None listed
Conditions
Brief summary
ATAHC II is a prospective longitudinal study of natural history and treatment outcomes following response-guided treatment of recent HCV infection. The main aim of the study is to identify the optimal therapeutic strategy for patients with recently acquired HCV infection. Eligible subjects will be offered HCV treatment with pegylated interferon alfa-2a with or without ribavirin, depending on their HIV status and their duration of infection. The duration of treatment will be guided by the subject’s virological response to treatment and will range from 8 weeks to 48 weeks. Subjects who are not eligible for HCV treatment or chose not to receive HCV treatment will be followed at regular intervals for 2 years
Interventions
Group 1: Untreated subjects - subjects who are not eligible or chose not to receive anti-hepatitis C treatment will be followed for up to 2 years.
Group 2: Treated subjects - subjects who are eligible for anti-hepatitis C treatment and chose to receive treatment will receive response-guided treatment. The duration of treatment will depend on the subject's virological response, ranging from 8 to 48 weeks. The type of treatment received will depend on the estimated duration of hepatitis C infect
Group 1: Untreated subjects - subjects who are not eligible or chose not to receive anti-hepatitis C treatment will be followed for up to 2 years. Group 2: Treated subjects - subjects who are eligible for anti-hepatitis C treatment and chose to receive treatment will receive response-guided treatment. The duration of treatment will depend on the subject's virological response, ranging from 8 to 48 weeks. The type of treatment received will depend on the estimated duration of hepatitis C infection and HIV disease status. Subjects will receive pegylated interferon alfa-2a with or without ribavirin. Early acute sub-group: Subjects who have been infected within the last 12 weeks of screening will be eligible to participate in the early acute sub-study and have 4 extra visits for collection of research blood samples between screening and baseline visits. The mode of administration of pegylated interferon alfa-2a is subcutaneous injection 180mcg weekly. The mode of administration of ribavirin is oral tablet, 800mg to 1200mg daily depending on the genotype of the subject (and the body weight of the subject if genotype 1).
Sponsors
The University of New South Wales (acting through the Kirby Institute, formerly the National Centre in HIV Epideiology and Clinical Research))
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and female subjects >= 16 years of age To have recently acquired HCV infection as defined below: A) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV antibody negative within the 24 months prior to anti-HCV antibody positive result OR B) i) First anti-HCV antibody 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
Exclusion criteria
Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples, and standard exclusion criteria for pegylated interferon alfa-2a and ribavirin.
Outcome results
None listed