DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral) (DARE-C II)

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Acute/early chronic, Recently acquired, Directly acting antiviral therapy, Sofosbuvir, Ribavirin Read More

Inclusion Criteria:

• Provision of written informed consent
• Male and female patients aged 18 years and above
• Willing to use two effective methods of contraception during the treatment period and 24 weeks post.
• HBsAg negative
• Detectable HCV RNA at screening (>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
• Compensated liver disease (Child-Pugh A)
• Negative pregnancy test at screening and 24 hours prior to first dose of study drugs
• Medically stable on the basis of physical examination, medical history and vital signs
• Adequate English to provide reliable responses to the study questionnaires
• Recent hepatitis C infection, as defined by: A) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 24 months prior to anti-HCV antibody positive result, OR B) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable

If co-infection with HIV is documented, the subject must meet the following criteria:

• Antiretroviral (ARV) untreated for >8 weeks preceding screening visit with CD4 T cell count >500 cells/mm3 OR
• On a stable ARV regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and an undetectable plasma HIV RNA level.

Exclusion Criteria:

• Standard exclusions to RBV therapy
• Pregnancy/lactation or male subjects whose female partners are pregnant
• Subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.INR of ≥1.5; Serum albumin <3.3 g/dL; Serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with Gilbert's syndrome.