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Mitchell Warren

Mitchell Warren

Posted: December 1, 2010 10:43 AM

Last week, 2,499 gay and bisexual men and transgender women from four continents made history when the iPrEx HIV prevention trial reported positive results. This landmark trial, hot on the heels of similar good news in July about 1% tenofovir microbicide gel, moves the world one step closer to ending the AIDS epidemic and points the way to a much-needed addition to the HIV prevention "tool box."

It is also the latest example of gay men advancing the fight against AIDS, adding to a 30-year history of pushing for--and often getting--faster access to treatment, better drugs, and more and better prevention programs.

The intervention tested in the iPrEx trial is known as PrEP (pre-exposure prophylaxis), using a daily dose of the antiretroviral treatment drug TDF/FTC (brand name Truvada) to prevent HIV. If it is implemented, it will be the first new biomedical prevention strategy for gay men since condoms were first recommended for HIV prevention by the US Public Health Service in 1986.

However, the next step for PrEP is not passing out pills to every gay man at risk for HIV infection. Like any good clinical trial, iPrEx answered one important question and raised many additional ones.

1. What are the best ways to ensure that people take a pill consistently? Many men in the iPrEx trial did not take the pill every day. The trial tells us that, like condoms, PrEP works when it is used correctly and consistently, but that doing this is hard.

2. What about drug resistance and HIV testing? Two cases of HIV drug resistance in the trial raise concerns about people who might begin PrEP while in the early stages of HIV infection, which is not detected by the standard HIV tests used at most clinics.

3. What are the long-term safety issues? Trial participants were on study drug for an average of 14 months, a relatively short amount of time. More information is needed about long-term safety and risk behaviors when HIV-negative people use TDF/FTC for prevention.

4. What about other populations? The iPrEx trial tells us only about PrEP for gay men, transgender women and other men who have sex with men. It may prove to have similar benefits for heterosexual men and women and injecting drug users, but these data will only come from other ongoing trials, which are now more important than ever.

5. How much and who pays? TDF/FTC ranges in price from 39 cents for a generic pill available in some developing countries to $35 a pill from a pharmacy in the United States. With resource constraints and challenges of delivering treatment today, how will we add this into the mix, and pay for it?

These and other open and valid questions are part of the discussion about whether the iPrEx results are a public health breakthrough or merely an interesting scientific finding with no application in the real world.

But the reality is that the world cannot afford to ignore the potential of PrEP or any new prevention tool.

There is no doubt that the next steps for PrEP will be hard, but the response to AIDS has always been hard. But, at its best, it has been groundbreaking. These challenges are real, but they are not insurmountable.

In the 1980s, AIDS treatment activists stormed the National Institutes of Health to demand accelerated research for anti-HIV drugs and pushed the Food and Drug Administration to change drug approval timelines. More recently, global AIDS activists demanded and got ambitious programs--and unprecedented resources--to bring life-saving medications to the poorest citizens of the planet despite warnings from many "experts" who said it could never be done.

Audacity. Global solidarity. Pragmatic innovation. These are the components of nearly every successful incursion against the AIDS epidemic. And they are needed with new urgency as the world contemplates what to make of the iPrEx result and how we might translate it into public health impact.

Audacity in imagining and exploring without delay, with fully-funded demonstration projects, what the iPrEx intervention can do for gay and bisexual men. Arguments about cost, feasibility and the comparatively less expensive condom cannot get in the way. Condoms, lube and other proven prevention strategies must be delivered and promoted worldwide--but the promise of PrEP shown in iPrEx demands that we test ways to deliver this, too.

Global solidarity in pursuing the potential impact of PrEP. This includes coordination with courageous groups and individuals working with gay men in sub-Saharan Africa and everywhere else where stigma, discrimination and criminalization imperil human rights. It also includes support for ongoing, and essential, PrEP trials among heterosexual men and women and injecting drug users.

Global solidarity, also, in ending the false dichotomy between treatment and prevention once and for all. Some HIV prevention researchers like to say we can't treat our way out of the epidemic. The truth is, even with these promising breakthroughs, we can't fully prevent our way out of this epidemic either. We need to treat those who are living with HIV and prevent infections among those who are at risk. And we can best do that by working together.

Pragmatic innovation in taking the steps that can make PrEP a powerful additional prevention tool--rather than taking the route of arguing that it is too complex or costly to pursue. AIDS touches every country in the world, and all health ministries should be taking steps now to evaluate whether an antiretroviral-based prevention strategy like the iPrEx intervention or the 1% tenofovir gel microbicide that showed promise among women in a South African trial earlier this year, can be used as a part of their country's response to the epidemic.

Pragmatic innovation, too, in pursuing additional prevention strategies. More work is needed to improve on the effectiveness and adherence of both oral PrEP and ARV-based topical microbicides; other drugs, formulations and delivery systems must be evaluated; and there is still a critical need for a vaccine that delivers long-lasting protection via a simple series of injections.

The response to the AIDS epidemic--from accelerated development and licensing of new drugs to expansion of AIDS treatment programs throughout sub-Saharan Africa--is already one of the great success stories of our time.

We are still a long way from ending the AIDS epidemic, but the iPrEx results could put us a little closer to the beginning of the end--if we seize the opportunity.

 

Follow Mitchell Warren on Twitter: www.twitter.com/@hivpxresearch