Season of Risk
Austin's HIV rate is on the rise, again. Can a "miracle drug" reverse the trend?
Nelson, a genderqueer 27-year-old, made a choice last year. Having spent six months working as an HIV tester and outreach coordinator at a local clinic, Nelson, whose last name was withheld by request, was well-versed in safer sex and harm-reduction practices. Then, after attending a conference in the fall of 2014 on the current state of HIV, where speakers discussed the new use of HIV medication Truvada as a pre-exposure prophylaxis (PrEP) against HIV, he decided it was time to get a prescription.
In comparison to AZT – the first HIV antiviral medication approved by the FDA in 1987 – Truvada is being hailed as a miracle drug. Known as a "combination therapy," two medications make up Truvada, which is used in conjunction with additional drugs to fight against the HIV virus. While the original cocktail of the Eighties is now referred to as an early antiretroviral therapy (ART), Truvada is part of the more complex and effective HIV medications known as HAART – highly active antiretroviral therapy. When used in conjunction with one or two other medications, Truvada substantially reduces the virus' progression to AIDS and even death by blocking its ability to replicate within the body.
"Currently, Truvada is the most-prescribed backbone for combination HIV antiretroviral therapy," says Ryan McKeel, the spokesperson for Gilead, the pharmaceutical company behind the drug. And while side effects are still present, they are much less severe. In addition to more efficient drugs for people living with HIV, PEP, or post-exposure prophylaxis, has been available and recommended by the Centers for Disease Control and Prevention since the early Aughts. Taken like the morning-after pill, PEP helps block the virus from taking hold in a non-infected body.
Truvada as PrEP (pronounced "prep") has been on the market since 2012, when the CDC approved it as a prophylaxis. In short, Gilead had accomplished what once seemed impossible. When taken daily by an HIV-negative person, PrEP is 99% effective in blocking the transmission of HIV – a disease that has killed more than 39 million people worldwide since the epidemic began in 1981. Today, the CDC, FDA, and, more locally, the Texas Department of State Health Services recommend PrEP in the fight against HIV. However, here in Texas, finding information on PrEP – let alone procuring a prescription – isn't especially easy. A Google search leads to a lot of dead ends, yet Austin/Travis County Health and Human Services Department Medical Director Dr. Philip Huang says that multiple clinics and physicians here in Austin can and will write qualified patients prescriptions for PrEP. ("Qualified patients" are defined as HIV-negative, hepatitis B-negative people who engage in "high-risk" behavior – that is: 1) are gay, bi, or men who sleep with men; 2) have multiple partners of unknown status; 3) use injection drugs; or 4) are in a sexual relationship with an HIV-positive person.)
Fresh from the conference and feeling empowered, Nelson made an appointment with his doctor at the Austin Regional Clinic. This was not his first visit. In fact, the doctor knew Nelson to be an informed member of the LGBTQ community, who openly sleeps with both men and women. But when Nelson requested a prescription for the HIV-blocking drug, his doctor refused.
"The first thing she said to me was, 'Well, there's a lot of syphilis out there,'" Nelson remembers. "At first I couldn't believe it. Like, I know syphilis is on the rise in Austin, but that wasn't what I was there to talk about. I got into it with her for like 20 minutes – I was really upset. In the end she denied me [a prescription for PrEP]."
When asked about Nelson's story, a spokesperson for ARC wrote in an email to the Chronicle, "We have a handful of doctors right now who prescribe PrEP. They include our providers who specialize in HIV and AIDS care .... The reason is because this is a brand new drug with new and complex protocols. It is not as simple as filling out a prescription and sending it to the pharmacy. Any provider who prescribes this new prophylaxis must learn the new protocol and if a provider does not have a patient base with this need, it is unlikely the provider will find a need to learn the extensive protocol required to prescribe it. As the demand for this increases, I am sure we will find more providers will prescribe it.
"Our doctors would not have 'denied' access to this drug .... It is our policy to refer patients to other doctors who can provide any services that we do not currently offer. It can be another doctor at ARC or outside of ARC."
Nelson says that his doctor did finally agree to give him a referral to another doctor who would prescribe the prophylaxis, but instead of writing the referral for him before he left her office, she said she would send it by mail. Weeks later, he received it, and unfortunately it came too late. In February, four months after his appointment and two months after he began to feel sick, Nelson tested positive for HIV, just three days before his 28th birthday.
"I'd been dating a guy who lived in Houston for several months. I guess he was having sex with other people and I didn't know about it," says Nelson with a pause. "For weeks after I was so angry. I had dreams every single night about her telling me 'no.' I'd wake up shaking. This could have been avoided if she had not decided to do this."
