Last week, a scheduled interim analysis from the UK PROUD study found that daily oral pre-exposure prophylaxis (PrEP) with TDF/FTC (Truvada) to be “highly protective against HIV for gay men and other men who have sex with men in the UK.”

The announcement of these results was quickly followed by articles in the two UK newspapers: the Independent reporting that the study had “dramatically sped up” plans for the NHS approve PrEP, while the Daily Mail reporting that “NHS England have set up a group looking into the viability offering Truvada.”

The NHS is the world’s largest publicly funded health service providing free care for anyone who is a UK resident. The next step for TDF/FTC as PrEP would be “adoption” by the NHS, which would make this strategy available to all UK residents via programs subsidized and staffed by the UK government health service. This adoption process has no equivalent in the US or elsewhere, including Africa, where multiple different agencies advise, control and fund healthcare. For example, in the United States, the Food and Drug Administration approved a prevention indication for TDF/FTC and the Centers for Disease Control and Prevention has recommended it, but availability is via private insurance, Medicaid and demonstration projects.

Now both countries could be at the forefront of delivering PrEP through very different health systems.

The possibility for this PrEP strategy in the UK is a welcome advance, especially to those following the PrEP discussion in Europe. Until now European governments and agencies have been slow to consider PrEP. Earlier this year, two days after their sister agency in US issued guidelines on PrEP use, and a few months before that the WHO endorsed PrEP for MSM and discordant couples, the European Centre for Disease Prevention and Control (ECDC) issued a brief cautionary comment on PrEP. The WHO strongly recommended men who have sex with men be offered tenofovir-based oral PrEP. The ECDC comment in contrast vacillated, articulating questions about cost and concerns about side effects, potential for drug resistance and condom migration that experience and research have shown so far to be of manageable or minimal impact.

For those interested in seeing whether PrEP might work in Europe, the ECDC guidance was interpreted as European ambivalence or hostility toward PrEP. The ECDC statement was the first normative guidance since the 2012 European Medicines Agency (EMA) guidance, and one could be forgiven for thinking that Europe would be very, very late to PrEP, if they arrived at all.

Despite the tone of ECDC comment, the PROUD study could trigger real action. There is even some cause to believe that Europe could overtake the United States in PrEP implementation.

Europe needs PrEP. Europe has a major epidemic among gay men and other men who have sex with men. Recent data in Western and Central Europe shows that the number of HIV diagnoses among gay men and other men who have sex with men increased by 33% between 2004 and 2011.

But PrEP requires integration into primary care systems, and many European countries have good health system infrastructure. One of the key challenges of PrEP uptake in the United States is developing systems and educating providers to deliver PrEP. Several European countries have that infrastructure and payor systems integrated into those structures already.

Cost is the principal objection to PrEP, and Truvada’s patent is good only until 2021 in the US but 2018 in Europe. So this PrEP strategy could go to generic pricing in Europe three years earlier than the US.

European advocates are organizing. Early advocacy is already happening in France, Germany and the United Kingdom. At the Melbourne AIDS conference in July, advocates from Belgium, France, Italy, Germany, Greece, Netherlands, Portugal, Spain and United Kingdom met to discuss the state of PrEP implementation in their countries. There, the consensus was that not much was happening on PrEP in Europe. But now, things may start to change.

Europe wasn’t involved in the early PrEP efficacy trials, but the interim results from the PROUD open label study validated the protective effect of a daily oral PrEP strategy provided in the context of comprehensive HIV prevention. At the same time, the recent news from PROUD raises questions about the future of IPERGAY, an ongoing placebo-controlled trial that is designed to test if oral TDF/FTC for PrEP taken on an intermittent or ‘on demand’ basis (as compared to daily use in the other studies) reduced risk of infection among gay men and other MSM. The trial is currently ongoing in France and Canada and may also expand to Germany.
Advocates on both sides of the Atlantic have questioned the use of a placebo arm in IPERGAY since the FDA approved daily Truvada for prevention last July. As French and other European regulators, however, have yet to approve the use of Truvada as PrEP, therefore it is not currently available for prevention, only treatment. In a recent discussion of the PROUD results, IPERGAY investigators indicated that the trials independent data review board would be communicating with the analogous body for the PROUD study to share confidential information about the trial data. This step could lead to changes in the IPERGAY protocol.

