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WELCOME 
OCTOBER 9, 2014 
CHICAGO – JOHN MARSHALL LAW SCHOOL 
Exploring the Pipeline
PROJECT READY, SET, PREP – PLUS 
EXPLORING 
THE PIPELINE
3
PRE-TEST 
LET’S SEE WHAT WE KNOW 
4
ARV-Based Prevention Pipeline (March 2014) 
PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV 
Pop Council 
IPM 
IPCP NIAID...
10
11
OUR AGENDA 
 Quick review treatment, PEP, PrEP 
 Video: The Rectal Revolution is Here: 
An introduction to rectal microb...
OUR AGENDA 
 New PrEP 
 New dosing strategies 
 New oral drugs 
 Long acting injectables 
 New male and female 
(rece...
OUR AGENDA 
 Pre/post test 
 Evaluations 
 Certificates of completion 
 These slides are online at 
www.myprepexperien...
15 
Unrestricted 
educational 
grant from 
Janssen 
Therapeutics to 
AFC 
- 2014 
Learn about 
research & 
development 
of...
EXPECTATIONS AND DISCLAIMERS 
16
THE ONLY 
DUMB QUESTION 
IS THE ONE YOU 
DIDN’T ASK 
17
18 
Discussion 
Learning 
The only 
“dumb” 
question is 
the one you 
didn’t ask 
OUR TIME 
TOGETHER
19 
>>> WHY IS THIS RELEVANT TO ME?
TREATMENT, PEP, PREP 
REVIEW 
20
PREVENTION REVOLUTION 
SEISMIC CHANGES 
21
HOW DOES HIV TREATMENT ACT AS PREVENTION? 
22
2011: TREATMENT IS 
PREVENTION TOO 
23
24
25
WHAT IS POST-EXPOSURE PROPHYLAXIS (PEP)? 
26
WHAT IS PRE-EXPOSURE PROPHYLAXIS (PREP)? 
27
2010: PREP WORKS! 
28
tinyurl.com/CDCprepguidelines 
29 
2014: Clinical Guidelines
Condomless is not “unprotected” 
30 
2014: Language Matters
THE DEVIL IS IN THE DETAILS 
PREP ACCESS 
31
ACCESSING PREP 
Any medical provider who can write a 
scrip can write one for Truvada as PrEP 
Most HIV docs familiar with...
PREP WARM LINE 
34 
Just launched! 
PrEPline, 855-448-7737 
The CCC Pre-Exposure Prophylaxis Service 
11 a.m. – 6 p.m. EST...
HANDY BROCHURE! 
35 
Designed to help individuals talk to 
their doctors about PrEP 
Before, during, after visit 
Questi...
ACCESSING PREP— INSURANCE 
FDA approval of 
Truvada enables 
private ins to cover 
Truvada 
on 
Medicaid 
formulary 
Ins c...
Insurance 
Medicaid 
Devil in the details 
• Prior auth 
• Deductibles 
• Co-pays 
• Tiers 
• Confusion 
37 
ACCESSING PRE...
Gilead 
support 
programs 
Medication 
Assistance 
Program 
500% FPL 
Co-pay 
program 
$300/mo. 
38 
NEWLY IMPROVED – OCTO...
PREP UTILIZATION 
39 
A total of 2,319 unique individuals who started 
TVD for PrEP between 01 Jan 2012 and 30 Sep 
2013 w...
Chicago PrEP 
Working 
Group 
Researchers 
Medical 
providers 
HIV planning 
members 
Advocates 
CBOs 
40
TAKING PREP IS 
THOUGHTFUL 
RESPONSIBLE 
CAREFUL 
41 
AWARE 
PRO-ACTIVE 
DISCIPLINED
TAKING PREP IS 
SAFER SEX 
42
43
INVESTMENT 
NEEDED 
INFRASTRUCTURE 
TRAINING 
SOCIAL MARKETING 
HEALTH CARE ACCESS 
BEST PRACTICES 
POLICY/ADVOCACY 
FEDER...