HIV Makes a Comeback
It's no longer breaking news that HIV is once again on the rise. The CDC estimates that more than 1.2 million people in the U.S. are living with HIV, and approximately 14% of them are unaware of their positive status. As of 2012, in the greater Austin area alone, 5,084 individuals are living with HIV – a number that has increased by 40.6% between 2006 and 2012. From Dr. Huang's latest data, 88% of the 815 new HIV cases from 2010-12 were male, and 75% of those cases were men who have sex with men. Though those numbers are several years old, Dr. Huang confirms that they're the most up-to-date in Texas, as he has yet to run more recent statistics.
"The number of people living with HIV has definitely increased," says Dr. Huang, "which is a mixed message. Clearly it means people are surviving more, but also new infections are on the rise." The numbers don't stop with HIV. Chlamydia, gonorrhea, syphilis, and HPV are also on the rise. From a 2013 report released by the county health department in the Travis County Medical Society Journal, 62,000 new sexually transmitted infection cases were diagnosed in Travis County in 2011. "The high incidence and overall prevalence of STIs in our community suggests that many residents are at substantial risk of exposure to STIs, underscoring the need for STI prevention," explains Dr. Huang.
At Travis County Health and Human Services, much of the work gets done behind the scenes. Along with supporting testing and safer sex education, Dr. Huang's office also follows up with positive patients and runs contact tracing – identifying the patient's previous partners to notify them of possible contraction. "Getting people into treatment as quickly as possible reduces the viral load, which is a form of prevention," Dr. Huang says. "We're also trying to address some of the complacency we're seeing here in the community."
Paul E. Scott, the executive director of AIDS Services of Austin, agrees that complacency is a growing issue in Austin, specifically within the gay and bi male communities. "It's a growing concern of ours – why are we seeing it in a population that grew up with the knowledge of HIV?" Scott also adds that young, gay men are the most at risk for HIV infection. ASA's Kanaka Sathasivan notes that "59% of new infections are in people younger than 35, and the majority of these are gay or bi men."
The rising numbers has caused a stir of concern among prevention workers who are dedicated to halting the uptick. ASA is one of several organizations within Travis County that will help high-risk individuals access PrEP. "When used correctly, PrEP is a very viable option for gay and bi men who want to protect themselves against HIV," explains Scott. "It's also a great option for men (and women) in committed relationships where one partner is living with HIV and the other partner is HIV-negative. It is critically important that all HIV prevention options be made available to any at-risk person."
Of course, to use PrEP correctly a client must adhere to taking one pill daily during a "season of risk." Most advocates for the prophylaxis recommend taking the drug when experiencing "seasonal" episodes of high-risk encounters, meaning one can go on PrEP for several months at a time, stop, and then start up again a few months later. However, PrEP does not immediately protect the user after swallowing that first pill. For people engaging in anal sex it takes seven days to be effective, but for those engaging in vaginal sex – or any other activity where sharing blood is involved, such as using injection drugs – PrEP takes 20 days before it protects against HIV.
Once PrEP has built up its armor around the cells susceptible to infection, it is 99% effective in preventing the contraction of HIV when taken daily. If the user begins to skip days, though, the effectiveness decreases significantly. "Efficacy for PrEP is just fantastic," says Ben Walker, the executive director of the newly certified nonprofit Austin PrEP Access Project (APAP). "When used correctly, it's more effective than condoms against HIV, but ideally it'll be used with condoms to prevent STIs [and pregnancy]."
In regards to side effects, it seems they are mostly mild, and happen during the brief "adjustment" period. Side effects can include mild diarrhea, nausea or stomach pain, dizziness, depressed mood, and/or strange dreams. Truvada also causes slightly decreased kidney function, although studies currently show that a patient's kidney function will return to normal once they discontinue use, and that PrEP does not affect overall kidney health. The CDC recommends that PrEP users receive follow-up testing (including monitoring of kidney function) and doctors' visits (every three months) for STI screenings. Last August, the AIDS Healthcare Foundation announced its concerns that people will fail to take the pill daily. If taken haphazardly, a patient could potentially not only contract HIV, but also develop a drug resistance to Truvada, which is commonly prescribed for people living with HIV. However, Walker assures that the likelihood of this is quite slim and does not outweigh the benefits of PrEP.
