16 th croi, montreal, 2009. hotel ac forum, barcelona – february 20 th 2009 16 th croi, montreal,...

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

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

José M. MiróInfectious Diseases Unit - ICMiD

Hospital Clinic - IDIBAPS University of Barcelona

Barcelona (Spain)

José M. MiróInfectious Diseases Unit - ICMiD

Hospital Clinic - IDIBAPS University of Barcelona

Barcelona (Spain)

Summary: Opportunistic Infections HCV/HBVCo-Infections &Tumors

Summary: Opportunistic Infections HCV/HBVCo-Infections &Tumors

E-mail address: [email protected] address: [email protected]

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. !~173 abstracts in 20 min. !

http://www.retroconference.org/2009http://www.retroconference.org/2009

Abs. # 36bLB

Abs. # 35Abs. # 35

Abs. # 36a

Abs. # 36cLB

Clinical Relevance of CMV viremia Boffi E, et al. CROI 2009, Montreal; Abstract 795.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.

Abs. # 32

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 Study day

EnrollmentEnrollment

OI/BI Treatment

Starts

OI/BI Treatment

Starts

Immediate Arm

Start ART

Immediate Arm

Start ART

Deferred ArmStart ART

Deferred ArmStart ART

RecommendedStart window

RecommendedStart window

48wks48

wks

48wks48

wks

-14-14 00 22 2828 4242 8484 224224

Study schemaStudy schema

Higher mortality deferred arm !





Outcome Immediate Deferred p-value

IRIS reported 10 13IRIS confirmed 8 (5.7%) 12 (8.5%)Lab AEsGrades 2-3-4 31 - 39 - 20 36 - 45 - 21 0.77Clinical AEsGrades 2-3-4 14 - 40 - 7 34 - 29 - 6 0.87Hospitalizations (>30 d.)

Subjects 39% 36% 0.63Hospital days (median) 5 6 0.79

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.

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.

Abs. # 34

Tuberculosis Other opportunistic infections IRIS HBV & HCV co-infections Cirrhosis & Liver transplantation Tumors




Efficacy of rGM-CSF as an Adjuvant for HBV Vaccination in Adults Infected with HIV-1

Parker S. CROI 2009, Montreal; Abstract 808.

Efficacy of rGM-CSF as an Adjuvant for HBV Vaccination in Adults Infected with HIV-1

Parker S. CROI 2009, Montreal; Abstract 808.

Does Telbivudine (Tyzeka) Have Activity Against HIV?

CROI 2009, Montreal; Abstracts 813a & 813b.

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. 813aAvila C et al. Abs. 813b

Entecavir Telbivudine

Abs. # 101

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.

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

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

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 Weeks 6 WeeksUNTREATED CONTROL

PegIFN alfa 2aMAINTENANCE

PegIFN + Wt-based ribavirin(72 Weeks Total Treatment)

72 Weeks

NR

2 log dropor RNA Neg

LBx LBx LBx

24 Wks

36 ACTGSites

*

*= Direct Entry of Nonresponders from Comparable Non-study Treatments

STEP 1

STEP 2

STEP 3

Abs. # 103LB

Survival Of HIV-HCV Co-infected Patients With Compensated Liver Cirrhosis: Impact Of Hepatitis C

TherapyM 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

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

All HCV

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 23 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

VARIABLES ASSOCIATED TO FIRST HEPATIC DECOMPENSATION

Univariate analysis

P Multivariate analysis

P

HCV therapy 0.38 (0.18-0.82) 0.01 1.31 (0.35-4.8) 0.7

HCV sustained virological response 0.18 (0.02-1.38) 0.1

Receiving HAART at baseline 1.4 (0.34-5.96) 0.63

HIV RNA BLQ at baseline 0.96 (0.43-2.1) 0.92

Non-Continuous HAART during follow up 3.5 (1.6-7.83) 0.002 2.5 (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

0.0005.8 (2.41-13.8)

62.2 (6.2-618)

0.001

0.001

Abs. # 106

VARIABLES ASSOCIATED TO SURVIVAL

Univariate analysis

P Multivariate analysis

P

HCV therapy 0.3 (0.14-0.61) 0.001 0.75 (0.33-1.7) ns

HCV sustained virological response 0.44 (0.1-1.9) 0.27

Receiving HAART at baseline 0.55 (0.21-1.44) 0.22

HIV RNA BLQ at baseline 0.62 (0.3-1.3) 0.19

Non-Continuous HAART during follow up 5.7 (2.6-12.4) 0.000 3.94 (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

0.000

4.22 (1.84-9.7)

17.2 (2.83-104)

0.002

0.001

-Decompensation during follow up 10.71 (5.21-22) 0.000 5.1 (2.35-11.3) 0.001

Abs. # 106

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.

1Hosp. Clínic-IDIBAPS. Univ. of Barcelona, Barcelona; 2Hosp. Cruces, Bilbao; 3Hosp. Univ. Vall d’Hebrón, Barcelona; 4Hosp. Univ. 12 de Octubre, Madrid; 5Hosp Bellvitge-IDIBELL, Barcelona; 6Hosp. La Fe, Valencia; 7Hosp. Ramón y

Cajal, Madrid; 8Organización 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.

1Hosp. Clínic-IDIBAPS. Univ. of Barcelona, Barcelona; 2Hosp. Cruces, Bilbao; 3Hosp. Univ. Vall d’Hebrón, Barcelona; 4Hosp. Univ. 12 de Octubre, Madrid; 5Hosp Bellvitge-IDIBELL, Barcelona; 6Hosp. La Fe, Valencia; 7Hosp. Ramón y

Cajal, Madrid; 8Organización Nacional de Trasplante (ONT), Madrid, Spain.

