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PAPERBACK
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5, 8, and 11-15 have evidence of ongoing HBV infection (HBsAg, HBeAg, and HBV DNA positive, with elevated liver enzyme levels).

Patient 3, who underwent liver transplantation, is doing well on cyclosporine, azathioprine, and prednisone. He is receiving long-term hepatitis B immunoprophylaxis and remains HBsAg and HBV DNA negative. He has physical signs of an ongoing peripheral neuropathy, confirmed by nerve conduction studies. He continues to be followed at Emory University and NIH every 3 to 6 months. Liver function is now normal, and a recent liver biopsy showed only nonspecific changes.

Patient 10 continues to be followed closely at NIH following liver transplantation. He has both clinical and electrophysiologic evidence of a peripheral neuropathy. His liver function is normal, and he remains HBsAg and HBV DNA negative on hepatitis B immunoprophylaxis. His immunosuppression consists of cyclosporine and prednisone treatment. He continues to be weak and to have difficulty walking, although he can drive a car. A follow-up liver biopsy has shown only nonspecific changes. He will continue to be followed at NIH and the University of Virginia on a regular basis.

CONCLUSIONS

Although the outcome was tragic, the IOM committee believes that there was sufficient justification for initiating the PPPC trial, that the protocol and consent form were appropriate, and that the conduct of the trial was equal to or better than the prevailing standards of care. There is no evidence that there was information available at the initiation of the PPPC trial or at any time during the trial itself that would have or should have averted the ultimate disaster.



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