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Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention

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Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention

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Project RSP+ Webinar - December 11, 2014. Presentation explores the pipeline of new HIV prevention technologies in the research and development phase. This project is an initiative of the AIDS Foundation of Chicago.

Project RSP+ Webinar - December 11, 2014. Presentation explores the pipeline of new HIV prevention technologies in the research and development phase. This project is an initiative of the AIDS Foundation of Chicago.

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Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention

  1. 1. Welcome Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention December 11, 2014 webinar Exploring the Pipeline
  2. 2. Use the question feature to ask questions during the webinar • All attendees are in listen-only mode • Everyone can ask questions at any time using the questions feature or by emailing ssemelka@aidschicago.org. • During Q & A breaks, the moderators will read questions that have been submitted
  3. 3. Can’t hear the audio? • Use your telephone! • Click on the “audio” tab • Dial the telephone number, access code, and PIN you see on your computer
  4. 4. Slides available for download at www.myprepexperience.org
  5. 5. Housekeeping & questions • Use the “questions” feature to ask questions OR • Email ssemelka@aidschicago.org • Can’t hear? Click the “audio” tab and dial the number and code • Download the slides at www.myprepexperience.org
  6. 6. Housekeeping & questions • Use the “questions” feature to ask questions OR • Email ssemelka@aidschicago.org • Can’t hear? Click the “audio” tab and dial the number and code • Download the slides at www.myprepexperience.org
  7. 7. PRE-TEST LET’S SEE WHAT WE KNOW 7
  8. 8. ARV-Based Prevention Pipeline (March 2014) PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV Pop Council IPM IPCP NIAID Pop Council R IPM HPTN/ACTG CONRAD IPM Gilead CONRAD Albert Einstein GSK CONRAD IPM CONRAD Janssen TaiMed Pop Council IPM IPM IPM IPM PBS IPM R IPM R Pop Council RTI Pop Council Mintaka ImQuest ImQuest DELIVERY SYSTEM Oral pills Vaginal gel Vaginal film Vaginal tablet Vaginal ring Long acting injectable Thin film polymer Phosphate Nano-fiber buffered saline PBS R Rectal gel IPM IPM IPM IPM TFV/ FTC TDF/ FTC MIV 150 TMC 278 MVA DAR Darunavir GRF TFV TDF DAP IQP IQP-0528 5P12 5P12-RANTES 744 Tenofovir Tenofovir disoproxil fumarate MIV 150 Maraviroc MAb GSK 744 Tenofovir disoproxil fumarate/emtricitabine Dapivirine Ripilvirine Monoclonal antibody Tenofovir/ emtricitabine Griffithsin DS003 DS003 (BMS793) No drug tested currently TFV Tenofovir prodrug ACTIVE DRUG RAL Raltegravir CDC CONRAD Adapted from AVAC Report 2013: Research & Reality. www.avac.org/report2013
  9. 9. 13
  10. 10. 14
  11. 11. OUR AGENDA  Quick review of treatment, PEP, PrEP  Microbicide research  Rectal products  Vaginal products  New PrEP  New dosing strategies  New oral drugs  Long acting injectables 15
  12. 12. OUR AGENDA  Multipurpose Technologies  Interesting formulations  Implementation 16
  13. 13. 17 Unrestricted educational grant from Janssen Therapeutics to AFC --- 2014 Learn about research & development of new prevention technologies
  14. 14. EXPECTATIONS AND DISCLAIMERS 18
  15. 15. THE ONLY DUMB QUESTION IS THE ONE YOU DIDN’T ASK 19
  16. 16. TREATMENT, PEP, PREP REVIEW 20
  17. 17. PREVENTION REVOLUTION SEISMIC CHANGES 21
  18. 18. HOW DOES HIV TREATMENT ACT AS PREVENTION? 22
  19. 19. 2011: TREATMENT IS PREVENTION TOO 23
  20. 20. 24
