The pill that could transform HIV/AIDS prevention
by Joey Saunders
Truvada is an FDA-approved and government-recommended pill that could prevent the spread of HIV and AIDS even via condomless sex, but few have heard of it and even fewer are taking it. The drug’s manufacturer, Gilead Sciences, does not even advertise it for PrEP (pre-exposure prophylaxis). But why? Why not announce this with megaphones and skywriting? Couldn’t this be the answer to stripping fear of death and disease from the one act most commonly associated with romantic love and intimacy? I want to tell you this is the end of AIDS and, while I think I may see that end in my lifetime, all I have for you is hope buried under footnotes and caveats. Let’s start digging, shall we?
Young discovery is a rush. Discovering how much blood our hearts can gush into our most wonderful parts when the right person makes eye contact. Heavy breathing and churning stomach give way to ecstatic dizziness as our lips meet. Soft and wet. Clothes are in the way until they aren’t. It feels amazing. There was a time gay men couldn’t feel amazing like that without thinking about death. The free love of the ’70s gave way to a kind of biblical plague in the early 1980s.
Today, young gay men are discovering each other with less fear. HIV/AIDS no longer conjures images of lesion-laden lepers from the third act of a Tony Kushner play. While stigma certainly remains, it’s dissolving. The days when almost every gay man had a friend or lover who died skeletal after months of suffering are ghostly memories. There’s absolutely more to it than this, but it’s worth mentioning that most new cases of HIV infection are men ages 13 to 24 who have sex with men. The Centers for Disease Control has seen a 22 percent increase in new HIV infections in this age group from 2008 to 2010 and is compiling data for 2012, data that Kansas City Care Clinic Medical Director, Dr. Craig Dietz, expects to prove just as troubling as the CDC’s 2010 findings.
I meet Dietz at a coffee shop as thunderbolts burn across the sky because, of course, it can’t be sunny while you talk about AIDS. He tells me about a young man who returned from military service in Afghanistan and came to the Kansas City Care Clinic. He did not self-identify as homosexual, but he had had sex with at least one man and tested positive for HIV-1. He refused treatment, refused to face being HIV positive, hid it from his friends and family and died of AIDS-related pneumonia within months.
“People react differently to being positive,” Dietz says, “not just emotionally but physically. Some people can live for years without even knowing they’re positive. Others are more sensitive, and if they don’t receive treatment right away the virus can act very quickly.”
On the microscopic level, HIV looks a bit like an exploding planet or a tennis ball with nails driven three-fourths of the way into it. It stands for Human Immunodeficiency Virus, which is a fancy way of saying it only infects humans and destroys important immune system cells (T cells that detect intruders like viruses and germs). Having fewer T cells makes a person more susceptible to illness. When you drop below 200 T cells per cubic millimeter of blood, you reach the stage of HIV called AIDS. Without treatment, people rarely live longer than three years with AIDS.
With treatment, an HIV-positive person could have a higher T cell count than some HIV-negative individuals thanks to huge medical advancements. Dr. Paul Jost, an infectious disease specialist in Kansas City, said, “When I started (in 1991) the drugs available were really awful like AZT and DDI.” He said while these treatments were better than nothing, most of his patients were “destined to die (…) Signing death certificates was a common, weekly thing.” As research funding increased thanks to protests, benefits and an increasingly visible gay community led by pioneers like Larry Kramer, doctors leaned away from AZT toward combining various drugs, a practice still popular today.
Truvada is a combination of tenofovir and emtricitabine that keeps HIV from using a special enzyme to destroy T cells and copy itself. Jost has prescribed Truvada to HIV-positive patients, as has Dietz. Jost, however, says the drugs he prescribes vary greatly from one patient to the next depending on cost, how each individual reacts to the drugs and how many pills they’re willing to take. “Today the medicine has come so far some patients can just take one pill a day and it works for them,” he said. Complara is one such drug, but Jost worries about its psychological risks. He likes Stribild but says the drug is expensive. Depending on how the patient reacts, he might recommend Atripla, a three-in-one medication that can cause vivid dreams. “Some patients say it’s like dreaming in Technicolor and wake up remembering every detail. Some can’t stand it, others really like it.”
Of these, only Truvada is FDA approved – in 2012 – to prevent HIV infection. As of last September, Gilead Sciences said it knew of only 2,319 prescriptions of Truvada for PrEP, of which 49 percent were for wmen. Jost and Dietz have never been asked to prescribe Truvada as a preventative drug for an HIV-negative patient. Research boasts that if you take Truvada once a day for the rest of your life, it is 99 percent likely that you will never become HIV positive. Jost is quick to point out that this has never been proven in clinical trials. While Dietz admits this as well, he also explains that these kinds of research trials would be difficult to conduct and fund due to ethical quandaries and scarce volunteers. Essentially, you would need to study hundreds of HIV negative volunteers having unprotected sex with HIV positive partners to collect accurate data. Still, Jost and Dietz agree, if someone who is HIV negative had a partner who was HIV positive they would prescribe the drug to them while still recommending safer sex practices. Jost doesn’t see any IV drug users, but Dietz does and would also prescribe Truvada to them, but he isn’t sure if they would be able to afford it.
