Hepatitis C, Chronic
Conditions
Brief summary
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.
Detailed description
Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.
Interventions
DRUGPEG-IFN alfa-2b
Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
DRUGribavirin
Ribavirin 200 mg capsules administered orally daily based on weight
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
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 is ≥40 kg and ≤120 kg weight * Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations. * Previously documented CHC genotype 4 infection * Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).
Exclusion criteria
* Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus * Treatment for hepatitis C with any investigational medication * Treatment with any investigational drug within 30 days of the screening visit * Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy * Autoimmune hepatitis or a history of autoimmune disease * Hepatic fibrosis score F4 * Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months * Autoimmune hepatitis or a history of autoimmune disease * Thyroid disease uncontrolled with conventional treatment * Epilepsy and/or compromised central nervous system (CNS) function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Sustained Virologic Response (SVR) | At 24 weeks after the completion of therapy (up to 72 weeks) | SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 44 Weeks of PEG-IFN Alfa-2b + RBV Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks. | 22 |
| 20 Weeks of PEG-IFN Alfa-2b + RBV Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks. | 23 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Missing completion status | 2 | 0 |
| Overall Study | Participant withdrew consent | 0 | 1 |
Baseline characteristics
| Characteristic | 44 Weeks of PEG-IFN Alfa-2b + RBV | 20 Weeks of PEG-IFN Alfa-2b + RBV | Total |
|---|---|---|---|
| Age, Continuous | 38.4 Years STANDARD_DEVIATION 10.79 | 37.1 Years STANDARD_DEVIATION 11.22 | 37.7 Years STANDARD_DEVIATION 10.91 |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 22 | 13 / 23 |
| serious Total, serious adverse events | 0 / 22 | 2 / 23 |
Outcome results
Primary
Number of Participants Achieving Sustained Virologic Response (SVR)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Time frame: At 24 weeks after the completion of therapy (up to 72 weeks)
Population: All Treated Population, which included all participants who received at least one dose of study medication after RVR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 44 Weeks of PEG-IFN Alfa-2b + RBV | Number of Participants Achieving Sustained Virologic Response (SVR) | 13 Participants |
| 20 Weeks of PEG-IFN Alfa-2b + RBV | Number of Participants Achieving Sustained Virologic Response (SVR) | 22 Participants |