MicrobicidesEnvision a product that could save lives

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2.7 million new infections annually

33.4 million people nowlive with HIV/AIDS

Amongst newly infected people:

50% are women (higher in some areas)

95% live in developing countries

80–90% of HIV+ people in southern Africa do not know they have HIV

<20% Sex workers with access to behaviour change programmes

11% HIV+ pregnant women with access to PMTCT

10–12% Adults in Africa accessing HIV testing

9% Men who have sex with men with access to appropriate behaviour change programmes

9% Sexually active people with access to male condoms

8% Injection drug users with access to harm reduction programmes

Percentage of at-risk people with access to HIV prevention

0

Rose to 45% recently

20 40 60 80 100

Global HIV Prevention Working Group 2008; WHO/UNAIDS/UNICEF 2007

The Global Campaign for Microbicides works to:

Ensure accountability; as science proceeds, protect the public interest.

Mobilise demand and investment for research and development of new prevention technologies.

Conduct advocacy for development, introduction, access, and use of new prevention products.

What is a microbicide?

A new type of product being developed that people could use vaginally or rectally to protect themselves from HIV and possibly other sexually transmitted infections.

How might a microbicide be delivered?

A suppository or a gel applied with an applicator before sex

Contents of a vaginal ring that stays in place for up to a month

Developing a film, vaginal tablet, soft-gel capsule

Protection

TechnologyEconomic

opportunities

Social power

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

What women need to protect themselves

We need microbicides that:

Are both contraceptive and not contraceptive. Help reduce the risk of getting other sexually

transmitted infections. Are inexpensive and easily available. Can be used without a partner’s active cooperation. Can be used vaginally or rectally. Can be used by HIV+ people (products not based

on ARVs).

Why would HIV+ people want microbicides?

To reduce the risk of co-infection with other HIV strains.

To reduce the risk of other sexually transmittedinfections, and yeast and bladder infections.

To allow conception whilst protecting partner.

PrEP

Clean injecting equipment

Cervical barriers: vaginal diaphragms

PMTCT

Vaccines

Voluntary counselling and

testing

HIV Prevention

Microbicides

Male and female condoms

Male circumcision

PEP

HIV preventionNot ARV-based ARV-based

Male and female condoms

Circumcision

Vaccines

Needle exchange

VCT

PEP

PrEP

Treatment for HIV+ partner

Vaginal and rectal

microbicides

Prevention of vertical

transmission(PMTCT)

With Primary Partner

With Casual or Outside Partner

Why condoms are not enough

Measure Evaluation. 1997–2002. http://www.measuredhs.com.

Source: Shattock R, Moore J. Inhibiting Sexual Transmission of HIV-1 Infection. Nature Reviews Microbiology. Vol. 1, October 2003.

2. Surfactants

3. Block binding4. Stop replication

1. Boost vagina’s natural defences

5. Future possibility

*STDs: sexually transmitted diseases

*

Early-stage concepts

Preclinical testing

More than 50 candidates

Early human safety trials

1 in large-scale

efficacy trials

The product pipeline

Source: Alliance for Microbicide Development

Outcomes of past studies

Signs of efficacy No efficacy

Safe

Carraguard®

BufferGel®

PRO 2000 0.5%

Trend toward harm

Nonoxynol-9

Savvy

Cellulose sulphate

Current and planned late-stage trials

ProductTrial sponsor

# women to be enrolled

Location(s) First results expected

Tenofovir gel

CAPRISA, CONRAD, USAID, FHI

980 women South Africa Early 2010

Tenofovir gel

MTN

1,680 (in gel arms of trial)

South Africa, Uganda, Zambia, Zimbabwe

2012

Dapivirine (TMC 120)