Efficacy data are one piece of the PrEP puzzle. Acceptability and perceived benefits are also key—though harder to measure. Here, too, the data from daily PrEP are promising. At the Melbourne Conference, Kimberly Koester presented on people’s experiences taking PrEP in the iPrEx OLE study. The most striking finding was not the absence of condom migration. It was that fear before, after and during sex was a part of these men’s lives:

“So, in general, the anxiety, the HIV anxiety, is gone. I won’t say it’s gone-gone. But it’s not in the front of my head as it used to be, where I was obsessively worried about it while sex was happening.”

Losing that fear is a message that will resonate in Europe, and sooner than we think.

Sex workers have begun to speak out about PrEP’s utility, educating their own communities about its benefits and challenges. Below is a PrEP primer targeted to those in the sex trade, written by AVAC PxROAR members Lindsay Roth and Cassie Warren. (PxROAR is an AVAC advocacy program to support research and uptake of biomedical HIV prevention.) Lindsay sits on the Board of SWOP-USA (Sex Workers Outreach Project) and founded SWOP-Philly, a collective of sex workers and allies. Cassie enrolls young people in health care and provides pleasure-centered sexual health education with linkages to PrEP and PEP at Broadway Youth Center in Chicago. The original article is available on Tits and Sass.

So you’re telling me you can take a pill to prevent HIV?

Yup. We believe that if done right, PrEP has the potential to be one of the best tools brought to market for receptive partner protection and power since the pill in the 1960’s. PrEP doesn’t double as a contraceptive, but it does reduce your risk of HIV by 90% when taken correctly. It’s still a sweet tool to have in your make-up bag, hard femme box, tool kit, whatever you call it. We are still in the middle of an epidemic, with trans and cis women, men who have sex with men, and injection drug users still being hit hard and unjustly. We deserve to have access to all the options that protect us against HIV.

In what follows, we’d like to lay out the basics of PrEP (no really, what is it? does it cost the first month’s rent?), add context to some of the controversies, and offer our take on what this means for sex workers. We do not anticipate that we’ll be able to answer all the questions people have in this one post, and we hope that you will comment or reach out to us directly if you’d like to know more.

What the heck is it?

PrEP stands for Pre-Exposure Prophylaxis. The main part to note here is “pre,” implying treatment before exposure. In this context, we are talking about exposure to HIV (Human Immunodeficiency Virus). So, PrEP is a medication an HIV-negative person would take to prevent them from becoming positive. Currently, Truvada is the only form of PrEP approved by the Food and Drug Administration.

Truvada is an NRTI (nucleoside analog reverse transcriptase inhibitor) which is just a fancy name for an HIV medication. It has been used to treat HIV since 2004. We used to know HIV as the virus that caused AIDS, and knew AIDS as a death sentence. However, because of advancements in the treatment of HIV, positive folks can live long, healthy lives. Folks can even be positive, on treatment, and unable to transmit the virus to anyone else. Recently the medical establishment stopped giving AIDS diagnoses: Because of new treatment options people can be at various stages in their HIV diagnosis, and we now classify HIV as stage 0, 1, 2 or 3 HIV.

Many readers may be familiar with PrEP’s sibling, PEP, or post-exposure prophylaxis, the use of antiretroviral drugs—ARVs (again, a fancy name for HIV medications)—to mitigate the risk of HIV transmission after a potential exposure. Any doctor can write a prescription for PEP, most Medicaid programs pay for it, and Gilead, the large research based pharmaceutical company which makes Truvada, has a patient assistance program to cover the the costs for the uninsured or underinsured, regardless of immigration status.

To summarize, PrEP vs. PEP:

• Truvada as PrEP is taken before an exposure to HIV, specifically one pill a day, every day.
• PEP is taken after an exposure to HIV, specifically within 72 hours, and consists of 30 days of full-regimen HIV treatment medication.
• Both prevent you from acquiring HIV.

How does PrEP work?