MORE DATA, MORE ENERGY AND 
MORE RESOURCES 
45 
WOMEN 
TRANSGENDER 
WOMEN AND MEN
46
VIDEO 
THE RECTAL REVOLUTION IS HERE 
AN INTRODUCTION TO RECTAL MICROBICIDE CLINICAL TRIALS 
47
48 
tinyurl.com/RectalRevEnglish 
tinyurl.com/RectalRevSpanish 
youtube.com/IRMAadvocacy
49 
rectalmicrobicides.org
SHOWTIME… 
50
DISCUSSION 
51
BREAK TIME 
52
www.hivresourcetracking.org
www.hivresourcetracking.org
STAGES OF CLINICAL TRIALS 
55 
Graphic courtesy International Partnership for Microbicides
PERSPECTIVE 
56 
Of 10,000 compounds that get 
tested in the lab, 5 make it to 
human trials and 1 makes it to 
market.
THE PREVENTION PACKAGE 
57 
 Condoms – male and female 
 Condom-compatible lubricant 
 Information/education 
 Counsel...
 A PRODUCT APPLIED TOPICALLY IN THE VAGINA OR THE 
RECTUM THAT CAN OFFER PROTECTION AGAINST HIV AND, 
IDEALLY, OTHER STIs...
RECTAL GELS 
MICROBICIDES 
59
An act of unprotected anal 
intercourse is 10 to 20 times more 
likely to result in HIV transmission 
compared to an act o...
62
MTN 017 
RECTAL GEL 
A Phase 2 Randomized Sequence 
Open Label Expanded Safety and 
Acceptability Study of Oral 
Emtricita...
N = 192 
RECTAL GEL 
[Sept ’13 – June ‘16 ] 
Participants 
Gay/MSM, 
transgender 
women 
Study sites 
• US (4) 
• Thailand...
017 IN BRIEF 
Study regimens include: 
RECTAL GEL 
• Rectal tenofovir gel used daily 
• Rectal tenofovir gel used before a...
Product 
Sequence 
N Period 1 
(8 weeks) 
Product Break 
(1 week) 
017 STUDY DESIGN 
Period 2 
(8 weeks) 
Product 
Break 
...
017 ADHERENCE 
PK monitoring, “real time” PK 
RECTAL GEL 
Layered approach to monitoring 
•SMS (text messages) 
• Product ...
RECTAL GEL
RECTAL GEL
RECTAL GEL
RECTAL GEL
72
RECTAL GELS 
 Combination HIV Antiretroviral Rectal 
Microbicide Program (CHARM) 
 Phase I 
 Maraviroc gel 
 Microbici...
74
76
VAGINAL GELS AND RINGS 
MICROBICIDES 
77
South Africa - 
2 sites in 
KwaZulu-Natal 
Phase IIB - 889 
HIV- women, 
18 – 40 
Enrolled May 
2007 – Jan. 
2009 
Vaginal...
CAPRISA 008 
 Implementation study 
underway 
 HIV-negative CAPRISA 004 
participants 
 Effectiveness/sustainability 
i...
80 
VAGINAL GELS
VOICE 
C, D 
Why women didn’t take study product 
Asked participants, partners, community members 
• Lack of social suppor...
VAGINAL GELS 
Phase III trial of tenofovir gel 
BAT24 dosing – hope to confirm 
CAPRISA 004 
2600 women, age 18-30, South ...
VAGINAL GELS 
Courtesy of FACTS 001
84 
Courtesy of FACTS 001
85 
VAGINAL GELS 
Courtesy of FACTS 001
86 
VAGINAL GELS 
Courtesy of FACTS 001
87 
VAGINAL GELS 
Courtesy of FACTS 001
VAGINAL RINGS 
MICROBICIDES 
88
VAGINAL RINGS 
Monthly vaginal ring with Dapivirine 
The Ring Study/IPM 023 
• Phase III 
• 1650 women 
• South Africa, Rw...
WHY AFRICA? 
90
www.hivresourcetracking.org
FILMS AND FIBERS 
MICROBICIDES 
92
 International Partnership for Microbicides 
 Early preclinical 
 Maraviroc/tenofovir film 
 Dapivirine/maraviroc film...
