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Treatment of Spanish HIV-infected Patients with Recurrent Hepatitis C Virus after Liver Transplantation with Pegylated Interferon + Ribavirin: Preliminary Results of the FIPSE OLT-HIV-05 - GESIDA 45-05 Cohort Study
Jose M. Miro*1, M Montejo2, L Castells3, A Rimola1, A Rafecas4, P Miralles5, J Fortun6, M Blanes7, M Mata8, J Pons9, and the Spanish OLT in HIV-Infected Patients Working Group
1Hosp Clin-IDIBAPS, Univ of Barcelona, Spain; 2Hosp Cruces, Bilbao; 3Hosp Univ Vall d'Hebrón, Barcelona, Spain; 4Hosp Univ Bellvitge, Barcelona, Spain; 5Hosp Gregorio Maranon, Madrid, Spain; 6Hosp Ramon y Cajal, Madrid, Spain; 7Hosp La Fe, Valencia, Spain; 8Hosp Univ Reina Sofia, Cordoba, Spain; and 9Hosp Univ Virgen de la Arrixaca, Murcia, Spain
Background: Recurrent hepatitis C virus (HCV) after liver
transplantation is a major cause of graft loss and death in HCV/HIV-co-infected
patients. We evaluate efficacy and safety of treatment with pegylated
interferon (pegINF) + ribavirin (RBV) for recurrent HCV after liver
transplantation in this population.
Methods: Prospective multi-center cohort study. In Spain since 2002,
80 liver transplants in 77 HIV-infected patients have been performed. Of these
patients, 13 died (17%), 71 (92%) were HCV/HIV co-infected, and 33 started
anti-HCV therapy with pegINF-α-2a or -α-2b + RBV, planned for 48
weeks. We present the results of the first 16 evaluable patients. Sustained
virological response was defined as undetectable serum HCV RNA viral load 6
months after therapy. We performed an intention-to-treat analysis.
Results: Median (IQR) age was 39 (38 to 45) years, 81% of recipients
were male, and former drug use (81%) was the most common HIV-1 risk factor.
Pre-liver transplantation median (IQR) MELD was 17 (12 to 21). Efavirenz (EFV)
-based regimens were the most common pre-liver transplantation (56%), and
post-liver transplantation (75%) ART. Median (IQR) CD4 cell count pre-liver
transplantation was 288 (180 to 425) cells/mm3 and all but 1 patient
had undetectable plasma HIV RNA viral load. Patients received cyclosporine- or
tacrolimus-based regimens in 32% and 68% of cases, respectively. Genotypes 1/4
or 2/3 were diagnosed in 12 (75%) and 4 (25%) cases, respectively. Median (IQR)
serum HCV RNA viral load before starting therapy was 1,434,000 (780,000 to
3,200,000) IU/mL. Treatment was started a median (IQR) of 7 (5 to 11) months after
liver transplantation. Overall, early virological response (decrease of 2 log
of HCV RNA viral load at 12 weeks), end of therapy response and sustained
virological response were seen in 9 (56%), 5 (31%), and 4 (25%) cases,
respectively. Sustained virological response rates for genotypes 1/4 or 2/3
were 17% and 50%, respectively. Six patients required erythropoietin, and 4, granulocyte colony stimulating
factor due to severe anemia and neutropenia, respectively. Anti-HCV treatment
was stopped due to toxicity or non-virological response in 2 (17%) and 6 (37%)
patients, respectively. Of the 12 non-responders, 6 died (50%) because of graft
loss due to recurrent HCV infection; 6 non-responders had been treated before
liver transplantation without sustained virological response. In addition to
these 16 cases, 1 patient was treated with pegINF alone without sustained
virological response, and another patient had a spontaneous clearance of HCV
reinfection without treatment.
Conclusions: The rate of sustained virological response
with pegINF + RBV was low (25%). New strategies are necessary to improve the
outcome of liver transplantation in co-infected patients.
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