HIV-HCV: Perspectives and New Frontiers in Solid Organ Transplantation
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- Adela Wells
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1 HIV-HCV: Perspectives and New Frontiers in Solid Organ Transplantation Christine Durand, MD Assistant Professor of Medicine and Oncology Johns Hopkins University, School of Medicine
2 Disclosures Scientific advisor for Gilead Sciences, Merck Pharmaceuticals, Bristol Myers Squibb Research support, paid to Johns Hopkins from Merck Pharmaceuticals, Viiv.
3 Outline HIV/HCV co-infection Outcomes in HIV/HCV transplant recipients HCV treatment in co-infected individuals New frontier: HCV+ donors for HCV- recipients
4 HIV/HCV co-infection and SOT Co-infection leads to increased liver- and nonliver morbidity and mortality (Lo-Re 2014, Chen 2009) Differences persist in modern ART era (Kirk 2013) End stage liver and kidney disease are a growing cause of morbidity and mortality in HIV-infected patients in the era of ART (Lucas 2014; Smith 2014) 1-2% of individuals on dialysis and liver transplant waitlist are HIV+, 20-40% HIV+ transplant candidates are HCV+
5 HIV Kidney Transplant (KT) Kidney N = 150 Patient survival 1 yr: 95% 3 yr: 91% 4 yr: 89% Graft survival 1 yr: 90% 3 yr: 77% 4 yr: 70% Stock PG/Roland M et al NEJM 2010;363: Roland M et al AIDS 2016.
6 HIV/HCV KT survival HIV+ > 65 years 1 yr: 95% 92% 3 yr: 91% 79.5% HIV+/HCV+ HIV+ 1 yr: 86% 94% p=.09 Stock PG et al. NEJM 2010; 363: year follow-up Hazard of death for HCV/HIV = (p =.19) Roland M et al AIDS 2016.
7 HIV/HCV KT outside the NIH trial 514 HIV+ KT recipients in SRTR, Matched 1:10 HIV- controls on race, age, sex, BMI, PRA, ATG induction, receipt of steroids, donor age, cold ischemia time Graft survival, patient survival through 10 years Locke JE/Segev. JASN, 2015
8 Overall survival out to 10 years A B 89% 89% 5 yrs 78% 64% P= yrs HIV+ compared matched HIV- Locke JE/Segev. JASN, 2015
9 Overall survival out to 10 years A B 89% 89% 5 yrs 78% 64% P= yrs 79% 67% 5 yrs P= % 29% 10 yrs P=.002 HIV+ compared matched HIV- HIV/HCV compared matched HCV+ Locke JE/Segev. JASN, 2015
10 HIV/HCV Liver Transplant (LT) US NIH study HIV/HCV+ N = 89 Terrault et al. Liver Transp 2012;18: Spanish study HIV/HCV+ N = 84 Miro et al. Am J of Trans 2012;12:
11 HIV/HCV Liver Transplant (LT) US NIH study HIV+/HCV+ HCV+ 3 yr: 60% 79% Spanish study HIV+/HCV+ HCV+ 5 yr: 54% 71%
12 Selected lower risk individuals HCV+/HIV+ US NIH Study HCV negative donor BMI > 21 No combined kidney transplant 3 year survival HIV+/HCV+ low high HCV+ 60% 72% 29% 79% Terrault et al Liver Transp 2012;18:
13 Selected lower risk individuals HCV+/HIV+ Spanish Study Favorable HCV genotype Lower MELD Experienced hospital 5 year survival HIV+/HCV+ low high HCV+ 54% 69% 17% 71% Miro et al. Am J of Trans 2012;12:
14 SRTR: HIV D-/R+ LT, impact of HCV N =180 LT recipients 1:10 matched HIV controls HIV+/HCV-, HIV+/HCV+, HIV-/HCV+, HIV-/HCV- Locke JE, Durand CM, Segev DL. Transplantation, 2016.
