June 21, 2013
This past April, the National Institute of Allergy and Infectious Diseases (NIAID) announced it would stop providing injections to participants enrolled in the HVTN (HIV Vaccine Trials Network) 505 study. HVTN 505 was aimed at studying the effectiveness of an HIV vaccine regimen in preventing HIV infection in trial participants or reducing the viral load among those that become infected with HIV.
The Data and Safety Monitoring Board (DSMB), the group of experts who examine the safety of patients and treatment efficacy during the course of a clinical trial, found that the vaccine regimen being studied did not prevent HIV nor did it reduce the viral load of participants that had been infected.
Over the past few years there has been considerable optimism and hope for the development of effective biomedical HIV prevention options, so the initial news was sobering. This is even more true given that nearly a year ago, the FDA approved Truvada for use as pre-exposure prophylaxis (PrEP), catapulting us into a new era of HIV prevention.
However, it's important to keep things in perspective. The news about HVTN 505, though in some ways a setback, is an excellent learning opportunity and provides us with valuable information about developing an HIV vaccine that will actually be effective.
To provide greater context around these issues, I interviewed Steve Wakefield of HVTN, a widely respected HIV prevention research advocate and thought-leader in the field.
What are your general reactions to the news about HVTN 505?
As an HIV vaccine advocate and believer in HIV vaccines as the way to end this epidemic, I am disappointed. It is very challenging that a strategy that seemed hopeful and asked people to invest did not result in a clear path forward. We have learned an incredible amount through in-depth analysis of tissue and blood from previous trials. This study was designed to give us an answer sooner and it did -- I would have preferred a different answer. The good news is that people participating in the study and telling the truth about sexual behaviors can open us up to a world of information on next generation HIV vaccines. To date, scientists have learned information from clinical trial data that provides accurate guides to future HIV vaccine studies. Sometimes one study can tell us the way forward on several fronts.
What are your thoughts about the future of HIV Vaccine research for gay men/MSM?
It is essential to find a vaccine that works for those most impacted which may mean those with the most new infections annually. It is equally important to find a vaccine that works for all populations. Gay men are the key to understanding how this vaccine and future vaccines will be used along with new information about HIV protection for those who are sexually active. Gay men will generate knowledge about PrEP, condom use, home test kits, and partner selection by serostatus. How are these new tools used? Do MSM who participated in HIV vaccine research have different responses than those who did not? Do HIV vaccines have a different effect on anal tissue than in the blood stream? These and many more questions are key to understanding how to make an effective HIV vaccine.
Do you have any recommendations for HIV prevention research advocates as it relates to moving the HIV vaccine research agenda forward?
Prevention advocates should not get caught in the "where do we spend our money?" discussion, but should instead note for the public that there is not enough money being spent. We currently spend less on HIV vaccine research than it costs to make four Hollywood movies. I look at the new movie releases across the summer and think: which one or two could I live without in order to stop HIV's devastation, in order to find a better condom or an HIV vaccine?
What are some critical lessons learned about HIV prevention research advocacy broadly that we can apply to our current moment as it relates to the HVTN 505?
HIV research has taken us from a somewhat toxic, one-drug treatment strategy to smart pills where you can get three or four drugs in one daily dose. Today's drugs are as different from early pills as our smart phones are from the rotary dial phones that we went home to answer. We are learning more and more about public health strategies to protect entire communities, partners and individuals who may not find answers in behavior change. Research is the way to end the devastating impact of HIV.
What are the top three issues/areas HIV prevention research advocates should prioritize in 2014? What should our advocacy agenda look like?
From my perspective, we should focus on ensuring access to treatment and prevention for all who need it. In the U.S., that means a watchdog/whistle blower attitude to policies.
Secondly, we should turn our attention to campaigns that help individuals understand how to choose strategies that protect them from HIV infection, including reducing one's number of partners and entering covenant agreements on safe, proper use of biomedical tools.
The third priority should be to ensure that we don't wait for the government to save our lives. HIV activism has worked best when a couple people agreed to move forward to save the lives of those around them -- not when we complained about government spending.
Charles Stephens is regional organizer at AIDS United.
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