Chronic Hepatitis C, Genotype 1 Clinical Trial
Official title:
Tailored Treatment of Hepatitis C Genotype 1
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment