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Hepatitis Research under the FDAFDA 

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In 1978, and following efforts over several years, FDA finalized regulations to help lessen the likelihood of hepatitis contamination of blood through labeling. Research suggested a significant difference in likelihood of such contamination from paid blood donors rather than volunteers. Henceforth, blood intended for transfusion had to be labeled as either paid or volunteer sourced.

Non-A, non-B Hepatitis Antigen attracted more research attention of Bureau scientists in 1978. This antibody system was detected using the older counter-electrophoresis test. It was found in s of 7 experimental animals infected by another animal infected with the same antibody system. Also, the same antigen was collected over 5-6 years from a patient suffering chronic hepatitis. That patient transmitted the same antigen to a nurse who experienced an accidental needle stick, and the patient’s antigen also was transmitted to an animal model. By mid-1984 90 percent of post-transfusion cases of hepatitis and up to 40 percent of community acquired cases in the U. S. were non-A, non-B. Though the agent had not yet been identified, research shed more light on its characteristics. It appeared to be a retrovirus or retrovirus-like entity, and additional observations of the agent in a half-dozen samples of serum- or plasma-based products brought the Office of Biologics Research and Review (OBRR), what biologics regulation at FDA was called in the early 1980s, closer to develop screening tests for non-A, non-B.

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Dive class grid-col-8 FDA licensed two tests in 1990 to detect Hepatitis C. Previously, researchers from CDC and industry constructed a non-A, non-B viral protein from a single stranded ribonucleic acid isolated from an animal model infected with non-A, non-B hepatitis. Recombinant DNA manipulation of this protein produced enough quantity to enable development of a commercial assay to detect antibodies to this viral protein. Clinical trials assessed the ability of this assay to detect antibodies formed against this viral protein, now designated c100-3, in donor blood. The trials showed that eliminating units that tested positive for antibodies to the c100-3 protein could eliminate non-A, non-B hepatitis, and that there was one major non-A, non-B virus, subsequently designated Hepatitis C. The first anti-HCV antibody test was licensed in May, and the second two months later.   Dive class grid-col-4 Image Modified Span class caption FDA announced in 1990 the first screening test for Hepatitis C (from the Hartford Courant, Friday, May 4, 1990).  Span class credit FDA History Office

In July 1986, OBRR licensed the first recombinant viral vaccine, for Hepatitis B. The same manufacturer, Merck, Sharp & Dohme, had received a license for a Hepatitis B vaccine some years earlier.
    
In July 1992, the Center for Biologics Evaluation and Research (CBER), which is what biologics regulation is still called at the FDA today, issued the first license for a treatment of chronic Hepatitis B for recombinant interferon alfa-2b. FDA had previously approved this for other indications, including hairy cell leukemia. CDC estimated at that time 750,000 to 1 million Americans had the Hepatitis B virus, and one-quarter would develop chronic, active hepatitis.

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