Tailored Treatment of Hepatitis C Genotype 1
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Medication dose per cured patient
Study Overview
Brief Summary
The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.
Detailed Description
The current standard regimen for patients with chronic hepatitis C virus (HCV) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and side-effects; in addition, the treatment is curative in only 50% of patients with genotype 1 of HCV. According to the current guidelines treatment with pegylated interferon and ribavirin is given for 24, 48 or 72 weeks depending on the time point when HCV-RNA becomes undetectable (week 4, 12 or 24). Patients with a very poor response may also be identified by applying a stopping rule at week 12 and 24. Still, most patients are treated for 48 weeks and a substantial number of those relapse after discontinuation.
In this study, standard treatment is compared with "tailored treatment", when the treatment duration is based on the time point when HCV RNA level is calculated to be 1 copy/mL, according measurements of HCV RNA on day 14, 21, 28 and 49. This arm also includes an earlier stopping rule: If the HCV RNA does not decline significantly between day 14 and 28, treatment is stopped after 5 weeks.
The advantage of tailored treatment is hypothesised to be that unnecessary side-effects and costs are avoided by an earlier identification of non-response and a treatment duration that is optimised for each patient.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Anti-HCV positive for > 6 months
- •Genotype 1
- •Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
- •Negative pregnancy test (for fertile women)
Exclusion Criteria
- •Pregnancy or breast-feeding
- •Antiviral or immune modulating treatment the last 6 months
- •Hepatitis B or HIV infection (HBsAg, anti-HIV)
- •Other significant chronic liver disease
- •History of bleeding esophageal varices or other signs of decompensation
- •Neutrophiles < 1.0 x 109/L or platelets < 50 x 109/L. S-creatinine > 2 x ULN
- •History of severe psychiatric disorder
- •Autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
- •Drug abuse, current or during the last year
Arms & Interventions
Standard of care
Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment is given for 24, 48 or 72 weeks depending on the time point (week 4, 12 or 24) when HCV RNA becomes undetectable by the Cobas Taqman assay. If HCV RNA has not declined 2 logs by week 12 or is detectable at week 24, treatment is stopped.
Intervention: Peg-interferon-alfa2a (Pegasys) (Drug)
Standard of care
Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment is given for 24, 48 or 72 weeks depending on the time point (week 4, 12 or 24) when HCV RNA becomes undetectable by the Cobas Taqman assay. If HCV RNA has not declined 2 logs by week 12 or is detectable at week 24, treatment is stopped.
Intervention: Ribavirin (Copegus) (Drug)
Tailored treatment
Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment duration is flexible, 24-72 weeks, depending on the time point when the HCV RNA level is calculated to be 1 copy/mL. If the decline between day 14 and 28 is poor, treatment is stopped after 5 weeks.
Intervention: Peg-interferon-alfa2a (Pegasys) (Drug)
Tailored treatment
Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment duration is flexible, 24-72 weeks, depending on the time point when the HCV RNA level is calculated to be 1 copy/mL. If the decline between day 14 and 28 is poor, treatment is stopped after 5 weeks.
Intervention: Ribavirin (Copegus) (Drug)
Outcomes
Primary Outcomes
Medication dose per cured patient
Time Frame: 26 weeks after end of treatment
Secondary Outcomes
- Sustained virological response and relapse rate(26 weeks after end of treatment)