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HIV: HISTORY CURRENT STATUS AND FUTURE

HIV: HISTORY CURRENT STATUS AND FUTURE. John G. Bartlett Johns Hopkins University School of Medicine Conflicts -- None. HIV REVIEW History Current standards Future. HIV NATURAL HISTORY. HIV transmission ↓ 2- 4 weeks Acute HIV (50 – 90 %) ↓ 1- 3 weeks Asymptomatic

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HIV: HISTORY CURRENT STATUS AND FUTURE

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  1. HIV: HISTORYCURRENT STATUS AND FUTURE John G. Bartlett Johns Hopkins University School of Medicine Conflicts -- None

  2. HIV REVIEW History Current standards Future

  3. HIV NATURAL HISTORY HIV transmission ↓ 2- 4 weeks Acute HIV (50 – 90 %) ↓ 1- 3 weeks Asymptomatic ↓ 8 years AIDS ↓ 1.3 years Death

  4. HIV RISK CATEGORIES (2010)CDC data – 48,298 cases MSM (gay men) – 63% Injection drug use – 8% Heterosexual transmission – 25% Blood transfusions – 0% Perinatal transmission – (162) African American – 44% Poverty – 2.1% (8 x ↑)

  5. HIV: HISTORY 1981-2013

  6. CDC: MMWR June 5, 1981 9 MSM with PCP CDC: MMWR July 3, 1981

  7. HIV/AIDS – FIRST DECADE HIV: Circa 1981-91 Patients: Most died • Diarrhea • Dementia • Disgrace • Image: IDU & MSM • Fear: Contagion • Untreatable

  8. WHO WINNING PHOTO AWARD:AIDS – THE HUMAN TRAGEDY

  9. Anthony Fauci“Goose pimples” 1981 ID/IMMUNOLOGY:Wegener disease & polyarteritis nodosa; Director of NIAID

  10. Child with hemophilia – HIV discovered 12/17/84 – banned from school and given 6 month diagnosis. Died 5 years later, 4 months before passage of the Ryan White Care Act – now $2 billion/year for HIV drugs for 500,000. Bono – “Greatest man I ever met” 1984 Ryan White

  11. Surgeon General under President Reagan Champion of – Sex education Condoms Handicapped children Cigarette harm “The Letter” was an AIDS wakeup call C. Everett Koop“The Letter” 1987

  12. AIDS QUILT – 1987 Panel are 3’ by 6’ with tributes to people who were lost to HIV → Washington Mall 1987-1996, weight = 54 tons, 94,000 names (20%)

  13. Civil disobedience: Wall Street 1987, NY Post Office 1987, St. Patrick’s Cathedral 1989, NIH 1990 (Now TAG) AIDS COALITION to UNLEASH POWER: 1987

  14. Martin DelaneyActivist (without AIDS)1945-2008 Founded Project Inform “for medically supervised guerrilla trials” – Major force in NIAID, FDA and ethics

  15. The Trial: AZT vs. placebo (n=282). DSMB stopped study: 19 deaths (placebo) vs. 1 (AZT) (Fischl MA. NEJM 1987;317:185)

  16. Jeff Murray, MDDeputy DirectorDivision of Antimicrobial Drug Products for FDA Major facilitator of HIV drugs (n=28) and, more recently HCV (#24 in trials)

  17. “I have AIDS” (Trumped efforts of millions to destigmatize HIV infection) MAGIC JOHNSONThe Announcement: 1991

  18. The development of protease inhibitors and beginning of HAART PROTEASE 1996

  19. HAART: IDV/AZT/3TC Results for NDV at 52 weeks – 80% vs. zero THE STUDY THAT CHANGED AIDS Gulick RM. Merck 035 NEJM 1997;337:734 ■IDV / 3TC / AZT ●IDV ∆AZT / 3TC

  20. “Hit hard and hit early” … Time Magazine: Man-of-the-year, 1996 David Ho

  21. Mortality From 1990-2004 in the Johns Hopkins HIV Clinical Cohort Lau B, et al. Non-AIDS Related Mortality Risk Exceeds AIDS-related Mortality Among Injecting Drug Users with CD4+ Counts Above 200 Cells/mm3. CROI Denver, CO, 2006

  22. NRTI NNRTI PI El CCR5 II 1987 AZT ------ ------ ------ ------ ------ 1991-92 ddI, ddC ------ ------ ------ ------ ------ 1995 d4T ------ ------ ------ ------ ------ 1996 3TC ------ SQV ------ ------ ------ 1997 ------ NVP RTV, IDV ------ ------ ------ 1997 ------ DLV NFV ------ ------ ------ 1998 ------ EFV ------ ------ ------ ------ 1999 ABC ------ APV ------ ------ ------ 2000 ------ ------ LPV ------ ------ ------ 2001 TDF ------ ------ ------ ------ ------ 2003 FTC ------ ATV ENF ------ ------ 2005 ------ ------ TPV ------ ------ ------ 2006 ------ ------ DRV ------ ------ ------ • ------ ------ ------ ------ MVC RAL • ------ ETR ------ ------ ------ ------ • ------ RPV ------ ------ ------ ------ • ------ ------ ------ ------ ------ EVG 2013 ------ ------ ------ ------ ------ DTG

  23. HIV SCIENCE AND CARE1996-2013 US & Europe (“Resource Rich”) • Fine tuning 1996-now • Treatment “done” – 2008 (Fauci) • New priorities: • International • Domestic: Cure & Prevention International (“Low Resource”) • Resource limits: Drugs • Infrastructure for chronic care • WHO – Plan universal ART when resources allow