The rationale behind PrEP is based on the way most doctors are treating HIV-positive individuals with ARVs. Truvada is a combination of two medications, tenofovir and emtricitabine. If HIV is presenting itself in one’s body, this medication blocks the replication of HIV in the body. Doctors currently prescribe one pill a day, as the medication must be present in the body to do its work. However, there are trials underway to test the efficacy of other ways of taking PrEP. So far, the results of the iPrEX OLE (open label extension) say that if you take it 2-4 times a week you are protected 85% of the time against HIV, and if you take it 5-7 times a week, you are protected 99% of the time against HIV (not other STIs or pregnancy). If you take it less than 2 times a week you have zero protection.¹

Can I take it right before I meet a date?

No. PrEP acts like a full metal jacket around your T-cells, so if HIV is introduced to your body it can’t get into the cells it wants to infect and replicate itself.² It takes about seven days to make this metaphorical metal jacket around the cells in the rectum (drugs taken orally are absorbed quicker in the digestive track), and about 20 days to make a metal jacket around the cells in the vagina (our apologies if you call your junk something else) and in the bloodstream. So, for full protection, you’d need to be taking it every day for a week before you’re protected during anal sex, and every day for three weeks before you are protected during vaginal sex or during any activity in which you would share blood (e.g., sharing needles for tattoos, hormones, drugs, piercings, etc.).

Talk nerdy to me.

There have been several trials on tenofovir-based prevention modes. This includes pills, like Truvada (which again, also contains emtricitabine), but also gel forms, called microbicides. There are campaigns for vaginal and rectal microbicides as another PrEP option to reduce HIV transmission.³

There have been four trials that found PrEP to provide protection from HIV in sexually active men and women (Partners PrEP, TDF2, iPrEX), as well as men and women who inject drugs (Bangkok Tenofovir Study).⁴

Even with great data coming from these clinical trials showing that “if you take it, it works,” there are some folks against it. Media coverage on PrEP often cites the FEM-PrEP and VOICE trials, which were done specifically on cisgender women with no success. Without writing a whole separate post about these studies, we’ll summarize by saying that the adherence of the women enrolled was too low to determine if the medication was effective, and analyses of these studies are currently being completed. Essentially, the researchers didn’t consider some important factors about cis women (who’s surprised?) and they were not able to gain any reliable data because the women enrolled in the study were not taking the drug enough to collect any data on if it was actually working or not.

The PrEP studies that showed efficacy (reliable data that it works) were inclusive of cis men and women and some transgender women and were conducted both in the US and abroad (mainly in African countries). There is, however, a dearth of data on how PrEP impacts US cis women, as the only domestic study was the iPrEx study that focused on MSM and transgender women. The US Women’s Working Group on PrEP has been working hard to bring awareness to this issue. We believe that if done right, PrEP has the potential to be one of the best tools brought to market for receptive partner protection and power since the pill in the 1960s. And while (right now) PrEP doesn’t double as a contraceptive, protecting against HIV even 85% of the time (for those at the lower end of adherence) is still a sweet tool to have in your make-up bag, hard femme box, tool kit, whatever you call it. We are still in the middle of an epidemic, with trans and cis women, men who have sex with men, and injection drug users still being hit hard and unjustly. We deserve to have access to all the options that protect us against HIV.

What are the side effects or collateral consequences of PrEP?

Truvada’s most common side-effects are nausea, headache and diarrhea, however these wane over a few weeks- or at least that’s what a handful of the clients I see experience, but some don’t experience side effects at all. Truvada can be tied to small decreases in kidney function but these are temporary and stop when PrEP use is stopped. Regular kidney monitoring is recommended with Truvada as PrEP. All follow up studies on kidney impact have shown that for the folks who did have problems with their kidneys, it wasn’t life threatening, and after a couple of weeks those folks chose to go back onto Truvada. Thinning of bones is another more serious side effect. This too is not so common but needs to be monitored for.