15 HCV Treatment in Transplant Direct acting antivirals cure HCV in % of patients Effective and tolerated with minimal drug interactions in transplant recipients
16 HCV Treatment in Transplant Direct acting antivirals cure HCV in % of patients Effective and tolerated with minimal drug interactions in transplant recipients Pre-transplant or post transplant? HCV+ donor organs for HCV+ candidates Wait times for organ: weeks vs years
17 DAA Treatment for HIV/HCV ALLY-2: GT1,2,3,4; DAC SOF 12 wks (Wyles 2014) C-EDGE: GT1,4,6; EBR GZR 12 wks (Rockstroh 2015) ION-4: GT1,4; LDV SOF 12 wks (Naggie 2015) TURQUOISE1: GT1; PrOD 12 vs 24 wks (Sulkowski 2015) ASTRAL5: GT1,2,3,4; SOF VEL 12 wks (Wyles 2016)
18 HIV/HCV co-infected individuals
19 SOF=sofosbuvir; LDV=ledipasvir; VEL=velpatasvir; SIM=simeprevir; DAC=daclatasvir; EBV GZR=grazoprevirelbasvir; PrOD=paritaprevir ritonavir ombitasvir dasabuvir; PrO=paritaprevir ritonavir ombitasvir ATV r DRV r LPV r EFV RPV ETR RAL EVG c DTG MVC TDF TAF SOF LDV VEL SIM DAC EBR GZR PrOD ATV=atazanavir; r=ritonavir; DRV=darunavir; LPV=lopinavir; EFV=efavirenz ; RPV=rilpivirine; ETR=etravirine; RAL=raltegravir; EVG=elvitegravir; c=cobicistat; DTG=dolutegravir; MVC=maraviroc; TDF= tenofovir disoproxil fumarate; TAF=tenofovir alafenamide fumarate; PrO
20 SOF=sofosbuvir; LDV=ledipasvir; VEL=velpatasvir; SIM=simeprevir; DAC=daclatasvir; EBV GZR=grazoprevirelbasvir; PrOD=paritaprevir ritonavir ombitasvir dasabuvir; PrO=paritaprevir ritonavir ombitasvir PIs ATV r DRV r LPV r EFV RPV ETR RAL EVG c DTG MVC TDF TAF SOF LDV VEL SIM DAC EBR GZR PrOD ATV=atazanavir; r=ritonavir; DRV=darunavir; LPV=lopinavir; EFV=efavirenz ; RPV=rilpivirine; ETR=etravirine; RAL=raltegravir; EVG=elvitegravir; c=cobicistat; DTG=dolutegravir; MVC=maraviroc; TDF= tenofovir disoproxil fumarate; TAF=tenofovir alafenamide fumarate; PrO
21 SOF=sofosbuvir; LDV=ledipasvir; VEL=velpatasvir; SIM=simeprevir; DAC=daclatasvir; EBV GZR=grazoprevirelbasvir; PrOD=paritaprevir ritonavir ombitasvir dasabuvir; PrO=paritaprevir ritonavir ombitasvir NNRTIs ATV r DRV r LPV r EFV RPV ETR RAL EVG c DTG MVC TDF TAF SOF LDV VEL SIM DAC EBR GZR PrOD ATV=atazanavir; r=ritonavir; DRV=darunavir; LPV=lopinavir; EFV=efavirenz ; RPV=rilpivirine; ETR=etravirine; RAL=raltegravir; EVG=elvitegravir; c=cobicistat; DTG=dolutegravir; MVC=maraviroc; TDF= tenofovir disoproxil fumarate; TAF=tenofovir alafenamide fumarate; PrO
22 SOF=sofosbuvir; LDV=ledipasvir; VEL=velpatasvir; SIM=simeprevir; DAC=daclatasvir; EBV GZR=grazoprevirelbasvir; PrOD=paritaprevir ritonavir ombitasvir dasabuvir; PrO=paritaprevir ritonavir ombitasvir INSTIs ATV r DRV r LPV r EFV RPV ETR RAL EVG c DTG MVC TDF TAF SOF LDV VEL SIM DAC EBR GZR PrOD ATV=atazanavir; r=ritonavir; DRV=darunavir; LPV=lopinavir; EFV=efavirenz ; RPV=rilpivirine; ETR=etravirine; RAL=raltegravir; EVG=elvitegravir; c=cobicistat; DTG=dolutegravir; MVC=maraviroc; TDF= tenofovir disoproxil fumarate; TAF=tenofovir alafenamide fumarate; PrO
23 SOF=sofosbuvir; LDV=ledipasvir; VEL=velpatasvir; SIM=simeprevir; DAC=daclatasvir; EBV GZR=grazoprevirelbasvir; PrOD=paritaprevir ritonavir ombitasvir dasabuvir; PrO=paritaprevir ritonavir ombitasvir ATV r DRV r LPV r EFV RPV ETR RAL EVG c DTG MVC TDF TAF SOF LDV VEL SIM DAC EBR GZR PrOD ATV=atazanavir; r=ritonavir; DRV=darunavir; LPV=lopinavir; EFV=efavirenz ; RPV=rilpivirine; ETR=etravirine; RAL=raltegravir; EVG=elvitegravir; c=cobicistat; DTG=dolutegravir; MVC=maraviroc; TDF= tenofovir disoproxil fumarate; TAF=tenofovir alafenamide fumarate; PrO