94 
VAGINAL NANOFIBERS 
PSEUDO TAMPON
 Weave maraviroc into water-soluble nano fibers 
 200 times thinner than strand of human hair 
 After insertion into va...
96
97
BREAK TIME 
98
DOSING 
PREP 
99
Alternative Dosing to Augment 
Pre-Exposure Prophylaxis Pill Taking 
540 HIV-negative volunteers, randomized to 3 arms 
Ga...
101 
INTERMITTENT PREP 
Intervention Préventive de l'Exposition aux Risques avec et pour les 
hommes Gays 
Action to Preve...
102 
INTERMITTENT PREP 
Regimen = Two Truvada 2 to 24 hours before sex, one tablet 
within 24 hours after sex, and another...
ORAL 
PREP 
103
104 
ORAL MARAVIROC 
Phase II safety and tolerability study – June ‘12 – July ‘15 
600 HIV-negative individuals – women an...
LONG ACTING INJECTABLES 
PREP 
105
106 
Graphic courtesy AVAC 
LONG ACTING INJECTABLES
107 
LONG ACTING INJECTABLES
108
MALE AND FEMALE (RECEPTIVE) 
NEW CONDOMS 
109
www.hivresourcetracking.org
The Woman’s Condom 
• Polyurethane with dissolving capsule 
applicator 
• Held in place by foam shapes 
• Trials demonstra...
• Cupid 
 Latex, inner sponge that aids insertion 
 Outer ring helps keep it in place during sex 
 Available in India, ...
• Panty Condom 
• Polyethylene sheath pre-lubricated w/ 
Vaseline 
• Limited distribution in Colombia, under 
review for W...
FEMALE CONDOMS 
• Origami 
• Silicone, accordion-like folding 
• Assessed acceptability and performance with 20 HIV-negati...
ANAL CONDOM 
 Origami 
BOOTY SPECIFIC 
 First condom designed specifically for receptive anal sex 
 Silicone 
 Fenway ...
116 
GATES FOUNDATION CONDOM CHALLENGE
117 
GATES FOUNDATION CONDOM CHALLENGE 
The common analogy is that wearing a 
condom is like taking a shower with a 
rainc...
CONCEPTS IN DEVELOPMENT 
• Air-Infused Female Condom 
• Uses air pressure to insert 
• Polyurethane 
• Female Pleasure Con...
COMBINATION PRODUCTS 
MULTIPURPOSE 
TECHNOLOGIES 
(MPTS) 
119
120
121 
Graphic courtesy AVAC 
MPTS
MPTS 
122 
Graphic courtesy AVAC
IMPLEMENTATION 
123
DBS TFV-DP levels at Week 4, by study site 
5.4 
10.8 
27 
60 
50 
40 
30 
20 
10 
Miami 
DC 
SF 
60% (557/922) of potenti...
U.S. CITIES INVOLVED IN DEMONSTRATION PROJECTS 
San Francisco (2) 
Boston (2) 
Miami 
D.C. 
Chicago (2) 
Los Angeles (2) 
...
SELECTED POST-APPROVAL DEMO/IMPLEMENTATION PROJECTS
127 
WE’RE IN THE 
HOME STRETCH
CHICAGO 
IMPLEMENTATION 
128
129 
SHIPP [SUSTAINABLE HEALTH CENTER 
IMPLEMENTATION PREP PILOT] 
 June 1. 2014 
 Implementation project examining PrEP...
130 
PROJECT PREPARE II 
CHICAG0 IMPLEMENTATION 
 Open label demo project AND safety study of PrEP in 
young gay/MSM ages...
131 
CHICAG0 IMPLEMENTATION 
HOWARD BROWN HEALTH CENTER 
 Evaluating PrEP in community 
health center setting 
 Collects...
132
MAPPING PATHWAYS 
IMPLEMENTATION 
133
Published 1 April, 2014 
mappingpathways.org
What is most striking is 
that [the] future is not 
driven by the science, it 
is driven by communities 
and the needs of ...