Additionally, Truvada is considered the backbone of all modern HIV-treatments and millions of individuals living with the virus take it as a life sustaining medication every day with non-life threatening side effects. As of June17, 2014 over 164 leading HIV/AIDS organization and 132 individuals signed on to reiterate their support of PrEP under the 2012 CDC guidelines. There is indeed great concern over the long term impact of PrEP, and it is too soon to tell what that may be. Anecdotal testimony from bloggers like this indicates that they have been healthier while on PrEP and that it provides motivation to stay on top of their health through regular testing and doctor visits. Although for us, the idea of clinic visits does send up red flags.

What strikes fear in my little junkie-hooker heart is just how much you have to interface with healthcare professionals to get on PrEP. I don’t think I could personally stand the potential shaming involved. Plus, lots of non-HIV specialized providers don’t even know what PrEP is. That’s why it’s important to find a good provider, which we know can be difficult, especially depending on where you live. Message us if you want some support with finding a provider or with getting materials together to bring to your provider about PrEP.

What does the process of obtaining the pills from a (knowledgeable) provider look like?

At the clinic I work at, it involves two appointments before you have the prescription in hand, then follow up every month for the first two months, then every three months (though every provider is different). The reason it’s every three months is because it’s important to test for HIV while on PrEP. This will prevent drug resistance if someone has acquired HIV.

During the first visit, you’ll talk about why you want to be on PrEP—they’ll ask you questions about your sexual practices and your drug use to assess your level of risk. If you don’t want to out yourself as a sex worker or an IDU, you could say you are in a monogamous relationship with a person who is HIV positive and you want to have an added layer of protection.⁵ You and the provider will have a discussion about what being on the medication looks like. Then they will take four small tubes of blood. Why all that blood? Folks on PrEP are monitored through regular HIV-testing and testing of the kidneys, liver, and other vital organs. During the second visit, when the results of your blood work are back (usually a week), you’ll discuss those results with your provider and then they will write you a prescription. Again, at the start, some providers may write the first prescription for one month, and then if PrEP works for you and your vitals come back normal after the first month, they’ll move to three month prescriptions.

How do I pay for PrEP?

There are a number of ways to obtain PrEP. Truvada is already covered by most private insurance plans and Medicaid. For folks with high co-pays or who are undocumented/uninsured, Gilead has two patient assistance programs to cover drug costs. PrEP will be more accessible if you go to the folks who know about Truvada as PrEP and are willing to prescribe it, which are typically HIV clinics, or clinics with a HIV, LGBT, or a community health focus.

So why should we care?

Some of you reading this may never have considered PrEP, and some never will. Which we totally support—we’re not trying to hustle to get everyone on PrEP, nor are our broke asses getting pharm money. We just want folks to know what options they do have to reduce risk, and to have some of the political framing; it’s always political. PrEP gives us an opportunity to advocate for sex workers’ rights. And I know we don’t always agree, but even with our different approaches PrEP still provides a lot of leverage and legitimacy, especially in the current HIV climate. The conversation about biomedical HIV interventions is not going away, and regardless of individual opinion, the folks at the top are still lumping us all into one category and labeling it “high risk” or “key population.” Meaning, they are going to target us, or in a more strategic move for us, they are making us a priority. If they’re making us a priority “to address” us as a “key population,” we should be at that table.

In other countries, especially where different legal frameworks allow sex workers to be more visible, PrEP is being studied specifically on sex workers. NSWP (Global Network of Sex Work Projects) has responded to this practice with several pieces that acknowledge the potential risks and benefits of PrEP for sex workers. The articles make it clear that sex workers need access to knowledge about PrEP, as well as engagement in policy and related programming.

In our opinion, in order for biomedical interventions to successfully impact sex worker communities, they must address two main concerns: The general disparities that sex workers experience in medical settings and the need for expanded access to biomedical interventions like PrEP in clinical settings.

There are several ways in which medical communities can better serve sex workers:

1. Sex workers must be at the table.

When it comes to HIV prevention in the sex industry, sex workers know best. Our insight is one of the medical community’s greatest assets as we develop effective interventions. Sex worker-led organizations from the global to the grassroots levels have been stakeholders in reducing HIV transmission by ending the stigma and criminalization of sex work. Domestic medical providers can consult with local sex worker-run organizations or “Pros Networks,” create advisory boards, hire current and former sex workers as staff, and work to include participant input in their programming. Creating a space for sex worker advocacy will create better interventions.

