Few HIV-positive Italians candidates for liver transplant if strict criteria used

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Few HAART-treated HIV-positive Italians are suitable candidates for organ transplant using strict criteria designed to minimise the risk of organ rejection or wastage due to the early death of the recipient, according to the results of an initial survey published in the September 26th edition of AIDS.

HIV-positive candidates for liver or kidney transplants were assessed using very strict criteria, which the Italians say are justified by the very poor prognosis of HIV-positive organ recepients and the shortage of organs for transplant. However, studies reported last year (see link below) suggest that HIV-positive patients who receive organs have a prognosis at least as good as HIV-negative individuals.

Project HOST (HIV organ sharing and transplantation) is an Italian multicentre study. It is designed to investigate several issues involved in organ transplants and HIV. These issues involve the incidence of end-stage organ disease in HIV-positive individuals (HOST 1); the need for organs (HOST 2); a strategy to expand the pool of organ donors (HOST 3); an evaluation of organ transplants in HIV-positive individuals (HOST 4); pre and post-transplant monitoring (HOST 5); and the definition of guidelines for transplant candidate selection and management (HOST 60).

Glossary

prognosis

The prospect of survival and/or recovery from a disease as anticipated from the usual course of that disease or indicated by the characteristics of the patient.

cirrhosis

Severe fibrosis, or scarring of organs. The structure of the organs is altered, and their function diminished. The term cirrhosis is often used in relation to the liver. 

exclusion criteria

Defines who cannot take part in a research study. Eligibility criteria may include disease type and stage, other medical conditions, previous treatment history, age, and gender. For example, many trials exclude women who are pregnant, to avoid any possible danger to a baby, or people who are taking a drug that might interact with the treatment being studied.

AIDS defining condition

Any HIV-related illness included in the list of diagnostic criteria for AIDS, which in the presence of HIV infection result in an AIDS diagnosis. They include opportunistic infections and cancers that are life-threatening in a person with HIV.

end-stage disease

Final period or phase in the course of a disease leading to a person's death.

Between autumn 2001 and September 2002, 38 Italian infectious diseases centres participated in the study. Data received from these centres has been entered into a database, and using standard scores (Child-Turcotte-Pugh) and classifications (united network organ sharing) used for Italian transplant patients, a virtual waiting list has been created.

In addition, investigators further stratified patients according to whether they have an HIV viral load below 50 copies/mL, a CD4 cell count above 200 cells/mm3, and a CD4 cell count above 350 cells/mm3.

Analysis has been conducted on 135 HIV-positive patients with cirrhosis. Of these 90% were also coinfected with hepatitis C virus.

Only 71 patients (52.5%) met the classification to be listed for a transplant. General exclusion criteria, including alcohol or drug addiction, methadone treatment, and the presence of an AIDS-defining illness reduced the pool of eligible patients to 27 (20%).

These patients were then divided according to the urgency of need, with one patient in group 2A (urgent need, death within seven days unless a new organ obtained) , ten in 2B (not as serious as 2A, but still in need of constant medical attention and frequent hospitalisation), and 16 in group 3 (serious organ damage with a transplant needed, but no immediate threat to life).

Patients eligibility for transplant was further reduced when the investigators assessed HIV viral load and CD4 cell count. Of the ten patients in group 2B, only eight individuals remaining as candidates for transplant when a test of a CD4 cell count above 200 cells/mm3 was applied, falling to only five when a CD4 cell count of 350 cells/mm3 was required. When the investigators further analysed the characteristics of these patients they found that if a viral load of under 50 copies/mL was a requirement for transplant as well as a CD4 cell count of above 350 cells/mm3 then no patient in group 2A would be a candidate for transplant and only one patient in group 2B. The number of patients who were on stand-by for organs would, however, increase to 19.

”These preliminary results seem to indicate” conclude the investigators, “that it is more than possible to determine a subgroup of patients with HIV infection who can be effectively evaluated for transplant in terms of a low risk of HIV progression towards AIDS and sufficient immune function.”

The selection criteria for transplant adopted by the Italian investigators is notably stricter than those used by US physicians who require a CD4 cell count above 100 cells/mm3 for kidney transplant and above 200 cells/mm3 for liver transplant. Nevertheless, the Italian investigators believe that their stricter criteria are justified.

Further information on this website

Organ transplants successful in people with HIV, but concerns over drug interactions - news story September 2002

Successful heart transplant in man with advanced HIV disease reported - news story June 2003

References

Costigliola P et al. Need for liver transplant in HIV-positive patients: first results of a specific survey in Italy, Project HOST. AIDS 17: 2119 - 2121, 2003.