5-Year Survival of HCV/HIV- Coinfected Liver Transplant Recipients (OLT): A Case-

Control Study

16th CROI 2009, Montreal (Canada) - 200916th CROI 2009, Montreal (Canada) - 2009

Abs. # 833

OLT in Spanish HIV-Infected Patients in the HAART Era (2002-07) (N=116)

OLT in Spanish HIV-Infected Patients in the HAART Era (2002-07) (N=116)

0

5

10

15

20

25

30

35

2002 2003 2004 2005 2006 2007

AliveDeath

0.5%** 1.5% 1.8% 3.0% 3.0%1.5%

84 cases84 cases84 cases84 cases

Abs. # 833

HIV+ (N=84) vs. HIV- (N=1,927): Patient Survival After OLT in HCV-Infected Patients According to HIV StatusHIV+ (N=84) vs. HIV- (N=1,927): Patient Survival After

OLT in HCV-Infected Patients According to HIV Status

49% (35-61%)49% (35-61%)

88% (79-93%)88% (79-93%)

66% (63-68%)66% (63-68%)83% (81-84%)83% (81-84%)

Main Characteristics & OutcomeMain Characteristics & Outcome

Male genderMale genderAgeAge ( (yearsyears)*)*HBV coinfectionHBV coinfectionHCC**HCC**Follow-up (yrs)*Follow-up (yrs)*RetransplantationRetransplantationDeathDeath

Male genderMale genderAgeAge ( (yearsyears)*)*HBV coinfectionHBV coinfectionHCC**HCC**Follow-up (yrs)*Follow-up (yrs)*RetransplantationRetransplantationDeathDeath

78%78%4242

16%16%8%8% 2.62.6

4 (4 (55%)%)30 (36%)30 (36%)

78%78%4242

16%16%8%8% 2.62.6

4 (4 (55%)%)30 (36%)30 (36%)

* * MeMediandian; ** Hepatocellular carcinoma. ; ** Hepatocellular carcinoma. * * MeMediandian; ** Hepatocellular carcinoma. ; ** Hepatocellular carcinoma.

78%78%4646

16%16%8%8%1.91.9

12 (12 (55%)%)50 (20%)50 (20%)

78%78%4646

16%16%8%8%1.91.9

12 (12 (55%)%)50 (20%)50 (20%)

HIV+HCVN=84

HIV+HCVN=84

HCVN=252

Abs. # 833

Case (N=84) - Control (N=252) Study: Patient Survival After OLT in HCV-Infected Patients According to HIV Status

Case (N=84) - Control (N=252) Study: Patient Survival After OLT in HCV-Infected Patients According to HIV Status

49% (35-61%)49% (35-61%)

77% (70-82%)77% (70-82%)

89% (85-92%)89% (85-92%)

88% (79-93%)88% (79-93%)

MELD - WL (1 unit increase)- WL (1 unit increase)MELD - WL (1 unit increase)- WL (1 unit increase)

VariableVariableVariableVariable HR (95%HR (95% CI)CI)HR (95%HR (95% CI)CI)

1.08 (1.02;1.15)1.08 (1.02;1.15)1.08 (1.02;1.15)1.08 (1.02;1.15)

PP value valuePP value value

.012.012.012.012

Multivariate Analysis of Mortality (Model I): Only Pre-OLT VariablesMultivariate Analysis of Mortality (Model I): Only Pre-OLT Variables

Pre-OLT variables (p<0.10)Pre-OLT variables (p<0.10)Pre-OLT variables (p<0.10)Pre-OLT variables (p<0.10)Abs. # 833

VariableVariableVariableVariable HR (95%HR (95% CI)CI)HR (95%HR (95% CI)CI) PP value valuePP value value

Pre-OLT + Donor and perioperative + Post-OLT variables (p<0.10)Pre-OLT + Donor and perioperative + Post-OLT variables (p<0.10)Pre-OLT + Donor and perioperative + Post-OLT variables (p<0.10)Pre-OLT + Donor and perioperative + Post-OLT variables (p<0.10)

Multivariate Analysis of Mortality (Model II): All Variables

Multivariate Analysis of Mortality (Model II): All Variables

HCV genotype - 2, 3 or 4- 2, 3 or 4 - - 11Cause of donor brain deathCause of donor brain death - - Cranial traumaCranial trauma - Other- OtherRBC RBC ttransfusionransfusion - - 3 units 3 units - > 3 units- > 3 unitsInvasive fungal Infection - No- No - Yes- Yes

HCV genotype - 2, 3 or 4- 2, 3 or 4 - - 11Cause of donor brain deathCause of donor brain death - - Cranial traumaCranial trauma - Other- OtherRBC RBC ttransfusionransfusion - - 3 units 3 units - > 3 units- > 3 unitsInvasive fungal Infection - No- No - Yes- Yes

12.53 (1.12; 5.70)

1 1 3.51 (1.05; 11.8)

1 1 3.25 (1.47;7.19)

15.60 (1.83;17.1)

12.53 (1.12; 5.70)

1 1 3.51 (1.05; 11.8)

1 1 3.25 (1.47;7.19)

15.60 (1.83;17.1)

.025.025

.041.041

.004.004

.002.002

.025.025

.041.041

.004.004

.002.002

Abs. # 833

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



Abs. # 29

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.

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.

Abs. # 30

Q&A from the audience

Q&A from the audience



16 th croi, montreal, 2009. hotel ac forum, barcelona – february 20 th 2009 16 th croi, montreal,...

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