- Provide women with safe, effective and affordable products they can use to protect themselves against HIV infection.
- Make these products available as quickly as possible where the need is most urgent.
What are the health needs and challenges?
HIV/AIDS is one of the world’s most serious and immediate threats to women’s health and has claimed more than 36 million lives worldwide. According to the World Health Organization (WHO), since the beginning of the epidemic, almost 75 million people have been infected with the HIV virus and about 36 million people have died of HIV. Globally, 35.3 million [32.2–38.8 million] people were living with HIV at the end of 2012. An estimated 0.8% of adults aged 15–49 years worldwide are living with HIV, although the burden of the epidemic continues to vary considerably between countries and regions. Sub-Saharan Africa remains most severely affected, with nearly 1 in every 20 adults living with HIV and accounting for 71% of the people living with HIV worldwide.
Vaginal microbicides are topical products being developed to prevent heterosexual transmission of HIV. Microbicides could take many forms, including those that could be used monthly or daily, or at or around the time of intercourse.
Researchers at the International Partnership for Microbicides (IPM) are developing a variety of products that include daily vaginal gels, films and tablets, as well as vaginal rings that would release an ARV drug gradually and provide protection against HIV for as much as a month at a time.
Description of partnership activities and how they address needs and challenges
IPM provides women with affordable and self-initiated HIV-prevention strategies to reduce HIV transmission and is developing microbicides based on existing antiretroviral (ARV) drugs being used to successfully treat HIV/AIDS and prevent mother-to-child transmission.
IPM receives non-royalty-bearing, non-exclusive licenses from companies to develop, manufacture and distribute novel ARV compounds for use as a vaginal microbicides in developing countries to help protect women from HIV. Some of the compounds, such as members of a class of ARV molecules known as fusion inhibitors, inhibit HIV infection by preventing the virus from fusing with the surface of target cells, which is an early step in the HIV infection process. These compounds may offer a novel way of blocking infections.
IPM focuses on preventing HIV transmission by accelerating the development and availability of safe and effective microbicides and other HIV prevention methods for use by women in developing countries.
Janssen, the pharmaceutical companies of Johnson & Johnson, established one of the very first public-private partnerships in the microbicides field with IPM in 2004, providing royalty-free licensing and technology transfer to develop, manufacture and commercialize dapivirine (TMC120) as a vaginal microbicide to reduce sexual transmission of HIV in resource-poor countries. In 2014, Janssen expanded this collaboration, granting IPM exclusive worldwide rights for dapivirine alone or in combination with either microbicidal antiretroviral medicines and/or in combination with contraceptives. IPM’s monthly vaginal microbicidal ring with dapivirine – potentially the first product of its kind – is now being studied in two parallel efficacy trials in multiple African countries with results expected in late 2015. IPM is also developing a 90-day ring that combines dapivirine with a contraceptive, which is set to enter clinical testing in 2015.
In October 2005, Bristol-Myers Squibb announced that it had granted a royalty-free license to IPM to develop, manufacture and distribute two new antiretroviral compounds as vaginal microbicides to protect women from HIV in resource poor countries. The compounds are HIV attachment inhibitors which bind directly to the HIV itself and prevent the virus attachment to the host cell receptor. The compounds are designed to prevent HIV from entering host cells, thus preventing infection.
MSD granted IPM a non-royalty-bearing, nonexclusive license to develop, manufacture and distribute a novel ARV compound for use as a vaginal microbicide to help protect women in developing countries. The compound, the fourth we have licensed to IPM, is a member of a class of ARV molecules known as fusion inhibitors, which inhibit HIV infection by preventing the virus from fusing with the surface of the target cells – an early step in the HIV process – potentially representing a novel way to block infection. Merck is also collaborating with Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents to advance early-stage product development research efforts.
IPM works with leading pharmaceutical and biotechnology companies, philanthropic foundations, local research centers in developing countries, civil society organizations and academic institutions to evaluate promising compounds, design optimal formulations, conduct preclinical and clinical trials, identify appropriate regulatory pathways for products and establish manufacturing and distribution capacity to ensure access to future products.
The promise that microbicides represent will be realized only if women can obtain these products easily and affordably, and will use them effectively once they are available.
Ensuring access to drugs in developing countries can be highly challenging because of weak health systems and a lack of skilled health workers and financing. New drugs have historically been designed and developed for industrialized markets, and introduced into developing countries only several years later, if at all.
Summary of impact and forward looking information
Findings from the first clinical trial of an ARV-based microbicide announced in July 2010 offer new cause for optimism. The trial, called CAPRISA 004, demonstrated proof-of-concept that an ARV-based microbicide can prevent women from becoming infected with HIV through sex with an infected male partner. Conducted in South Africa among 889 women, the CAPRISA trial found a 39 percent lower HIV infection rate in women using 1% tenofovir gel as compared to those women using a placebo gel. Dozens of potential drugs that interrupt HIV transmission or replication are currently being studied as possible microbicide candidates.
*MSD is known as Merck in the United States and Canada.