A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011.

Official Title
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Treatment Outcomes in the Management of Patients With Chronic Hepatitis C: A Case Study of Faculty of Medicine Vajira Hospital, University of Bangkok Metropolis

Conditions
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Hepatitis C, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010 Availability of data for at least 6 months following the diagnosis date Exclusion Criteria: Patients who participated in an investigational clinical trial Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency virus (HIV) Patients with known severe medical conditions that are contraindicated to HCV treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy | SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Were HCV Seronegative at the End of Treatment | End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment. | End of Study, up to 36 months after diagnosis. | 
| Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion | HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT. | End of Study, up to 36 months after diagnosis. | 
| Percentage of Participants Who Progressed From CHC to Cirrhosis |  | Diagnosis and End of Study, up to 36 months after diagnosis. | 
| Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) |  | Diagnosis and End of Study, up to 36 months after diagnosis. | 
| Percentage of Participants Who Died | Any cause of death (including non-liver disease related) was reported. | Diagnosis and End of Study, up to 36 months after diagnosis |