Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders.

摘要: The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial was designed to determine whether maintenance interferon therapy could slow disease progression in patients who had failed eradicate hepatitis virus (HCV) during prior treatment (nonresponders). Ten clinical sites, a virological testing center, and data coordinating center (DCC) were selected collaborate the design implementation of final protocol. Eligible been treated previously with for at least 12 weeks, or without another antiviral, ribavirin, but still persistent viremia. Because received variety treatments, as perceived benefit enrollment, we incorporated Lead-in period long-acting pegylated alfa-2a plus ribavirin into study design, combination believed be more effective not approved by Food Drug Administration Trial's inception. If achieve clearance from blood after 20 weeks this therapy, they entered main trial week 24 randomized receive either lower dose weekly alone no further an additional 3 1/2 years. original protocol amended later three respects improve enrollment adapt approval including allowing proceed directly part if resembling completed. changes enhanced while upholding goals its integrity.