136 
>>> HOW CAN I MAKE THIS 
RELEVANT TO THOSE I SERVE?
137
 INTERNATIONAL RECTAL MICROBICIDE ADVOCATES 
ADVOCACY 
 rectalmicrobicides.org 
 MAPPING PATHWAYS 
 mappingpathways.or...
POST-TEST 
LET’S SEE IF WE KNOW A LITTLE MORE 
139
 ACCESS Grand Boulevard 
 Aidsmap 
 AVAC – Global Advocacy for HIV Prevention 
 CORE Center 
 FACTS 
 HIV Prevention...
THANK YOU 
141
CONTACT 
JPICKETT@AIDSCHICAGO.ORG
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
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Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention

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This is a training on the research and development pipeline for new HIV prevention technologies - including PrEP, microbicides, and new male and female condoms. It was conducted by AIDS Foundation of Chicago's Jim Pickett on Thursday, October 9, 2014 in Chicago, Illinois. These slides have been revised and updated from the same training conducted in Bloomington, IL on Sept 29.

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Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention

  1. 1. WELCOME OCTOBER 9, 2014 CHICAGO – JOHN MARSHALL LAW SCHOOL Exploring the Pipeline
  2. 2. PROJECT READY, SET, PREP – PLUS EXPLORING THE PIPELINE
  3. 3. 3
  4. 4. PRE-TEST LET’S SEE WHAT WE KNOW 4
  5. 5. 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 CONRAD IPM Gilead CONRA D Albert Einstein GSK CONRAD IPM CONRAD Janssen TaiMe d Pop Council HPTN/ACT G 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 /FT C MIV 150 TMC 278 MVA DAR Darunavir GRF TFV TDF DAP IQP IQP-0528 744 Tenofovir Tenofovir disoproxil fumarate MIV 150 Maraviroc MAb GSK 744 Tenofovir disoproxil fumarate/emtricita bine Dapivirine Ripilvirine Monoclonal antibody Tenofovir/ emtricitabine Griffithsin DS00 3 DS003 (BMS793) No drug tested currently 5P1 2 5P12- RANTES TFV Tenofovir prodrug ACTIVE DRUG RAL Raltegrav ir CDC CONRAD Adapted from AVAC Report 2013: Research & Reality.
  6. 6. 10
  7. 7. 11
  8. 8. OUR AGENDA  Quick review treatment, PEP, PrEP  Video: The Rectal Revolution is Here: An introduction to rectal microbicide clinical trials  Microbicide research  Rectal products  Vaginal products 12
  9. 9. OUR AGENDA  New PrEP  New dosing strategies  New oral drugs  Long acting injectables  New male and female (receptive) condoms  Multipurpose Technologies  Interesting formulations  Implementation 13
  10. 10. OUR AGENDA  Pre/post test  Evaluations  Certificates of completion  These slides are online at www.myprepexperience.org
  11. 11. 15 Unrestricted educational grant from Janssen Therapeutics to AFC - 2014 Learn about research & development of new prevention technologies
  12. 12. EXPECTATIONS AND DISCLAIMERS 16
  13. 13. THE ONLY DUMB QUESTION IS THE ONE YOU DIDN’T ASK 17
  14. 14. 18 Discussion Learning The only “dumb” question is the one you didn’t ask OUR TIME TOGETHER
  15. 15. 19 >>> WHY IS THIS RELEVANT TO ME?
