irkutsk | 664035 | Russia |
| Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590 | Moscow | 115093 | Russia |
| Infectious Clinical Hosp #1 /ID# 218497 | Moscow | 125310 | Russia |
| Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499 | Samara | 443029 | Russia |
| Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253 | Yekaterinburg | 620102 | Russia |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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