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16 th CROI, Montreal, 2009. Hotel AC Forum, Barcelona – February 20 th 2009 16 th CROI, Montreal, 2009. Hotel AC Forum, Barcelona – February 20 th 2009.

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Presentation on theme: "16 th CROI, Montreal, 2009. Hotel AC Forum, Barcelona – February 20 th 2009 16 th CROI, Montreal, 2009. Hotel AC Forum, Barcelona – February 20 th 2009."— Presentation transcript:

1 16 th CROI, Montreal, 2009. Hotel AC Forum, Barcelona – February 20 th 2009 16 th CROI, Montreal, 2009. Hotel AC Forum, Barcelona – February 20 th 2009 José M. Miró Infectious Diseases Unit - ICMiD Hospital Clinic - IDIBAPS University of Barcelona Barcelona (Spain) José M. Miró Infectious Diseases Unit - ICMiD Hospital Clinic - IDIBAPS University of Barcelona Barcelona (Spain) Summary: Opportunistic Infections HCV/HBVCo-Infections &Tumors E-mail address: jmmiro@ub.edu

2  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors OIs, Hepatitis Coinfections & Tumors N= 44 N= 19 N= 11 N= 77 N= 5 N= 17 N= 44 N= 19 N= 11 N= 77 N= 5 N= 17 ~173 abstracts in 20 min. ! http://www.retroconference.org/2009

3  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors OIs, Hepatitis Coinfections & Tumors

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30  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors OIs, Hepatitis Coinfections & Tumors

31 Clinical Relevance of CMV viremia Boffi E, et al. CROI 2009, Montreal; Abstract 795. 1,170 Patients: CMV specific IgG positive, CD4≤ 100; Swiss HIV Cohort.

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36  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & liver transplantation  Tumors OIs, Hepatitis Coinfections & Tumors

37 Immediate vs. Deferred cART in the Setting of Acute AIDS-Related OIs (ACTG A5164) Zolopa AR, et al. CROI 2008, Boston; Abstract 142. Study day Enrollment OI/BI Treatment Starts OI/BI Treatment Starts Immediate Arm Start ART Immediate Arm Start ART Deferred Arm Start ART Deferred Arm Start ART Recommended Start window Recommended Start window 48 wks 48 wks 48 wks 48 wks -14 0 0 2 2 28 42 84 224 Study schema Higher mortality deferred arm !

38 Immediate vs. Deferred cART in the Setting of Acute AIDS-Related OIs (ACTG A5164) Zolopa AR, et al. CROI 2008, Boston; Abstract 142. Outcome ImmediateDeferredp-value IRIS reported1013 IRIS confirmed8 (5.7%)12 (8.5%) Lab AEs Grades 2-3-431 - 39 - 2036 - 45 - 210.77 Clinical AEs Grades 2-3-414 - 40 - 734 - 29 - 60.87 Hospitalizations (>30 d.) Subjects39%36%0.63 Hospital days (median)560.79

39 Risk Factors for IRIS during a RCT of Early vs. Deferred cART in AIDS-Related OIs (ACTG A5164) Grant P, et al. CROI 2009, Montreal; Abstract 775.

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47  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & Liver transplantation  Tumors  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & Liver transplantation  Tumors OIs, Hepatitis Coinfections & Tumors

48 Efficacy of rGM-CSF as an Adjuvant for HBV Vaccination in Adults Infected with HIV-1 Parker S. CROI 2009, Montreal; Abstract 808.

49 Does Telbivudine (Tyzeka) Have Activity Against HIV? CROI 2009, Montreal; Abstracts 813a & 813b. Yes, Case Report Suggests Anti-HIV Activity Lab Studies Say No ! Low E et al. Abs. 813a Avila C et al. Abs. 813b Entecavir Telbivudine

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57 Hyaluronic Acid (HA) as a Prognostic Marker of Liver-related Death in HIV/Viral Hepatitis Coinfected Patients Peters L et al. CROI 2009, Montreal; Abstracts 821. Levels of HA in healthy population = 0-75 ng/mL

58 Sustained Long-term Antiviral Maintenance with Pegylated Interferon in HCV/HIV Coinfected Patients (SLAM-C): Role of Early Virologic Response in Extended Therapy with PEG- Interferon (PEG) and Weight-Based Ribavirin (WBR) in HCV-HIV Coinfection RT Chung, T Umbleja, AA Butt, ZD Goodman, JW Andersen, M Koziel, B Alston, M Peters, M Sulkowski, KE Sherman for the ACTG A5178 Team Abs. # 103LB

