Hepatitis C, Chronic
Conditions
Keywords
hepatitis C
Brief summary
The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.
Interventions
PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks
Rebetol administered based on body weight 800-1200 mg/day (\<65 kg: 800 mg; 65 - 85 kg: 1000 mg; \>85 kg: 1200 mg) orally for 48 weeks
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
* Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol * Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR) * Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase \[ALT\]) levels above the upper normal limit for gender * Documented chronic hepatitis C (CHC) of genotype 1/4/5/6 * A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4
Exclusion criteria
* Known hypersensitivity for any active ingredient or constituent * Pregnancy or lactation * Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt * Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months * Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance \<50 mL/minute * Hepatitis of immunologic origin or medically documented history of auto-immune disease * Severe hepatic disorder or decompensated cirrhosis * Pre-existing thyroid disorder, except if under control with classical treatment * Epilepsy or central nervous system disorder * Hemoglobin pathology, eg, thalassaemia, sickle cell anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants Who Had a Virological Response (VR) at Week-72 | Treatment Week 72 | VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PegIntron Plus Rebetol Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6. | 538 |
| Total | 538 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease complication | 3 |
| Overall Study | Lost to Follow-up | 34 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Serious side effects | 11 |
| Overall Study | Side effects | 20 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | PegIntron Plus Rebetol |
|---|---|
| Age, Customized <50 years | 301 Participants |
| Age, Customized >=50 years | 204 Participants |
| Age, Customized age not available | 33 Participants |
| Sex/Gender, Customized Female | 203 Participants |
| Sex/Gender, Customized Gender not available | 33 Participants |
| Sex/Gender, Customized Male | 302 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Study Participants Who Had a Virological Response (VR) at Week-72
VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond.
Time frame: Treatment Week 72
Population: Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron Plus Rebetol | Number of Study Participants Who Had a Virological Response (VR) at Week-72 | 176 Participants |