  21. 21. 25
  22. 22. WHAT IS POST-EXPOSURE PROPHYLAXIS (PEP)? 26
  23. 23. WHAT IS PRE-EXPOSURE PROPHYLAXIS (PREP)? 27
  24. 24. 2010: PREP WORKS! 28
  25. 25. tinyurl.com/CDCprepguidelines 29 2014: Clinical Guidelines
  26. 26. Condomless is not “unprotected” 30 2014: Language Matters
  27. 27. THE DEVIL IS IN THE DETAILS PREP ACCESS 31
  28. 28. PREP WARM LINE 33 Recently launched! PrEPline, 855-448-7737 The CCC Pre-Exposure Prophylaxis Service 11 a.m. – 6 p.m. EST http://nccc.ucsf.edu/2014/09/29/introducing-the-ccc-prepline/
  29. 29. HANDY BROCHURE! 34 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  30. 30. ACCESSING PREP— INSURANCE FDA approval of Truvada enables private ins to cover Truvada on Medicaid formulary Ins companies covering, so far ADAP does not cover PrEP 35
  31. 31. Insurance Medicaid Devil in the details • Prior auth • Deductibles • Co-pays • Tiers • Confusion 36 ACCESSING PREP— INSURANCE
  32. 32. Gilead support programs Medication Assistance Program 500% FPL Co-pay program $300/mo. 37 NEWLY IMPROVED – OCTOBER 15, 2014
  33. 33. PREP UTILIZATION 38 A total of 2,319 unique individuals who started TVD for PrEP between 01 Jan 2012 and 30 Sep 2013 were included in the analysis. • 48.8% of PrEP users were women. • Mean age was 38.2 ± 12.2 years • Males were significantly older (39.5 ± 12.0) than females (36.8 ± 12.3). p<0.0001 • 12.3% of individuals were under 25 years old. • The proportion of males under 25 was 8.0% (95% CI 6.5 – 9.5) significantly lower than that of women 16.8% (95% CI 14.6 – 19.0). p<0.0001 Overall distribution of TVD for PrEP prescriptions by prescriber specialty: • Family Practice (18%) • Internal Medicine (16%) • Infectious Diseases (11%) • Nurse Practitioners (9%) • Physician Assistants (9%) WY CO ND SD MI OK AR  Uninfected individuals receiving TVD for PrEP were: DE – 1.8 times more likely to be female (95% CI 1.6 – 1.9) – 1.4 times more likely to be younger than 25 years old (95% CI 1.3 – 1.7) MA – 3.6 times more likely to be treated by a non-ID physician (95% CI 3.2 – 4.1). WA OR CA NV ID UT AZ MT NM NE KS WI MN IA MO IL IN OH KY ME NH VT RI NY CT NJ PA NY C, LI A K TX LA AL GA SC NC WV MD MS TN VA FL Midwest 16% Northeast 25% South 32% West 27% Prescribers of TVD for PrEP are located in 49 of the 50 U.S. states Overall Midwest Northeast South West Unique PrEP users n (%) 2,319* 373 (16%) 570 (25%) 729 (32%) 604 (27%) Mean age in years (SD) 38 (12) 37 (12) 37 (12) 40 (12) 38 (12) Younger <25 y/o 12.3% 16.4% 12.3% 9.7% 12.4% Female 48.8% 53.6% 51.4% 51.4% 39.2% Medicaid 9.9% 15.3% 15.3% 6.6% 5.1%
  34. 34. 39
  35. 35. www.hivresourcetracking.org
  36. 36. www.hivresourcetracking.org
  37. 37. STAGES OF CLINICAL TRIALS 42 Graphic courtesy International Partnership for Microbicides
  38. 38. PERSPECTIVE 43 Of 10,000 compounds that get tested in the lab, 5 make it to human trials and 1 makes it to market.
  39. 39. THE PREVENTION PACKAGE 44  Condoms – male and female  Condom-compatible lubricant  Information/education  Counseling/risk reduction  HIV testing  STI testing/treatment  HEP A and B vaccinations
  40. 40.  A PRODUCT APPLIED TOPICALLY IN THE VAGINA OR THE RECTUM THAT CAN OFFER PROTECTION AGAINST HIV AND, IDEALLY, OTHER STIs  IDEALLY WOULD HAVE A CONTRACEPTIVE VERSION, AND ANOTHER TO ALLOW FOR PREGNANCY – ARV/NON-ARV  FORMULATED AS A GEL/LUBRICANT, FILM, FIBER, VAGINAL RING  A RECTAL MICROBICIDE MIGHT BE DELIVERED VIA GEL/LUBRICANT, DOUCHE/ENEMA, OR …  MICROBICIDES ARE STILL IN DEVELOPMENT  THEY ARE NOT AVAILABLE YET! 45 MICROBICIDES
  41. 41. RECTAL GELS MICROBICIDES 46
  42. 42. An act of unprotected anal intercourse is 10 to 20 times more likely to result in HIV transmission compared to an act of unprotected vaginal intercourse.
