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The Search for Microbicides: A Promising New Prevention Tool for Women US Congress, Women’s Policy Inc. Zeda Rosenberg, Sc.D. December 3, 2008. Women and Men With HIV in 2007. The Face of HIV Is Increasingly…. Female Young Married and monogamous A mother. World Bank Photo.

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The search for microbicides a promising new prevention tool for women

The Search for Microbicides:

A Promising New Prevention Tool for Women

US Congress, Women’s Policy Inc.

Zeda Rosenberg, Sc.D.

December 3, 2008


Women and men with hiv in 2007

Women and Men With HIV in 2007


The face of hiv is increasingly

The Face of HIV Is Increasingly…

Female

Young

Married and monogamous

A mother

World Bank Photo


The face of hiv in the u s

The Face of HIV in the U.S.

  • Women account for 26% of AIDS cases, more than triple the rate from 20 years ago

  • Girls account for 57% of new HIV infections among youth ages 13 to 19

AIDS is the leading cause of death for African-American women ages 25 to 34

Washington, D.C.has highest AIDS prevalence in US (2,017 per 100,000)

The number of women living with AIDS in Washington, DC increased 76% over past 6 years


Microbicides and hiv prevention

Microbicides and HIV prevention

  • Existing HIV prevention options:

    • Abstinence

    • (Be) Faithful

    • Condoms: Male and female

    • Treatment of sexually transmitted infections

    • Prevention of mother-to-child transmission

    • Male circumcision

    • Post-exposure prophylaxis

  • Possible new prevention options — in research:

    • Topical microbicides

    • Oral prevention pills (PrEP)

    • HIV vaccines

    • Other


Microbicides a human rights issue for women

Microbicides: A Human Rights Issue for Women

  • Microbicides could restore women’s right to self-protection by providing them with a prevention tool

  • Microbicides will eventually be developed with both contraceptive and non-contraceptive properties — allowing women to bear children while significantly reducing risk of HIV infection


Status of microbicide development

Status of Microbicide Development


Microbicides

Microbicides

  • Topical products to prevent HIV transmission

  • Could be delivered in many forms:

Tablet, capsule, film

Gel applicator

Ring

  • Ideally safe, effective, low cost, user-friendly


Microbicide efficacy trials summary

Microbicide Efficacy Trials Summary

  • 9.5 trials completed or stopped

    • N9, Savvy, CS, Carraguard, PRO 2000 (2%)

    • All early generation products

  • 3 trials ongoing

    • BufferGel, PRO 2000 (0.5%) — early generation

    • Tenofovir — next generation

  • 2 trials planned

    • Tenofovir, Dapivirine — next generation


Early next generation microbicides

Early Generation

Next Generation

  • First microbicides tested, some still in efficacy trials

  • Not HIV specific

  • Gel formulations

  • To be applied vaginally within a few hours before sex

  • No concern about potential resistance

  • Newer products in different stages of preclinical and clinical research

  • Specific to HIV (ARV-based)

  • Various forms: gel, ring, film, tablet

  • Longer duration of action: daily gels, monthly rings, etc.

  • ARV resistance is a possible issue that needs to be investigated

Early & Next Generation Microbicides


Microbicides in product development

Microbicides in Product Development

Lactin-V

NCp7’s

GM Biotics (Osel)

Free virus

BufferGel

PRO2000

SPL7013 (VivaGel)

RANTES analogs

Cyanovirin-N

DS003 (BMS 793)

DS001 (Merck 167)

Maraviroc (Pfizer)

DS007 (Merck L’644)

Attachment

Fusion

S-DABO

Dapivirine

UC781

Tenofovir

PC-815

Pyrimidinediones (Samjin)

