Telaprevir in Genotype 3 HCV
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very
      high chance of developing fatal complications of their disease unless they receive effective
      treatment. Unfortunately the best drugs that are currently available to treat genotype 3
      hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with
      advanced liver disease and therefore a large number of patients who have failed treatment are
      waiting for new, better drugs. Currently there are no treatments available for these
      patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which
      works very well in these patients. In patients with genotype 3 hepatitis C small scale trials
      and laboratory studies show that some patients do respond quite well and others respond a
      little bit when given telaprevir. In patients who have exhausted all other treatment options
      the investigators speculate that telaprevir treatment may help some patients by clearing
      their infection. The purpose of this study is to see if telaprevir can help these patients
      and to determine if the investigators can predict in advance which people can be helped.
    

Detailed description: 
      This is an open label, 'proof of concept' study to examine the hypothesis that telaprevir is
      effective in patients with genotype 3 HCV and cirrhosis who have failed to respond to
      pegylated interferon and ribavirin. The study will examine the hypothesis that pretreatment
      viral testing will identify patients who will respond to antiviral therapy with telaprevir.

      Patients who are eligible for the study will be asked if they are willing to participate and
      if they wish to join the study they will be asked to sign the informed consent form. After
      signing the consent form patients will attend the hospital and be screened for the trial.
      This will involve a physical examination and blood samples will be taken. Patients will be
      provided with an injection of pegylated interferon to be self administered every week along
      with ribavirin tablets (4 tablets a day) and telaprevir tablets (6 tablets a day). Patients
      will be taught how to self administer the pegylated interferon medication. Patients will
      reattend every week for the next 4 weeks. At each visit they will be asked questions about
      the medication that they are taking, questions about how they are feeling and any side
      effects and 30 mls of blood will be taken.

      At the fourth visit (week 4) the amount of circulating HCV will be assessed using a standard
      laboratory assay and patients will be telephoned within 1 week of the visit. If the viral
      load is more than 1000 IU/ml therapy will be stopped as the chance of the patient responding
      to therapy is very low (in the clinical studies with genotype 1 HCV no patients responded who
      had a viral load of >1000 IU/ml at week 4). If patients are responding to therapy they will
      be asked to continue with medication and seen again 4 weeks later (8 weeks after initiating
      therapy).

      At week 8 of therapy patients will be asked questions about the medication that they are
      taking, questions about how they are feeling and any side effects and blood will be taken.
      Again the viral load will be tested and if the viral load is more than 1000 IU/ml therapy or
      the viral load has not decreased by 3 logs from baseline therapy will be stopped as the
      chance of the patient responding to therapy is very low. If patients are responding to
      therapy they will be asked to continue with medication and seen again 4 weeks later (12 weeks
      after initiating therapy).

      At week 12 of therapy patients will be asked questions about the medication that they are
      taking, questions about how they are feeling and any side effects and blood will be taken. At
      this visit they will be told to stop taking the telaprevir tablets as the recommended
      duration of telaprevir therapy is 12 weeks. Patients will continue to take pegylated
      interferon and ribavirin.

      Patients will be seen again every 4 weeks for another 8 weeks and they will continue to take
      pegylated interferon injections every week and 4 ribavirin tablets every day. At each clinic
      visit they will be asked questions about the medication that they are taking, questions about
      how they are feeling and any side effects and blood will be taken.

      After 24 weeks of therapy (i.e. 4 weeks after the last visit) patients will be seen again and
      asked questions about the medication that they are taking, questions about how they are
      feeling and any side effects and blood will be taken. At this visit they will be told to stop
      taking all medication. They will be asked to return in 12 weeks.

      12 weeks after stopping therapy patients will return to the clinic and asked questions about
      how they are feeling and any side effects and blood will be taken. They will be asked to
      return in 12 weeks.

      24 weeks after stopping therapy patients will return to the clinic and asked questions about
      how they are feeling and any side effects and blood will be taken. The study will then end
      and they will return to routine clinical follow up where they will be seen by their clinical
      team.
    

Intervention name(s): Telaprevir; 40 Kd Pegylated interferon alfa 2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 375 mg film coated tablets; 180 µg in pre-filled syringe for sub-cutaneous injection; 200 mg tablets
Other intervention name(s): INCIVO; Pegasys; Copegus
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telaprevir; Genotype 3 HCV