Drugs, Fear and Loathing: Why Are So Few Getting HIV Prevention Drugs?

Drugs, Fear and Loathing: Why Are So Few Getting HIV Prevention Drugs?

It's clear that the U.S. is failing when it comes to HIV prevention. Infections are rising among gay men, and new biomedical approaches are either not being promoted or are actively discouraged by providers. The AIDS activist group ACT UP/NY has documented numerous instances of people being denied these new approaches or being forced to confront real barriers to their use, as well as a shocking lack of concern among government health bureaucrats.

An Ongoing Crisis

Each year, over 2 1/2 million people are infected with HIV worldwide. Even in the U.S., where the epidemic has not widely spread beyond fairly defined groups, the number of new cases remains a problem. The CDC estimates that in 2010 there were 47,500 new infections. While the overall rate of infections has remained steady for several years, it's been decreasing for most groups but rising for men who have sex with men (MSM), a category that includes transgender women. Between 2008 and 2010, new infections increased by 12% among MSM, and by 22% among young MSM aged 13-24. In 2010, two-thirds of all new infections occurred among MSM. A gay man was 30 times likelier to get infected than a straight man. African American MSM were 6.6 times likelier to become infected than white MSM.

Most new infections in the U.S. occur as the result of sex. In 2010, 78% of infections in men and 63% of all infections were from male-to-male sexual contact. While clinical trials have shown that biomedical approaches like circumcision reduce HIV transmission, there is little evidence that supports behavior- based prevention efforts like safer sex classes and counseling. When those efforts are directed at MSM, some data show a short-term reduction of sexual risk (accompanied by a drop in new infections), but the reduction of risk behavior vanishes after several months. Condoms are highly effective, but studies estimate that MSM use them less than half the time when they have anal sex. (Straight men use them about 5% of the time.)

The Promise

ACT UP has documented numerous instances of people being denied PEP and PrEP or being forced to confront real barriers to their use, as well as a shocking lack of concern among health bureaucrats.

Given the persistence of sexual transmission of HIV and the low rate of condom use, it's not surprising that the world of AIDS has turned toward pharmaceutical prevention. For many years medications have successfully treated HIV. Could they also prevent infection?

Treatment as Prevention (TasP) targets people living with HIV. When people with HIV take medications regularly, their viral load often drops to undetectable levels. HPTN 052, a large clinical trial, found that HIV treatment reduced the sexual transmission of HIV by more than 96% in HIV serodiscordant couples (in which one partner has HIV and the other does not). Further data have bolstered these findings. A 2013 review of three studies that included 991 heterosexual couples estimated an HIV transmission rate of almost zero when the positive partner has an undetectable viral load.

These encouraging findings have to be taken with some caution. Only 2% of the couples in the HPTN 052 study were male couples, and the great majority of new infections in the U.S. occur through male-to-male sex. There are good medical reasons for thinking an undetectable viral load greatly reduces risk in MSM as well. But we should also remember that anal sex has about 18 times the risk of vaginal sex. Another caution is the presence of HIV in the semen of some men who have undetectable viral loads and the risk for transmission this represents.

These cautions do not constitute an argument against TasP. But more than 17 years after highly effective HIV treatment was introduced, only 25% of people with HIV in the U.S. have undetectable viral loads. We will not put an end to HIV transmission anytime soon if we rely on TasP alone. So two types of prevention target HIV-negative people with HIV drugs.



Post-Exposure Prophylaxis is a 28-day course of HIV drugs (often Truvada and Isentress) that, if started within 72 hours after exposure to HIV (and the sooner the better), can prevent HIV infection. There has never been a clinical trial that established its effectiveness, because it's unethical to randomize someone to no treatment after an HIV exposure given that PEP may be effective. But one non-randomized study of over 200 gay men estimated that PEP reduced HIV transmission by 83%. In 2005, the CDC issued recommendations for non-occupational PEP (nPEP) for exposures from sex or sharing a needle. In New York State, guidelines for both occupational PEP and nPEP call for the use of Truvada with Isentress. But more than eight years after the CDC first published nPEP guidelines, it remains largely unknown and unused in the communities most at risk.