  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. ACCESSING PREP Any medical provider who can write a scrip can write one for Truvada as PrEP Most HIV docs familiar with PrEP Chicago:  Research (Project PrEPare)  UC and ACCESS Grand Blvd  Howard Brown Health Center  CORE Center – clinic coming soon  Chicago PrEP Working Group 32
  29. 29. PREP WARM LINE 34 Just 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/
  30. 30. HANDY BROCHURE! 35 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  31. 31. 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 36
  32. 32. Insurance Medicaid Devil in the details • Prior auth • Deductibles • Co-pays • Tiers • Confusion 37 ACCESSING PREP— INSURANCE
  33. 33. Gilead support programs Medication Assistance Program 500% FPL Co-pay program $300/mo. 38 NEWLY IMPROVED – OCTOBER 15, 2014
  34. 34. PREP UTILIZATION 39 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%
  35. 35. Chicago PrEP Working Group Researchers Medical providers HIV planning members Advocates CBOs 40
  36. 36. TAKING PREP IS THOUGHTFUL RESPONSIBLE CAREFUL 41 AWARE PRO-ACTIVE DISCIPLINED
  37. 37. TAKING PREP IS SAFER SEX 42
  38. 38. 43
  39. 39. INVESTMENT NEEDED INFRASTRUCTURE TRAINING SOCIAL MARKETING HEALTH CARE ACCESS BEST PRACTICES POLICY/ADVOCACY FEDERAL STATE LOCAL PUBLIC PRIVATE 44
  40. 40. MORE DATA, MORE ENERGY AND MORE RESOURCES 45 WOMEN TRANSGENDER WOMEN AND MEN
  41. 41. 46
  42. 42. VIDEO THE RECTAL REVOLUTION IS HERE AN INTRODUCTION TO RECTAL MICROBICIDE CLINICAL TRIALS 47
  43. 43. 48 tinyurl.com/RectalRevEnglish tinyurl.com/RectalRevSpanish youtube.com/IRMAadvocacy
  44. 44. 49 rectalmicrobicides.org
  45. 45. SHOWTIME… 50
  46. 46. DISCUSSION 51
  47. 47. BREAK TIME 52
  48. 48. www.hivresourcetracking.org
  49. 49. www.hivresourcetracking.org
  50. 50. STAGES OF CLINICAL TRIALS 55 Graphic courtesy International Partnership for Microbicides
  51. 51. PERSPECTIVE 56 Of 10,000 compounds that get tested in the lab, 5 make it to human trials and 1 makes it to market.
  52. 52. THE PREVENTION PACKAGE 57  Condoms – male and female  Condom-compatible lubricant  Information/education  Counseling/risk reduction  HIV testing  STI testing/treatment  HEP A and B vaccinations
  53. 53.  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! 58 MICROBICIDES
  54. 54. RECTAL GELS MICROBICIDES 59
  55. 55. 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.
  56. 56. 62
  57. 57. 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
  58. 58. N = 192 RECTAL GEL [Sept ’13 – June ‘16 ] Participants Gay/MSM, transgender women Study sites • US (4) • Thailand (2) • RSA (1) • Peru (1)
  59. 59. 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
  60. 60. 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
  61. 61. 017 ADHERENCE PK monitoring, “real time” PK RECTAL GEL Layered approach to monitoring •SMS (text messages) • Product returns • CASI (computer assisted self interview)
  62. 62. RECTAL GEL
  63. 63. RECTAL GEL
  64. 64. RECTAL GEL
  65. 65. RECTAL GEL
  66. 66. 72
  67. 67. RECTAL GELS  Combination HIV Antiretroviral Rectal Microbicide Program (CHARM)  Phase I  Maraviroc gel  Microbicide Trials Network  Phase I – in development  Dapivirine gel
  68. 68. 74
  69. 69. 76
  70. 70. VAGINAL GELS AND RINGS MICROBICIDES 77
  71. 71. 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
  72. 72. 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 79 VAGINAL GELS
  73. 73. 80 VAGINAL GELS
  74. 74. 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
  75. 75. 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
  76. 76. VAGINAL GELS Courtesy of FACTS 001
  77. 77. 84 Courtesy of FACTS 001
  78. 78. 85 VAGINAL GELS Courtesy of FACTS 001
  79. 79. 86 VAGINAL GELS Courtesy of FACTS 001
  80. 80. 87 VAGINAL GELS Courtesy of FACTS 001
  81. 81. VAGINAL RINGS MICROBICIDES 88
  82. 82. 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
  83. 83. WHY AFRICA? 90
  84. 84. www.hivresourcetracking.org
  85. 85. FILMS AND FIBERS MICROBICIDES 92
  86. 86.  International Partnership for Microbicides  Early preclinical  Maraviroc/tenofovir film  Dapivirine/maraviroc film  Phase I  Dapivirine film 93 VAGINAL FILMS
  87. 87. 94 VAGINAL NANOFIBERS PSEUDO TAMPON
  88. 88.  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 95 VAGINAL NANOFIBERS VIA UNIVERSITY OF WASHINGTON
  89. 89. 96
  90. 90. 97
  91. 91. BREAK TIME 98
  92. 92. DOSING PREP 99
  93. 93. 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 100 INTERMITTENT PREP
  94. 94. 101 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)
  95. 95. 102 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.
