A 37-year-old woman involved in a Phase II clinical trial of theexperimental hepatitis B drug fialuridine (FIAU) who receiveda liver transplant on July 9 and was in RfairS condition as ofMonday was downgraded to RcriticalS condition on Wednesday.
According to a spokeswoman for the University of Virginia, hercondition was worsening. Another FIAU trial patient, a 63-year-old man who received a liver transplant on July 19, wasalso downgraded from RseriousS to Rcritical.S
In addition, a patient who had been under observation at theNational Institutes of Health (NIH) clinical center in Bethesda,Md., was transferred to the University of Pittsburgh (UOP) onWednesday. UOP is equipped with liver transplant facilities.According to NIH spokeswoman Elizabeth Singer, thetransferred patientUs condition is assumed to be worsening.
Of the 10 FIAU trial patients treated at the NIH who receivedthe drug for 67 to 90 days, three have died from liver failureand intractable lactic acidosis (toxicities believed to be directlyrelated to FIAU), two are now in critical condition after livertransplants, one is being treated at transplant-equipped EmoryUniversity, one is at UOP, and three have been discharged fromNIH care but are still being monitored twice a week.
RThe more time that goes by without serious adverse events,the better off these patients appear to be,S said Singer. RWekeep hoping that this will be the limit.S -- Lisa Piercey
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