24 SOF=sofosbuvir; LDV=ledipasvir; VEL=velpatasvir; SIM=simeprevir; DAC=daclatasvir; EBV GZR=grazoprevirelbasvir; PrOD=paritaprevir ritonavir ombitasvir dasabuvir; PrO=paritaprevir ritonavir ombitasvir ATV r DRV r LPV r EFV RPV ETR RAL EVG c DTG MVC TDF TAF SOF LDV VEL SIM DAC EBR GZR PrOD ATV=atazanavir; r=ritonavir; DRV=darunavir; LPV=lopinavir; EFV=efavirenz ; RPV=rilpivirine; ETR=etravirine; RAL=raltegravir; EVG=elvitegravir; c=cobicistat; DTG=dolutegravir; MVC=maraviroc; TDF= tenofovir disoproxil fumarate; TAF=tenofovir alafenamide fumarate; PrO
25 hcvguidelines.org
26 HCV treatment in liver transplant
27 For HIV+/HCV+ transplant recipients hcvguidelines.org
28 Clinical case: HIV/HCV SOT 55 year old African American with HIV infection on efavirenz, abacavir, lamivudine Renal transplant, 2 months prior Chronic hepatitis C, genotype 1a Treatment naive F3 disease on biopsy
29 Clinical case: HIV/HCV SOT 55 year old African American with HIV infection on efavirenz, abacavir, lamivudine Renal transplant, 2 months prior Chronic hepatitis C, genotype 1a Treatment naive F3 disease on biopsy LDV/SOF for 12 weeks
30 Clinical case: HIV/HCV SOT LDV/SOF for 12 weeks Baseline viral load 1.2 million Week 4 viral load < 15 IU/mL Remained < 15 IU/mL on treatment
31 Clinical case: HIV/HCV SOT LDV/SOF for 12 weeks Baseline viral load 1.2 million Week 4 viral load < 15 IU/mL Remained < 15 IU/mL on treatment Week 4 off treatment: 550,000 IU/mL
32 Clinical case: HIV/HCV SOT LDV/SOF for 12 weeks Baseline viral load 1.2 million Week 4 viral load < 15 IU/mL Remained < 15 IU/mL on treatment Week 4 off treatment: 550,000 IU/mL Genotype: Q80K positive, NS5A resistance
33 Relapse in HIV/HCV SOT Reasons for failure? Multiply immunocompromised (transplant, HIV) African American, on EFV, ION4 study lower SVR12 rates unexplained by PK data Retreatment options June 2015 Sofosbuvir + Paritaprevir ritonavir ombitasvir dasabuvir + ribavirin for 24 weeks February 2016 confirmed SVR12
34 EPIDEMIOLOGY RESEARCH GROUP IN ORGAN TRANSPLANTATION EXPANDER: Exploring Transplants Using Hepatitis-C Infected Donor Kidneys for HCV- Negative Recipients Christine M. Durand, Diane Brown, Nicole Bair, Russell Wesson, Michael A. Chattergoon, Guido Massaccesi, Ashraf Reyad, Fizza Naqvi, Darin Ostrander, Mary Grace Bowring, Samantha Halpern, Allan B. Massie, Sarah Rasmussen, Jeremy Sugarman, Dorry L. Segev, Mark Sulkowski, Niraj M. Desai
35 HCV+ Donors Number of HCV+ donor kidneys exceeds number of HCV+ kidney transplant candidates
36 Bowring/Durand ASTS 2016
37 Bowring/Durand ASTS 2016
38 HCV+ Donors Number of HCV+ donor kidneys exceeds number of HCV+ kidney transplant candidates > 40% of recovered HCV+ kidneys discarded 4X discard rate compared to HCV- Potential pool of HCV+ kidneys may be larger since not all HCV+ kidneys are recovered
39 Opioid overdose death donors Bowring/Durand ATC 2016
40 Overdose death donors: 25% HCV+ Bowring/Durand ATC 2016
41 Major advances in HCV Treatment Direct acting antivirals cure HCV in % of patients, 1 effective and tolerated with minimal drug interactions in studies of transplant recipients 2 In 2016, Grazoprevir/Elbasvir (GZR/EBR) approved for HCV treatment in chronic or end-stage renal disease 3 1 Sulkowski NEJM Kwo NEJM Roth Lancet 2015
42 EXPANDER: Objectives To explore the use of HCV D+ kidneys for transplant for HCV- recipients (HCV D+/R-)
43 EXPANDER: Objectives To explore the use of HCV D+ kidneys for transplant for HCV- recipients (HCV D+/R-) To use DAAs pre- and post-transplant prophylaxis to prevent HCV infection in HCV- recipients
44 EXPANDER: Objectives To explore the use of HCV D+ kidneys for transplant for HCV- recipients (HCV D+/R-) To use DAAs pre- and post-transplant prophylaxis to prevent HCV infection in HCV- recipients
