Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, Genotype 1, Nonresponder, Relapser, Betaine, Antiviral therapy Read More

Inclusion Criteria:

• Subject must be willing to give informed consent and be able to adhere to dose and visit schedules.
• History of chronic hepatitis C, genotype 1, non-responders or relapsers as documented by genotype testing and HCV RNA levels at 12 weeks ( < 2 log change) during therapy or at 3 - 12 months post therapy, respectively.
• Adult subjects 18-70 years of age, of either gender
• Liver biopsy within 3 years prior to the screening 1 visit with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis C.
• Compensated liver disease with the following maximum hematologic, biochemical and serologic criteria at the Screening visit (WNL=within normal limits) Hemoglobin > 12 g/dl for females and >13 g/dl for males, WBC > 3000/mm3, Platelets > 80,000/mm3, Direct Bilirubin - WNL. Indirect bilirubin - WNL, Albumin - WNL, Serum Creatinine - WNL.
• Fasting glucose should be 70 -140 mg/dl, results between 116-140 require a HbA1c < 8.5%
• TSH - WNL
• Subjects with a history of mild depression may be considered for entry in to this study provided that a pretreatment assessment of the subject's affective status supports that the subject is clinically stable.
• Subjects with a history of substance abuse must have abstained from using the substance for at least one year prior to the Screening visit.
• Antinuclear antibodies (ANA) < 1:320
• No radiologic evidence of a focal mass suggestive of hepatoma and/or ascites.

Exclusion Criteria:

• Pregnant or nursing subjects. Subjects who intend to become pregnant during the study period. Subjects with partners who intend to become pregnant during the study period.
• Prior response to therapy and failure to achieve SVR which may have been due to treatment non-compliance, in the assessment of the investigator based upon subject's medical history.
• Participation in any clinical trial of a HCV protease inhibitor of any duration. Subjects may have received other investigational agents for the treatment of HCV, as long as they have also received an adequate course of Peg-IFN/RBV [i.e., the investigational agent could not have replaced either Peg-IFN (such as Albuferon) or RBV (viramidine)].
• History of new hepatitis C exposure within the last 6 months
• Current or intended use of G-CSF and/or GM-CSF during the stud period is prohibited. Current use of erythropoietin (EPO) is prohibited.
• Suspected hypersensitivity to any interferon product or ribavirin
• Participation in any other clinical trial within 30 days of Screening visit 1
• Treatment with any investigational drug within 30 days of Screening visit 1.
• Any other cause for liver disease other than CHC, including but not limited to: hemachromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Autoimmune hepatitis, Alcoholic liver disease, Non-alcoholic steatohepatitis (NASH), Drug-related liver disease
• Known coagulopathies including hemophilia
• Known hemoglobinopathies
• Known G6PD deficiency
• Known coinfection with HIV and/or HBV
• Evidence of active or suspected malignancy or a history of malignancy within the last five years (with the exception of adequately treated basal cell carcinoma of the skin).
• Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices or hepatic encephalopathy
• Subjects with organ transplants other than cornea or hair transplant
• Any Known preexisting medical condition, that could interfere with the subject's participation in and completion of the study including, but not limited to moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation and/or suicidal attempt; Subjects with a past history or current use of lithium and/or antipsychotic drugs; CNS trauma or seizure disorder; Clinically significant ECG abnormalities and/or significant cardiovascular dysfunction within the past 2 years prior to Screening ; Poorly controlled diabetes mellitis; Chronic pulmonary disease (COPD); Immunologically mediated disease such as inflammatory bowel disease, rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis or symptomatic thyroid disorder; Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids: History of, or active clinical gout.
• Substance abuse, such as alcohol (>80 g/day), IV drugs and inhaled drugs. Subjects with a history of substance abuse must have abstained from the abuse substance for at least one year. Subjects with clinically significant retinal abnormalities
• Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
• Subjects who are part of the staff personnel directly involved with the study
• Subjects who are immediate family members of the investigational study staff