Update on Microbicides: the search for a new method of HIV prevention

Lori Heise, Director Global Campaign for Microbicides

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Microbicides: new hope for HIV prevention

• 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

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Eventually, microbicides could come in many forms

First 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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1. physical barriers 2. boosts vagina’s natural defenses 3. surfactants 5. anti-retrovirals 4. entry inhibitors

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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

15+ products Laboratory Testing 2-6 Years 4 products 4 products 6 products Phase 1 (safety) 1 Year Phase 2 ( Expanded safety) 2 Years Phase 2b/3 (effectiveness) 2 to 4 years Phase 1 and 2 HIV+, penile & rectal studies 10 + Years

10+ Years www.global-campaign.org

• • • •

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

condoms Reduce transmission 80 to 90% ? consistency of use microbicides ?

Reduce transmission 40 to 60% consistency of use www.global-campaign.org

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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Acceptability & Use Dynamics

• 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

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Microbicides:

Where Gender, Technology & Sexuality Meet 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.

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Percent of ever-partnered women reporting physical and/or sexual violence by an intimate partner Ever Bangladesh province Brazil province Ethiopia province Namibia city Peru province Samoa Thailand province Tanzania province 61.7

36.9

70.9

35.9

69.0

46.1

47.4

55.9

Source: WHO Multi-Country Study on Domestic Violence and Women’s Health Last 12 months 31.9

14.8

53.7

19.5

34.2

22.4

22.9

29.1

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Sexual Autonomy?

Percent of women interviewed who believe that a man is justified in beating his wife if… Bangladesh province Brazil province Ethiopia province Namibia capital Peru province Samoa Thailand province Tanzania province Wife disobeys 38.7

10.9

77.7

12.5

46.2

19.6

25.3

49.7

Source: WHO Multi-Country Study on Domestic Violence and Women’s Health Wife refuses sex 23.3

4.7

45.6

3.5

25.8

7.4

7.3

41.7

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Girls’ and Women's Protection Strategies

Social Power

Protection

Technology Economic Opportunities

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

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