IPM

TBD Various TBD

Tenofovir gel

MRC/UVRI

TBD Mozambique, South Africa, Tanzania, Uganda, Zambia

TBD

Source: Alliance for Microbicide Development

Clinical trial sites in 2010

Source: Alliance for Microbicide Development

THE AMERICAS

United States: Phase 1, 1/ 2, 2

Puerto Rico: Phase 1

Dominican Republic: Phase 1

SUB-SAHARAN AFRICA

Kenya: Phase 1

South Africa: Phase 1, 2B, 3

Tanzania: Phase 3

Uganda: Phase 2, 3

Zambia: Phase 3

Zimbabwe: Phase 3

ASIA/PACIFIC

Thailand: Phase 1

Australia: Phase 1/2

Experience of a trial participant

Recruitment: Participant

receives information

about the trial in her own

language

Screening Visit 1: Education about the

trial, HIV and pregnancy test,

sexually transmitted infection tests and treatment, baseline

data collected

Screening Visit 2: Results of tests,

counselling, education about trial

reinforced

Randomisation: Participant

assigned by chance to a group

Family Planning Informed

consent for screening

Informed consent to enrol

Condoms + placebo

Condoms + experimental gel

When can we expect a microbicide?

Results of CAPRISA 004 study of tenofovir gel announced in July 2010.

Found safe and effective: 39% reduction in infections

A larger trial now needed to confirm the results

– then one to two years for product review and licensing in each country

Who is doing the research?

Research entity Examples Funding sources

Not-for-profit health groups and academic institutions

MTN, CONRAD, FHI, CAPRISA

Governments (South Africa DST, US NIH, UK DFID), philanthropic foundations

Public-private partnerships

IPM European/US/Canadian governments, philanthropic foundations, UNFPA, World Bank

Smaller pharmaceutical companies

Endo

StarPharma

Venture capital, some government grants

Comparing microbicides: ARV vs. no ARV

ARV No ARV

More potent against HIV May be long lasting Not contraceptive

Could work against HIV and other sexually transmitted infections

Could be contraceptive

May cause more side effects May cause resistance Unlikely to protect against

other sexually transmitted infections

May be less potent against HIV

Must be used at time of sex

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If ARV-based microbicides work…

1. Only taken if you KNOW you are HIV negative.– So regular HIV testing is necessary.

2. May be available by prescription only.– So access to a qualified health care provider is

necessary.

3. Only the dosing used in trials is known to work.– For now, must be applied daily or before sex.

What is drug resistance?

HIV makes thousands of copies of itself daily.

Every time HIV copies itself, errors can occur, like typing errors on a page.

These are mutations—changes that can make the virus weaker or stronger.

A mutation that makes HIV able to resist an ARV drug = drug-resistant HIV.

Drug resistance from microbicides?

Most likely when using only one drug or one type of ARV.

Can become HIV+ whilst using ARV-based microbicide.

Continued use if you do not know you are HIV+ may lead to resistance.

Options for treatment may be more limited—you might pass on resistant virus.

There are unanswered questions at this point.

Questions women have about microbicides in general

If I use a microbicide,

how will I make my man use a condom?

What will they say about me?

How much will it cost?

Where will I get it?

Questions women have about ARV-based microbicides

Will it make me

sick?

Can I use an ARV-based microbicide

when I am pregnant?

Will it hurt my baby? What about

breastfeeding?

If I think my man has HIV, but I do not know for sure, will I be able to get microbicides?

Advocates call for next steps

Research and develop microbicides that are:

– ARV based and not ARV based.

– Contraceptive, non-contraceptive, and broad spectrum.

– Designed specifically for vaginal use and rectal use.

Conduct more research into resistance, alternate dosing, and impact on pregnancy and breastfeeding.

Call for action on access issues: cost, testing, and prescription only.

Increase community engagement. Ensure ethical standards and dialogue.

Visit www.global-campaign.org

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I don’t want to die before I turn 25. I refuse to sit down and watch my generation fall to pieces. I am going to make a difference. Will you?Rumbidzai Grace Mushangi, age 15, Zimbabwe

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“How do you know that?”

The notes for this slide list the sources for facts in this presentation. You can cite these as the sources for your information. This list includes sources for facts and statistics that are not well known. We do not list sources here for commonly known statistics.