The Hindu Business Line : Microbicides: HIV killers in the making

Though the Government has announced its policy of providing anti-retro viral drugs free to the affected, the incidence of HIV is on the rise, especially among women, calling for more affordable alternatives such as microbicides.

AFTER MORE than a decade, research into the development of microbicides that have the potential to halt the transmission of HIV (Human immuno-deficiency virus) and save millions of women, seems to be throwing up some positive results.

A potent vaccine is still a distance away and the cocktail of Anti-Retro-viral drugs (ARVs) remains comparatively expensive for the affected who are largely poor. Desperately needed are alternatives, especially for women, the number of whom infected by the deadly virus has of late been swelling in African and Asian countries.

The announcement by British scientists of impending clinical trials in Africa of two gels has raised hope once again that women could in the near future have a product to protect themselves from HIV. The UK's Department for International Development (DFID) is funding up to $23.5 million for this microbicide development project over a five-year period.

Clinical trials involving around 12,000 women in South Africa, Zambia, Tanzania, Uganda and Cameroon are to be undertaken for the drugs over the next three years. If successful, the products would hit the market before 2010.

Another big hope is the seaweed-based microbicide — Carraguard, an initiative of the New York-based Population Council, an affiliate of the Rockefeller Foundation. Carraguard is made from carrageenan, a carbohydrate gel derived from the seaweeds grown along the coasts of Chile and Nova Scotia. With clinical trails planned, the product is in line to reach the post of a commercial market among the first.

At least 60 microbicide candidates being tested with many are set to enter Phase-3 clinical trials. However, the costs of Phase-3 clinical trials that must cover a large test population can go up to $46 million, which incidentally exceeds the US Government's total budget for microbicide research in 2000. What microbicides will do is entrust to women the option to protect themselves; they need not rely on men to use a condom. The microbicide can halt the virus in multiple ways, which include killing the virus before it enters the body, creating a barrier, or preventing it from taking hold if it manages to slip in.

A microbicide can be made in various forms, including gels, creams, films, lubricants, sponge or a ring which gradually release the active ingredient, and prevent the sexual transmission of HIV as also other sexually transmitted infections (STIs). Among the promising product in the pipeline are Buffergel from Reprolect of Baltimore; Pro 2000 from Interneuron Pharma; Cellulose Sulphate from Polydex Pharmaceuticals; and Carraguard from Population Council, according to the Global Campaign for Microbicides.

The only major clinical trial of a microbicide so far has been of Nonoxynol-9, a spermicide used along with condoms. But it had to be given up because besides killing sperm and viruses, Nonoxynol-9 also killed vaginal wall cells, causing ulceration and inadvertently opening up an entry point for HIV.The slow progress in microbicides has been attributed to the lack of interest from big drug industries which do not see these gels as potential money spinners, and are hence not putting in funds for research. Estimates by the Alliance for Microbicide Development, a group of scientists and biotech companies, put the figure at $50 million for the successful development of a microbicide.

Microbicides are a public health good for which the social benefits are high but the economic incentive to private investment is low. Therefore, public funding is the best hope for now. The National Institute of Health (NIH), the leading health research funding agency in the US, has developed a strategic plan for the development of microbicides. NIH's Ms Fulvia Veronese, who was in India attending an International AIDS conference in Chennai, said with HIV vaccines still some time away, the growing involvement of the Rockefeller Foundation, the Melinda and Gates Foundation, USAID and the Global Microbicide Concerns augurs well for an accelerated progress in the development of a microbicide.

The Global Campaign for Microbicides has mobilised $40 million in the last two years for conducting research on microbicides.

A good microbicide can help in averting at least 2.5 million new infections over three years in women, children and men, which would result in a saving of over $2.7 billion in public healthcare expenditure, argues, Ms Ananthy Thambinayagam of the Campaign. Though large pharmaceutical companies have shown little interest in pursuing microbicides, the persistent efforts in recent years have brought in 35 biotech companies, 44 non-profit research entities and four public sector entities into the fold of the microbicide world, she said.

In India also efforts have been initiated, though in a small way. The Global Campaign for Microbicides has involved stakeholders and policy makers in discussions to get a major programme going. The Indian Council of Medical Research (ICMR) has a task force on microbicides.

Interestingly, the National Institute for Research in Reproductive Health (NIRRH), Mumbai, an ICMR institute which has developed `Praneem', a herbal microbicide targeted to protect against pregnancy and sexually transmitted infections, is undertaking research to see if a variant can be developed to halt HIV transmission. Two-three other institutes in the country have started work on the development of candidate products.

With the incidence of HIV on the rise in many States, especially among women, and the mother-to-child transmission increasing alternatives to protect against the deadly virus are urgently needed. Though the Government has announced its policy of providing ARVs free to the affected, the huge number of vulnerable people calls for more affordable and accessible alternatives such as microbicides. In Andhra Pradesh, Maharashtra, and Tamil Nadu where the number of infected women, especially teenage girls, is a cause of concern, an option that gives women the chance to protect themselves could indeed be an effective solution.

The Rockefeller Foundation and the Population Council's efforts are directed towards establishing the feasibility of microbicides as well as show drug majors that these drugs can indeed be potential money-spinners. Carraguard, the seaweed-based, microbicide is expected to emerge as a commercial product in the next five years but the process can be accelerated if pharma companies chip in.

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