This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.
The aim of the present study is to determine whether prolonged interferon-based therapy can be achieved and maintained in a reasonable number of subjects over several years' time, and whether the anticipated benefits are worth the risk and expense involved. The study population will be limited to those at highest risk of progression to cirrhosis or its complications, namely, patients with established fibrosis or cirrhosis on biopsy at study entry. Since all patients enrolled will have had different previous treatments, the present study design provides that all patients entering the long-term portion of the study have begun at a common starting point and have had a second chance at reaching a sustained virologic response. In the initial course of therapy all patients will be treated with peginterferon plus ribavirin for a period of 24 weeks, with virologic assessment at 20 weeks to refute their nonresponder status. Thus, patients entering the long-term study will know that they have been given the very latest regimen in an attempt to achieve virologic clearance and, having failed, now can be certain that they are non-responders to conventional therapy. It is anticipated that approximately 20% will have no detectable virus in serum at the 20 week point, and that this group may continue treatment and receive a full course of 48 weeks' therapy. Those who remain HCV-positive in serum at 20 weeks will be randomized to receive either continued peginterferon (without further ribavirin) or no further treatment beyond careful observation for the ensuing 3 and 1/2 years. Week 20 responders who develop detectable HCV RNA at weeks 36, 48, 60 or 72 may be randomized to receive either continued peginterferon (without further ribavirin) or no further treatment beyond careful observation for an additional 42 months.Therapeutic endpoints will be of two types: histologic progression of disease as well as development of evidence of cirrhotic decompensation. The extent of side effects of interferon as well as a detailed assessment of quality of life will be obtained for all study participants.
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