Hepatitis C, Chronic
Conditions
Brief summary
This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with chronic hepatitis C virus (HCV)\[any genotype\] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C. * Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.
Exclusion criteria
* Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner. * Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry. * Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate). * Participants treated for a period shorter than the enrollment period. * Co-infection with Human Immumodeficiency Virus (HIV). * Co-infected with Hepatitis B Virus (HBV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) | From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment | Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) | From 24 weeks post-treatment to 72 weeks post-treatment | Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up. |
Participant flow
Recruitment details
Participants who had achieved a viral response prior to this study (negative for Hepatitis C Virus \[HCV\] ribonucleic acid \[RNA\] at the end of treatment as per product label) were recruited for follow-up on the present study.
Pre-assignment details
A total of 279 participants enrolled in the study. Twenty-one participants failed screening and 258 participants were evaluable at Visit 1 (V1), which could be performed up to Week (Wk) 4 after the end of treatment.
Participants by arm
| Arm | Count |
|---|---|
| PEG IFN Alfa-2b + RBV Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study. | 258 |
| Total | 258 |
Baseline characteristics
| Characteristic | PEG IFN Alfa-2b + RBV |
|---|---|
| Age, Continuous | 45.72 years STANDARD_DEVIATION 9.94 |
| Sex: Female, Male Female | 106 Participants |
| Sex: Female, Male Male | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 258 |
| serious Total, serious adverse events | 5 / 258 |
Outcome results
Primary
Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)
Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid
Time frame: From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment
Population: The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG IFN Alfa-2b + RBV | Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) | 13.65 Percentage of participants |
Secondary
Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)
Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up.
Time frame: From 24 weeks post-treatment to 72 weeks post-treatment
Population: The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2).~187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG IFN Alfa-2b + RBV | Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) | 0.58 Percentage of participants |