the opioid crisis and its effect on transplantation
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Jan 17, 2023 •379 likes •1.67k views

The Opioid Crisis and Its Effect on Transplantation Greg J. McKenna, M.D. Simmons Transplant Institute Baylor University Medical Center Dallas, TX The Opioid Epidemic How Bad is it ? Opioid Epidemic How Bad Is It ? Overwhelming July 5th

  1. Opioid Epidemic Mortality Rate by Ethnicity All-Cause All External Poisonings Mortality Causes White Non-Hispanics 33.9 32.8 22.2 Black Non-Hispanics -214.8 -6.0 3.7 Hispanics -63.6 -2.9 4.3 WNH Education Class High School or Less 134.4 68.7 44.3 Some College -3.3 18.9 14.6 College Degree -57.0 3.6 4.6 White vs Hispanic > 4 x higher ≤ High School vs ≥ College > 8 x higher Source: Case et al. PNAS. 2015

  2. Opioid Epidemic Mortality Rate by Ethnicity All-Cause All External Poisonings Mortality Causes White Non-Hispanics 33.9 32.8 22.2 Black Non-Hispanics -214.8 -6.0 3.7 Hispanics -63.6 -2.9 4.3 WNH Education Class High School or Less 134.4 68.7 44.3 Some College -3.3 18.9 14.6 College Degree -57.0 3.6 4.6 ≤ High School vs ≥ College > 8 x higher White vs Hispanic > 4 x higher Source: Case et al. PNAS. 2015

  3. Opioid Epidemic Mortality Rate by Ethnicity All-Cause All External Poisonings Mortality Causes White Non-Hispanics 33.9 32.8 22.2 Black Non-Hispanics -214.8 -6.0 3.7 Hispanics -63.6 -2.9 4.3 WNH Education Class High School or Less 134.4 68.7 44.3 Some College -3.3 18.9 14.6 College Degree -57.0 3.6 4.6 ≤ High School vs ≥ College > 8 x higher White vs Hispanic > 4 x higher Source: Case et al. PNAS. 2015

  4. Opioid Epidemic Mortality Rate by Ethnicity +11% 10 Non-Hispanic Whites 5 mortality rate of non-Hispanic whites age 25-54 yrs over % Change in Mortality 0 -5 -10 Hispanics -14% -15 Non-Hispanic Blacks -20 -23% -25 2000 2005 2010 2015 Year Source: NY Times

  5. Opioid Epidemic Mortality Rate by Cause Mortality by Cause White Non-Hispanic Ages 45 - 54 Poisonings 30 Lung Cancer Drug overdoses are expected Deaths per 100.000 population Suicide 25 to remain the leading cause of death for Americans <50 yr Liver Disease 20 Synthetic opioids, (primarily 15 fentanyl and its analogues) continue to push the mortality Diabetes rate higher 10 5 2000 2005 2010 2015 Year Source: Case et al. PNAS. 2015

  6. Opioid Epidemic Overdose Death by Opioid Type 11 Any Opioid 10 9 Deaths per 100,000 population 8 7 6 Commonly Prescribed 5 Opioids 4 Heroin Synthetic 3 Opioids 2 1 0 2000 2002 2004 2006 2008 2010 2012 2014 2016 Year Source: CDC/NHCS, National Vital Statistics System, Mortality. US Dept of Health and Human Services

  7. Opioid Epidemic Age Distribution of Overdose Deaths 30 45-54 Deaths per 100,000 population 25 35-44 20 25-34 15 55-64 10 15-24 65+ 5 0 1999 2001 2003 2005 2007 2009 2011 2013 2015 Year 2012 -2015 shows significant upswing of 25 -44 year olds Source: CDC

  8. The Opioid Epidemic What is the Cause ?

  9. Opioid Epidemic Causes What is Causing the Opioid Epidemic ? Narcotics are commonly prescribed by physicians Intended to be used “appropriately” Compton W et al NEJM (2016) described 10.3 million using Rx opioids non medically/not prescribed. National Health and Nutrition Examination Survey 1999-2006: % adults using Rx opioid last 30d 5.0% 6.9% 1999-2012: % adults using Rx opioid >>morphine 17.0% 37.0% 1999-2010: Rx opioid sold 4x over 11 yrs Source: D Goldberg, 2017 “Impact of the Opioid Epidemic on Organ Donation”

