Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.
Interventions
BIOLOGICALPegIntron (peginterferon alfa-2b; SCH 54031) injector
PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling
Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with chronic hepatitis C * At least 18 years old * Treatment-naïve or relapse to interferon monotherapy * Platelets \>= 100,000/mm\^3 * Neutrophil counts \>= 1,500/ mm\^3 * Thyroid Stimulating Hormone (TSH) must be within normal limits * Hemoglobin \>= 12 gr/dl (females); \>= 13 gr/dl (males) * Intravenous drug abusers (Ex-IVDA) participants being under stable substitution for at least 6 months * Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment * Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment
Exclusion criteria
* Contraindications as per the SPC and approved European labeling * Hypersensitivity to the active substance or to any inteferons or to any of the excipients * Pregnant woman * Woman who are breast-feeding * Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt * A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months * Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \< 50 mL/min * Autoimmune hepatitis or history of autoimmune disease * Severe hepatic dysfunction or decompensated cirrhosis of the liver * Pre-existing thyroid disease unless it can be controlled with conventional therapy * Epilepsy and/or compromised central nervous system function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) | 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6 | HCV-RNA level was measured by polymerase chain reaction (PCR). |
| Number of Participants With Early Virologic Response (EVR) | Treatment Week 12 | EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12 |
| Number of Participants With Sustained Virologic Response (SVR) | 24 weeks post-treatment (Week 48 or 72, depending on genotype) | SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT |
| Number of HCV-RNA Negative Participants at Follow-up | 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) | HCV-RNA was measured by PCR. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PegIntron + Rebetol Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling. | 2,302 |
| Total | 2,302 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 58 |
| Overall Study | Did not receive drug | 316 |
| Overall Study | Lack of Efficacy | 242 |
| Overall Study | Lost to Follow-up | 73 |
| Overall Study | Missing end of therapy data | 205 |
| Overall Study | Multiple reasons | 39 |
| Overall Study | Other | 97 |
| Overall Study | Withdrawal by Subject | 77 |
Baseline characteristics
| Characteristic | PegIntron + Rebetol |
|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment Germany | 2302 participants |
| Sex/Gender, Customized Female | 766 participants |
| Sex/Gender, Customized Gender information not captured | 367 participants |
| Sex/Gender, Customized Male | 1169 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 151 / 2,302 |
| serious Total, serious adverse events | 58 / 2,302 |
Outcome results
Primary
Number of HCV-RNA Negative Participants at Follow-up
HCV-RNA was measured by PCR.
Time frame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)
Population: Number of participants with results at the 6 month follow-up examination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron + Rebetol | Number of HCV-RNA Negative Participants at Follow-up | 887 Participants |
Primary
Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)
HCV-RNA level was measured by polymerase chain reaction (PCR).
Time frame: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6
Population: Number of evaluable participants at EoT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron + Rebetol | Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) | 1306 Participants |
Primary
Number of Participants With Early Virologic Response (EVR)
EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12
Time frame: Treatment Week 12
Population: Number of evaluable participants at 12 weeks of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron + Rebetol | Number of Participants With Early Virologic Response (EVR) | 1168 Participants |
Primary
Number of Participants With Sustained Virologic Response (SVR)
SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT
Time frame: 24 weeks post-treatment (Week 48 or 72, depending on genotype)
Population: Number of evaluable participants with follow-up information
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron + Rebetol | Number of Participants With Sustained Virologic Response (SVR) | 888 Participants |