  43. 43. 49
  44. 44. MTN 017 RECTAL GEL A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
  45. 45. N = 192 RECTAL GEL [Sept ’13 – June ‘16 ] Participants Gay/MSM, transgender women Study sites • US (4) • Thailand (2) • RSA (1) • Peru (1)
  46. 46. 017 IN BRIEF Study regimens include: RECTAL GEL • Rectal tenofovir gel used daily • Rectal tenofovir gel used before and after sex • Truvada tablets taken daily Each participant will follow all of the study regimens for eight weeks, with a weeklong break between regimens when no product will be used • The order in which participants follow study regimens will be based on random assignment All participants receive standard HIV prevention package
  47. 47. Product Sequence N Period 1 (8 weeks) Product Break (1 week) 017 STUDY DESIGN Period 2 (8 weeks) Product Break (1 week) Period 3 (8 weeks) 1 31 Daily Truvada Daily rectal gel Rectal gel before and after sex 2 31 Rectal gel before and after sex Daily Truvada Daily rectal gel 3 31 Daily rectal gel Rectal gel before and after sex Daily Truvada 4 31 Daily rectal gel Daily Truvada Rectal gel before and after sex 5 31 Daily Truvada Rectal gel before and after sex Daily rectal gel 6 31 Rectal gel before and after sex Daily Rectal gel Daily Truvada Slide courtesy of Dr. Ross D. Cranston, 017 Principal Investigator RECTAL GEL
  48. 48. 017 ADHERENCE PK monitoring, “real time” PK RECTAL GEL Layered approach to monitoring •SMS (text messages) • Product returns • CASI (computer assisted self interview)
  49. 49. RECTAL GEL
  50. 50. RECTAL GEL
  51. 51. RECTAL GEL
  52. 52. RECTAL GEL
  53. 53. 59
  54. 54. RECTAL GELS  Combination HIV Antiretroviral Rectal Microbicide Program (CHARM)  Phase I  Maraviroc gel  Microbicide Trials Network  Phase I – in development  Dapivirine gel
  55. 55. 61
  56. 56. VAGINAL GELS AND RINGS MICROBICIDES 63
  57. 57. South Africa - 2 sites in KwaZulu-Natal Phase IIB - 889 HIV- women, 18 – 40 Enrolled May 2007 – Jan. 2009 Vaginally formulated tenofovir gel Results July 20, 2010 – AIDS 2010
  58. 58. CAPRISA 008  Implementation study underway  HIV-negative CAPRISA 004 participants  Effectiveness/sustainability in rural and urban clinics  Oct ‘12 – Mar ’15 VOICE [MTN]  Phase 2B, randomized, double-blind, placebo-controlled, 5-arm trial  5029 women in trial – Uganda, S. Africa, Zimbabwe  Studied daily use of following :  Vaginal tenofovir 1% gel  Oral tenofovir  Oral Truvada  Results announced March 2013 69 VAGINAL GELS
  59. 59. 70 VAGINAL GELS
  60. 60. VOICE C, D Why women didn’t take study product Asked participants, partners, community members • Lack of social support • Hearing that other women were not using product • Ambivalence about not knowing if placebo or active drug • Concerns about side effects, lack of side effects • Stigma of using drug used by PLWHIV
  61. 61. VAGINAL GELS Phase III trial of tenofovir gel BAT24 dosing – hope to confirm CAPRISA 004 2600 women, age 18-30, South Africa, 10 sites Oct 2011 ~ late 2014 Results 2015
  62. 62. VAGINAL GELS Courtesy of FACTS 001
  63. 63. 74 Courtesy of FACTS 001
  64. 64. 75 VAGINAL GELS Courtesy of FACTS 001
  65. 65. 76 VAGINAL GELS Courtesy of FACTS 001
  66. 66. 77 VAGINAL GELS Courtesy of FACTS 001
  67. 67. VAGINAL RINGS MICROBICIDES 78
  68. 68. VAGINAL RINGS Monthly vaginal ring with Dapivirine The Ring Study/IPM 023 • Phase III • 1650 women • South Africa, Rwanda • Apr 2012 ~ mid 2015 ASPIRE/MTN 027 • Phase III • 3500 women • Malawi, SA, Uganda, Zambia, Zimbabwe • July 2012 ~ end 2014 Slide courtesy AVAC TWO TRIALS