Founded by Walker and Marcus Sanchez, APAP opened shop in mid-December when the two men noticed Austin's growing need for a clinic well-versed in PrEP. Both men are veterans of the fight against HIV: Before starting APAP, Walker spent three years working and researching public health, including two and a half years as a case manager of ASA's Health Insurance and Medication Access Program, and Sanchez is a local graphic designer and digital marketer with four years' experience in the nonprofit world of HIV/AIDS awareness and sexual health promotion. "[Since its release] people have wanted to be on PrEP, they were excited about it, because people understand their own risky behaviors. But here in Austin they were having a difficult time finding answers," says Walker. "It's really important to have someone answer those questions. We want to be a one-stop for PrEP that's giving people two resources: doctors and copay information."
Some PrEP naysayers worry that the drug, which works like a contraceptive against HIV infection, will undermine the decades of advocacy work for condom usage. Yet studies show that a "high percentage of people don't use condoms a high percentage of the time," explains Walker. Instead of replacing condoms, PrEP offers high-risk individuals an additional layer of protection against a lifelong, life-threatening disease. And it's unlikely that adults who are currently using condoms routinely are going to throw away their safer-sex stash in favor of the pill. Instead, people who are less likely to wrap it up will now have an alternative – or additional – option with PrEP.
"This is not a PrEP versus condoms debate," says Walker. "They're like seatbelts and airbags: When I drive I don't stop wearing my seatbelt because I have airbags in my car. But I'm really glad that the airbags are there."
Though APAP began as navigation assistance, the donation-based organization has started to "roll out" a clinic as well. Their soft opening was Sunday, May 10, with a follow-up clinic Saturday, May 16, at Seton Medical Center. All interested parties were required to make an appointment ahead of time. Several local doctors, including well-respected HIV physician Cynthia Brinson, donated their time to aid APAP clients, and plan to continue to do so in the future.
San Francisco and Beyond
While PrEP is just starting to gain footing here in Texas, there are pockets throughout the country where the pre-exposure prophylaxis is easily accessible. Both New York and, more recently, Washington have instituted state-based PrEP assistance programs. In New York, Prep-AP offers drug and doctor reimbursement to all eligible parties; however, if the patient is uninsured, only the medication – not the follow-up care – will be covered. Washington's PrEP DAP allows interested individuals who meet three eligibility requirements to apply to its program. In December, Illinois announced a similar plan, but when Governor Bruce Rauner took office in February he halted all "nonessential" spending; APAP-like grassroots organizations are now popping up throughout the state to fill the void.
PrEP has also established a stronghold in California, particularly in San Francisco. Strongly affected by the first AIDS epidemic of the Eighties, the city has implemented through its public health department the three-pronged "Getting to Zero" plan, with the goal of being the first U.S. city with zero new HIV infections, deaths, or stigma. Aside from steps two (getting people diagnosed and into care early on in their infection) and three (keeping people in and connected to care) – both of which greatly reduce the risk of transmitting the virus – the San Francisco project has also become a major proponent of PrEP.
In late 2012, soon after CDC approval, PrEP Demonstration Project opened in San Francisco, D.C., and Miami. A community access program to provide Truvada to high-risk individuals, the Demo Project fueled a growing interest in the Bay Area. But City Supervisor Scott Wiener really shone a spotlight on the drug last year when he publicly declared that he personally was using PrEP. "His announcement popularized what was already a growing interest," sums up Derrick Mapp, a health counselor at San Francisco's Shanti L.I.F.E. Program, an "HIV self-management and life-enhancement program."
"PrEP is highly effective when used correctly and is the most powerful, cutting- edge tool to prevent getting HIV," says Mapp, "especially when used in collaboration with other sexual health methods, like seropositioning" (where people with differing HIV statuses, decide who is the receptive or insertive partner). "This is the most full-forward advancement in sexual wellness with regards to HIV prevention since the 'Use a Condom Every Time' campaign."
Getting to Zero's numbers back Mapp's assertion. The education about and the availability of PrEP in San Francisco have already helped decrease the city's transmission rates, says Walker. "You have to understand your own behaviors – what's risky, what's not, and then know what strategies we have. It's about expanding our education." Considering San Francisco's success, the Texas Legislature's most recent push for greater abstinence-only funding, which would reallocate money from HIV prevention work, is all the more dire. (See "Texas House Funnels HIV Funds to Abstinence Education," April 1.)
As is common in many HIV discussions, the conversation often tends to center around the LGBTQ community – specifically gay and bi men, transwomen, and men who sleep with men. However, HIV affects a much broader spectrum of society, including sex workers, though they frequently go unmentioned. Yet there is some discussion about the topic. According to Walker, the CDC recommends PrEP for commercial sex work (as well as for injection drug users – though Gilead's McKeel notes that PrEP is only 74% effective when taken daily by ID users), regardless of sex or gender.
