A Night of Gratitude and Reflection: Where are we now in PrEP research in the Bay Area?

On September 10th 2014, Bridge HIV hosted a panel of leading, local HIV prevention researchers to discuss some of the latest PrEP studies as well as to give insight into what lies ahead in the PrEP research field.

The event was in honor of the several hundred participants who have volunteered for an array of studies in hopes of finding new and innovative ways to prevent HIV. We’re devoting this blog post to recapping the most poignant information from this important evening. Special thanks goes out to Bridge HIV, San Francisco City Clinic, and the San Francisco AIDS Foundation for sponsoring and supporting this special occasion.

The evening began with a presentation of the recently-released results of the iPrEx Open Label Extension (OLE) study by Dr. Robert Grant—protocol chair of iPrEx and iPrEx OLE. The iPrEx trial, which published results in 2010, was the first clinical trial that proved that daily oral Truvada was safe and effective for HIV prevention for gay and bi men and transgender women. The iPrEx study, along with the results of the Partners PrEP study (PDF of results) in Africa, provided key data that led to the FDA approval of Truvada for PrEP in July 2012. iPrEx OLE enrolled previous iPrEx participants and other volunteers who had participated in previous blinded PrEP trials. Study participation was 72 weeks and all HIV-negative participants were offered the choice to take PrEP or not, in addition to receiving the standard package of HIV prevention services, including HIV testing and counseling, provision of condoms and lube, and STI testing and treatment.

The OLE study sought to answer the question: If barriers to obtaining Truvada for PrEP were removed, who would be interested in using it? The study found that most of the individuals who wanted to continue taking Truvada were those whose sex practices may put them at risk for acquiring HIV. Additionally, better adherence to PrEP was associated with greater protection from HIV. There were no HIV infections in individuals with drug levels in blood consistent with taking Truvada at least 4 times a week, and partial protection seemed to be offered by 2-3 doses per week. In other words, adherence needed to be relatively good, but not perfect. To further examine the frequency of taking Truvada and adherence, Dr. Grant is also working on HPTN 067, also known as the ADAPT study (Alternative Dosing to Augment PrEP Tablet use). The ADAPT study is examining intermittent (non-daily) PrEP use in order to understand the feasibility (but not efficacy) of using PrEP before and after sex.

At the San Francisco City Clinic, the PrEP Demonstration Project in the U.S has been in progress and the Co-Principal Investigator, Stephanie Cohen, joined us to provide some background and preliminary results of what the roll-out of PrEP may look like in the “real world,” i.e. outside the setting of a clinical trial. The PrEP Demo Project is an open label study taking place at municipal STD clinics in San Francisco, Washington D.C., and Miami, Florida. The Demo Project is hoping to identify what situations might prompt people to go on/off PrEP, what retention of those that do decide to take PrEP is, and what PrEP adherence looks like in a non-trial setting. Additional questions the study is seeking to answer include whether and how people on PrEP change their sexual behaviors and how feasible it is to deliver PrEP in the setting of an urban, public health clinic. Overall, there was high PrEP uptake across racial and ethnic identities, education, and socioeconomic status. Individuals who reported more risk practices have been more interested to enroll and those who declined often stated that they did not have time to participate in the study. Enrolled participants expressed a variety of reasons for taking part in the study, but most commonly individuals reported: 1) wanting to feel more protected during sex, 2) altruism or wanting to help the community, or 3) being in an HIV sero-discordant/magnetic relationship.

Likening the future of PrEP to the variety of contraception options available to women, Bridge HIV’s own Dr. Albert Liu presented current and upcoming research which showcase new directions for PrEP that could serve as an alternative to, or be used in tandem with, oral Truvada. For example, MTN-017, is a study looking at whether a rectal gel containing tenofovir (one of the medications in Truvada) is a safe and acceptable form of PrEP for men having anal sex. Since the gel, also known as a microbicide, is applied rectally, it delivers high levels of the drug to targeted areas and could reduce potential side effects, as less is absorbed into the bloodstream. The study is currently enrolling gay and bisexual men and transgendered women at 8 sites around the world. Dr. Liu also announced the upcoming study, HPTN 077, which will be testing the safety and tolerability of a long-acting injectable form of the anti-HIV drug cabotegravir as PrEP. The injectable—if effective— would have a longer lasting effect in the body and could therefore be taken less frequently, perhaps every 3 months. To start off, enrolled participants will take an oral version of the drug to ensure tolerability in each individual and then, once safety is established, participants will begin a series of 6 injections.

In addition to highlighting the future directions of PrEP, Dr. Liu described current, ongoing studies that are helping us to understand more about measuring levels of anti-HIV medications in the body, and whether that can help predict adherence. For instance, DOT-DBS, which stands for Directly Observed Therapy- Dried Blood Spots, is a study enrolling individuals at very low risk for HIV who will take oral Truvada according to different weekly regimens and will have their DBS and hair tested to measure the level of medication found in the body. A similar study taking place at UCSF is also measuring Truvada levels in hair samples of participants. Finally, Dr. Liu revealed a study which will launch in early 2015 that will examine the safety and pharmacokinetics of a vaginal ring for PrEP. Stay tuned for updates and information.

PrEP Demonstration Project Program Coordinator—Robert Blue—discussed the current state of accessing PrEP in San Francisco. Currently, many people trying to access to PrEP in San Francisco are facing barriers to do so, with regards to health insurance plans which may not cover Truvada, or which require a high co-pay for the drug. Blue highlighted an important resource that may help folks trying to access PrEP—the Gilead Patient Assistance Program, which is a resource provided by the manufacturers of Truvada which assists eligible, HIV negative, adults who do not have health insurance or are in need of financial assistance with the prescription co-pays. Blue also mentioned that, due to the need and desire expressed by individuals in San Francisco, City Clinic, along with Magnet, San Francisco AIDS Foundation and Ward 86, have engaged in a conversation to coordinate efforts to have the City help with access to PrEP.

Before opening the floor to questions, a participant of the Demo Project at San Francisco City Clinic took the stage and explained his journey towards becoming a study participant and taking PrEP. He expressed that the conversation around PrEP must be extended to those who are living in smaller towns across America, where access to PrEP may be even more limited, so that awareness can become universal. Questions asked by the audience ranged from the political landscape surrounding PrEP to the competency health care providers in the Bay area should possess in order to properly prescribe PrEP. Dr. Robert Grant responded to the former by explaining that, depending on the administration in office, topics involving sex and HIV can become a “political football”. He does, however, remain hopeful that San Francisco can be one of the first to reach zero new HIV infections. In regards to the latter, it was said that there will soon be a hotline for healthcare providers to consult on the topic of PrEP. Additionally, with matters of health care and medical innovations, it is frequently the case to see progress begin from the bottom-up; that is, from the patient to the provider to the institution. No matter what route PrEP takes, the panel’s speakers are committed to providing support, in any way they can, to the roll-out of this effective strategy.
Written by: Rafael Gonzalez and Hailey Gilmore