  24. “AIDS in Africa is so devastating – it threatens the social, political and economic stability of the world” ↓ Clinton Foundation (2001) • Low cost drugs • Pediatric HIV President Bill ClintonState of the Union Speech: 2000

  25. Subsaharan Africa:12% global population69% of HIV cases

  26. CLINTON FOUNDATION 2002-

  27. Bush: Do those HIV drugs work? O’Neil: “Let me tell you about my morning in the Moore Clinic” Bush: “Tony , we need to do something, Think big – really big” President George W. BushPEPFAR: 2002

  28. Fauci: “Thinking big” Collaborators – M. Dybul, P. Mugyeni, E. Goosby, J.W. Pape Plan Proposed: Would be considered January 2003: “Seldom have we been offered the opportunity to do so much for so many” President George W. Bush

  29. Peter Mugyeni and Laura BushState of the Union Address Bush: “$15 billion for Africa” Mugyeni: Jumped up → cheered → hugged the First Lady

  30. Bono: “PEPFAR – Greatest act of heroism since we jumped into WWII” NYTimes 12/1/11

  31. Need to put banner Prominent Voices to Address AIDS 2012 Leaders from the worlds of science, diplomacy, politics, philanthropy and entertainment are speaking at AIDS 2012, including:  •  President Bill Clinton  • U.S. Secretary of State Hillary Rodham Clinton  • U.S. Secretary of Health and Human Services Kathleen Sebelius  • South African Deputy President KgalemaMotlanthe • Former U.S. First Lady Laura Bush  • HRH Mette-Marit, Crown Princess of Norway  • World Bank President Jim Yong Kim  • UNAIDS Executive Director Michel Sidibé • Nobel Laureate Françoise Barré-Sinoussi • NIAID Director Anthony Fauci • Philanthropist Bill Gates  • Humanitarian Elton John  • Actress Whoopi Goldberg

  32. Hillary Rodham Clinton2012 IAS Conference – Washington DC “Blueprint for an AIDS-free generation”

  33. HIV REVIEW History Current standards Future

  34. HIV TREATMENT (DHHS & IAS-USA) Test: All persons age 13-64 yrs yrs(CDC); annual if risk Treat: Everybody with HIV What: TDF/FTC or ABC/3TC plus EFV, DRV/r, ATV/r, RAL Monitor: VL, CD4, etc. Change: VL >200 or ADR

  35. LIFE EXPECTANCY – DENMARKHelleberg M. CID 2012 [in press] 35 year old man HIV

  36. HIV CARE AND RESEARCH

  37. HIV REVIEW History Current standards Future

  38. HIV: THE FUTURE (US) Research priorities • Treatment – done (2008) • Prevention • Cure Operational challenges • Care delivery: 28% have controlled HIV viremia • Who will be primary provider (Is this a specialty • Healthcare reform

  39. TransmissionHIV transmission efficiency correlates with Viral Load – No transmissions with VL <1500 c/mL (2000) Transmission efficiency• 1/900 coital acts• M→F & F→M near equal• Maximum risk in primary HIV Treatment for prevention• HPTN 052 (2012)• Changed Global policy Never been a confirmed case with sexual transmission (BMHIVA) (2013) Quinn T. NEJM 2000;342:921

  40. HIV TREATMENT FOR PREVENTION:HPTN 052 M. Cohen (PI) (Cohen MS. NEJM 2011;365:493) Protocol: Discordant couples, CD4 350-550: Randomized to ART vs. no ART until CD4 <250 Results: N=1,763 (M=890, F-873) ART No Art n=886 n=877 HIV transmission* 1*** 27** *Linked cases (28 transmissions unlinked) **Protection with ART = 96% -- Study continues to determine durability ***Single exception preceded viral suppression

  41. HPTN 052: The study that changed HIV global strategy

  42. Treatment as Prevention: Effect of ART Coverage on HIV Incidence in Rural South Africa(Tanser F. 2012 CROI;Abstr. 136LV) Spatial Estimates of Proportion of HIV Patients on ART Adjusted HIV Infection Rate by ARV Coverage Category 2007 2008 2009 P=0.590 P=0.002 2010 2011 P<0.001 P=0.015 <10% 10-20% 20-30% 30-40% >40% Annual population based HIV surveillance in rural KwaZulu-Natal 2004 – 2011: 1395 HIV seroconversions among 16,588 HIV negative adults ≥15 years of age Tanser F, et al. 19th CROI; Seattle, WA; March 5-8, 2012. Abst. 136LB.

  43. Efficacy of Daily OralFTC/TDF PrEP FDA approved TDF/FTC for PrEP July 2012 . Candidates: High risk MSM and discordant couples

  44. “The Berlin Patient” • HIV + leukemia → chemotherapy and stem cell tx → 5 yrs; No HIV detected (R. Siliciano) • 2012: 2 more patients – Brigham Hospital, Boston (IAS Conference 2012)

  45. The “Gardner Cascade”(Gardner EM. CID 2011;52:793)

  46. Estimated 14% have viral suppression!!

  47. Sensitivity: 93% Specificity: 99.8% Distribution: Walmart, CVS, Walgreens, RiteAid, Kroger, etc. MAKE IT EASY

  48. P4P4P: THE STATUS OF PAYING PATIENTS FOR SELF CARE Practice: Widespread and international Incentives: Cash, groceries, lottery tickets, meal tickets. Conditions: Chronic – smoking, obesity , BP control, diabetes, HIV HIV trial: HPTN 65 – Controlled trial, (unblinded) HIV test – $25, Enroll in care – $70, NDV – $280/yr (1.7% of HIV care cost) Status: Widely practiced, no one wants to talk about it. Adherence guidelines refused (Ann Intern Med 2012;156:817)

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