45 HCV- Participant Inclusion Criteria On deceased donor transplant waitlist at JHU On dialysis or GFR < 15 ml/min 50 years old HCV- EXPANDER Trial
46 EXPANDER Trial HCV- Participant Inclusion Criteria On deceased donor transplant waitlist at JHU On dialysis or GFR < 15 ml/min 50 years old HCV- HCV+ Donor Inclusion Criteria Age Creatinine < 3.0 mg/dl, normal renal biopsy Qualitative HCV NAT+, UNOS screening test HCV genotype sent to commercial lab
47 EXPANDER Trial HCV- Participant Inclusion Criteria On deceased donor transplant waitlist at JHU On dialysis or GFR < 15 ml/min 50 years old HCV- HCV+ Donor Inclusion Criteria Age Creatinine < 3.0 mg/dl, normal renal biopsy Qualitative HCV NAT+, UNOS screening test HCV genotype sent to commercial lab
48 EXPANDER Trial HCV- Participant Inclusion Criteria On deceased donor transplant waitlist at JHU On dialysis or GFR < 15 ml/min 50 years old HCV- HCV+ Donor Inclusion Criteria Age Creatinine < 3.0 mg/dl, normal renal biopsy Qualitative HCV NAT+, UNOS screening test HCV genotype sent to commercial lab HCV D+/R- Transplant N =10 GZR EBR on call to OR Daily for 12 weeks GT1a GT1b, 4 NS5a resistant variants No No change
49 EXPANDER Trial HCV- Participant Inclusion Criteria On deceased donor transplant waitlist at JHU On dialysis or GFR < 15 ml/min 50 years old HCV- HCV+ Donor Inclusion Criteria Age Creatinine < 3.0 mg/dl, normal renal biopsy Qualitative HCV NAT+, UNOS screening test HCV genotype sent to commercial lab HCV D+/R- Transplant N =10 GZR EBR on call to OR Daily for 12 weeks GT1a GT1b, 4 GT2, 3 NS5a resistant variants Yes No Add sofosbuvir Treat for 12 weeks Add ribavirin Treat for 16 weeks No change
50 Monitoring and Endpoints Recipient HCV Plasma RNA Post-operative day (POD1) On treatment weeks (TW) 1, 2, 3, 4, 8, 12 Follow up off treatment (FW) 2, 4, 8, 12 Primary endpoints Safety: adverse events related to GZR/EBR Efficacy: HCV RNA FW12 (definition of HCV cure)
51 Results From 8/2016 2/2017: 10 HCV D+/R- transplants 10/10 participants have completed treatment Safety: No adverse events related to treatment Efficacy: 6/10 have reached final endpoint (FW12)
52 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Age: median 30 (21-42)
53 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White
54 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose
55 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose
56 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI KDPI: median 45 (34-62)
57 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a *Donor qualitative nucleic acid test positive
58 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a *Donor qualitative nucleic acid test positive
59 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a *Donor qualitative nucleic acid test positive
60 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a *Donor qualitative nucleic acid test positive
61 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a *Donor qualitative nucleic acid test positive
62 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Age: median 71 (57-76)
63 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male
64 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time Median time on the waitlist: 4.2 months (0.8-36)
65 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry Median time on the waitlist: 4.2 months (0.8-36) Median wait from study entry to transplant: 1 month
66 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW)
67 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW) POD 1 <15 <15 <15 <15 ++ <15 94 < <15 32
68 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW) POD 1 <15 <15 <15 <15 ++ <15 94 < <15 32