In October, Lindsay Roth and Cassie Warren, both advocates for sex workers' rights and HIV prevention, penned a particularly informative essay for the blog Tits and Sass, discussing how PrEP could be a useful preventative tool for sex workers. "PrEP gives us an opportunity to advocate for sex workers' rights," they wrote, going on to point out that other countries are specifically focusing studies on the convergence. Yet, because obtaining a PrEP prescription requires fairly frequent visits to the doctor, it may be difficult for some sex workers to maintain a regimen, be it due to lack of access to health care or fear of "shaming" as Roth and Warren put it. However, Walker is committed to serving anybody and everybody who wants or needs information about PrEP.
"We're happy to help anyone," he states, specifically referring to sex workers. "There are no restrictions based on income, employment, or health insurance status." To that end, APAP has partnered with Austin Harm Reduction Coalition, a nonprofit that works to prevent HIV and hepatitis C in injection drug users. Together they're conducting street outreach in hopes of reaching people who might not hear about it elsewhere. Walker also clarifies that PrEP is definitively safe and approved for both cis and trans men and women, but it's still uncertain exactly how or if PrEP affects prescribed hormones. "It's pretty telling," says Walker. "If it was controversial or had a high level of risk, the CDC wouldn't recommend it so inclusively."
Paying for PrEP
Stigma is not the only potential obstacle to PrEP. There's also the price tag associated with Truvada. Without insurance, the medication rings up at approximately $1,500 per month. Fortunately, most private health plans will cover PrEP, and Insure Central Texas health care navigator Arianna Anaya confirms that Truvada is covered by every major plan on the HealthCare.gov Marketplace. However, the drug can still carry a hefty copay. That's where Gilead comes in. The company offers copay assistance of up to $3,600 a year toward a PrEP prescription.
"There are financial assistance programs to help with the costs of the medication and that can mitigate any medication co-pays," explains Scott, and APAP can help connect interested parties with that assistance. "What we do is help find copays available to meet that deductible," says Walker. "We never tell people what insurance they should have, but we can inform them of how insurance can best cover their PrEP prescription."
But if the first step is finding a physician willing to write a prescription, Walker says that despite what happened to Nelson, the prophylaxis does not require a referral and can be prescribed by any family doctor. In fact, he urges people to talk with their primary care providers about PrEP in hopes that the more demand doctors see, the less timid they'll be about prescribing it.
According to Dr. Huang, Austin Regional (where Nelson originally went) and the Austin Diagnostic Clinic both currently prescribe PrEP. However, don't expect the physicians at either Planned Parenthood or People's Community Clinic to jot down a PrEP prescription any time soon.
Sarah Wheat, the vice president of community affairs for Planned Parenthood Greater Texas, chalks up their lack of PrEP prescriptions to the lack of requests. "We don't provide Truvada, but most likely because we don't see enough patients that need it." It's unclear whether or not this will change if demand increases. Instead, Planned Parenthood informs people of the existence of PrEP, and refers patients who test positive to clinics more equipped to handle the diagnosis, including prescribing antivirals. As one of Texas' very first HIV counseling and testing sites in 1985, People's Community Clinic offers STI testing and birth control, but does not currently prescribe PrEP. Requests for comment from People's Community Clinic were declined.
It's been just over three months since Nelson learned he was positive. Today he says he's found closure, and that he's not trying to point the finger at his former doctor – whom he's chosen not to name – though he believes his status as a genderqueer, Hispanic "male" negatively affected her treatment of him. "What made it worse was that she didn't really give me a valid argument. She started out with, 'It might not be safe,' but then slowly unraveled into a moral ethics dilemma. This thought seems to be embedded in some people's head that kids are going to go out and have unprotected sex because of PrEP, but it's just being proactive. People are already having sex." Several of Nelson's friends – including his current partner, who's HIV negative – have been denied PrEP prescriptions. In his partner's case, the doctor denied him PrEP despite knowing Nelson's positive status.
"He's getting a referral to an infectious disease doctor, but in that time frame anything can happen. Doctors have the ability to make unilateral decisions for the well-being of a patient, but you can't make a decision like this for me – you can't tell me I can't protect myself," says Nelson, who is just starting to figure out his antiviral medication. Now he just wants to help give other people a voice. "I hope people who have gone through something similar can read this and feel like they're not the only ones."
Embracing his passion for activism, Nelson plans to continue working with at-risk and HIV-positive individuals. He's also one of many Austinites who's hopeful about APAP's work. He sums it up best: "The most important thing about PrEP is that it's another tool in the tool kit to protect yourself."