  10. Opioid Epidemic Causes Why is Heroin Commonly Abused ? in M.D. prescribing habits have led to under-Rx after initial over-Rx opioids Cost: Heroin vs oral opioids Oxycodone: $30 for 30mg oxycodone tab Street Price $20 for 2x10mg/325mg Percocent tab Heroin: $5-10 for bag of heroin (1-5 bags per day) Onset of Action: Rapid IV: Peak onset 20 s Duration: 4 hrs Smoking: Peak onset 10 min Duration: 5 hrs Snorting: Peak onset 30 min Duration: 3-5 hrs Source: D Goldberg, 2017 “Impact of the Opioid Epidemic on Organ Donation”

  11. Opioid Epidemic Reasons for the Opioid Epidemic Subsequent MD Under-Rx Initial MD Over-Rx Drug Promotion by Pharma Companies Millennials Entitlement Patient Satisfaction Metrics Use of Pain Scale

  12. The Opioid Epidemic Where is This Occurring ?

  13. Opioid Epidemic Geographic Impact The opioid epidemic does not appear to be affecting all of the US equally The most frequent geographic location is related to the demographics of the opiate abuser Location are places where rural, white populations predominate

  14. Opioid Epidemic Geographic Impact Age- Adjusted Rates of Overdose Deaths Per State 2015 Age-Adjusted Rate 2.8 - 11.0 11.1 - 13.5 13.6 - 16.0 16.1 - 18.5 18.6 - 21.0 21.1 - 41.5 Source: CDC Predominance of deaths in the Appalachian region, Southwest and industrial heartland

  15. Opioid Epidemic Geographic Impact 0 5 10 15 20 25 30 35 40 45 West Virginia New Hampshire Age-Adjusted Rate of Drug Kentucky Ohio Overdose Deaths by State Rhode Island Pennsylvania 2010 Massachusetts New Mexico 2015 Utah Tennessee Connecticut Delaware Maine Predominance of Overdose Maryland Deaths Occur in the: Michigan Nevada - Appalachian States Indiana Arizona - Northeast States Louisiana Oklahoma - Southwest States District of Columbia Missouri - Industrial Heartland Vermont Wyoming New Jersey 0 5 10 15 20 25 30 35 40 45

  16. Opioid Epidemic Geographic Impact 0 5 10 15 20 25 30 35 40 45 West Virginia New Hampshire Age-Adjusted Rate of Drug Kentucky Ohio Overdose Deaths by State Rhode Island Pennsylvania 2010 Massachusetts New Mexico 2015 Utah Tennessee Connecticut Delaware Maine Predominance of Overdose Maryland Deaths Occur in the: Michigan Nevada - Appalachian States Indiana Arizona - Northeast States Louisiana Oklahoma - Southwest States District of Columbia Missouri - Industrial Heartland Vermont Wyoming New Jersey 0 5 10 15 20 25 30 35 40 45

  17. Opioid Epidemic Geographic Impact 0 5 10 15 20 25 30 35 40 45 West Virginia New Hampshire Age-Adjusted Rate of Drug Kentucky Ohio Overdose Deaths by State Rhode Island Pennsylvania 2010 Massachusetts New Mexico 2015 Utah Tennessee Connecticut Delaware Maine Predominance of Overdose Maryland Deaths Occur in the: Michigan Nevada - Appalachian States Indiana Arizona - Northeast States Louisiana Oklahoma - Southwest States District of Columbia Missouri - Industrial Heartland Vermont Wyoming New Jersey 0 5 10 15 20 25 30 35 40 45

  18. Opioid Epidemic Geographic Impact 0 5 10 15 20 25 30 35 40 45 West Virginia New Hampshire Age-Adjusted Rate of Drug Kentucky Ohio Overdose Deaths by State Rhode Island Pennsylvania 2010 Massachusetts New Mexico 2015 Utah Tennessee Connecticut Delaware Maine Predominance of Overdose Maryland Deaths Occur in the: Michigan Nevada - Appalachian States Indiana Arizona - Northeast States Louisiana Oklahoma - Southwest States District of Columbia Missouri - Industrial Heartland Vermont Wyoming New Jersey 0 5 10 15 20 25 30 35 40 45

  19. Opioid Epidemic Geographic Impact 0 5 10 15 20 25 30 35 40 45 Florida Alaska Age-Adjusted Rate of Drug North Carolina Alabama Overdose Deaths by State Wisconsin Colorado 2010 Washington Idaho 2015 Illinois Arkansas Montana New York Predominance of Overdose Georgia Virginia Deaths Occur in the: Mississippi Oregon - Appalachian States Kansas California - Northeast States Hawaii Minnesota - Southwest States Iowa Texas - Industrial Heartland North Dakota South Dakota Nebraska 0 5 10 15 20 25 30 35 40 45