Reverse Transcription

Integration

Early-generation compounds

Protein synthesis and assembly

Next-generation compounds

Budding

Maturation


Arv based microbicides in development

ARV-Based Microbicides in Development

* Also being developed in combination


Countries hosting microbicide trials

Countries Hosting Microbicide Trials

  • Thailand

  • Tanzania

  • Uganda

  • United States

  • Zambia

  • Zimbabwe

  • Australia

  • Belgium

  • Dominican Republic

  • Kenya

  • Malawi

  • South Africa


Ethical guidelines for clinical trials

Ethical Guidelines for Clinical Trials

  • Many studies taking place in developing countries

  • Community engagement

  • Monitoring social harms

  • Informed consent process

  • Risk reduction counseling

  • Family planning / condoms

  • Management of pregnancy

  • STI screening and treatment

  • Testing positive at screening

  • Participants who seroconvert

  • Treatment for physical harms

  • Post-trial access to products

Guidelines

Key issues

  • UNAIDS/WHO ethical guidelines in HIV prevention trials, 2007

  • UNAIDS/AVAC good participatory practices, 2007

  • South Africa GCP guidelines, 2006

  • IPM ethical guidelines, 2006

  • Nuffield Council on Bioethics, 2005

  • GCM consensus points, 2005

  • CIOMS biomedical guidelines, 2002

  • WMA Declaration of Helsinki, 2000

  • ICH GCP, 1996


Preparing for access

Preparing for Access


Access principles

Access Principles

  • Availability

  • Accessibility

  • Acceptability

  • Affordability


The important role of pepfar

The Important Role of PEPFAR

PEPFAR and other programs can help by:

  • Providing treatment for those infected with HIV during trials

  • Helping to ensure that a microbicide, once developed, is widely available and affordable


The potential of microbicides

The Potential of Microbicides


Realistic expectations

Realistic Expectations

  • Drug development is a long complex process – many products do not succeed, but these efforts help us develop better products


Cause for optimism

Cause for Optimism

  • New generation of microbicides with highly potent ARVs

  • Multiple mechanisms of action against HIV

  • Single drugs or combinations

  • Longer duration of protection

  • Multiple formulations to give women more options

  • Increased focus on adherence

  • Novel trial designs

  • Increased support from donors, pharma, scientific, advocacy and local communities


Contribution of microbicides to global development

Contribution of Microbicides to Global Development

  • Improvement in health

  • Local capacity-building

  • Gender equality

  • UN Millennium Development Goals


Funding

Funding


Microbicide donors

Microbicide Donors

  • Belgium

  • Canada

  • Denmark

  • France

  • Germany

  • Ireland

  • Netherlands

  • Norway

  • South Africa

  • Spain

  • Sweden

  • United Kingdom

  • United States

  • European Commission

  • World Bank

  • UNFPA

  • Rockefeller Foundation

  • Gates Foundation


U s government funding for microbicides

U.S. Government Funding for Microbicides

* incomplete

Source: Alliance for Microbicide Development, 2008 (www.microbicide.org), based on information from CDC, NIH/OAR, and USAID compiled by HIV Vaccines and Microbicides Tracking Working Group (www.hivresourcetracking.org)


Cost and financial gap

Cost and Financial Gap

In 2007, the total global investment in microbicide research & development was approximately US$226.5 million

The microbicide field estimated in 2006 that $280 million would be needed in each of the subsequent five years to accelerate product development at the necessary levels


Leadership and political will

Leadership and Political Will


Women urgently need microbicides

“No matter where a woman lives, who she is, or what she does, a woman should never need her partner’s permission to save her life.”

Women Urgently Need Microbicides

BILL GATES, 2006


The search for microbicides a promising new prevention tool for women

Leadership in Support of Microbicides

The growing excitement around a microbicide is entirely warranted. This is a preventive technology whose time has come… it would appear that where preventive technologies are concerned, the microbicide is first in line – Stephen Lewis

Our foundation is now partnering with the International Partnership for Microbicides to help accelerate their work by guaranteeing proper care and treatment for all the participants in the test trials– Bill Clinton

We want to call on everyone … to help speed up what we hope will be the next big breakthrough on the fight against AIDS - the discovery of a microbicide or an oral prevention drug ... – Bill Gates

We believe the most promising breakthrough that could be available soon is an effective microbicide or oral prevention drug

– Melinda Gates

We are so close (to a microbicide) at this point that the question everybody is asking is no longer if, but when ... and the moment can't come too soon – Sen. Barack Obama


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