Dietz wonders if men who can afford the drug might be inclined to take it before going on a gay cruise or a trip to Fire Island so they can have unprotected sex with multiple partners. The thing about Truvada is that, like birth control, you need to take it every day for it to work best. Jost worries it may encourage irresponsible behavior, especially among his younger patients who “have no concept of what AIDS is really like.” Dietz is ambivalent but tends to think that if a person is going to engage in unprotected sex, and Truvada could prevent spreading HIV, it’s certainly better than nothing.
Dietz clarifies, “Even if it prevents HIV infection, I’d still recommend condom use to prevent spreading HPV, Hepatitis C, syphilis.” Dietz also worries if a person is HIV positive but doesn’t know it, he could actually become super-infected. This can also happen if two HIV-positive men have unprotected sex and yield a particularly nasty strain of HIV that is more difficult to treat. However, as incidents of super-infections increase, newer and stronger treatments with fewer side effects are on the horizon.
Jost mentions a new-ish drug by Viiv that he is hopeful about, while Dietz mentions that Tivicay (made by Viiv), while not FDA approved for PrEP, may have the potential to be used as an intermittently taken drug that could be just as effective, if not more so, in preventing transmission. The real key though, says Dietz, “are the elite controllers.” He explains that one in 300 people, often called Long-term Nonprogressors (LTNPs), have a mutation that makes them resistant to HIV. Even if they become infected, they could live a long, healthy life without ever knowing they’re positive or requiring medication. While Dietz would still recommend a mild treatment regimen, he holds out hope that researching how LTNPs naturally control the virus could lead to a preventative vaccine. For now, though, there’s just Truvada.
A friend of mine, who we’ll call “Jack,” is in his mid-30s and discovered three years ago that he is HIV positive. His partner of many years, “Matt,” is HIV-negative. They have a fairly open relationship but are loving and have raised a bright son in his early teens. Neither had heard of Truvada for PrEP. Matt and Jack still have sex with each other; sometimes they use condoms, sometimes they don’t. Jack is undetectable, meaning his HIV treatment has brought his T-cell count up so high that his viral load is undetectable and his risk of transmission is decreased by 92-98 percent. Matt seems interested in talking to his doctor about Truvada, but Jack wonders, “Maybe this is just because I’m already positive but, like, what’s the difference, you know? … At the end of the day if you’re taking (Truvada) every day for life to not get HIV, it’s sort of the same as the end result. Like, I have to take my medicine forever. Either way you’re taking a pill for life.”
“I guess the cost would be a big question mark for me,” Matt said.
Dietz thinks the cost of Truvada for PrEP wouldn’t be very different than a typical HIV treatment regimen. Jost says, while many of Dietz’s patients are covered by government funding and often have no insurance, Jost’s patients typically have private insurance through their employer or some form of Medicare or Medicaid. Still, treatment costs can be around $20,000 annually. Both PrEP patients and HIV-positive patients must come in often to run lab tests and, for PrEP patients, to ensure they remain HIV-negative, which add to costs. Insurance coverage varies but Jost is determined.
“We always find a way to get patients the drugs they need. Sometimes it takes a lot of filling out forms to get assistance or to qualify for trials. A lot of the time we have to work with insurance and just explain their need. Insurance is always about what’s going to cost them the least now; they don’t think in the long term. So, the better drugs are harder to get approved sometimes.”
Jack works two jobs and has help from Matt but he finds it hard to believe that some people can afford quality treatment. “It’s crazy how expensive things can get if you’re employed with insurance and not too far above the poverty line. You could easily spend more than half of a monthly paycheck on really good (treatment).” Jack says in the past he’s had to compromise and take more inexpensive medicines when things were tight and had to suffer through side effects. “They weren’t all horrible. I took one called Atripla which sometimes made me a little red, not bad, but if I ate too close to bedtime I would have these really weird dreams. And remember them so well. It was actually kind of cool because I never really remembered my dreams before.”
Jack recalls an Atripla-induced dream where he is encased in a giant human heart like a baby in a womb. A spectral woman made of glass cuts him out of the heart where he meets Matt in a field crawling with serpents. Just as they kiss the dream rewinds itself until Jack is back in the heart again, swathed in darkness. He says the dream felt so real that when he awoke he was disoriented in his bed, in the darkness, unsure if he was still sleeping.
If Truvada is truly more effective than condoms at preventing HIV, it would be like something out of a fantastic dream for those who are able to afford it. Most insurers now cover its steep $15,000-per-year price tag, and, with incidences of HIV infection holding strong at around 50,000 new cases annually, the Centers for Disease Control could use an alternative to condoms.
With recent CDC surveys reporting nearly 60 percent of gay men having had unprotected anal sex in at least the last year (almost a 20 percent increase since 2005), it isn’t so surprising that on May 14 the U.S. Public Health Service officially recommended Truvada for PrEP for individuals at high risk for HIV infection. This would include not only gay men, but anyone who is not in a mutually monogamous relationship with an HIV-negative partner. With so much support from the CDC, FDA and U.S. Public Health Service, it begs the question: Are doctors only hesitant to prescribe Truvada because they worry it may encourage promiscuity? Birth control faced similar challenges in its early days but today it, a pill taken daily to prevent the creation of new life, is normal and ubiquitous while Truvada for PrEP, a pill taken daily to prevent being infected by a potentially deadly virus, remains stigmatized and rarely prescribed.