Hepatitis C, Chronic
Conditions
Keywords
hepatitis C
Brief summary
This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).
Interventions
DRUGVaniprevir 600 mg b.i.d.
Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
DRUGVaniprevir 300 mg b.i.d.
Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
DRUGPegylated interferon
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
DRUGRibavirin
Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (\<75 kg or ≥75 kg, respectively), for 48 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has participated in a prior vaniprevir clinical trial * Participant agrees to use acceptable birth control method during treatment
Exclusion criteria
* More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028 * Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue * Participant received any investigational therapy for HCV after participating in the prior study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | up to 72 weeks | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. |
| Number of Participants Who Experienced a Serious Adverse Event | up to 72 weeks | Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose. |
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event | 48 weeks | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. |
| Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24) | 72 weeks | SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily. | 21 |
| Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily. | 24 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV | Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV | Total |
|---|---|---|---|
| Age, Continuous | 52.5 Years STANDARD_DEVIATION 7.4 | 48.1 Years STANDARD_DEVIATION 8.4 | 50.2 Years STANDARD_DEVIATION 8.1 |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 14 Participants | 20 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 21 | 23 / 24 |
| serious Total, serious adverse events | 4 / 21 | 1 / 24 |
Outcome results
Primary
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time frame: 48 weeks
Population: All participants as treated population consists of all participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event | 2 Participants |
| Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event | 1 Participants |
Primary
Number of Participants Who Experienced an Adverse Event
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time frame: up to 72 weeks
Population: All participants as treated population consists of all participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV | Number of Participants Who Experienced an Adverse Event | 21 Participants |
| Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV | Number of Participants Who Experienced an Adverse Event | 23 Participants |
Primary
Number of Participants Who Experienced a Serious Adverse Event
Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
Time frame: up to 72 weeks
Population: All participants as treated population consists of all participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV | Number of Participants Who Experienced a Serious Adverse Event | 4 Participants |
| Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV | Number of Participants Who Experienced a Serious Adverse Event | 1 Participants |
Primary
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.
Time frame: 72 weeks
Population: Population includes only a subset of participants previously treated with placebo + peg-IFN + RBV in a vaniprevir study and excludes participants for failure to receive \>=1 dose of study drug, lack of any post-allocation endpoint data subsequent to \>=1 dose of study drug, lack of baseline data, or missing data due to discontinuation from the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24) | 66.7 Percentage of participants |
| Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24) | 70.6 Percentage of participants |