Translating clinical efficacy into public health effectiveness
The recently concluded XIX International AIDS Conference in Washington, DC, appears to have gone a considerable distance on changing the dialogue on ending AIDS, with new emphasis on preventing transmission in the first place as one of the strategies that wouldl complement a comprehensive HIV prevention, treatment, care and support plan to end the disease.
In this context, it is necessary to look beyond the current phase of trials in HIV prevention research so that if the product being tested is proved to be effective, the means and well-thought plan to make it available for those people in need can be developed without delay.
HIV prevention research is going ahead with rectal microbicides phase II efficacy clinical trials about to begin in the US, Thailand, South Africa and Peru. Other hopeful developments include the US Food and Drug Administration’s approval of the microbicide Truvada as pre-exposure prophylaxis for HIV prevention, vaginal microbicide research and HIV vaccine science progress and unprecedented emphasis on treatment as prevention.
"We need a plan that the day efficacy trials are over participants, should continue to have access to the products,” said Mitchell Warren, executive director of AVAC – Global Advocacy for HIV Prevention. “We have spent a lot of time talking about how difficult rolling out pre-exposure prophylaxis is going to be, we don’t yet have fully funded demonstration projects to tell us how to translate clinical efficacy into public health effectiveness. I want to make sure that when we do get the results of the phase III rectal microbicides study, we do know what to do then and that we have resources to do it."
Warren is right. For example, the FDA approved female condoms as early as 1993. Even 19 years after, and despite their effectiveness in preventing HIV as well as other sexually transmitted infections and unintended pregnancies, female condoms are yet to be made available in the way they should have been to address the unmet needs of women to protect themselves.
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