Drugs, Fear and Loathing: Why Are So Few Getting HIV Prevention Drugs?
June 23, 2014
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.)
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.
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:
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.
This article was provided by ACRIA and GMHC. It is a part of the publication Achieve. Visit ACRIA's website and GMHC's website to find out more about their activities, publications and services.
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