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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

US Congress, Women’s Policy Inc.

Zeda Rosenberg, Sc.D.

December 3, 2008

The face of hiv is increasingly
The Face of HIV Is Increasingly…



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


  • Topical products to prevent HIV transmission

  • Could be delivered in many forms:

Tablet, capsule, film

Gel applicator


  • 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



GM Biotics (Osel)

Free virus



SPL7013 (VivaGel)

RANTES analogs


DS003 (BMS 793)

DS001 (Merck 167)

Maraviroc (Pfizer)

DS007 (Merck L’644)








Pyrimidinediones (Samjin)

Reverse Transcription


Early-generation compounds

Protein synthesis and assembly

Next-generation compounds



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


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

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

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

Microbicide donors
Microbicide Donors

  • Belgium

  • Canada

  • Denmark

  • France

  • Germany

  • Ireland

  • Netherlands

  • Norway

  • South Africa

  • Spain

  • Sweden

  • United Kingdom

  • United States

  • European Commission

  • World Bank


  • Rockefeller Foundation

  • Gates Foundation

U s government funding for microbicides
U.S. Government Funding for Microbicides

* incomplete

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

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

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


Leadership in Support of Microbicides does, a woman should never need her partner’s permission to save her life.”

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