  20. The Opioid Epidemic Does this Geographical Specificity Impact Organ Donation ?

  21. The Opioid Epidemic Does this Geographical Specificity Impact Organ Donation ? Yes

  22. Opioid Epidemic Impact on Transplant per Region

  23. Opioid Epidemic Impact on Transplant per Region Northeast

  24. Opioid Epidemic Impact on Transplant per Region Northeast Appalachians

  25. Opioid Epidemic Impact on Transplant per Region Industrial Heartland Northeast Appalachians

  26. Opioid Epidemic Impact on Transplant per Region Industrial Heartland Northeast Appalachians Southwest

  27. Opioid Epidemic Impact on Liver Transplants per Region 80 Region 1 60 Percent Change in Liver Transplants Region 11 Region 4 40 Region 3 Region 5 / 10 Region 2 20 Region 8 Region 6 0 Region 7 -20 -40 Region 9 -60 2007 2009 2011 2013 2015 2017 Year

  28. Opioid Epidemic Impact on Liver Transplants per Region 80 Northeast Region 1 60 Percent Change in Liver Transplants Region 11 Region 4 40 Region 3 Region 5 / 10 Region 2 20 Region 8 Region 6 0 Region 7 -20 -40 Region 9 -60 2007 2009 2011 2013 2015 2017 Year

  29. Opioid Epidemic Impact on Liver Transplants per Region 80 Region 1 60 Percent Change in Liver Transplants Region 11 Region 4 40 Appalachians Region 3 Region 5 / 10 Region 2 20 Region 8 Region 6 0 Region 7 -20 -40 Region 9 -60 2007 2009 2011 2013 2015 2017 Year

  30. Opioid Epidemic Impact on Liver Transplants per Region 80 Region 1 60 Percent Change in Liver Transplants Region 11 Region 4 40 Region 3 Industrial Region 5 / 10 Heartland Region 2 20 Region 8 Region 6 0 Region 7 -20 -40 Region 9 -60 2007 2009 2011 2013 2015 2017 Year

  31. Opioid Epidemic Impact on Liver Transplants per Region 80 Region 1 60 Percent Change in Liver Transplants Region 11 Region 4 40 Region 3 Region 5 / 10 Region 2 20 Region 8 Region 6 Southwest 0 Arizona +202% Region 7 California +8% -20 -40 Region 9 -60 2007 2009 2011 2013 2015 2017 Year

  32. Opioid Epidemic Impact on Liver Transplants per Region 80 Northeast Region 1 60 Percent Change in Liver Transplants Region 11 Region 4 40 Appalachians Region 3 Region 3 Industrial Region 5 / 10 Region 2 Heartland 20 Region 8 Region 6 Southwest 0 Arizona +202% Region 7 California +8% -20 -40 Region 9 -60 2007 2009 2011 2013 2015 2017 Year

  33. Opioid Epidemic Impact on Liver Transplants per Region Organ allocation has been one of the most contentious issues in liver transplantation for the last 5 years Region A Region B Discrepancy Population Population VS Organ Donation Organ Donation Political pressure for redistricting Change organ allocation rules

  34. Opioid Epidemic Impact on Liver Transplants per Region Organ allocation has been one of the most contentious issues in liver transplantation for the last 5 years Region A Region B Discrepancy Population Population VS Organ Donation Organ Donation Political pressure for redistricting Change organ allocation rules

  35. Opioid Epidemic Impact on Liver Transplants per Region The UNOS regions and OPOs with organ donation now roughly correspond to those areas where the opioid epidemic predominates. Fixed decisions regarding organ allocation are being considered in which calculations are being made from the variable opioid epidemic. Aggressive strategies that might reduce the opioid epidemic, would also quickly alter the organ donation calculation. Subsequent re-redistricting would not be as rapid

  36. Opioid Epidemic and Transplant First Summary Opioids have quickly become the leading cause of death in < 50 yr The opioid epidemic predominantly impacts rural young white males in: 1) Northeast US 3) Industrial Heartland 2) Appalachians 4) Southwest US The opioid epidemic has dramatically the number of organ donors The increase in US donor organs is not homogenous and is clustered in the UNOS Regions where the epidemic predominates Decisions on future redistricting and organ allocation need to consider the variable impact of opioid epidemic

