CompletedPhase 4ACTRN12611000513910

Treatment of recently acquired hepatitis C infection study

The effectiveness of Response-guided therapy strategies in recent hepatitis C infection

Sponsor

The University of New South Wales (acting through the Kirby Institute, formerly the National Centre in HIV Epideiology and Clinical Research))

Enrollment

120 participants

Start Date

Sep 22, 2011

Study Type

Interventional

Conditions

Hepatitis C

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

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This trial studies the treatment of recently acquired hepatitis C infection using pegylated interferon and ribavirin. It focuses on people who were diagnosed with hepatitis C within the last six months, when early treatment may be more effective at clearing the virus before it becomes a chronic infection.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 eligibl

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).