Pharma Strategy Blog

There are many lessons for microbicide access can be drawn from the international family planning/sexual and reproductive health movement and its successes and difficulties in reducing fertility rates throughout the world. This report covers the execution issues.

With 6,800 new HIV infections occurring globally each day, new prevention strategies are desperately needed. While microbicides are not a magic bullet, researchers believe they could prevent millions of infections. And with leading scientists concluding that a vaccine is likely to be at least 10 years away, we need to make a strong commitment to developing microbicides. Scientists estimate that even a 60 percent effective microbicide could prevent 2.5 million HIV infections in three years among women, men and children in the developing world.

A UN population fund report has shown, in India, a majority of married women are subject to forced sex, and are hence vulnerable to HIV.// Therefore, there is a definite need for protective methods that are under the control of a woman, as the prevalent male-controlled methods are not even 20 percent helpful. A new thrust to the fight against HIV/AIDS may be provided by over-the-counter microbicides, which are gels, creams, films, or suppositories, meant for women. This is a blessing for many sex workers, who despite stocking up with condoms are unable to persuade many a recalcitrant customer to use protection. This callousness is present despite the awareness about AIDS in India, which has touched the five million mark.

Microbicides would provide an additional, complementary tool for individuals and communities to protect themselves against HIV infections and other STIs. For women, it would represent the first female-controlled method of protection against HIV and STIs. With the option of contraceptive and non-contraceptive microbicides, women could choose to become pregnant without risking HIV or other STI infections. For people living with HIV/AIDS, microbicides could help prevent infections from STIs, prevent re-infection with strains of HIV and provide protection in sero-discordant couples.

Topical microbicides are pharmaceutical products, which function through a variety of mechanisms disrupting the entry or the life cycle of the HIV virus. Some microbicides have also properties that make them effective against other sexually transmitted infections or make them effective contraceptives. There are no microbicides on the market today, but clinical trials in humans have begun with 18 preparations and several others are under preclinical research. It seems realistic to assume that within 5-10 years a few of the preparations would have finalized phase 3 studies and if successful, accepted by regulatory authorities.

New, anti-infective substances that can be developed as gels, creams, foams, films, even impregnated sponges and suppositories may prove to be a ground-breaking approach to preventing the spread of HIV, the virus that causes AIDS, according to an international authority and clinical pharmacologist at Advocate Bethany Hospital in Chicago, Illinois. The substances, called microbicides, are currently being developed for use in women prior to sex as a way of preventing the spread of such sexually transmitted diseases as gonorrhea and syphilis.

Microbicides/Spermicides: Opportunities for Industrial Collaboration – Summary of an International Conference

The Initiative brought together experts in scientific research, product development, public health, economics and advocacy, to help bring to market this critical health technology that women worldwide are demanding as they cope with staggering levels of HIV/AIDS infection. The results are five fact-based studies that detail:
* A scientific plan for accelerating development;
* A pharmaco-economics study of the potential market size and the expected return on investment;
* An assessment of the public health impact;
* A framework to ensure access to the products;
* A plan of action for microbicide advocacy.

Research funding of £90m is to be directed towards British researchers to develop a gel which will “stop HIV/Aids in its tracks” reported The Times. It is hoped the funding by the UK government and the Bill and Melinda Gates Foundation will lead to a gel that could be applied before sex to prevent transmission of the HIV virus. A gel of this type is important as it would allow women to apply their own protection rather than relying on a partner to use a condom.

Microbicides kill or immobilise sexually transmitted infectious (STI) pathogens, form a barrier between the pathogen and the vaginal or rectal tissue, block the infection early on, prevent the pathogen from replicating once it has entered the cells, and boost the vaginal defence system. Norick says that microbicides protect both partners and that some can even prevent pregnancy. Most of them will eventually become available across the counter and inexpensively too.

To prevent sexually transmitted HIV, the most desirable active ingredients of microbicides are antiretrovirals (ARVs) that directly target viral entry and avert infection at mucosal surfaces. However, most promising ARV entry inhibitors are biologicals, which are costly to manufacture and deliver to resource-poor areas where effective microbicides are urgently needed. Here, we report a manufacturing breakthrough for griffithsin (GRFT), one of the most potent HIV entry inhibitors.

HIV is a serious and growing women’s health issue globally. In Sub-Saharan Africa, 61 percent of all adults living with HIV are women, and the number of women and girls infected with HIV has increased in every region of the world, with rates rising particularly rapidly in Eastern Europe, Asia, and Latin America. Biologically, women are two to four times more vulnerable than men to sexually transmitted HIV infection. Their vulnerability increases due to their lack of economic and social power in many societies, where women often cannot control sexual encounters or insist on protective measures such as abstinence or mutual monogamy. Many women who get infected with HIV have only one partner – their husbands.

The Pharmaco-Economics Working Group was established as part of the Rockefeller Foundation’s Microbicide Initiative, started in early 2001. This was
one of four Working Groups formed to examine the key steps in creating a microbicide: (1) understand the public and private views of investment in microbicide development; (2) develop ways to ensure access to the product; (3) advocate investment in and adoption of a product; and (4) identify the scientific and technical requirements for developing a product. The reports from the other Working Groups are contained in companion volumes
within this series. The pharmaco-economic work has been completed in two sections: the private investment view and the public investment view. This report covers the private investment view of the microbicide market.

Role of microbicides in preventing HIV and STD's

“Community involvement” represents on-the-ground implementation of science’s accountability to society, at the local as well as global level. Engaging a wide range of stakeholders as active and informed partners in decision-making about the research and its implementation enhances both the scientific validity and ethical integrity of clinical trials. This has been widely recognised in the field of AIDS research, and almost all publicly-funded research networks require a community involvement component. Generally this has been done by forming a community advisory board (CAB) or similar structure, a model developed in the US in the early days of activist involvement in HIV treatment trials. Recently, however, research networks are questioning whether the CAB model is the best or only approach to developing partnership with communities. The community liaison teams at various trial sites are exploring a variety of strategies to engage with communities as partners in the research enterprise