It should be noted that the sex industry is large and diverse and not all individuals engaged in sex work or survival sex work will identify with those terms. It is important that organizations create a safe space free of judgment, criminalization, or diversion, where individuals who trade sex feel safe self-identifying and self-advocating.

2. More US-based participant informed research about sex workers

Good data on sex workers is scarce, especially in the US, largely due to the criminalized nature of sex work here. Participant-informed research will encourage sex workers to feel safe participating in studies that can better articulate the landscape of sex work in the US As we well know, sex workers have many other needs beyond HIV-related ones. It is our recommendation that in order to encourage interest and buy-in, biomedical prevention must be packaged in with other needs articulated in a patient-centered practice. Again, patient-centered practices are best achieved with the institution of safe spaces. These should be combined with holistic, harm reduction oriented outreach, which has historically been successful at reaching the most marginalized of sex worker communities. Furthermore, we must consider more broadly what access to PrEP means, not only for sex workers, but for many populations marginalized by the medical community.

3. Expand mobile testing to make PrEP more accessible.

There’s a paradox involved in making PrEP available to especially marginalized populations who may not engage medical care because of stigma, unique logistics, or both: Providers who have the legal ability to prescribe PrEP (e.g. MDs, CRNPs or PA-Cs) oftentimes do not have adequate practice settings (logistical accessibility, adequate harm reduction counseling skills, opportunities for routine follow up and monitoring), whereas those providers who do have access to relevant patient populations, viable logistics, lower cost of services and likelihood of patient engagement (i.e. community based testing sites staffed by licensed HIV testers, nurses, and/or social workers) do not typically have staff present to prescribe this medication. This means that PrEP is not reaching the populations who stand to benefit the most from it, including sex workers and survival sex workers.

There are several things that medical providers can do to facilitate PrEP access. PrEP could become more accessible to clients if clinics considered changing their logistics. For example, clinics could stay open later or help with transportation, create safer spaces by using affirming language (e.g. appropriate gender pronouns) and staff the practice with representatives from the populations they wish to serve (for instance, hiring transgender testers to work with a transgender population). Mobile testing units have been successful domestically in testing individuals,⁶ and this model presents an opportunity from which we can deliver other interventions, including PrEP.

There are a number of possibilities that would increase awareness of PrEP in sex worker communities, a community that has historically been met through outreach efforts. Mobile testing units literally “meet people where they are” and help remove barriers from engaging in care. This model of HIV testing could be a realistic way to meet individuals who are lost to medical care but who could benefit from PrEP as a prophylaxis and a re-engagement tool.

Most medical sites would require a more robust staff. Staff providers able to write for PrEP would be necessary, as well as social workers or trained peer workers who could help individuals enroll in insurance or patient assistance programs, and discuss risk reduction. Expanding prescribing authority to nurses for Truvada is another option that would allow low-cost interventions to meet the needs of individuals who may work in nontraditional settings, such as sex workers.

Time will tell what PrEP, microbicides, or even an HIV vaccine will mean for sex workers. What we can expect is that policy makers and HIV service providers will continue to target domestic sex workers as “high risk” and “key” populations. And we should be PrEPared (see what I did there?) with the facts about these interventions so we aren’t always on the defense, but can have a seat at the table to advocate for what we think PrEP should mean for sex workers.

We can use the dialogue being generated by policy makers, the medical community and the media around biomedical HIV interventions, like PrEP, to push a comprehensive and intersectional agenda around sex worker health and safety. We all know that criminalization is what renders sex workers “high risk,” and interventions like PrEP do not mitigate this. However they do give us a legitimate platform to discuss these issues with policy makers, scientists, and healthcare workers.⁷ And, this is buzzing so hard in the HIV movement right now—lots of national and international organizations (Amnesty, the World Health Organization) are making recommendations for countries to decriminalize sex work. Of course, we’d like more discussion of anti-criminalization, but starting the PrEP conversation means getting invited to other dialogues. And there is an opportunity here for some strategic moves. If you’ve got ideas, we’d love to hear them. If you want to know more about PrEP for your possible personal use, please reach out. We both are available to respond to comments and hope this information helps answer questions about PrEP, as well as provoking more discussion.

