Background:  The safety and efficacy of orthotopic liver transplantation (OLT) in HIV-1-infected patients is currently being re-evaluated in the HAART-era.

Methods: Prospective cohort study of all Spanish HIV-1-infected patients who underwent OLT. Inclusion criteria: Liver criteria were the same as for the non-HIV-1-infected population;  no previous CDC stage C events except tuberculosis, pre-OLT CD4 cell count greater than 100 cells/mm³ and undetectable plasma RNA HIV-1 viral load on HAART or detectable plasma viral load off HAART with post-transplant suppression predicted; and no heroin or cocaine abuse for the last 2 years and no alcohol abuse for the last 6 months. OLT and HIV characteristics at base line and during follow-up were collected using a standardized CRF.

Results: The first OLT in an HIV-1-infected patient was performed in January 2002. Six sites have transplanted 15 HIV-infected patients, 10 in the year 2003. Median (range) age was 38 (35 to 51) years, 80% of recipients were male and former drug use (73%) was the most common HIV-1 risk factor. HCV-related cirrhosis (93%) was the leading indication for OLT. Pre-OLT Child-Pugh class was C, B or A in 6, 7 and 2 cases, respectively. The latter two cases had hepatocellular carcinoma. Pre-OLT antiretroviral therapy was given in 13 cases (efavirenz-based HAART in 9, three NRTI in 3 and protease-inhibitor-based HAART in 1 patient). Median (range) CD4 cell count pre-OLT was 247 (142 to 589) cells/mm³ and 12 patients (80%) had undetectable plasma viral load. 13 recipients received a cadaveric graft and two a graft from a living donor. Immunosuppression therapy was the standard in each center. There was no operative mortality. Median (range) follow-up was 6 (1 to 21) months. None of the patients required re-transplantation. All patients received HAART after OLT. Only one patient died (7%) at 3 months. Death was non-HIV related. One patient had to stop HAART at 4 months because of massive liver steatosis. There was neither clinical nor immunological HIV-1 progression in the remaining cases except in one. Four subjects (27%) experienced rejection and 10 out of 13 (77%) patients with more than one month of follow-up have became HCV re-infected. Therapy with peg-interferon plus ribavirin was started in 3 cases.

Conclusions: OLT is a safe and effective procedure at short/mid-term for selected HIV-1-infected patients in the HAART era. However, HCV re-infection is a cause for concern.

Keywords: HCV; Liver transplantation; HIV-1