Pre-Exposure Prophylaxis is a daily dose of HIV meds that can prevent HIV infection if taken before exposure. In 2012, the FDA approved Truvada for PrEP in HIV-negative people who are at high risk for HIV from repeated sexual exposure. According to the FDA, "Truvada for PrEP is meant to be used as part of a comprehensive HIV prevention plan that includes risk reduction counseling, consistent and correct condom use, regular HIV testing, and screening for and treatment of other sexually transmitted infections. Truvada is not a substitute for safer-sex practices." A year later, the CDC expanded its guidance on the use of PrEP to include the prevention of HIV through shared needles. It has promised final clinical guidelines by the end of the year.

Truvada gained its approval as PrEP due to two large clinical studies. In iPrEX, 2,500 HIV-negative MSM from Latin America, Thailand, and the U.S. took either Truvada or a placebo pill once a day. The study found that Truvada reduced the risk of HIV by 44%. But many people assigned to Truvada missed doses or never took it at all. In people who took it consistently, the reduction was 73%. It's estimated that people who took two doses a week reduced their risk by 76%. Taking four or more doses a week might have reduced risk by over 95% -- but these are only estimates.

The Partners PrEP Study enrolled over 4,700 couples in Uganda and Kenya, with one negative and one positive partner. Those who were negative took Truvada, Viread, or a placebo. Viread reduced infections by 67% and Truvada by 75%. In people who were found to have drug in their systems, Viread reduced infections by 86% and Truvada by 90%. So both studies found that Truvada can be protective, but showed that many people find it hard to take a pill every day to prevent a future infection.

The Barriers

In 2011, the CDC introduced "High-Impact Prevention", the prevention component of the National HIV/AIDS Strategy. But in the booklet that accompanied the rollout, PEP is not mentioned. A recent article in POZ magazine reported that only 15% of hospital emergency rooms in Massachusetts had a protocol for nPEP, and only 13% of health care sites in Los Angeles had PEP on location; only 3% would provide it to uninsured patients. In the summer of 2013, ACT UP/NY called on the New York State Department of Health (NYS DOH) to revise its outdated nPEP guidelines. That same year, activists in New Jersey and Chicago reported searching in vain for their state's guidelines. Across the country advocates complain that, although nPEP has long been the standard of care, few people are aware of it and even fewer know how to get it.

It's hard to find out how extensively nPEP is used in the U.S. POZ magazine found only 800 reports had been filed in a national surveillance registry that the CDC established in 2008. Some hospitals in New York City report a few hundred nPEP patients a year. After ACT UP's call for updated nPEP guidelines, NYS DOH brought them into line with guidelines for occupational exposure. But the situation surrounding nPEP in New York City remains far less than ideal. ACT UP has uncovered many significant mistakes that have occurred recently, including:

  • A doctor in the E.R. of a world-class Manhattan teaching hospital told a man who sought PEP after condomless receptive anal sex that he didn't need it. Only after 11 hours and a friend's intervention did he receive it. His insurance did not pay for the drugs.
  • A Manhattan clinic turned away a 19-year-old seeking PEP because he had no government-issued ID.
  • A young, undocumented immigrant was sent from one Brooklyn E.R. to another, and was told to return the next day. A friend got the drugs for him only after contacting a hospital administrator and paying $750 for the drugs.
  • A young man, worried that his time was running out, left a Brooklyn E.R. after several delays and mistakes in his care. He later received PEP at a Manhattan E.R.
  • A young, homeless queer youth received only a three-day starter pack of PEP from a Brooklyn E.R., with no counseling. He seroconverted.
  • After two days and much stress, the wife of a man with HIV received only a three-day starter pack from a Manhattan E.R., with no follow-up.
  • A Manhattan clinic's PEP hotline, closed for a holiday, sent a young caller to that institution's E.R., where he was told there was no such thing as PEP. Only an ACT UP member's intervention secured the PEP, after much delay and patient stress.

