Efficacy of Heat Treatment of Factor VIII Concentrate

Cuthbert, R. J. G.; Ludlam, C. A.; Brookes, E.; McClelland, D. B. L.

doi:10.1111/j.1423-0410.1988.tb03904.x

Cited by 5 publications

(1 citation statement)

References 2 publications

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“…[21][22][23][24] Studies of currently licensed products have demonstrated a high degree of safety; there have been no HIV infections with any product currently licensed in the United States. 5,[25][26][27][28][29][30][31][32][33] However, it should be emphasized that the rarity of these infections requires that many patients be enrolled in these trials. An incidence of 1 infection per 1000 patients per year would not be detectable in a trial of 40 or 50 patients.…”

Section: Human Immunodeficiency Virusmentioning

confidence: 99%

Viral Safety of Clotting Factor Concentrates

Fricke

Lamb²

1993

Semin Thromb Hemost

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The efforts to reduce the risk of viral disease due to clotting factor concentrates have been quite successful. However, additional steps need to be taken to protect the users of these products. First, all patients should be vaccinated against hepatitis B. Second, vaccines against other viruses need to be developed. There is a great deal of interest in an HIV vaccine, and a vaccine against hepatitis C would also be a great boon to the "at risk" population. Third, more effective inactivation procedures need to be implemented in the manufacturing of concentrates other than Factor VIII, including Factor IX Complex, Coagulation Factor IX (Human), and Anti-Inhibitor Coagulant Complex. Despite the advances that have been made, it should be remembered that none of these procedures is perfect and the risk will never be reduced to zero. This is because the plasma pools will always contain infectious virus and the manufacturing process, regardless of how carefully controlled, cannot be made fail-safe. Errors will be made that result in contamination or inadequate treatment of products. For this reason, strict adherence to standard operating procedures and good manufacturing practices is essential. The investments of time, money, and hard work that have been made toward improving the safety of clotting factor concentrates have yielded a handsome return thus far. It is hoped that continued efforts in this direction will result in even greater benefits.

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