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Ana Moreno-Zamora 1 , Rafael B á rcena 2 , Santos del Campo 2 , Alfonso Muriel 3 ,

In the HAART Era, in Viral Cirrhosis Liver Transplant (LT) Candidates, HIV-Coinfection is an Independent Predictor of Mortality while on the Waiting List, but not after LT. Ana Moreno-Zamora 1 , Rafael B á rcena 2 , Santos del Campo 2 , Alfonso Muriel 3 ,

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Ana Moreno-Zamora 1 , Rafael B á rcena 2 , Santos del Campo 2 , Alfonso Muriel 3 ,

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  1. In the HAART Era, in Viral Cirrhosis Liver Transplant (LT) Candidates, HIV-Coinfection is an Independent Predictor of Mortality while on the Waiting List, but not after LT Ana Moreno-Zamora1, Rafael Bárcena2, Santos del Campo2, Alfonso Muriel3, Jesús Fortún1, Adolfo Martínez4, Marisol Arevalillo4, Carmen Quereda1, María J Pérez-Elías1, José L. Casado1, Javier Graus2, Fernando García-Hoz2, Gema de la Poza2, Gema Arranz2, María L. Mateos5, Javier Nuño6, and Santiago Moreno1 Liver Transplant Unit(Services of 1Infectious Diseases, 2Gastroenterology, 4Transplant Coordination Unit, and 6General and Digestive Surgery), 3Clinical Biostatistics, and 5Microbiology (Viral Hepatitis Section) . Hospital Ramón y Cajal. Madrid. Spain

  2. Background • Since the widespread use of HAART, liver related death due to viral cirrhosis (HCV and/or HBV) has arisen as the most frequent cause of non-AIDS related death1-3. • HIV subjects with end-stage liver disease (ESLD) have a shortened survival compared to non-HIV subjects4, and are increasingly considered for liver transplantation (LT). • Recent data support the MELD score as the best predictor of survival on waiting list (WL) in patients with ESLD, regardless HIV status5. 1 Mocroft A, et al. AIDS 2005; 19:2117-2125 2 Weber R, et al. Arch Inter Med 2006; 166: 1632-1641 3 Koziel MJ, et al. N Engl J Med 2007; 356: 1445-1454 4 Ragni MV, et al. Liver Transpl 2005; 11 5 Subramanian A, et al. Gastroenterology 2010; 138 (1): 159-164

  3. Objectives To describe the features of our cohortof patients with viral cirrhosis (HCV and/or HBV) entering the WL for LT since the acceptance of HIV-coinfected subjects. For the whole cohort, to assessindependent predictors of mortality: - On WL - After LT Among HIV-subjects,to assess predictors of mortality on WL including HIV-related factors (HAART, CD4 counts, HIV-RNA).

  4. Methods • Patients: all subjects with viral cirrhosis entering WL for LT. • Study Period: January 2001-June 30th 2010. • Setting: Ramón y Cajal Hospital (Reference Center for LT). • Statistical analyses: 1. Descriptive statistics: demographics ESLD-related events, Child-Pugh and MELD scores outcomes after LT Comparisons according HIV-coinfection (2, Fisher´s Exact test, Mann-Whitney-U) 2. Univariate and multivariate analyses of predictors of mortality on WL Univariate: Log-rank test and Cox-regression. Multivariate Cox-regression model 3. Univariate and multivariate analyses of predictors of mortality after LT* Univariate: Log-rank test and Cox-regression. Multivariate Cox-regression model *excluding patients with early mortality (survival <90d post-LT)

  5. Results(I): Patients entering WL/year Viral etiology: 333/515 (65%)

  6. Results (II): Etiology HIV(-) n=282(85%) HCV HBV n=230 81% HIV(+) n=51(15%) n=10 4% n=42 15% HCV n=41 80% HBV n=10 20% Delta Virus Coinfection HIV (-): 8/52(15%) HIV (+): 7/10 (70%)

  7. Results (III): Outcome on WL in HCV p= 0.001*

  8. Results (IVa):Baseline features Considering only HCV subjects: 240 HIV(-) and 51 HIV(+)

  9. Results (IVb): Baseline Features

  10. Results (V) Univariate Analysis of Baseline Predictors of Mortality on WL(HCV cohort)

  11. HCC Ascites No Ascites HCC No HCC Ascites 90 days92% vs 75% 180 days84% vs 58% 365 days75% vs 49% 90 days73% vs 96% 180 days55% vs 90% 365 days45% vs 82% P=0.0001* P=0.0001* Days on WL Days on WL SBP HE No SBP No HE HE SBP 90 days72% vs 84% 180 days53% vs 72% 365 days40% vs 63% 90 days70% vs 89% 180 days59% vs 75% 365 days52% vs 63% P=0.002* P=0.009* Days on WL Days on WL