When members of ACT UP argued for a public health campaign about PEP, an official of the city's Department of Health and Mental Hygiene (DOHMH) countered that such a campaign would not be cost-effective, since the number of actual infections prevented would be small. ACT UP argued that people who seek out PEP are a valuable HIV prevention resource. They may be at high risk for HIV and often do not have access to regular health care, but are interested enough in their health to seek out treatment. They are on the front lines of new HIV infections. In the U.S., new infections appear to be concentrated into sub-groups with little access to health care. To extend care to high-risk people who are HIV-negative would prevent human misery and lower HIV treatment costs.

Photo: Bacilio Mendez II, actupny.com
Photo: Bacilio Mendez II, actupny.com

Other Concerns

Payment for PEP is piecemeal. Even though PEP is considered the standard of care, it has not actually been approved by the FDA. Medicaid coverage varies from state to state, and some but not all private insurers pay for it. And for the uninsured? Gilead and Merck own the drugs specified in the NYS DOH PEP guidelines and both have plans that provide drug to the uninsured. NYS DOH has a useful fact sheet on payment options for nPEP (search for "Payment Options" at health.ny.gov). The National Alliance of State and Territorial AIDS Directors put out a fact sheet on the Patient Assistance Programs (PAPs) of all the companies whose drugs are recommended in state PEP and national PrEP guidelines (search for PEP at nastad.org).

When it comes to PrEP, some suggested barriers to its use have not been seen. It was feared that people who took Truvada and then became HIV infected might develop drug resistance. Yet, in the PrEP trials, the only people to show resistance were those who began taking Truvada after they'd already been infected. They tested negative because they were still in the "window period" and had yet to produce antibodies to HIV. Mathematical models have confirmed that the risk of PrEP leading to drug resistance is almost nonexistent.

Another frequently voiced fear is that people taking PrEP (gay men in particular) would "risk compensate" -- that is, use condoms less frequently. But in iPrEX and Partners PrEP, reports of condom use actually went up. Self-reporting on sexual activity isn't always accurate. But in both trials the number of sexually transmitted infections went down, which wouldn't have happened if most people in the studies had abandoned condoms. Another PrEP trial reported similar findings: risky behavior declined or remained stable, whether or not participants started taking pills immediately or months later, as the trial's design required.

There has been one problem across all PrEP trials. A significant number of participants took the pills only sometimes, or never. Adherence was so poor in two PrEP trials in women in Africa that the trials had to be stopped early. The FEM-PrEP trial found drug in fewer than half of the women taking it. The VOICE trial found drug in less than 30% of participants. Many trials and demonstration projects tell us that PrEP is highly protective if taken according to directions, but that many people do not take it as prescribed, even when they get especially extensive counseling. Before PrEP can play a significant role in HIV prevention, poor adherence will have to be addressed.

Since its approval, the rollout of Truvada for PrEP has not been swift. In September 2013, Gilead released information about early PrEP use from 55% of U.S. pharmacies. There were only 1,774 users (about 3,200 when expanded to all pharmacies). The median age of users was 37, and about half were women. About half received the drug before FDA approval, meaning they were participants in a clinical study. And almost none of them were the young gay guys or transgender women -- groups where the new-infection crisis is concentrated.

Gilead's numbers confirm what activists know: people with the highest risk for HIV know little about PrEP. Many doctors are wary of prescribing it. Representatives of Gilead have complained that the lack of a network of providers who will prescribe it is a major reason for its slow rollout. Few U.S. doctors were involved in the PrEP trials, and many HIV docs (who normally prescribe Truvada for treatment) see few, if any, HIV-negative patients.

