"There is an urgent need to mobilize clinical efforts, service delivery, education, implementation research, and policy to optimize PrEP access and use," said UCLA's Dr. Raphael Landovitz in his compelling plenary address to the 4,000 participants of the 2015 Conference on Retrovirus and Opportunistic Infections ( CROI ) that took place in Seattle Feb. 23-26.
CROI attendees heard variations of this enthusiastic, insistent refrain everywhere, from session rooms to hallways at the Washington State Convention Center, spilling onto sidewalks, into bars and across farm-to-table restaurants across the city. Many likened this year to 1996, which ushered in combination therapy for HIV treatment, heralded the rise of highly effective protease inhibitors and called for a "hit hard, hit early" approacha revolutionary, game-changing year.
This year was PrEP's "protease moment."
Two major trials among gay and bisexual men ( conducted in the United Kingdom, France and Canada ) reported extremely high rates of effectiveness at CROI. Both the UK's PROUD study and the French/Canadian IPERGAY studies reported an HIV risk-reduction rate of 86 percent. PROUD participants took Truvada as PrEP in a daily regimen. IPERGAY participants took their Truvada before and after sex, starting with a double dose two to 24 hours before sex, and one single-pill dose 24 hours after sex, and another single pill 24 hours after that. They were instructed to continue one pill daily as long as they were engaging in sexual intercourse.
"These results are extremely exciting and show PrEP is highly effective at preventing HIV infection. Concerns that PrEP would not work in the real world were unfounded," said Dr. Sheena McCormack, chief investigator of the PROUD study. As the study was only meant to be a feasibility pilot project, McCormack described her reaction to the high rates of effectiveness as "Wow, wow, wow!"
IPERGAY study coordinator Professor Jean-Michel Molina observed that "these very good results were obtained in MSM ( men who have sex with men ) at high risk of HIV infection who did not routinely use condoms" and observed that 34 percent of participants contracted other sexually transmitted infections during the study.
It is important to point out that the 86-percent effectiveness reported in both these studies included the small number of individuals who were not taking PrEP as instructed and consequently became infected with HIV. The 86 percent is a population level estimate. Individuals taking PrEP as instructed can expect much higher rates of protection, approaching 99 to 100 percent.
How does this research translate to Chicago?
"The truth of PrEP should spread like wildfire in the gay community. PrEP clearly can prevent HIV infection and save lives in Chicago. PrEP works!," exclaimed the University of Chicago's Dr. Renslow Sherer, who was at CROI. He mentioned that "work is underway in Chicago to model the possible impact of PrEP. We now have another powerful prevention tool to bring the annual number of new cases from 1,200 per year down by 30 percent ... or more."
"These two studies are important for PrEP implementation in Chicago for different reasons," said Dr. Sybil Hosek, a psychologist and PrEP researcher based at the Ruth M. Rothstein CORE Center who also attended the conference. "The UK PROUD study demonstrated PrEP effectiveness in a real-world setting. The level of interest in PrEP shown by men who may benefit from it the most, along with the feasibility of implementing a PrEP study in public health clinics, suggests support for a strategy of PrEP clinics in public health settings in Chicago, such as the one we are starting at the CORE Center," she said.
Said Howard Brown Health Center's ( HBHC's ) CEO David Munar: "It is critical for agencies like ours to continue reaching our community with large-scale education and patient assistance to make sure that as many people who can benefit from PrEP gain access to it."
HBHC's PrEP coordinator Bryan Bautista-Gutiérrez elaborated on this theme. "We need to ensure that people get low barrier PrEP access and support on the city and state levels," he said. "We must pressure our government representatives and officials to support PrEP. We need to continue to fight for better and more competent medical care for all LGBT people, especially those disparately impact by HIV such as young gay and bisexual men and trans women of color, and working-class queers."
Regarding IPERGAY, Hosek said "the study is important because it provides evidence for a potentially new PrEP dosing strategy." Indeed, IPERGAY's dosing strategy offers a new way to potentially prescribe PrEP. At the same time, it complicates the messaging around taking PrEP which has, until now, called for daily dosing. The IPERGAY strategy has also not been proven to work in women or injection drug usersalthough clinical trials have proven that daily PrEP works for these populations.
"In the context of IPERGAY, what are we now going to recommend to our gay clients?" asked clinician and PrEP researcher Dr. John Schneider of the University of Chicago. "Shared decision making will be critical, and careful attention will need to be paid to determine whether daily PrEP, or PrEP before and afer sex, should be used. I may no longer be able to ask 'when was your last missed dose?' and have this information mean much in isolation."
Jeff Berryeditor of the locally produced, global Positively Aware magazinedelivered a word of caution for "event-driven" dosing of PrEP. "[This dosing regimen used in IPERGAY] is not yet approved in the United States or in the Truvada label," he said. "I think we still need to see more data to show how long you have to be on PrEP before there is enough drug in your body to reach the highest level of protection."
While there is an urgent imperative to capitalize on this historic moment in HIV history and scale up PrEP services, Munar mentioned another pressing need: "We must stop the shame and stigma around wanting to be protected against HIV. We need to applaud people who seek out education and PrEP treatment, because they are doing their part to help curb the epidemic."
Jim Pickett is director of prevention advocacy at the AIDS Foundation of Chicago.