59 SLAM-C: Maintenance with Peg-INF in HIV/HCV Coinfected Patients (ACTG 5178) Sherman K, et al. CROI 2008, Boston; Abstract 59. PegIFN alfa 2a + Wt-based ribavirin 12 Weeks6 Weeks UNTREATED CONTROL PegIFN alfa 2a MAINTENANCE PegIFN + Wt-based ribavirin (72 Weeks Total Treatment) 72 Weeks NR 2 log drop or RNA Neg LBx LBx LBx 24 Wks 36 ACTG Sites * *= Direct Entry of Nonresponders from Comparable Non-study Treatments STEP 1 STEP 2 STEP 3

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67  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & Liver transplantation  Tumors  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  Cirrhosis & Liver transplantation  Tumors OIs, Hepatitis Coinfections & Tumors

68 Survival Of HIV-HCV Co-infected Patients With Compensated Liver Cirrhosis: Impact Of Hepatitis C Therapy M Montes, J Pascual,, M Lopez-Dieguez, C Tural, C Quereda, E Ortega, A Arranz, M Von Wichmann, E Barquilla, J Arribas, and GESIDA 37/03-FIPSE 36680/07 Study Group. Abs. # 106

69 OBJECTIVE  To evaluate the effect of therapy for chronic hepatitis C in HIV-HCV coinfected patients with compensated liver cirrhosis on:  Survival  The incidence of first hepatic decompensation Abs. # 106

70 AllHCV Treated HCV Non Treated P Median duration HIV infection (years), (IQR)13 (9-17)12 (8-16)13(9-17)0.18 Median duration HCV infection (years)23 0.77 Transmission route IVDU (%)213 (85.9)158 (86)55 (86)1 CDC stage C (%)79 (32)58 (31.5)21 (33.3)0.96 Receiving HAART at baseline (%)218 (88.3)166 (90.2)52 (82.5)0.11 - HIV-RNA - Baseline (median, IQR) - % HIV RNA BLQ* 50 (49-199) 60.4 50 (49-199) 66.5 50 (50-1765) 51.7 0.001 0.04 Baseline CD4 cell count (median, IQR) Nadir CD4 cell count (median IQR) 437 (284-646) 179 (83 - 272) 441 (293-644) 180 (91-261) 424 (212-648) 160 (72-333) 0.71 0.25 HCV treatment received (%) – Sustained virological response (%) – Still receiving HCV treatment (%) – Non responders or relapsers (%) 184 (74,2)184 44 (24) 3 (1.6%) 137 (74.4) -------- -------- BASELINE CHARACTERISITICS (2) *Below limit of quantification (50-200) c/ml. Abs. # 106

71 VARIABLES ASSOCIATED TO FIRST HEPATIC DECOMPENSATION Univariate analysis PMultivariate analysis P HCV therapy0.38 (0.18-0.82)0.011.31 (0.35-4.8)0.7 HCV sustained virological response0.18 (0.02-1.38)0.1 Receiving HAART at baseline1.4 (0.34-5.96)0.63 HIV RNA BLQ at baseline0.96 (0.43-2.1)0.92 Non-Continuous HAART during follow up3.5 (1.6-7.83)0.0022.5 (1.02-6.1)0.046 CD4 <100 cel/µL at baseline CD4 nadir at baseline 0.048 (0-1382) 0.99 (0.99-1) 0.56 0.41 - Child Pugh score B at baseline - Child Pugh score C at baseline 8.2 (3.66-18.68) 60.5 (7.1-516.5) 0.000 5.8 (2.41-13.8) 62.2 (6.2-618) 0.001 Abs. # 106

72 VARIABLES ASSOCIATED TO SURVIVAL Univariate analysis PMultivariate analysis P HCV therapy0.3 (0.14-0.61)0.0010.75 (0.33-1.7)ns HCV sustained virological response0.44 (0.1-1.9)0.27 Receiving HAART at baseline0.55 (0.21-1.44)0.22 HIV RNA BLQ at baseline0.62 (0.3-1.3)0.19 Non-Continuous HAART during follow up5.7 (2.6-12.4)0.0003.94 (1.64-4.44)0.002 CD4 <100 cel/µL at baseline CD4 nadir at baseline 1.4 (0.2-10.3) 0.99 (0.99-1) 0.73 0.45 - Child Pugh score B at baseline - Child Pugh score C at baseline 9.4 (4.4-20.6) 44 (9.7-201) 0.000 4.22 (1.84-9.7) 17.2 (2.83-104) 0.002 0.001 - Decompensation during follow up10.71 (5.21-22)0.0005.1 (2.35-11.3)0.001 Abs. # 106