¹www.aidsmap.com/Overall-PrEP-effectiveness-in-iPrEx-OLE-study-50-but-100-in-those-taking-four-or-more-doses-a-week/page/2892435/

² Check out a video that illustrates this process here.

³ We both work with an organization, AVAC, which is tracking research on PrEP. You can find great information at www.avac.org/prep/track-research

⁴www.avac.org/prep/track-research

⁵ Also, here is a list of the CDC guidelines for providers and there is now a hotline for providers to get information.

⁶ In Philly, for instance, there has been great success in testing through these measures.

⁷ Additionally, Michael Weinstein for AHF (AIDS Healthcare Foundation), yes, that same guy who is trying to get condoms in porn, is at it again, using PrEP as a battleground for his respectability politics. He believes the only HIV prevention that should be used is condoms, an option which is not feasible, accessible or even desired by all. There is a petition for his resignation.

Today the leaders of the PROUD study of daily oral TDF/FTC (brand-name Truvada) for PrEP among gay men and other MSM in the UK announced that the trial protocol would change due to early evidence of effectiveness. The study’s official statement said, in part, “Interim analysis of the PROUD study data has shown that pre-exposure prophylaxis is highly protective against HIV for gay men and other men who have sex with men (MSM) at high risk of infection. On this basis, the PROUD Steering Committee has announced that participants currently on the deferred arm of the study, who have not yet started PrEP, will be offered the opportunity to begin PrEP ahead of schedule.”

The specific data on rates of HIV infections, PrEP adherence and risk behaviors that guided this decision were not made available. However, based on what has been released, it is clear that this is welcome news that confirms, once again, that this PrEP strategy works when it is taken correctly and consistently. It is also clear that rates of HIV infections among PROUD participants were higher than the study had originally anticipated. The number the team had anticipated at this stage in the trial would not have been sufficient to generate a conclusion about effectiveness. The study is thus also a grave reminder that comprehensive health care, including HIV prevention and treatment still isn’t reaching all gay men and transwomen who need it.

PROUD’s original design called for a two-phase investigation: A 500-person pilot study, scaling up to a 5000-person trial. In the pilot, which launched in 2012, half the participants were randomly assigned to receive daily oral PrEP immediately, along with a comprehensive prevention package including access to post-exposure prophylaxis (PEP). The other half were assigned to a deferred arm that would receive the comprehensive prevention package for 12 months and then be offered the opportunity to initiate the PrEP strategy. This two-arm design also would have been used in the expanded, second phase of the study.

This announcement came after a scheduled review of the data by the trial’s independent review body (the Independent Data Monitoring Committee, or IDMC). As a next step, the PROUD team has developed and submitted a protocol amendment that would allow all of the participants, including those in the deferred arm, to receive PrEP. They have also begun the process of calling participants back to inform them about the trial data. Right now, the UK National Health Service does not cover TDF/FTC for PrEP. Once the protocol amendment is approved, all PROUD participants will have access to PrEP. Additional steps, including analysis of all the data, will lead to NHS consideration of PrEP as public health tool.

One key question is: What does the development with PROUD mean for IPERGAY, a study of an intermittent PrEP strategy using TDF/FTC (that is also enrolling gay men and other MSM? IPERGAY is placebo-controlled, meaning that participants do not know whether they are receiving the active drug or an inactive pill. IPERGAY has been under some degree of scrutiny for its placebo-controlled design since it launched after the iPrEx trial which found efficacy among gay men, MSM and transgender women with once-daily dosing. The trial team has defended the design, in part by pointing out that IPERGAY was testing a different dosing strategy. With additional evidence of efficacy from PROUD, this placebo-controlled design needs to be re-examined once again. IPERGAY investigators have indicated that the PROUD and IPERGAY DSMBs will be communicating in the near future to share information and generate a recommendation for the IPERGAY protocol.

AVAC will be following developments and providing updates as more information becomes available, please watch the blog and also check out our resources on avac.org/prep and prepwatch.org. We congratulate the PROUD team and recognize with gratitude the commitment and contributions of all of the trial participants.