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

Hoffmann-La Roche49 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology

Bangkok, Thailand

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: End of Study, up to 36 months after diagnosis.

Percentage of Participants Who Progressed From CHC to Cirrhosis

Time frame: Diagnosis and End of Study, up to 36 months after diagnosis.

Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)

Time frame: 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.

Time frame: Diagnosis and End of Study, up to 36 months after diagnosis

Data from ClinicalTrials.gov

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