69 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW) POD 1 <15 <15 <15 <15 ++ <15 94 < <15 32
70 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW) POD 1 <15 <15 <15 <15 ++ <15 94 < <15 32 TW1 <15 <15 <15 <15 <15 <15 <15 55 <15 <15
71 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW) POD 1 <15 <15 <15 <15 ++ <15 94 < <15 32 TW1 <15 <15 <15 <15 <15 <15 <15 55 <15 <15 TW4 <15 <15 <15 <15 <15 <15 missed <15 <15 <15 TW8 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15 TW12 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15
72 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW) POD 1 <15 <15 <15 <15 ++ <15 94 < <15 32 TW1 <15 <15 <15 <15 <15 <15 <15 55 <15 <15 TW4 <15 <15 <15 <15 <15 <15 missed <15 <15 <15 TW8 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15 TW12 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15 HCV RNA Follow up off treatment (FW) FW2 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15 FW4 <15 <15 <15 < 15 <15 <15 <15 <15 <15 FW8 <15 <15 <15 <15 <15 <15 <15 <15 <15 FW12 <15 <15 <15 <15 <15 <15 <15
73 DONORS D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 Age, yrs Sex Female Female Female Male Male Male Female Male Male Female Race White White White White White White White White White White Death Trauma Overdose Trauma Anoxia Trauma Overdose Overdose Overdose Overdose Overdose KDPI HCV Ab HCV RNA <15* 46,733 62,400 4,645,289 2,090,042 1,760, ,140,000 HCV GT ND ND ND 1a/3a 1a 1a 3a 2 ND 1a HCV R- R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 Age, yrs Race White White White White White Asian White Black White White Sex Male Female Male Male Male Male Female Male Male Male Wait time From entry HCV RNA on treatment (TW) POD 1 <15 <15 <15 <15 ++ <15 94 < <15 32 TW1 <15 <15 <15 <15 <15 <15 <15 55 <15 <15 TW4 <15 <15 <15 <15 <15 <15 missed <15 <15 <15 TW8 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15 TW12 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15 HCV RNA Follow up off treatment (FW) FW2 <15 <15 <15 <15 <15 <15 <15 <15 <15 <15 FW4 <15 <15 <15 < 15 <15 <15 <15 <15 <15 FW8 <15 <15 <15 <15 <15 <15 <15 <15 <15 FW12 <15 <15 <15 <15 <15 <15 <15
74 EXPANDER Results Percent with undetectable HCV RNA at each visit Percent /10 9/10 10/10 10/10 10/10 10/10 9/9 9/9 7/7
75 EXPANDER Conclusions Donors: Young, Caucasians, 6/10 overdose death, low KDPI 4/10 low HCV RNA, 3/10 non-gt1 HCV
76 EXPANDER Conclusions Donors: Young, Caucasians, 6/10 overdose death, low KDPI 4/10 low HCV RNA, 3/10 non-gt1 HCV Recipients: GZR EBR and GZR EBR SOF was well-tolerated 9/10 had low level HCV RNA only on POD1 9/9 have undetectable HCV at FW4, (includes GT 2/3 donor)
77 EXPANDER Conclusions Donors: Young, Caucasians, 6/10 overdose death, low KDPI 4/10 low HCV RNA, 3/10 non-gt1 HCV Recipients: GZR EBR and GZR EBR SOF was well-tolerated 9/10 had low level HCV RNA only on POD1 9/9 have undetectable HCV at FW4, (includes GT 2/3 donor) HCV D+/R- transplant with DAAs as pre/post transplant prophylaxis may decrease HCV+ organ discard and safely expand the donor pool
78 Acknowledgements Co-PI Niraj Desai, MD Infectious Diseases: Mark Sulkowski, MD Diane Brown, MSN Darin Ostrander, PhD Shanti Seaman, BA Michael Chattergoon, MD PhD Guido Massaccesi, BS Bioethics Jeremy Sugarman, MD Nephrology: Fizza Naqvi, MD EXPANDER Participants EPIDEMIOLOGY RESEARCH GROUP IN ORGAN TRANSPLANTATION Mary Grace Bowring, MPH Samantha Halpern, BA Sarah Rasmussen, BA Allan B. Massie, PhD Dorry L. Segev, MD PhD Transplant Surgery Nicole Bair, BSN Russell Wesson, MD Ashraf Reyad, MD
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