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

The document provides an overview of current advancements in HIV prevention technologies, including pre-exposure prophylaxis (PrEP) and rectal microbicides. It outlines various clinical trials, user demographics, insurance access issues, and ongoing research into different delivery methods and formulations for both vaginal and rectal applications. The agenda includes discussions on new dosing strategies, product implementations, and data on PrEP utilization among various populations.

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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 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.
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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
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
OUR AGENDA  Pre/post test  Evaluations  Certificates of completion  These slides are online at www.myprepexperience.org
15 Unrestricted educational grant from Janssen Therapeutics to AFC - 2014 Learn about research & development of new prevention technologies
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 Chicago:  Research (Project PrEPare)  UC and ACCESS Grand Blvd  Howard Brown Health Center  CORE Center – clinic coming soon  Chicago PrEP Working Group 32
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/
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
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
Insurance Medicaid Devil in the details • Prior auth • Deductibles • Co-pays • Tiers • Confusion 37 ACCESSING PREP— INSURANCE
Gilead support programs Medication Assistance Program 500% FPL Co-pay program $300/mo. 38 NEWLY IMPROVED – OCTOBER 15, 2014
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%
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 FEDERAL STATE LOCAL PUBLIC PRIVATE 44
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  Counseling/risk reduction  HIV testing  STI testing/treatment  HEP A and B vaccinations
 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
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 of unprotected vaginal intercourse.
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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
N = 192 RECTAL GEL [Sept ’13 – June ‘16 ] Participants Gay/MSM, transgender women Study sites • US (4) • Thailand (2) • RSA (1) • Peru (1)
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
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
017 ADHERENCE PK monitoring, “real time” PK RECTAL GEL Layered approach to monitoring •SMS (text messages) • Product returns • CASI (computer assisted self interview)
RECTAL GEL
RECTAL GEL
RECTAL GEL
RECTAL GEL
72
RECTAL GELS  Combination HIV Antiretroviral Rectal Microbicide Program (CHARM)  Phase I  Maraviroc gel  Microbicide Trials Network  Phase I – in development  Dapivirine gel
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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 Vaginally formulated tenofovir gel Results July 20, 2010 – AIDS 2010
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
80 VAGINAL GELS
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
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
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, 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
WHY AFRICA? 90
www.hivresourcetracking.org
FILMS AND FIBERS MICROBICIDES 92
 International Partnership for Microbicides  Early preclinical  Maraviroc/tenofovir film  Dapivirine/maraviroc film  Phase I  Dapivirine film 93 VAGINAL FILMS
94 VAGINAL NANOFIBERS PSEUDO TAMPON
 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
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BREAK TIME 98
DOSING PREP 99
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
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)
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.
ORAL PREP 103
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)
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 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
• 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
• 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
FEMALE CONDOMS • Origami • Silicone, accordion-like folding • Assessed acceptability and performance with 20 HIV-negative hetero San Fran couples
ANAL CONDOM  Origami BOOTY SPECIFIC  First condom designed specifically for receptive anal sex  Silicone  Fenway conducting Phase 1 safety trials with gay men
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 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
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
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 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
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
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 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
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
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
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 implementation.
136 >>> HOW CAN I MAKE THIS RELEVANT TO THOSE I SERVE?
137
 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
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 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
THANK YOU 141
CONTACT JPICKETT@AIDSCHICAGO.ORG

