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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
10.8. Appendix 8: Criteria for Allowing Inclusion of Participants With Chronic Stable
HIV, HCV, or HBV Infection
Potential participants with chronic stable HIV, HCV, or HBV infection may be considered
for inclusion if they fulfill the following respective criteria.
Known HIV infection
• Confirmed stable HIV disease defined as documented viral load <50 copies/mL and
3
CD4 count >200 cells/mm within 6 months before enrollment, and on stable
antiretroviral therapy for at least 6 months.
Known HCV infection
• History of chronic HCV with evidence of sustained virological response (defined as
undetectable HCV RNA) for ≥12 weeks following HCV treatment or without
evidence of HCV RNA viremia (undetectable HCV viral load).
Known HBV infection
Confirmed inactive chronic HBV infection, defined as HBsAg present for ≥6 months and the
following:
• HBeAg negative, anti-HBe positive
• Serum HBV DNA <2000 IU/mL
• Persistently normal ALT and/or AST levels
• In those who have had a liver biopsy performed, findings that confirm the absence of
significant necroinflammation.
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