73 José M. Miró, 1 Miguel Montejo, 2 Lluis Castells, 3 Juan C. Meneu, 4 Antonio Rafecas, 5 Marino Blanes, 6 Jesús Fortún, 7 Gloria de la Rosa, 8 Iñaki Pérez, 1 Antonio Rimola, 1 and the Spanish OLT in HIV-Infected Patients Working Group. 1 Hosp. Clínic-IDIBAPS. Univ. of Barcelona, Barcelona; 2 Hosp. Cruces, Bilbao; 3 Hosp. Univ. Vall d’Hebrón, Barcelona; 4 Hosp. Univ. 12 de Octubre, Madrid; 5 Hosp Bellvitge-IDIBELL, Barcelona; 6 Hosp. La Fe, Valencia; 7 Hosp. Ramón y Cajal, Madrid; 8 Organización Nacional de Trasplante (ONT), Madrid, Spain. José M. Miró, 1 Miguel Montejo, 2 Lluis Castells, 3 Juan C. Meneu, 4 Antonio Rafecas, 5 Marino Blanes, 6 Jesús Fortún, 7 Gloria de la Rosa, 8 Iñaki Pérez, 1 Antonio Rimola, 1 and the Spanish OLT in HIV-Infected Patients Working Group. 1 Hosp. Clínic-IDIBAPS. Univ. of Barcelona, Barcelona; 2 Hosp. Cruces, Bilbao; 3 Hosp. Univ. Vall d’Hebrón, Barcelona; 4 Hosp. Univ. 12 de Octubre, Madrid; 5 Hosp Bellvitge-IDIBELL, Barcelona; 6 Hosp. La Fe, Valencia; 7 Hosp. Ramón y Cajal, Madrid; 8 Organización Nacional de Trasplante (ONT), Madrid, Spain. 5-Year Survival of HCV/HIV- Coinfected Liver Transplant Recipients (OLT): A Case- Control Study 16 th CROI 2009, Montreal (Canada) - 2009 Abs. # 833

74 OLT in Spanish HIV-Infected Patients in the HAART Era (2002-07) (N=116) 0.5%**1.5%1.8%3.0% 1.5% 84 cases Abs. # 833

75 HIV+ (N=84) vs. HIV- (N=1,927): Patient Survival After OLT in HCV-Infected Patients According to HIV Status 49% (35-61%) 88% (79-93%) 66% (63-68%) 83% (81-84%)

76 Main Characteristics & Outcome Male gender Age (years)* HBV coinfection HCC** Follow-up (yrs)* RetransplantationDeath Male gender Age (years)* HBV coinfection HCC** Follow-up (yrs)* RetransplantationDeath78%4216%8% 2.6 2.6 4 (5%) 30 (36%) 78%4216%8% 2.6 2.6 4 (5%) 30 (36%) * Median; ** Hepatocellular carcinoma. 78%4616%8%1.9 12 (5%) 50 (20%) 78%4616%8%1.9 12 (5%) 50 (20%) HIV+HCV N=84 HIV+HCV N=84 HCV N=252 Abs. # 833

77 Case (N=84) - Control (N=252) Study: Patient Survival After OLT in HCV-Infected Patients According to HIV Status 49% (35-61%) 77% (70-82%) 89% (85-92%) 88% (79-93%)

78 MELD - WL (1 unit increase) - WL (1 unit increase) MELD - WL (1 unit increase) - WL (1 unit increase) VariableVariable HR (95% CI) 1.08 (1.02;1.15) P value.012.012 Multivariate Analysis of Mortality (Model I): Only Pre-OLT Variables Pre-OLT variables (p<0.10) Abs. # 833

79 VariableVariable HR (95% CI) P value Pre-OLT + Donor and perioperative + Post-OLT variables (p<0.10) Multivariate Analysis of Mortality (Model II): All Variables HCV genotype - 2, 3 or 4 - 2, 3 or 4 - 1 - 1 Cause of donor brain death - Cranial trauma - Cranial trauma - Other - Other RBC transfusion -  3 units -  3 units - > 3 units - > 3 units Invasive fungal Infection - No - No - Yes - Yes HCV genotype - 2, 3 or 4 - 2, 3 or 4 - 1 - 1 Cause of donor brain death - Cranial trauma - Cranial trauma - Other - Other RBC transfusion -  3 units -  3 units - > 3 units - > 3 units Invasive fungal Infection - No - No - Yes - Yes 1 2.53 (1.12; 5.70)1 3.51 (1.05; 11.8)1 3.25 (1.47;7.19) 1 5.60 (1.83;17.1) 1 2.53 (1.12; 5.70)1 3.51 (1.05; 11.8)1 3.25 (1.47;7.19) 1 5.60 (1.83;17.1).025.041.004.002.025.041.004.002 Abs. # 833

80  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  SOT in HIV-infected patients  Tumors  Tuberculosis  Other opportunistic infections  IRIS  HBV & HCV co-infections  SOT in HIV-infected patients  Tumors OIs, Hepatitis Coinfections & Tumors

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86 High Dose AZT plus Valganciclovir in The Treatment of Kaposi’s Sarcoma-Associated Herpesvirus - Associated Multicentric Castleman’s Disease. Uldirch T et al. CROI 2009, Montreal; Abstracts 864.

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92 Q&A from the audience OIs, Hepatitis Coinfections & Tumors


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