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When Will Women Have Choices?. Sharon Hillier University of Pittsburgh School and Medicine Microbicide Trials Network. IAS, Washington DC, July 26, 2012. Overview. What is choice are what are options? Male and female barriers - PowerPoint PPT Presentation
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When Will Women Have Choices?
Sharon HillierUniversity of Pittsburgh School and Medicine
Microbicide Trials Network
IAS, Washington DC, July 26, 2012
Overview
What is choice are what are options?
Male and female barriers
When will topical microbicide products go to the FDA for registration?
What are the next generation products?
What is Choice?
Choice is rational, and can be in opposition to desire. What distinguishes choice is that before a choice is made there is a rational deliberation or thinking things through
What is an Option?
The power or freedom to choose
Many women may choose to use an HIV prevention method but it may not be an option for them because they do not have the power or freedom to make that choice
Many people just don’t like them
Reduces sensation Lack of spontaneity Lack of partner cooperation Requires male erection Requires withdrawal after
ejaculation Contraceptive Embarrassment Implies mistrust Loss of intimacy Relationship-specific
So Why Not Male Condoms?
Female Barriers and Female Condoms Diaphragms
Randomized trial showed diaphragms not effective for prevention of HIV
Female Condoms Polyurethane More expensive than male condoms Large, nondiscreet Do not require an erect penis No clinical trials demonstrating their
effectiveness for prevention of HIV
What We Have Learned about Barriers
Sometimes women can make the choice to have their partner use a male condom, but it is not an option for them because they cannot negotiate condom use, they want to become pregnant or they do not like the lack of intimacy
Many women choose not to use female condoms even when they are offered
Why Microbicides?
Discretion and control: women can take pills or use gel products under their own control
Nondisruptive: use of the products can be several hours in advance of sexual activity
Noncontraceptive: allows conception for women who desire it
Contraceptives: Many Choices
But every choice is not an option….
For many women, a contraceptive method might be licensed and might be a woman’s first choice but their insurance will not cover it
In many countries, the family planning programs only stock oral contraceptives and Depo Provera
A better range of options improves uptake and use
So How Do We Increase Choice forHIV Prevention in Women?
We have to have products which women choose to use in our clinical trials Only 50% of women enrolled in MTN-001 chose
to take their tablets or use their gel daily Only 40% of women enrolled in CAPRISA-004
had 80% adherence to gel product Vaginal rings which can be inserted once
every month (dapivirine ring) or every 3 months (tenofovir ring in development) will make it easier to use prevention
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 42010 2011 2012 2013 2014 2015
ARV-based HIV Prevention Timeline * **As of February 2012
MTN 017Rectal TFV gel
* Trial end-dates are estimates; due to the nature of clinical trials the actual dates may change. For full trial details, see www.avac.org/trials. ** Not all trials included are effectiveness trials. Trials included on this list are mainly phase II/IIb, III/IIIb and IV trials.
VOICE/MTN 003
FACTS 001
FACTS 002 (adolescents)
CAPRISA 004 CAPRISA 008
Earliest regulatory submission
TFV gel
Positive efficacy resultArm stoppedRegulatory submission/filing
DPV ring
Oral TDF/FTCOral TDF
Rectal TFV gel
TFV gel
Planned
US FDA filing and decision
Oral TDF/FTC
Oral TDF
FEM-PrEP
TDF2/CDC 4940 TDF2 Open-Label Extension2007
2009
2007
2009
The Ring Study/IPM 027 DPV ring
Earliest regulatory submission
ASPIRE/MTN 020
Final results pendingiPrEx iPrEx Open-Label Extension (OLE)2007
2008 Partners PrEP Partners PrEP (no placebo)
Bangkok Tenofovir Study/CDC 43702005
VOICE/MTN 0032009
Coital Use of Tenofovir for Women
• FACTS 001 designed as a confirmatory study of CAPRISA 004.
• Study is testing before and after sex dosing of 1% tenofovir gel in 18-30 year old South African women
• 2900 women enrolling at 9 sites in South Africa.• About 1400 women enrolled now• Will support licensure datafor FDA licensure forcoital use of tenofovir
First Generation Rings
FDA Approval of PrEP
FDA Advisory Committee May 10, 2012 evaluated the supplemental NDA for Truvada Approval granted earlier this week for prevention of
sexual transmission of HIV based on results of iPrEx and Partners PrEP
FACTS-001 tenofovir gel study still ongoing for use of gel product before and after sex; regulatory filing in 2015
Dapivirine ring FDA filing anticipated for 2015
Next Generation Rings
Courtesy D. Friend, CONRAD and J. Manning, USAID
• HIV, STI, Contraception• TNF/LNG 90 day IVR (CONRAD)
• HIV, HSV, pregnancy protection• Segmented design; co-extruded reservoir
LNG segment• Sheep vaginal tissue: > 1% TFV gel over 90 days; Target trial date: Q4, 2012 TFV LNG TNF LNG
• HIV, Contraception• Dapivirine + HC Vaginal Ring (IPM)
• 60 day use• Preclinical formulation ongoing
Take Home Lessons
We need to HIV prevention products which women want (and that they will choose to use)
Data from completed and ongoing studies have shown that many women do not choose to use oral tablets or gels even when they are available
A greater range of prevention options will increase uptake and use of products
The Road Ahead: Choice
The time will come when a woman will be able to choose from among different methods the one that is just right for her
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