Chronic Hepatitis C
Conditions
Keywords
cirrhosis
Brief summary
Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.
Detailed description
Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a. Must have Child's Class A cirrhosis/compensated and no history of decompensation
Interventions
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
DRUGSimeprevir
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
DRUGRibavirin
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
DRUGSofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Sponsors
Center For Hepatitis C, Atlanta, GA
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
* chronic hepatitis c, * cirrhosis biopsy-proven, or via fibrotest, * CPT score less than 7, * genotype 1a, * INR 2.3 or less, * serum albumin greater than 2.7 gm/dL, * total bilirubin less than 3 gm/dL, * platelet count 50,000 per cubic milliliter or more * GFR \>50 ml/min
Exclusion criteria
* non genotype 1a, * history of CPT class B or C or decompensation or history of same, * HIV or HBV coinfection, * prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent, * uncontrolled psychiatric or cardiopulmonary disorders, * planning pregnancy or unwilling/unable to practice contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Sustained Virologic Response 12 (SVR-12) | 12 weeks post-therapy | Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy |
Secondary
| Measure | Time frame |
|---|---|
| Serum HCV RNA Level | 4 and 12 weeks into therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Therapy Arm | 58 |
| Interferon-containing Arm | 24 |
| Total | 82 |
Baseline characteristics
| Characteristic | Oral Therapy Arm | Interferon-containing Arm | Total |
|---|---|---|---|
| Age, Customized 18 years or older | 58 participants | 24 participants | 82 participants |
| Age, Customized Younger than 18 years old | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 20 Participants | 9 Participants | 29 Participants |
| Sex: Female, Male Male | 38 Participants | 15 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 58 | 22 / 24 |
| serious Total, serious adverse events | 0 / 58 | 1 / 24 |
Outcome results
Primary
Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
Time frame: 12 weeks post-therapy
Population: All participants that received at least a single dose of medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Oral Therapy | Proportion of Participants With Sustained Virologic Response 12 (SVR-12) | 54 participants |
| Interferon-containing Arm | Proportion of Participants With Sustained Virologic Response 12 (SVR-12) | 18 participants |
Comparison: Null hypothesis is no difference between two regimens in SVR-12.p-value: 0.02Chi-squared
Secondary
Serum HCV RNA Level
Time frame: 4 and 12 weeks into therapy
Population: All participants that received at least a single dose of medication
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Oral Therapy | Serum HCV RNA Level | Serum HCV RNA level at 4 weeks | 154 IU/ml |
| All Oral Therapy | Serum HCV RNA Level | Serum HCV RNA level at 8 weeks | 31 IU/ml |
| Interferon-containing Arm | Serum HCV RNA Level | Serum HCV RNA level at 4 weeks | 880 IU/ml |
| Interferon-containing Arm | Serum HCV RNA Level | Serum HCV RNA level at 8 weeks | 740 IU/ml |