  96. 96. ORAL PREP 103
  97. 97. 104 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)
  98. 98. LONG ACTING INJECTABLES PREP 105
  99. 99. 106 Graphic courtesy AVAC LONG ACTING INJECTABLES
  100. 100. 107 LONG ACTING INJECTABLES
  101. 101. 108
  102. 102. MALE AND FEMALE (RECEPTIVE) NEW CONDOMS 109
  103. 103. www.hivresourcetracking.org
  104. 104. The Woman’s Condom • Polyurethane with dissolving capsule applicator • Held in place by foam shapes • Trials demonstrate safe, acceptable, and easy to use, and has comparable functionality to FC2 • Additional studies, including contraceptive efficacy, are in process • Received CE marking • Commercially available in China and South Africa FEMALE CONDOMS
  105. 105. • Cupid  Latex, inner sponge that aids insertion  Outer ring helps keep it in place during sex  Available in India, Brazil, Indonesia, The Netherlands, South Africa, Mozambique, and Kyrgyz Republic  Pre-qualified by WHO/UNFPA, enabling bulk procurement  Safe, acceptable, and comparable functionality to FC2  CE marking • Cupid 2  Same construction, thinner sponge  Under evaluation for functionality FEMALE CONDOMS
  106. 106. • Panty Condom • Polyethylene sheath pre-lubricated w/ Vaseline • Limited distribution in Colombia, under review for WHO pre-qualification • Phoenurse • Polyurethane, silicone lubricated • Insertion tool • Limited availability in China & Brazil, under review for WHO pre-qualification FEMALE CONDOMS
  107. 107. FEMALE CONDOMS • Origami • Silicone, accordion-like folding • Assessed acceptability and performance with 20 HIV-negative hetero San Fran couples
  108. 108. ANAL CONDOM  Origami BOOTY SPECIFIC  First condom designed specifically for receptive anal sex  Silicone  Fenway conducting Phase 1 safety trials with gay men
  109. 109. 116 GATES FOUNDATION CONDOM CHALLENGE
  110. 110. 117 GATES FOUNDATION CONDOM CHALLENGE The common analogy is that wearing a condom is like taking a shower with a raincoat on. A redesigned condom that overcomes inconvenience, fumbling, or perceived loss of pleasure would be a powerful weapon in the fight against poverty. – Dr. Papa Salif Sow, senior program officer, Gates Foundation
  111. 111. CONCEPTS IN DEVELOPMENT • Air-Infused Female Condom • Uses air pressure to insert • Polyurethane • Female Pleasure Condom • Elliptical opening • Ribbed exterior • Pleasure focus • Non-Gender Specific Internal Silicone Condom • Refining silicone Origami condoms • Intended for both vaginal and anal intercourse 118 GATES FOUNDATION CONDOM CHALLENGE
  112. 112. COMBINATION PRODUCTS MULTIPURPOSE TECHNOLOGIES (MPTS) 119
  113. 113. 120
  114. 114. 121 Graphic courtesy AVAC MPTS
  115. 115. MPTS 122 Graphic courtesy AVAC
  116. 116. IMPLEMENTATION 123
  117. 117. DBS TFV-DP levels at Week 4, by study site 5.4 10.8 27 60 50 40 30 20 10 Miami DC SF 60% (557/922) of potentially eligible participants enrolled, indicating strong interest in PrEP use Patients were more likely to enroll if they: • Had prior PrEP awareness • Were at higher risk (2-5 or >5 episodes of anal sex with HIV+ partner in the last 12 months) 98% (n=136) of those with drug levels at Week 4 had TFV-DP detected • Most participants (77%) had TFV-DP level consistent with taking ≥4 