Hepatitis C
Conditions
Brief summary
To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.
Detailed description
Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
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
* Willingness to participate * 18 years or older, either gender, any race * Must have Hepatitic C Virus Low Viral Load \[LCV LVL\] (positive, but \<600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction \[HCV-RNA/qPCR\] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1 * Subject considered suitable for treatment per local label * Investigator considers suitable and subject consents to be treated
Exclusion criteria
* Does not show negative polymerase chain reaction \[PCR\] at week 4 * Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant * Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the Summary of Product Characteristics \[SmPC\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of HCV LVL G1 Participants Who Relapsed | Week 24 of follow-up | Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PegIntron Plus Rebetol Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170) | 170 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse events | 2 |
| Overall Study | Did not enter follow-up | 4 |
| Overall Study | Discontinued follow-up | 5 |
| Overall Study | Discontinued treatment | 14 |
| Overall Study | Disease progression | 1 |
| Overall Study | Eligibility criteria not met | 281 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Non-compliance | 5 |
| Overall Study | Not treated | 14 |
Baseline characteristics
| Characteristic | PegIntron Plus Rebetol |
|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 482 |
| serious Total, serious adverse events | 11 / 482 |
Outcome results
Primary
Number of HCV LVL G1 Participants Who Relapsed
Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.
Time frame: Week 24 of follow-up
Population: The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PegIntron Plus Rebetol | Number of HCV LVL G1 Participants Who Relapsed | 16 Participants |
95% CI: [0.06, 0.15]