Much of the commentary on PrEP in the gay press and in gay social media has been by old-school safer-sex advocates who have a dim view of pharmaceutical prevention. Truvada's side effects and the chance of resistance are frequently exaggerated. PrEP users have been caricatured as out-of-control, drugged-up sex fiends. Many in the community fear that Big Pharma wants to put every gay guy on drugs. In fact, Gilead has refused to advertise Truvada for PrEP, and the paltry numbers of people taking it show that.

Integrating PEP, PrEP, and HIP

DOHs must promote PEP guidelines based on the latest science, and see to it that local providers follow them. States must mandate that providers connect patients with drug companies' Patient Assistance Programs.

As a longtime AIDS activist of the generation that invented safer sex, I want to say to my community: Yes, HIV drugs are strong and can have long-term toxicity. But the HIV virus is diabolical. Unchecked, it takes over the body at the cellular level. If low-dose drugs, taken for a period of time, can prevent infection in a core group of people who are at high risk for HIV and who cannot or will not alter their behavior, then that's preferable to infection. In my personal life, I will continue to practice behavioral rather than pharmaceutical prevention. But I know that not everyone shares my sex habits or my personal philosophy -- or is as old as I am. Everyone who is HIV negative and at risk deserves to know about the full range of HIV prevention tools available in 2013, and to have access to those tools.

I want to tell my community that the recent spike in gay HIV rates is an emergency. The first version of safer sex that we invented stressed self-empowerment: In a dark time we were making sex possible again. Somewhere along the way, the message became one of deprivation -- "don't do this!" -- rather than possibility. We have to restart a conversation about the kind of sex we are having, putting HIV prevention in a wider discussion of pleasure and health. This conversation should rechannel the strengths of the first generation of safer sex messages and talk about condom use, lower risk sex, risk reduction, and other risk factors like drug use.

Because knowing your HIV status is the first step toward getting treatment and making smarter sex decisions, we have to make testing a natural part of the lives of people at high risk for HIV. These are often people who have no contact with the health care system. With a robust testing campaign, San Francisco has been able to drive down the number of its residents who are HIV positive and unaware of it to about 7%. We must demand similar results from all our cities.

We must educate our communities about meds to prevent HIV. Our local Departments of Health must promote PEP guidelines based on the latest science, and see to it that local providers follow them. States must mandate that when uninsured patients seek PEP, providers connect them with drug companies' Patient Assistance Programs. And states would be wise to connect them as well to counseling and care that might keep them HIV negative. Uniform PEP guidelines across the country could improve care.

The future of PrEP depends on increasing adherence. The Open Label Extension of iPrEX and PrEP Demonstration Projects around the country are studying what kind of counseling maximizes adherence. Further trials will study the effectiveness of intermittent PrEP -- taking the drug a couple of times a week, or just before sex. Unlike HIV treatment, PrEP will be taken for a limited time. Further studies will have to identify whether it should be used for a few years or months, based on individual sex habits. Other trials are looking at longer lasting drugs like injectables that could improve adherence, and at other methods of delivery such as gels and rings. Because so many infections are happening beyond the reach of traditional care, engagement between the health care bureaucracy and communities at risk could help identify who are the best people to take PrEP.


This is a moment of promise for HIV prevention. But that promise is fragile. The Affordable Care Act at last gives disease prevention official standing. Will it bring with it the funding we'll need to enact truly High-Impact HIV Prevention? Will it bring widespread, easy HIV testing, sex-friendly counseling, and care for people at high risk for HIV? Longer lasting, low-toxic prevention drugs, and skilled providers to prescribe them? Innovative prevention research, vaginal and rectal microbicides, alternatives to the condom, even a vaccine?

In reality, HIV service providers don't know how they are going to continue providing services. We're living with the budget cuts caused by sequestration, uncertainty about the future of the Ryan White CARE Act, and a campaign to defund Obamacare before it's fully begun. If this campaign is successful, it will dash the best hope that we will any day soon put a dent in the ongoing scourge of more and more HIV infection.

Jim Eigo is a writer and activist who works on HIV prevention issues with ACT UP/NY.