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Potential concerns for simian foamy virus (SFV) transmission by blood and blood products

Potential concerns for simian foamy virus (SFV) transmission by blood and blood products. Hira Nakhasi, Ph.D. DETTD/OBRR/CBER/FDA BPAC, December 13, 2001. Potential concerns for simian foamy virus (SFV) transmission by blood and blood products. Issue:

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Potential concerns for simian foamy virus (SFV) transmission by blood and blood products

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  1. Potential concerns for simian foamy virus (SFV) transmission by blood and blood products Hira Nakhasi, Ph.D. DETTD/OBRR/CBER/FDA BPAC, December 13, 2001

  2. Potential concerns for simian foamy virus (SFV) transmission by blood and blood products • Issue: FDA seeks advice on its approach to assessing the possible transfusion risk from SFV

  3. Background Information • Infections in Primates • Simian Foamy viruses (SFV) belong to retroviridae family. • Prevalence of SFV infection in wild animals is high • Seroprevalence higher in captive vs wild animals.. • Precise mode of transmission is not clear; transmission by saliva is indicated in animals. • Virus has been isolated from various organs of infected animals, but without evidence of pathology.

  4. Background Information • Infections in humans • Some human populations in Africa harbor SFV infections • Humans who are occupationally exposed to non-human primates can be infected by SFV. • Association of several diseases in humans with SFV infection is tenuous • Thorough analysis resulted in failure of such an association.

  5. Current Concerns • Unlinked CDC serosurvey of North American zoo workers identified positive workers • 4/322 were identified as seropositive for SFV originating from chimpanzees; all 4 individuals handled non-human primates. • Seropositivity to SFV found in ~1.8-3.0% of persons occupationally exposed to non-human primates • Unlinked SFV surveillance of non-human primate handlers conducted by Health Canada found 2/46 seroreactive • 1/46 individual serum sample tested strongly positive in SFV western blot (WB) analysis. • 1/46 serum sample reacted weakly in SFV WB test.

  6. Current Concerns……. • SFV has been isolated from human peripheral blood lymphocytes of workers exposed to non-human primates. • Look back study by CDC and ARC • 4 transfused recipients who received blood components from one SFV positive donor tested negative for SFV 1.5 to 7 years post transfusion. • Data appear insufficient to exclude risk from transfusion

  7. Topics to be discussed • A. Review of SFV biology and pathogenesis. (Arifa Khan, FDA) • B. Review of investigation on human infections with SFV and proposed human studies (Louisa Chapman, CDC) • C. Review of risk assessment (Paul Sandstrom, Health Canada) • D. Proposed animal study on SFV transmission by blood (Arifa Khan, FDA)

  8. Questions for the Committee • 1. Does the committee agree that the currently available data are insufficient to determine whether SFV can cause adverse health effects in humans?

  9. Questions for the Committee cont..... • 2. Does the committee agree that currently available data are insufficient to determine whether SFV can be transmitted by blood transfusion?

  10. Questions for the Committee cont...... • 3. Please comment on the adequacy of the proposed studies to evaluate SFV transmission by blood transfusion.

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