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

  • 1.
    WELCOME OCTOBER 9,2014 CHICAGO – JOHN MARSHALL LAW SCHOOL Exploring the Pipeline
  • 2.
    PROJECT READY, SET,PREP – PLUS EXPLORING THE PIPELINE
  • 3.
  • 4.
    PRE-TEST LET’S SEEWHAT WE KNOW 4
  • 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.
  • 10.
  • 11.
  • 12.
    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
  • 13.
    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
  • 14.
    OUR AGENDA Pre/post test  Evaluations  Certificates of completion  These slides are online at www.myprepexperience.org
  • 15.
    15 Unrestricted educational grant from Janssen Therapeutics to AFC - 2014 Learn about research & development of new prevention technologies
  • 16.
  • 17.
    THE ONLY DUMBQUESTION IS THE ONE YOU DIDN’T ASK 17
  • 18.
    18 Discussion Learning The only “dumb” question is the one you didn’t ask OUR TIME TOGETHER
  • 19.
    19 >>> WHYIS THIS RELEVANT TO ME?
  • 20.
  • 21.
  • 22.
    HOW DOES HIVTREATMENT ACT AS PREVENTION? 22
  • 23.
    2011: TREATMENT IS PREVENTION TOO 23
  • 24.
  • 25.
  • 26.
    WHAT IS POST-EXPOSUREPROPHYLAXIS (PEP)? 26
  • 27.
    WHAT IS PRE-EXPOSUREPROPHYLAXIS (PREP)? 27
  • 28.
  • 29.
  • 30.
    Condomless is not“unprotected” 30 2014: Language Matters
  • 31.
    THE DEVIL ISIN THE DETAILS PREP ACCESS 31
  • 32.
    ACCESSING PREP Anymedical 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
  • 34.
    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/
  • 35.
    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
  • 36.
    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
  • 37.
    Insurance Medicaid Devilin the details • Prior auth • Deductibles • Co-pays • Tiers • Confusion 37 ACCESSING PREP— INSURANCE
  • 38.
    Gilead support programs Medication Assistance Program 500% FPL Co-pay program $300/mo. 38 NEWLY IMPROVED – OCTOBER 15, 2014
  • 39.
    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%
  • 40.
    Chicago PrEP Working Group Researchers Medical providers HIV planning members Advocates CBOs 40
  • 41.
    TAKING PREP IS THOUGHTFUL RESPONSIBLE CAREFUL 41 AWARE PRO-ACTIVE DISCIPLINED
  • 42.
    TAKING PREP IS SAFER SEX 42
  • 43.
  • 44.
    INVESTMENT NEEDED INFRASTRUCTURE TRAINING SOCIAL MARKETING HEALTH CARE ACCESS BEST PRACTICES POLICY/ADVOCACY FEDERAL STATE LOCAL PUBLIC PRIVATE 44
  • 45.
    MORE DATA, MOREENERGY AND MORE RESOURCES 45 WOMEN TRANSGENDER WOMEN AND MEN
  • 46.
  • 47.
    VIDEO THE RECTALREVOLUTION IS HERE AN INTRODUCTION TO RECTAL MICROBICIDE CLINICAL TRIALS 47
  • 48.
  • 49.
  • 50.
  • 51.
  • 52.
  • 53.
  • 54.
  • 55.
    STAGES OF CLINICALTRIALS 55 Graphic courtesy International Partnership for Microbicides
  • 56.
    PERSPECTIVE 56 Of10,000 compounds that get tested in the lab, 5 make it to human trials and 1 makes it to market.
  • 57.
    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
  • 58.
     A PRODUCTAPPLIED 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
  • 59.
  • 60.
    An act ofunprotected anal intercourse is 10 to 20 times more likely to result in HIV transmission compared to an act of unprotected vaginal intercourse.
  • 62.
  • 63.
    MTN 017 RECTALGEL 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
  • 64.
    N = 192 RECTAL GEL [Sept ’13 – June ‘16 ] Participants Gay/MSM, transgender women Study sites • US (4) • Thailand (2) • RSA (1) • Peru (1)
  • 65.
    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
  • 66.
    Product Sequence NPeriod 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
  • 67.
    017 ADHERENCE PKmonitoring, “real time” PK RECTAL GEL Layered approach to monitoring •SMS (text messages) • Product returns • CASI (computer assisted self interview)
  • 68.
  • 69.
  • 70.
  • 71.
  • 72.
  • 73.
    RECTAL GELS Combination HIV Antiretroviral Rectal Microbicide Program (CHARM)  Phase I  Maraviroc gel  Microbicide Trials Network  Phase I – in development  Dapivirine gel
  • 74.
  • 76.
  • 77.
    VAGINAL GELS ANDRINGS MICROBICIDES 77
  • 78.
    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
  • 79.
    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
  • 80.
  • 81.
    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
  • 82.
    VAGINAL GELS PhaseIII 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
  • 83.
  • 84.
    84 Courtesy ofFACTS 001
  • 85.
    85 VAGINAL GELS Courtesy of FACTS 001
  • 86.
    86 VAGINAL GELS Courtesy of FACTS 001
  • 87.
    87 VAGINAL GELS Courtesy of FACTS 001
  • 88.
  • 89.
    VAGINAL RINGS Monthlyvaginal 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
  • 90.
  • 91.
  • 92.
    FILMS AND FIBERS MICROBICIDES 92
  • 93.
     International Partnershipfor Microbicides  Early preclinical  Maraviroc/tenofovir film  Dapivirine/maraviroc film  Phase I  Dapivirine film 93 VAGINAL FILMS
  • 94.
    94 VAGINAL NANOFIBERS PSEUDO TAMPON
  • 95.
     Weave maravirocinto 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
  • 96.
  • 97.
  • 98.
  • 99.
  • 100.
    Alternative Dosing toAugment 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
  • 101.
    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)
  • 102.
    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.
  • 103.
  • 104.
    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)
  • 105.
  • 106.
    106 Graphic courtesyAVAC LONG ACTING INJECTABLES
  • 107.
    107 LONG ACTINGINJECTABLES
  • 108.
  • 109.
    MALE AND FEMALE(RECEPTIVE) NEW CONDOMS 109
  • 110.
  • 111.
    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
  • 112.
    • 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
  • 113.
    • 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
  • 114.
    FEMALE CONDOMS •Origami • Silicone, accordion-like folding • Assessed acceptability and performance with 20 HIV-negative hetero San Fran couples
  • 115.
    ANAL CONDOM Origami BOOTY SPECIFIC  First condom designed specifically for receptive anal sex  Silicone  Fenway conducting Phase 1 safety trials with gay men
  • 116.
    116 GATES FOUNDATIONCONDOM CHALLENGE
  • 117.
    117 GATES FOUNDATIONCONDOM 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
  • 118.
    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
  • 119.
    COMBINATION PRODUCTS MULTIPURPOSE TECHNOLOGIES (MPTS) 119
  • 120.
  • 121.
  • 122.
    MPTS 122 Graphiccourtesy AVAC
  • 123.
  • 124.
    DBS TFV-DP levelsat 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
  • 125.
    U.S. CITIES INVOLVEDIN 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
  • 126.
  • 127.
    127 WE’RE INTHE HOME STRETCH
  • 128.
  • 129.
    129 SHIPP [SUSTAINABLEHEALTH 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
  • 130.
    130 PROJECT PREPAREII 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
  • 131.
    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
  • 132.
  • 133.
  • 134.
    Published 1 April,2014 mappingpathways.org
  • 135.
    What is moststriking is that [the] future is not driven by the science, it is driven by communities and the needs of implementation.
  • 136.
    136 >>> HOWCAN I MAKE THIS RELEVANT TO THOSE I SERVE?
  • 137.
  • 138.
     INTERNATIONAL RECTALMICROBICIDE 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
  • 139.
    POST-TEST LET’S SEEIF WE KNOW A LITTLE MORE 139
  • 140.
     ACCESS GrandBoulevard  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
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