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New Information on Liver & Kidney Transplants in HIV+ Patients
Reported by Jules Levin
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Last week I sent you a report on Michelle Roland's oral presentation at Barcelona. My report was titled "Liver Transplants Successful in HIV". The full original report is accessible at the end of this report. This report contains information from Dr Roland's office that address few questions that came up following her Barcelona talk.
There was a question regarding the 4 deaths, if 2 of the 4 were in patients who were ineligible for the study but received transplants anyway. There were 19 liver transplant recipients (HIV+) in Roland's study, and 4 of the 19 died. There were 2 additional deaths among those individuals who were not eligible for the study because they did not meet study criteria (n=8).
What we learned from the study: Criteria for HIV+ Transplants
There were 8 patients who were not eligible by study criteria due to a history of opportunistic infections, low CD4 count, or HIV RNA >50. Patients with a history of opportunistic infections were ineligible for the study. That was the criteria the study protocol set. Now, Dr Roland feels patients with an OI history can be candidates for transplant.
To be eligible for the study patients had to have >200 CD4s for a kidney transplant and >100 CD4s to receive a liver transplant. As well, viral load was required to be <50 for recipients of kidney transplant. For liver recipients patients had to have <50 copies or if they were intolerant to ARTs patients could be accepted into study if it was felt they would be more tolerant of ART after the transplant. Now, Dr Roland feels that if a patient is not very advanced or ill and CD4 or viral load is just off the criteria the patient may do fine.
As a result, Dr Roland has opened up or liberalized her study criteria.
HCV+ Patients Do Not So Far Appear to Do as Well As HBV+ Patients
Dr Roland suggests this may be due in part to that HCV+ patients don't do as well, in general, post-transplant as discussed in my original article. As well, Dr Roland suggests this could be because HIV accelerates HCV. Other reasons that have been suggested are drug-drug interactions, poor control of HCV after transplant or immunosuppressive drugs. It remains unclear if using pegylated interferon plus ribavirin will improve outcomes, but it's thought that it might improve post-transplant progression of HCV disease compared to using standard interferon/ribavirin.
In Roland's study, of the 19 HIV+ liver transplant recipients who were transplanted under similar study criteria the retrospective data shows:
--9 patients had HCV and have been followed for an average of 422 days (as of 6/15/02). 3 of these patients have died (day 169, 438, 584).
--3 of the 19 had HBV and they have been followed for an average of 332 (as of 6/15/02).
--4 patients had both HBV & HCV and the average follow-up has been 561 days for these patients (as of 6/15/02). 2 of these patients died (day 13, 1696)
--3 patients had neither HBV or HCV and had an average follow-up of 612 days (as of 6/15/02).
The restrospective data on 26 HIV+ kidney transplants from this study, who again were transplanted under this study criteria show:
--19 of the 26 were cadaveric donors with an average followup of 236 days (range 141-788 days). There has been one death at day 186.
--7 of these 26 were from living donors. The average followup for them has been 195 days (range 3-1484) and there has been 1 death at day 371.
HIV+ Priority
In my article I discussed how HIV+ in general have a lower priority for receiving transplants and what the historical thinking was regarding that. This study was planned to try and reverse that thinking and to improve reimbursement. Insurance reimbursement is more difficult for liver transplants in HIV because of prior thinking. This study was initiated to try to establish data proving that HIV+ patients could respond well and to change insurance reimbursement. At the 13 centers participating in this study and doing liver and kidney transplants, people with HIV have the same priority as those without HIV. They hope to have additional funding to expand to 17 centers.
Link to original report on the study presentation at Barcelona:
www.natap.org/2002/barcelona/day25.htm
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