A review of clinical studies evaluating the efficacy of HIV inactivation methods

Seroconversion surveillance is informative and must be continued. The level of safety is now so high that individual candidate cases of seroconversion need exquisite investigation to exclude the possibility of another source of the HIV infection. Consequently, we must be mindful that the inappropriate assignment of an HIV seroconversion incident to a blood product not only misrepresents the risk associated with currently available blood products, but may unfairly and devastatingly damage the reputation of a necessary and precious biological product. Inappropriate anxiety about a product, with resultant abandonment of its therapeutic benefit, may drastically reduce available factor concentrates, encourage price escalations associated with shortages, and lead unsettled patients to reduce their levels of prescribed therapy--with life threatening consequences. By monitoring the HIV-antibody testing records for all collection sites of a company's source plasma procurement network, the number and percent of donors found to be confirmably HIB-antibody positive might provide a clue to possible changes in the level of the undetected virus burden introduced into the source plasma supply. However, the combined efforts to develop higher purity products, combined with stringent inactivation methods has resulted in a product mix in use in the U.S. and elsewhere that seems to carry a risk of HIV seroconversion of less than 1 per 1000 patient-years of therapy.