PrEP advocates bemoan drug approval delays

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Statistics present a disturbing picture of the HIV epidemic in South Africa and the country’s response, write John Mutsambi, an AVAC Fellow – a US based organisation that advocates for HIV prevention to end Aids – and Brian Kanyemba, Yvette Raphael and Ntando Yola, leaders in PrEP advocacy in South Africa in a Mail & Guardian report. They ask, in delaying the implementation of pre-exposure prophylaxis (PrEP), has South Africa failed to embrace the wisdom of science?

This new option for HIV-negative people at substantial risk of HIV infection is a combination antiretroviral drug, TDF/FTC, taken once a day, which can drastically reduce their chances of becoming infected. Research studies show that, when this two-in-one pill is taken correctly and consistently, it is more than 90% effective.

Mutsambi et al say there have been unexplained delays by the Medicine Control Council to approve and license TDF/FTC as pre-exposure prophylaxis and the Department of Health’s response to South Africans voicing their demand for this action has been silence. The council should approve TDF/FTC before the end of this year, they say.

They say advocates welcomed the World Health Organisation’s (WHO) new guidelines for HIV treatment, released in September. These recommended that “oral PrEP…should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination HIV prevention approaches”.

The new guidelines have broken the silence among policymakers on the future of pre-exposure prophylaxis in South Africa, they say. Following their release, Yogan Pillay, the health department’s deputy director-general for HIV, endorsed the WHO guidelines. This demonstration of commitment is an important step in realising our dreams about providing pre-exposure prophylaxis.

Mutsamb et al say: “As HIV prevention advocates, we talk to many people, including potential users of TDF/FTC. We hear from a host of people from all walks of life who are demanding pre-exposure prophylaxis. They want to know when the drug will be available in South Africa and how they can get access to it. These questions have been previously been impossible to answer, but now we hope to work with health department. Will the department follow through on its commitment and the ethical imperative to provide medicine that is a crucial step in confronting the HIV epidemic?

“We would like to see such a programme rolled out in the shortest possible time, and through existing structures, where possible. We know that implementation of this new intervention will not be easy. It requires political will, dedicated advocacy, domestic sources of funding and international donor commitment. More importantly, investment must be based on decisions that are driven by evidence rather than sentiment. The health department will need support from a variety of stakeholders – much of which can and will come from the huge groundswell of civil society support for the implementation of a pre-exposure prophylaxis programme.”

They write: “As we prepare to support the department in planning and executing such a roll-out, we have questions. What are the department’s plans for this? What are the timelines? Has the department started seriously with advocates in the provinces? What are the advocacy issues that civil society can push? We need effective models to deliver PrEP. Demonstration or pilot projects in South Africa and around the world will provide us with the knowledge to guide a roll-out in real-world settings. The health department can also take advantage of data on existing public health programmes that can be adapted for providing TDF/FTC.

“Some organisations that already provide comprehensive HIV prevention services are suggesting that the department use existing structures and services to start and expand the provision of PrEP and integrate it into combination treatment and prevention programmes.

“Within these organisations, there are champions who have already established positive working relationships in communities. They can help to identify barriers to implementing and recommend strategies to address the barriers.

“Young women tell us, ‘we recommend that youth-friendly clinics be established and that health staff be sensitised about the unique needs and problems that young people face.’ Similarly, sex workers have suggested that TDF/FTC should be provided ‘within user-sensitised facilities’ and, where possible, through mobile clinics. Men who have sex with men are calling for the medicine and some are already getting it from private clinicians through ‘off label’ prescriptions.

“As advocates, we will continue our work to educate the public about TDF/FTC, how to get it and how it can further strengthen existing HIV prevention efforts. But we know that there is more to be done through working closely with people and with social marketers.

“We will also continue preparing for the results of a vaginal microbicide ring study expected early next year. The vaginal ring, another form of PrEP, slowly releases the antiretroviral drug dapivirine over the course of a month. If proven safe and effective, the vaginal ring could expand options for women-initiated HIV prevention methods.

“Civil society is working with the International Partnership for Microbicides, the organisation which developed this technology, and other partners who conducted microbicide research among South Africans to plan for the results and introduce the product if it is proven effective. No microbicide has yet been licensed for use.

“We acknowledge South Africa’s remarkable success in fighting HIV. There is now opportunity to build on these successes by taking advantage of new innovations such as TDF/FTC to reduce the chance of infections and save on treatment costs. HIV-negative South Africans have a right to use this life-saving intervention now. We should not have to wait until people are agitated and take to the streets to demand these tools.

“Will South Africa show global leadership and take immediate action to get PrEP into people’s hands? Or will our collective conscience be haunted in years to come, knowing we could have averted new infections and saved on costs of lifetime HIV treatment and sickness? The science is clear that TDF/FTC works when taken correctly and consistently; now we must follow this evidence and act on it.”

Full Mail & Guardian report

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