Viral Kinetics in HCV Clearance in Subjects With Hemophilia

Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.

Inclusion criteria

• Hemophilia A or B
• HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype)
• Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment
• Liver biopsy or non-invasive marker that permits fibrosis staging within 12 months of enrollment. If a biopsy was not performed within 1 year, non-invasive markers may be utilized during screening period. Cirrhosis is not an exclusion factor
• Age ≥ 18 years
• Prior HCV treatment naïve or experienced
• HCV viral load detectable during screening period
• Absence of exclusion criteria
• Sexually active subjects (both male and female) must agree and commit to the use of a medically acceptable form of contraception for the duration of the study and for 6 months following the last dose of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception.

Exclusion criteria

• Hemoglobin <11
• Pregnancy (during screening period or any time during treatment)

• females, that are planning to become pregnant or are breastfeeding
• males, whose partner is pregnant or is planning to become pregnant
• HIV Infection
• Prior History of:

• Hepatitis B (HBsAG negative - must have documentation of negative results within one year prior to enrollment or during screening period if not performed in that time window
• Homozygotic alpha-1-anti-trypsin (a1AT) deficiency - documentation of a1AT level <80 (at anytime prior to screening). If <80, phenotype testing should not demonstrate zz phenotype. All other phenotypes are not exclusionary,
• History of Homozygotic Genetic Hemochromatosis (at anytime prior to enrollment) with evidence of iron overload requiring phlebotomy,
• Autoimmune markers (antinuclear antibody (ANA) and/or antismooth muscle antibody (ASMA)) >1:160.
• Any other significant liver disease or process (to be determined by the investigator). Non-alcoholic fatty-liver disease (NAFLD) is not an exclusion.
• History of Decompensated liver disease evidenced by any prior history of hepatic encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count < 100,000
• Active thyroid disease (OK if on thyroid replacement with normal thyroid-stimulating hormone (TSH); if TSH abnormal must have normal free thyroid index)
• Chronic renal insufficiency, defined as creatinine clearance < 50 ml/min. (estimated by Modification of Diet in Renal Disease (MDRD) formula)
• Life-threatening disease processes that could preclude completion of trial in opinion of investigator.
• Any condition which the investigator feels will preclude safe completion of the treatment regimen including severe psychiatric disorders, active alcohol or recreational drug abuse.
• Inability to provide informed consent.
• Use of systemic corticosteroids or immunomodulatory drugs within 1 month (Nasal steroids are permitted.)
• Uncontrolled seizure disorder (in opinion of investigator)
• Concurrent autoimmune processes with active disease that may be exacerbated by interferon-based therapies (e.g. Crohn's Disease, Rheumatoid arthritis) in the opinion of the investigator. Psoriasis permitted if controlled with topical medications at the time of study enrollment.
• Use of prohibited medications (as described in the telaprevir package insert) within 14 days of the first dose of study medications