Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
Infection
About this trial
This is an interventional treatment trial for Infection focused on measuring Infection, Hepatitis C Genotype 1 Infection, Hepatitis C virus, HCV, Hepatocellular Carcinoma, HCC, Liver Transplantation, Pegylated Interferon Alfa 2a, PegIFN alfa-2a, Ribavirin, RBV, Telaprevir, Incivek, Antiviral drugs
Eligibility Criteria
Inclusion Criteria:
- Males or females aged ≥ 18 and ≤ 70 years
- Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum
- HCV genotype 1 infection
- Child-Pugh-Turcotte (CPT) score < 7 and Model for End-Stage Liver Disease (MELD) score < 18
- PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null responders and relapsers)
Hepatocellular carcinoma within transplant criteria in the United Network for Organ Sharing (UNOS) Region IV:
- Single lesion up to 6 cm, or
- Two or three lesions with largest no greater than 5 cm and the total tumor diameter no greater than 9 cm
- Listed for liver transplantation
- Willingness to give written consent and agree to double contraception
Exclusion Criteria:
- Decompensated cirrhosis
- Baseline platelet count less than 35,000/µL
- Baseline hemoglobin level less than 10 g/dL
- Baseline absolute neutrophil count less than 750/mm3
- Baseline creatinine clearance < 50 mL per min.
- Women with a positive pregnancy test at baseline or men whose female partners are pregnant or are contemplating pregnancy
- Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment guidelines
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.