  37. Opioids and Organ Donation HCV+ Donors

  38. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV — Impact of Opioid Epidemic Recent abrupt rise in incidence of acute HCV Acute HCV incidence has 3x over last few years. Timing of HCV incidence parallels the opioid epidemic The acute HCV matches the demographics and geography of the opioid epidemic

  39. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV — Impact of Opioid Epidemic Recent abrupt rise in incidence of acute HCV Acute HCV incidence has 3x over last few years. Heroin 5x Heroin Use 33% HCV+ Opioid HCV Abuse in IVDU Abuse Transmission (2002 to 2013) Timing of HCV incidence parallels the opioid epidemic The acute HCV matches the demographics and geography of the opioid epidemic

  40. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV — Impact of Opioid Epidemic Opioids/Heroin Overdose Deaths Organ Donors

  41. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV — Impact of Opioid Epidemic Opioids/Heroin Overdose Deaths Organ Donors + Opioids/Heroin HCV Transmission Acute HCV+

  42. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV — Impact of Opioid Epidemic Opioids/Heroin Overdose Deaths Organ Donors + Opioids/Heroin HCV Transmission Acute HCV+ = HCV+ Organ Donors

  43. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV+ Organ Donors 9,972 10% 10000 Region 1 Total Donors 9,079 HCV+ Donors 8,596 8,268 8,143 8,126 8,085 8,017 8,022 7,989 7,943 8% 8000 7,593 7,150 6.8% 6.8% 6,457 6,190 6% 6% 6,080 5,985 6% 5,824 6000 5,804 5,479 5,418 5,345 5.1% 5.1% 4.4% 4.4% 4.4% 4.4% 4.2% 4.3% 4.3% 4.2% 4.2% 4.2% 4.2% 4.2% 4.1% 4.1% 4% 4% 3.9% 3.9% 3.9% 3.9% 3.8% 3.8% 4% 4000 3.2% 3.4% 3.4% 3.2% 3% 3% 2.9% 2.9% 2.8% 2.8% 2.8% 2.8% 2.7% 2.7% 2.6% 2.6% 2% 2000 682 548 437 352 348 361 322 335 331 320 335 301 285 252 197 213 166 181 140 152 149 160 0% 0 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015

  44. Opioids and Organ Donation HCV+ Donors Median Deceased Donor Age By HCV Status 50 HCV + HCV - 45 40 35 30 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 Median age of HCV+ donor: 47 yr in 2012 35 yr in 2016 ( 12 yr over 5 yr)

  45. Opioids and Organ Donation Utilizing HCV+ Donors We have been transplanting HCV+ donor liver allografts into HCV+ recipients for almost 20 years with acceptable outcomes Many centers are very comfortable using HCV+ donor livers

  46. Opioids and Organ Donation Utilizing HCV+ Donors Many HCV+ kidney donor allografts have gone untransplanted however. 900 HCV+ Kidneys Discarded HCV+ Kidneys Transplanted 800 Discarded 700 Transplants 600 500 Transplanted 400 300 200 100 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Transplant Year 2/3 of kidneys from HCV+ donors are discarded Source: D Goldberg, 2017

  47. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV — Impact of HCV - DAA Therapy The landscape of HCV has changed dramatically over the last few years Key has been the HCV Direct Acting Antiviral Agents (HCV - DAA) HCV - DAA SVR in 98 - 99% pts - Across multiple genotypes - Previous unresponsive to Rx Mild side effect profile has made staying on Rx easy Last decade saw a impressive in HCV infection Nearly all listed transplant patients have had their HCV treated

  48. Opioids and Organ Donation HCV+ Donors 12 week therapy 1 tablet daily Cure Rate = 99.7 % 622/624 pts

  49. Opioids and Organ Donation HCV+ Donors Change in Incidence of HCV — Impact of HCV - DAA Therapy HCV+ Chronic ESLD Rx HCV - DAA pts listed for OLTx

  50. Opioids and Organ Donation Utilizing HCV+ Donors Because of the opioid epidemic, there are significantly HCV+ donors 335 HCV+ donors 682 HCV+ donors 2x more HCV+ donor allografts over last 4 yrs (2012) (2016) HCV+ allografts are youngest of the last 20 years, and are younger than HCV- allografts. The age means improved allograft quality. Because of Rx HCV - DAA , there are significantly HCV+ ESLD pts. It has become harder to find a recipient for HCV+ livers, so otherwise suitable organs have been discarded

  51. Opioids and Organ Donation HCV+ Donors into HCV - Recipients Opportunities 1) Use of organs that were previously discarded 2) waiting time for recipient 3) wait list mortality 4) No posttransplant survival — Often young donors 5) Opportunity for some recipients who might not get a donor

  52. Opioids and Organ Donation HCV+ Donors into HCV - Recipients Pitfalls 1) Infecting patient with potentially lethal virus 2) HCV - DAA Rx is expensive (Who is the payor ?) 3) HCV - DAA Rx not indicated for treating acute HCV 4) HCV - DAA Rx are paid for after willfully infecting patient.

