Hepatitis C, Chronic
Conditions
Brief summary
The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.
Detailed description
Physicians will record information (from the time of first exposure to pegylated interferon alfa-2b and ribavirin) from the medical notes of participants who fit the inclusion criteria. To prevent selection bias, data are to be taken from the latest consecutive, unique participants seen by the physician over the previous 48 months. This provides a method of random sampling from a physician practice.
Interventions
BIOLOGICALPeginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.
Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months will be included. They will be divided into: * Completer participants: Patients with a diagnosis of HCV genotype 1 who have completed a course of interferon alfa-2b and ribavirin, with no prior treatment for HCV (ie, previously treatment naïve). Completer participants must have at least 24 weeks of follow up data available post completion of treatment to ensure ability to assess SVR rates. * Early terminators: Participants who have terminated treatment early due to adverse events or other reasons (ie, exposure is incomplete).
Exclusion criteria
* Participants currently undergoing therapy and therefore have not terminated treatment, ie, exposure is still ongoing. * Co-infected HCV participants (eg, human immunodeficiency virus \[HIV\] or hepatitis B virus \[HBV\]). * Participants who received their first HCV treatment in relation to a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Treatment Success | Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks. | Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Genotype 1 Hepatitis C Virus Infection. Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months | 442 |
| Total | 442 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Acute HCV infection | 1 |
| Overall Study | Adverse Event | 41 |
| Overall Study | Drug Relapse | 1 |
| Overall Study | HCV RNA negative after 4 weeks | 9 |
| Overall Study | Lack of Efficacy | 82 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Non-compliance | 2 |
| Overall Study | Only to have 24 week regimen | 1 |
| Overall Study | Participant moved away | 1 |
| Overall Study | Responder at 12 weeks, PCR + at 24 weeks | 2 |
| Overall Study | Tolerability | 23 |
| Overall Study | Viral Relapse | 1 |
Baseline characteristics
| Characteristic | Participants With Genotype 1 Hepatitis C Virus Infection. |
|---|---|
| Age, Customized | 43 Years STANDARD_DEVIATION 10.13 |
| Region of Enrollment United Kingdom | 442 participants |
| Sex/Gender, Customized Female | 143 participants |
| Sex/Gender, Customized Gender information missing | 3 participants |
| Sex/Gender, Customized Male | 296 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 442 |
| serious Total, serious adverse events | 17 / 442 |
Outcome results
Primary
Participants With Treatment Success
Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).
Time frame: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.
Population: Number of participants who had treatment success.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Genotype 1 Hepatitis C Virus Infection. | Participants With Treatment Success | Genotype 1a | 117 Participants |
| Participants With Genotype 1 Hepatitis C Virus Infection. | Participants With Treatment Success | Genotype 1b | 63 Participants |
| Participants With Genotype 1 Hepatitis C Virus Infection. | Participants With Treatment Success | Genotype 1a and 1b | 4 Participants |
| Participants With Genotype 1 Hepatitis C Virus Infection. | Participants With Treatment Success | Genotype 1c | 0 Participants |
| Participants With Genotype 1 Hepatitis C Virus Infection. | Participants With Treatment Success | Genotype 1 subgroup unspecified | 59 Participants |