A Prospective Study Of Anti-hepatitis C Virus Positive Blood Donors

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Abstract

When anti-HCV donor screening was introduced in 1990, it became apparent that many donors would need to be notified and counseled regarding a positive test result and that transfer of that information to the donor might invoke uncertainty and fear. Under Dr. Alter legacy a study to enroll anti-HCV positive donors from NIH and from the Greater Chesapeake Region of the American Red Cross was initiated. There were multiple objectives: from testing related questions to transmission and risk factors to possible treatment and long term follow up. A 15-year within study analysis was published in 2012. In that 15-year analysis, biopsied patients had been followed for a mean of 25 years since their presumed HCV exposure from either blood transfusion or shared intravenous drugs (IVDU). We intended to follow these subjects as long as resources allowed. Our primary goal has always been to define the natural history of HCV infection, but the primary goal became to treat this cohort to cure then. The extraordinarily high cure rate (95-98%) and very low toxicity of new direct acting anti-virals dictated that we treated all HCV RNA+ patients in this cohort. While we continued to follow the natural history of HCV infection in untreated subjects, we initiated a new study with the NIDDK Liver Service referring this cohort to the treatment and to follow the outcome of curative therapy. In 2023 the NIDDK protocol closed the treatment phase so, there was no longer a NIH study to refer HCV positive patients to for treatment. We currently have no active patients remaining on the protocol. We closed the study on November 3, 2023 after we saw the last active study patient in clinic for their annual visit. The study is open to data analysis.The repository of serum samples in the study which were obtained 4 times in the first year and every 6 months for up to 20 years after enrollment is invaluable for sequential studies of viral load, viral quasispecies, and humoral immune responses. One particular aspect we will follow is whether any patients lose HCV RNA or antibodies to HCV once they have established chronic infection.