  53. Opioids and Organ Donation HCV+ Donors into HCV - Liver Recipients HCV+ Deceased Donor Liver Transplants by Recipient HCV Status at Time of OLTx 400 HCV Donor +/ Recipient + HCV Donor +/ Recipient - 340 334 300 Number of Transplants 257 205 199 200 166 156 140 138 129 129 115 93 100 86 74 62 59 49 43 41 40 33 29 11 10 9 8 7 6 5 5 4 4 4 4 3 3 2 0 0 1 0 0 1 0 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 Transplant Year Source: Stewart, unpublished analysis 2017

  54. Opioids and Organ Donation HCV+ Donors into HCV - Liver Recipients HCV+ Deceased Donor Liver Transplants by Recipient HCV Status at Time of OLTx 400 HCV Donor +/ Recipient + HCV Donor +/ Recipient - 340 334 300 Number of Transplants 257 205 199 200 166 156 140 138 129 129 115 93 100 86 74 62 59 49 43 41 40 33 29 11 10 9 8 7 6 5 5 4 4 4 4 3 3 2 0 0 1 0 0 1 0 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 Transplant Year Source: Stewart, unpublished analysis 2017

  55. Opioids and Organ Donation HCV+ Donors into HCV - Kidney Recipients HCV+ Deceased Donor Kidney Transplants by Recipient HCV Status at Time of OLTx 400 360 HCV Donor +/ Recipient + HCV Donor +/ Recipient - 350 300 Number of Transplants 227 223 222 217 201 199 200 188 184 177 174 150 148 143 133 132 129 119 112 105 94 100 55 51 51 49 45 45 44 40 31 29 27 27 27 26 26 24 23 22 22 21 21 20 0 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 Transplant Year Source: Stewart, unpublished analysis 2017

  56. Opioids and Organ Donation HCV+ Donors into HCV - Kidney Recipients HCV+ Deceased Donor Kidney Transplants by Recipient HCV Status at Time of OLTx 400 360 HCV Donor +/ Recipient + HCV Donor +/ Recipient - 350 300 Number of Transplants 227 223 222 217 201 199 200 188 184 177 174 150 148 143 133 132 129 119 112 105 94 100 55 51 51 49 45 45 44 40 31 29 27 27 27 26 26 24 23 22 22 21 21 20 0 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 Transplant Year Source: Stewart, unpublished analysis 2017

  57. Opioids and Organ Donation HCV+ Donors into HCV - Heart Recipients HCV+ Deceased Donor Heart Transplants by Recipient HCV Status at Time of OLTx 100 HCV Donor +/ Recipient + HCV Donor +/ Recipient - 75 Number of Transplants 50 32 29 27 25 22 22 22 14 14 9 7 7 6 5 4 4 4 4 3 2 2 2 2 2 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 Transplant Year Source: Stewart, unpublished analysis 2017

  58. Opioids and Organ Donation HCV+ Donors into HCV - Heart Recipients HCV+ Deceased Donor Heart Transplants by Recipient HCV Status at Time of OLTx 100 HCV Donor +/ Recipient + HCV Donor +/ Recipient - 75 Number of Transplants 50 32 29 27 25 22 22 22 14 14 9 7 7 6 5 4 4 4 4 3 2 2 2 2 2 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 Transplant Year Source: Stewart, unpublished analysis 2017

  59. Opioids and Organ Donation HCV+ Donors into HCV - Recipients THINKER Trial — Kidney Transplant Trial Pilot trial for transplanting HCV+ donors into T ransplanting HCV - recipients H epatitis C Kidneys 10 HCV - kidney recipients consented Mean waiting time 58 d I nto Kidney from HCV+ donor N egative Recipient viremic by POD 3 K idnEy Rx with elbasvir-grazoprevir* for 12 wks R ecipients 100% cured of HCV *Can be used at any level of renal function, no cardiotoxicity

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