The second international conference on microbicides opened in Antwerp, Belgium, on Sunday 12 May with 650 registered participants from 44 countries. It is an AIDS conference in all but name, at which the overwhelming concern is to give women new options, particularly in Africa and Asia, to protect themselves from HIV.
A positive mood at the meeting reflects a major increase in political commitment and funding since the previous event in Washington, DC, two years earlier. However, as several candidate products enter the most costly and difficult phase of their development, designed to find out whether the products can protect women against HIV, this commitment will be put to the test.
Why Antwerp? The venue reflects the key role of researchers at the Institute of Tropical Medicine in this small Belgian city in global clinical programmes to study microbicides for HIV prevention. One of the most famous – Dr Peter Piot, who now heads UNAIDS – was here to deliver an opening address.
Why microbicides? Dr Arndt Houveler of the European Commission’s Directorate for Research placed microbicide development within the framework of research directed at HIV/AIDS, tuberculosis and malaria as diseases of poverty. For the EU, microbicides now have equal status with the development of treatments and vaccines against all three diseases as an integral part of the response that is being supported by the Commission, the Council of Ministers, and member states including the UK’s Department for International Development.
The 2003-2006 EU biomedical research Framework Programme can offer tens of millions of euros to take one or more products through to early clinical trials, within an overall three-year budget of €150 million across the seven areas. (Whether and at what speed this happens will depend on a scientific review process that still seems a little uncertain.)
Microbicides also feature, alongside those treatments and vaccines, in the plans for a European-developing countries clinical trials programme or platform, which was launched last month at a meeting in Barcelona. Final details of this programme, including its legal structure, remain to be agreed over the next 6-9 months, but it will be a partnership between the global North and South to support clinical trials related to all three diseases, with €200 million allocated over three years from EC funds.
Dr Peter Piot spoke of the progress that had been made with the UN General Assembly’s recognition of the need for microbicides, in the Declaration of Commitment from the Special Session on HIV/AIDS. This commitment stands alongside the call for HIV vaccine development, and Dr Piot stressed that as the global HIV epidemic is still in in its very early stages, and will be with us for generations, both will be needed. Women definitely need microbicides, but men, ‘gay and straight’ also have much to gain. Acceptability and sustainability of microbicide use will depend a great deal on male support, even for such a female-centred approach.
The scientific challenges of microbicides had proven greater than he and others had first assumed, though he remained optimistic that they can be overcome. As with vaccines, there is no ‘magic bullet’ in prospect, but the tendency to fall into ‘scepticism and cynicism’ must be resisted, because it does nothing to help mobilise the support that will be required to get imperfect products into use where they can make a real difference.
Developing demand is the surest way of getting funds mobilised, and UNAIDS with the support of Kofi Annan as UN General Secretary would continue to make the case. ‘Our vision of a world that is successfully fighting AIDS is a vision that needs to include microbicides,’ said Dr Piot.
Further opening presentations were given by Dr Kim Dickson-Tetteh, a Ghanaian working at the Chris Hani Baragwanath Hospital in Soweto, South Africa, and Dr Charlotte Watts of the London School of Hygiene and Tropical Medicine.
Dr Dickson-Tetteh spoke of the continuing ethical, cultural and political challenges involved in testing microbicides. Some of the basic ideas were very hard to translate and explain to the majority of women affected by HIV who would need to be recruited into clinical trials.
There continued to be a very real culture of silence around HIV, with suspicion and stigma still far too common. While this may be changing, the progress remains very slow. Politicians' concerns over possible exploitation in trials could be enough to prevent people participating.
In 1998 the debate had been whether participants in microbicide trials were entitled to best available interventions to prevent HIV; now that debate had moved on to trying to decide what those best interventions might be. In its place we now had a still-difficult set of questions about the proper, fair and sustainable level of provision of care and treatment for anyone who becomes HIV positive during a trial.
Dr Watts discussed the public health potential of a microbicide with moderate efficacy and usage, presenting results from a mathematical modelling exercise she and colleagues had done for the Rockefeller Foundation.
She concluded that even such a microbicide would have a substantial impact on the global epidemic, perhaps most substantial in Asia where the epidemics in India and China are still at relatively early stages. To maximise any benefit, it would be necessary to plan now for the widest access, especially for poorer women.
Implicitly, for the EU and other public funders, microbicides will stand or fall on their ability to prevent HIV, although current candidate products are all designed to prevent other infections too, and their appeal to some very important populations – such as young women in wealthier countries and HIV positive women - may depend on proving they can do this.
The conference continues to Wednesday 15 May and further reports will appear on aidsmap.com during the week.