doses/week Interest in FTC/TDF for PrEP and adherence as measured by drug levels were high in this demonstration research project 43.2 13.6 2 2 18.4 42.9 34.7 0 4 4 40 52 0 BLQ <250 250-550 >550-950 >950 (<2 doses/wk) (2 doses/wk) (4 doses/wk) (daily dosing) Samples, % DBS TFV-DP level, in fmol/punch (estimated dosing) PrEP Demonstration Project PREP IMPLEMENTATION IN STD CLINICS: HIGH UPTAKE AND DRUG DETECTION AMONG MSM 48-week, open-label PrEP demonstration project in MSM and transgender women in San Francisco, Miami and Washington, DC (N=557); Sept 2012 – Jan 2014 Cohen S, et al, CROI 2014; Boston. # 954 IMPLEMENTATION
  118. 118. U.S. CITIES INVOLVED IN DEMONSTRATION PROJECTS San Francisco (2) Boston (2) Miami D.C. Chicago (2) Los Angeles (2) San Diego Rochester NYC (2) Oakland Birmingham Orlando Philadelphia (2) Memphis Nashville New Orleans Houston(2) Detroit Baltimore Aurora * NYC = Manhattan, Harlem, Bronx and Brooklyn Chapel Hill Jackson Providence Newark Seattle (2) Cleveland Atlanta Dallas Tampa Bethesda Annandale UPDATED Demonstration and Implementation projects have a planned enrollment of approximately 8,000 participants. 125 IMPLEMENTATION
  119. 119. SELECTED POST-APPROVAL DEMO/IMPLEMENTATION PROJECTS
  120. 120. 127 WE’RE IN THE HOME STRETCH
  121. 121. CHICAGO IMPLEMENTATION 128
  122. 122. 129 SHIPP [SUSTAINABLE HEALTH CENTER IMPLEMENTATION PREP PILOT]  June 1. 2014  Implementation project examining PrEP use in primary care settings in Chicago, Newark, Houston, and Philadelphia  Serves women and men  Access Grand Boulevard Specialty Clinic  5401 South Wentworth Avenue PS-PREP  Jan 1, 2015  Randomized clinical trial of PrEP linkage program by DIS staff, UC and CDPH CHICAG0 IMPLEMENTATION
  123. 123. 130 PROJECT PREPARE II CHICAG0 IMPLEMENTATION  Open label demo project AND safety study of PrEP in young gay/MSM ages 15-22  Actively enrolling 300 youth in 13 US sites, Chicago  Evaluating:  Safety of PrEP use among young HIV-neg gay/MSM  Acceptability, patterns of use, adherence  Risk patterns  Texting to encourage adherence  Demographic and/or behavioral difs among youth  Interested in PrEP study  Who stays on PrEP
  124. 124. 131 CHICAG0 IMPLEMENTATION HOWARD BROWN HEALTH CENTER  Evaluating PrEP in community health center setting  Collects info on why patient AND provider are considering PrEP  Data quality can be monitored by visit types, provider, and testing location  Process enabling improved communication and tracking of those interested in PrEP, on PrEP, discontinuing PrEPages 15-22
  125. 125. 132
  126. 126. MAPPING PATHWAYS IMPLEMENTATION 133
  127. 127. Published 1 April, 2014 mappingpathways.org
  128. 128. What is most striking is that [the] future is not driven by the science, it is driven by communities and the needs of implementation.
  129. 129. 136 >>> HOW CAN I MAKE THIS RELEVANT TO THOSE I SERVE?
  130. 130. 137
  131. 131.  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
  132. 132. POST-TEST LET’S SEE IF WE KNOW A LITTLE MORE 139
  133. 133.  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 140 ACKNOWLEDGMENTS Thank you
  134. 134. THANK YOU 141
  135. 135. CONTACT JPICKETT@AIDSCHICAGO.ORG

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