Telaprevir Open-Label Study in Co-Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to collect safety and tolerability data on telaprevir treatment
      in combination with Peg-IFN-alfa and RBV in patients with HIV/genotype 1 chronic HCV
      coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment
      into an ongoing clinical study of telaprevir.
    

Detailed description: 
      In this study, all patients will receive open-label (all people involved know the identity of
      the intervention) telaprevir in addition to Peg IFN-alfa and RBV for treatment of hepatitis C
      virus (HCV) and protocol permissible treatments for HIV. Chronic hepatitis C infection causes
      inflammation of the liver which can potentially cause long-term complications of the current
      liver disease (fibrosis or cirrhosis). Therefore it is important the patient is treated for
      this infection. Telaprevir is an experimental medication that has been tested for the
      treatment of hepatitis C infections in several previous studies in more than 2500 patients.
      Telaprevir is a member of a new class of drugs being developed for chronic hepatitis C:
      Direct Acting Antiviral (DAA) agents. Unlike pegylated interferon (Peg-IFN) and ribavirin
      (RBV), DAA agents act directly on the hepatitis C virus (HCV) replication cycle. The aim of
      the telaprevir treatment is to eradicate the Hepatitis C virus out of the patient's body.
      This can be measured by testing the amount of a certain part of this Hepatitis C virus,
      called the Ribonucleic acid (RNA [HCV RNA]) in their blood. It is possible that the patient
      will not respond to the therapy and the levels of HCV RNA in their blood will not decrease or
      even increase. Based on these results it might be decided the patient will not benefit from
      treatment and he/she need to stop the telaprevir only or all medication for their hepatitis C
      infection. The doctor will keep them informed about the patient's reaction to the treatment
      and will take the necessary measurements as prescribed by the study protocol and routine
      medical practice. During the study the patient will simultaneously be treated with the
      therapy that the doctor would normally prescribe for treatment of their chronic hepatitis C
      infection: "ribavirin (RBV)" and "pegylated interferon alfa (PEG-INF-alfa)". Telaprevir is
      always administered in combination with RBV and PEG-IFN-alfa. In function of the patient's
      specific HIV status, the doctor has prescribed, or not, a specific treatment that the patient
      will continue to take during the study. This treatment could be: (a) efavirenz, tenofovir
      disoproxil fumarate (TDF), plus either emtricitabine or lamivudine, (b) efavirenz, abacavir,
      plus either emtricitabine or lamivudine, (c) ritonavir-boosted atazanavir, TDF, plus either
      emtricitabine or lamivudine, (d) ritonavir-boosted atazanavir, abacavir, plus either
      emtricitabine or lamivudine, (e) raltegravir, TDF, plus either emtricitabine or lamivudine,
      (f) raltegravir, abacavir, plus either emtricitabine or lamivudine or (g) etravirine, TDF,
      plus either emtricitabine or lamivudin, (h) etravirine, abacavir, plus either emtricitabine
      or lamivudine, (i) rilpivirine, TDF, plus either emtricitabine or lamivudine, (j)
      rilpivirine, abacavir, plus either emtricitabine or lamivudine, (k) no treatment. In an
      interim analysis of a Phase 2a study, human immunodeficiency virus (HIV)-1/HCV genotype 1
      coinfected patients currently receiving HIV therapy who had telaprevir added to Peg
      IFN-alfa-2a and RBV regimen for treatment of their HCV genotype 1 infection had a higher HCV
      RNA response (undetectable HCV RNA) at Weeks 4 and 12 than those who received only the
      Peg-IFN-alfa-2a and RBV regimen. These responses were sustained through Week 24, with 73.7%
      of patients who had telaprevir added to the Peg-IFN-alfa-2a and RBV regimen and 54.5% of
      patients who received only the Peg-IFN-alfa-2a and RBV regimen also achieving undetectable
      HCV RNA at Week 24. Patients with severe fibrosis or cirrhosis have a lower likelihood of
      sustained virologic response (SVR) and also have the greatest risk of liver failure,
      hepatocellular carcinoma (HCC), and death. Administering telaprevir in this difficult to
      treat population may reduce the risk of long-term complications associated with HCV in
      patients with HIV/HCV genotype 1 coinfection. All patients eligible to enter the study will
      receive telaprevir (750 or 1,125 mg every 8 hours based on their Highly Active Antiretroviral
      Therapy (HAART) regimen) during the first 12 weeks of the study in combination with Peg IFN
      alfa/RBV. Patients will subsequently be treated with Peg-IFN-alfa/RBV for an additional 36
      weeks. The total duration of Peg-IFN-alfa/RBV will be 48 weeks. HCV RNA levels should be
      measured at Weeks 4, 12, 24 and 48. All patients should have a posttreatment follow-up visit,
      including measurement of plasma HCV RNA levels, performed 24 weeks after the last
      administered dose of treatment. Note that in certain countries, an additional main objective
      of the study is to provide Early Access to telaprevir in this population.
    

Intervention name(s): Telaprevir; Telaprevir
Intervention type(s): Drug; Drug
Intervention description(s): type = exact number, unit = mg, number = 750, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with pegylated interferon alfa (Peg-IFN alfa) and ribavirin (RBV) during 48 weeks for eligible non treated HIV patients and for patients whose highly active antiretroviral therapy (HAART) regimen is the combination of ritonavir-boosted atazanavir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or the combination of raltegravir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.; type = exact number, unit = mg, number = 1125, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with Peg-IFN alfa and RBV during 48 weeks when patient's HAART regimen is the combination of efavirenz, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C Infection; Chronic Hepatitis C Co-Infected Patients; Hepatitis C; Severe Fibrosis; Compensated Cirrhosis; VX-950HPC3005