  69. 69. WHY AFRICA? 80
  70. 70. www.hivresourcetracking.org
  71. 71. FILMS AND FIBERS MICROBICIDES 82
  72. 72.  International Partnership for Microbicides  Early preclinical  Maraviroc/tenofovir film  Dapivirine/maraviroc film  Phase I  Dapivirine film 83 VAGINAL FILMS
  73. 73. 84 VAGINAL NANOFIBERS NANO FIBERS
  74. 74.  Weave maraviroc into water-soluble nano fibers  200 times thinner than strand of human hair  After insertion into vagina, fibers can dissolve and release an effective dose in about 6 min  Intercourse could further disperse drug throughout the vagina 85 VAGINAL NANOFIBERS UNIVERSITY OF WASHINGTON POPULATION COUNCIL
  75. 75. DOSING PREP 86
  76. 76. Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking 540 HIV-negative volunteers, randomized to 3 arms Gay men, transgender women, cisgender women Bangkok, Cape Town, New York City Began late 2011, ongoing 87 INTERMITTENT PREP
  77. 77. 88 INTERMITTENT PREP Intervention Préventive de l'Exposition aux Risques avec et pour les hommes Gays Action to Prevent Risk Exposure By and For Gay Men Randomized, placebo controlled, pilot study to assess adherence and feasibility. France Jan ‘12, Quebec July ’13 Gay men, Canada (50) and France (300) – haven’t used condoms for anal w/at least 2 partners in past 6 mos Controversial study design AIDS 2014 – good adherence (CASI, pill counts, plasma, hair)
  78. 78. 89 INTERMITTENT PREP Regimen = Two Truvada 2 to 24 hours before sex, one tablet within 24 hours after sex, and another tablet within 48 hours after sex.
  79. 79. ORAL PREP 90
  80. 80. 91 ORAL MARAVIROC Phase II safety and tolerability study – June ‘12 – July ‘15 600 HIV-negative individuals – women and gay men All U.S. sites Comparing 4 regimens • Maraviroc • Maraviroc + Emtricitabine (FTC) • Maraviroc + Tenofovir (TDF) • Truvada (TDF +FTC)
  81. 81. LONG ACTING INJECTABLES PREP 92
  82. 82. 93 Graphic courtesy AVAC LONG ACTING INJECTABLES
  83. 83. 94 LONG ACTING INJECTABLES
  84. 84. 95 WE’RE IN THE HOME STRETCH
  85. 85. COMBINATION PRODUCTS MULTIPURPOSE TECHNOLOGIES (MPTS) 96
  86. 86. 97
  87. 87. Female Condoms: The Original MPT • Several others beyond FC2 are 98 available outside of the US • Scientists are developing new options
  88. 88. 99 Graphic courtesy AVAC MPTS
  89. 89. MPTS 100 Graphic courtesy AVAC
  90. 90. MAPPING PATHWAYS IMPLEMENTATION 101
  91. 91. Published 1 April, 2014 mappingpathways.org
  92. 92. What is most striking is that [the] future is not driven by the science, it is driven by communities and the needs of implementation.
  93. 93. 104
  94. 94.  INTERNATIONAL RECTAL MICROBICIDE ADVOCATES ADVOCACY  rectalmicrobicides.org  MAPPING PATHWAYS  mappingpathways.org  MY PREP EXPERIENCE  myprepexperience.org  CHICAGO FEMALE CONDOM COALITION  chicagofemalecondom.org  AVAC – GLOBAL ADVOCACY FOR HIV PREVENTION  avac.org  PREP WATCH  prepwatch.org
  95. 95. POST-TEST LET’S SEE IF WE KNOW A LITTLE MORE 106
  96. 96.  ACCESS Grand Boulevard  Aidsmap  AVAC – Global Advocacy for HIV Prevention  CORE Center  FACTS  HIV Prevention Trials Network  HIV & Microbicides Resource Tracking Working Group  Howard Brown Health Center  International Partnership for Microbicides  Jessica Terlikowski/AFC  Microbicide Trials Network  Population Council  Treatment Action Group  University of Chicago 107 ACKNOWLEDGMENTS Thank you
  97. 97. THANK YOU 108
  98. 98. CONTACT JIM – JPICKETT@AIDSCHICAGO.ORG JESSICA – TERLIKOWSKI@AIDSCHICAGO.ORG

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