  12. HIV (-) HIV (+) Non-significant variables Gender, isolated HCV or HBV, HBsAg+, Variceal bleeding P=0.001* Days on WL Cox Univariate Analysis of Baseline Continuous Variables BMI(P=0.003*), MELD at inclusion in WL (P=0.0001*), Body weight at inclusion in WL (P=0.011*), Age at inclusion in WL (P=0.10)

  13. Results (VI) Independent predictors of Mortality on WL (Cox-regression multivariate model) • Variables included in the model: HIV-coinfection, BMI, MELD and Age at inclusion in WL, prior ascites, SBP, HE, or HCC. • Independent Predictors of Mortality on WL: Age at inclusion in WLHR 1.025; 95% CI 1.000-1.051; p=0.048* Prior ascites HR 2.406; 95% CI 1.320-4.384; p=0.004* MELD at inclusion in WL 15-19 HR 1.572; 95% CI 0.898-2.752; p=0.114 20-24 HR 4.253; 95% CI 2.255-8.023; p=0.0001* >25 HR 7.292; 95% CI 3.688-14.417; p=0.0001* HIV-coinfectionHR 1.950; 95% CI 1.115-3.409; p=0.019*

  14. Results (VII) Univariate Analysis of Baseline Predictors of Mortality on WL(HIV-coinfected)

  15. HAART HIV-RNA<50 HAART Yes No No HAART P=0.10 P=0.12 90 days71% vs 62% 180 days61% vs 39% 365 days54% vs 20% 90 days70% vs 61% 180 days58% vs 41% 365 days52% vs 14% Non-significant variables: CD4 cell counts >100 or >200 cells/ml Cox Univariate Analysis of Baseline Continuous Variables MELDat inclusion in WL (P=0.0001*) Non-significant: HIV-RNA, CD4 (% or absolute counts), BMI, Body weight, Age at inclusion in WL

  16. HIV+ non-HIV <15 <15 15-19 15-19 20-24 20-24 >25 >25 P=0.0001* P=0.0001* <20 <20 >20 >20 P=0.0001* P=0.001*

  17. Liver Transplantation(N=188)

  18. Results (VIII):Etiology HCV N=152 HCV/HBV N= 12 HCV HBV HBVN=24 n=12 6% n=24 13% n=152 81% HIV+ N=19 (10%) HCV/HBV-coinfection higher in HIV+ 5/19 (26%) vs 7/145 (5%) P=0.006*

  19. Results (IX):Post LT Outcomes *selecting HCV subjects: 145 HIV(-) and 19 HIV+ #Fibrosing cholestatic hepatitis

  20. Results (X) Univariate Analysis of Predictive Factors of Mortality after LT(HCV patients) Median follow-up: 116 weeks (0-471)

  21. CMV HBsAg+ 1y 73% vs 92% 2y53% vs 85% 3y 53% vs 80% 5y 53% vs 69% 1y 100% vs 85% 2y100% vs 74% 3y 100% vs 69% 5y 100% vs 61% P=0.002* P=0.027* antiHBV-γ HIV 1y 95% vs 84% 2y91% vs 72% 3y 91% vs 68% 5y 84% vs 60% 1y 94% vs 85% 2y81% vs 74% 3y 81% vs 69% 5y 65% vs 61% P=0.06 P=0.77 Continuous variables: MELD at LT (p=0.033), receptor Age (p=0.12)

  22. Results (XI) Independent predictors of Mortality after LT (Cox-regression multivariate model) • Variables included in the model: MELD at LT, receptor Age, CMV infection, HBsAg+ • Independent predictors of Mortality after LT: CMV infectionHR 2.621; 95% CI 1.396-4.921; p=0.003* MELD at LTHR 1.074; 95% CI 1.017-1.135; p=0.011* Receptor AgeHR 1.050; 95% CI 1.014-1.088; p=0.006*

  23. Conclusions (I) • In our series, HIV+ patients accounted for 15% of subjects with viral cirrhosis entering WL, and 10% of those undergoing LT . • There were significant differences in baseline features and ESLD-related events between HIV+ and non-HIV infected subjects: -HIV+ subjects were significantly younger and had significantly higher rates of HCV/HBV or HCV/HBV/delta coinfections, with no cases of isolated HBV-cirrhosis. -HIV+ subjects had significantly higher rates of ascites and SBP, and significantly lower rates of HCC as the indication for LT. • Despite similar time frames from first evaluation for LT to inclusion in WL, and similar MELD scores at inclusion in WL, HIV-coinfection was an independent predictor of mortality on WL.

  24. A MELD score >20 at inclusion in WL was an independent predictor of mortality on WL, regardless HIV-coinfection. After a median follow-up of 116 weeks after LT, HIV-coinfection did not lead to worse outcomes. A higher MELD score or older age at LT, and the development of CMV infection after LT were independent predictors of mortality during follow-up. Conclusions (II)

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