A Jo Robinson, Terrence Higgins Trust in cooperation with the Global Campaign for Microbicides ...

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www.global-campaign.org

Jo Robinson, Terrence Higgins Trust

in cooperation with the

Global Campaign for Microbicides


Topical Microbicides:

A New Hope for Non-condom

Prevention of HIV and STIs

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• What is a microbicide?

• Why is it needed?

• Basic science - how might it work?

• Clinical science - products in development

• Why this is a political issue and what you can do to get involved

Objectives

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What is a microbicide?

• Microbicides are substances that can reduce the transmission of HIV and other STD pathogens when applied vaginally and, possibly, rectally.

• Currently, they are topical products formulated as gels or creams applied with an applicator.

• Future formulations could include sponges, time-released vaginal rings or gels combined with barrier devices such as diaphragms or cervical caps.

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Why is it needed?

• HIV & AIDS kill more people than any other infectious disease

- in Botswana, 36% of all adults are infected.

- in Sub-Saharan Africa, 67% of the almost 9 million HIV youth (15-25 years) are female

• HIV is rapidly becoming a “women’s epidemic”

- of every 10 people newly infected with HIV, 6 are women

- even in the developed world, rates of new infections among women are rising

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0102030405060708090

100

Burkina FasoCameroon

Cote d'IvoireEthiopiaGuineaKenyaMalawi

Mozambique

RwandaSouth Africa

TanzaniaTogo

UgandaZambiaZimbabwe

Country

Percentage

% usedcondom withlast casualpartner

% usedcondom withlast mainpartner

Women of reproductive age in

Sub-Saharan Africa who reported condom use in last

sex act

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100% use last 5 acts43%truck stop ♀Tanzania

Of sex acts protected34%sex workersIndonesia

Always use last week23%sex workersBangladesh

High consistency24%IDUsUkraine

Consistent use39%std clientsUSA

Consistent use26%sex workersZimbabwe

Last any partner24%youthCameroon

Regular use22%married womenRwanda

Consistent use7%general popNicaragua

Consistent use17%high risk ♀5 US Cities

NotesCondom Use

PopulationLocation

Condom use with regular partner post

intervention

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Need for rectal microbicide for anal male-to-male sex• 48.8% of all men who had sex with men had had

unprotected anal intercourse in the last year (N=15,971)

• 34.5% of men with HIV said they had definitely or probably had had unprotected anal sex a man they thought was HIV negative in the last year (N=1,070)

• 14.59% of HIV negative (at last test) or untested men said they definitely, or probably, had had unprotected anal sex with a man they thought was HIV positive in the last year (N=7,576)

Source: Out and about. Findings from the United Kingdom

Gay Men’s Sex Survey 2002. Sigma Research

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Need for rectal microbicide for male-

female anal sex • 6 - 13% of heterosexual women in the US

had anal sex in the last year (Gross et al, 2000)

• In one US study, 32% of high-risk women participants reported anal sex in past six months (Gross et al 2000)

• In a Chinese study of 1300 people from 41 cities, nearly 70% of men and women reported engaging in anal intercourse (Burton 1990).

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Basic science

How it might work

Microscopic rectal tissue

• Single layer columnar epithelium, with crypts

• Epithelium is mobile above a porous basement membrane

• Rectal shedding is common during sex

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What would they be like?

• Some will also prevent pregnancy

• Others will be microbicidal but not contraceptive

• Many candidate products are broad spectrum reducing risk of some other STIs, in addition to HIV

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Will Women Use

Microbicides?• In US study, an estimates 21.3 million women

interested in using a microbicide (Darroch & Frost, 1999)

• Even in resource-poor countries, women at risk are willing to pay twice as much (or more) than the local price of a condom

(EU study, 1998; Hardy, et al 1998)

• Women have widely different needs and formulation preferences so multiple products will be the key to widespread acceptability and use

Dominican Republic

Los Angeles, USANorfolk, USA

Providence, USAPhiladelphia, USA

Côte d’Ivoire

BrazilSouth Africa

ZimbabweMalawiTanzaniaUganda

India Chiang Rai, ThailandNigeria

New York, USA

Yaoundé, Cameroon

Cincinnati, USA

Miami, USA

Baltimore, USA

London, UKAntwerp, Belgium

Birmingham, USA

Washington, USA

Houston, USA

BotswanaZambia

clinical trial sites in 2003

Alliance for Microbicide Development

Ghana

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Timeline

Source: Tufts Center for the Study of Drug Development

Laboratory Testing

2-6 Years

Phase 1

1 Year

Phase 2

2 Years

Phase 3

3.5 Years

Phase 1 and 2 penile and rectal studies, HIV+, etc.

10 + Years

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Where are we now?

0

5

10

15

20

25

30

35

40

45

50

Preclinical Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3

Source: Alliance for Microbicide Development

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Current microbicides in development

• 60 product leads are under development

• 6 potential products about to enter phase III or phase II/b trials in the next few years

• Average time for a product lead to go through required testing and registration is 10.5 years

• 45 additional products that are still in pre-clinical testing

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When will microbicides be available?

1st generation2nd generation3rd generationExpectedlaunch200720122017FormulationVaginal onlyVaginal &rectalVaginal &rectalIndicationsHIV, possibly otherSTIs, contraceptiveHIV, herpes,gonorrhoea, HPV,Chlamydia, choiceof contraceptive ornon.HIV, herpes,gonorrhoea, HPV,Chlamydia, choiceof contraceptive ornon.HIVeffectiveness50%70% 85%-95%UsagesWithcondom/deviceUsed aloneUsed aloneAccessPrescription only –developed countriesOTC – developingcountriesOver thecounterOver thecounterSource: The Microbicides Initiative

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What can you do now?

• Get your organisation sign up to the Global Campaign

• Get more information and stay up to date with new developments; sign up for email updates from Global Campaign website: www.global-campaign.org

• Join the UK/Ireland Campaign email: [email protected]

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UK/Ireland Campaign for Microbicides

• Objectives:

• Increasing awareness and advocacy

• Accelerating scientific research and development

• Ensuring effective access and use

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Thank you to:

• Robin Shattock, St. George’s Hospital, London

• Charles Lacey, Imperial College, London

• Rebekah Webb, Global Campaign for Microbicides

• Kim Mulji, Naz Foundation

A Jo Robinson, Terrence Higgins Trust in cooperation with the Global Campaign for Microbicides ...

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