Hepatitis C, Chronic
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy | 6 months | SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were HCV Seronegative at the End of Treatment | End of Study, up to 36 months after diagnosis. | End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment. |
| Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion | End of Study, up to 36 months after diagnosis. | 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. |
| 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 | Diagnosis and End of Study, up to 36 months after diagnosis | Any cause of death (including non-liver disease related) was reported. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Cirrhotic CHC Observation Only Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. | 37 |
| HCV - Related Cirrhosis Observation Only Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. | 12 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Other | 0 | 2 |
Baseline characteristics
| Characteristic | Non-Cirrhotic CHC Observation Only | HCV - Related Cirrhosis Observation Only | Total |
|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 10.9 | 53.9 years STANDARD_DEVIATION 8.2 | 47.2 years STANDARD_DEVIATION 10.77 |
| Sex: Female, Male Female | 12 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 25 Participants | 8 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
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
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy | 59.5 percentage of participants |
| HCV - Related Cirrhosis Observation Only | Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy | 58.3 percentage of participants |
Secondary
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
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | Percentage of Participants Who Died | 2.7 percentage of participants |
| HCV - Related Cirrhosis Observation Only | Percentage of Participants Who Died | 0 percentage of participants |
Secondary
Percentage of Participants Who Progressed From CHC to Cirrhosis
Time frame: Diagnosis and End of Study, up to 36 months after diagnosis.
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | Percentage of Participants Who Progressed From CHC to Cirrhosis | 0 percentage of participants |
| HCV - Related Cirrhosis Observation Only | Percentage of Participants Who Progressed From CHC to Cirrhosis | 0 percentage of participants |
p-value: 0.034Chi-squared
Secondary
Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)
Time frame: Diagnosis and End of Study, up to 36 months after diagnosis.
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) | 2.7 percentage of participants |
| HCV - Related Cirrhosis Observation Only | Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) | 8.3 percentage of participants |
p-value: 0.007Chi-squared
Secondary
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.
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | Percentage of Participants Who Were HCV Seronegative at the End of Treatment | 91.9 percentage of participants |
| HCV - Related Cirrhosis Observation Only | Percentage of Participants Who Were HCV Seronegative at the End of Treatment | 91.6 percentage of participants |
Secondary
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.
Population: All enrolled participants;
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Cirrhotic CHC Observation Only | Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion | Virological Relapse | 0 percentage of participants |
| Non-Cirrhotic CHC Observation Only | Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion | Biochemical Relapse | 0 percentage of participants |
| HCV - Related Cirrhosis Observation Only | Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion | Virological Relapse | 0 percentage of participants |
| HCV - Related Cirrhosis Observation Only | Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion | Biochemical Relapse | 14.3 percentage of participants |