update on microbicides: the search for a new method of hiv prevention

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Update on Microbicides: the search for a new method of

HIV preventionLori Heise, Director

Global Campaign for Microbicides

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• Any substance that can substantially reduce transmission of sexually transmitted infections (STIs), including HIV, when applied vaginally or rectally– User/woman-initiated– Some leads effective against HIV and other STIs – Contraceptive and non-contraceptive– Likely to offer some protection to a woman’s partner

should she be infected – Early products will be partially effective– Goal is inexpensive, over-the-counter product

Microbicides: new hope for HIV prevention

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Eventually, microbicides could come in many formsFirst generation products will be gels applied with an applicator

Future formulations could include vaginal rings or sponges that could be left in for weeks at a time

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3. surfactants

4. entry inhibitors

5. anti-retrovirals

2. boosts vagina’s natural defenses

1. physical barriers

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Other important uses• Rectal microbicides

– Limited work underway– Scientifically much more difficult– Vaginal microbicides tested for

rectal safety• HIV positive women

– Help prevent re-infection and STDs– May protect partners; requires

separate trials

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Research Pipeline in 2006

Phase 1

(safety)1 Year

10 + Years10+ Years

Laboratory Testing

2-6 Years

Phase 2(Expanded

safety)2 Years

Phase 2b/3(effectivenes

s)2 to 4 years

Phase 1 and 2 HIV+, penile & rectal studies

6 products4

products4 products 15+ products

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When could we expect a microbicide?

• The current set of phase III trials will be yielding results in early 2008 through 2009.

• Assuming one of these shows efficacy, a microbicide may be available in a handful of countries in the next 5 years

• Initial availability will most likely be via “introductory studies” prior to actual registration in country.

• If the current set of products does not prove effective, the time horizon will be longer (although remember, there are several second-generation leads already in human safety testing)

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Condom Migration ?

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A Balancing Act to Minimize HIV Risk

condomsReduce

transmission 80 to 90%

? consistency of use

microbicidesReduce transmission

40 to 60%? consistency of

use

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The Prevention “Trade-Off”

• A low efficacy method used consistently can achieve the same protection as a high-efficacy method used less consistently

• A 90% efficacious method (like condoms) used in 20% of sex acts, provides less protection than a:

• 70% efficacy used> 30% of the time• 50% efficacy used> 40% of the time• 30% efficacy used> 60% of the time

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What do we know about likely use?

• Multiple studies document widespread interest– Substantial acceptability literature based on actual use– 2 market studies: one global and one US

• In clinical trials and acceptability studies where women have experience using products, they articulate clear advantages to microbicides:– Easier to use than condoms– Allows skin on skin intimacy– Woman initiated

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• Covert use was an early premise of the microbicide field• Recent research suggests that most women would tell

their partner • some women afraid to risk• others want partners involved

• “Passive acquiescence” versus “active involvement” • Can be “negotiated” once rather than at every act

of intercourse• No need to talk about sex• Allows skin to skin intimacy• Can enhance pleasure

Acceptability & Use Dynamics

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Microbicides can begin the discussion about sex and power. But, it can’t end there.

Changing the power balance between men and women is essential for real and sustained change.       

Microbicides: Where Gender, Technology & Sexuality

Meet

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Percent of ever-partnered women reporting physical and/or sexual violence by an intimate

partnerEver Last 12

monthsBangladesh province 61.7 31.9

Brazil province 36.9 14.8Ethiopia province 70.9 53.7Namibia city 35.9 19.5Peru province 69.0 34.2Samoa 46.1 22.4Thailand province 47.4 22.9Tanzania province 55.9 29.1

Source: WHO Multi-Country Study on Domestic Violence and Women’s Health

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Percent of women interviewed who believe that a man is justified in beating his wife if…

Wife disobeys

Wife refuses

sexBangladesh province 38.7 23.3Brazil province 10.9 4.7Ethiopia province 77.7 45.6Namibia capital 12.5 3.5Peru province 46.2 25.8Samoa 19.6 7.4Thailand province 25.3 7.3Tanzania province 49.7 41.7

Sexual Autonomy?

Source: WHO Multi-Country Study on Domestic Violence and Women’s Health

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Girls’ and Women's Protection Strategies

Protection

Technology Economic Opportunities

Social Power

Brady, Martha. Population Council, Conceptual Framework. 2005.

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With condoms safer sex is his decision, We want to make it yours

To download facts sheets & original reports visit: www.global-campaign.org