It's been almost two years since the Centers for Disease Control and Prevention (CDC) released historic guidelines for using the oral antiretroviral medication Truvada (tenofovir/FTC) to reduce the risk of HIV infection in uninfected individuals. The U.S. government now recommends that hundreds of thousands of people at risk of becoming HIV positive take the medication once daily. That prevention strategy is known as pre-exposure prophylaxis or PrEP. Recent studies have shown that it is more than 90% effective in preventing infection if taken at least four times per week.
Truvada became the first medication ever to be approved for adult HIV prevention in July 2012. That marked a major milestone in the 35-plus-year global epidemic. Awareness has increased significantly. Many private insurers and most Medicaid programs will now cover it. Some state and municipal governments have developed programs to help residents pay for Truvada. PrEP has become almost ubiquitous in discussions across hook-up apps, social media networks, news coverage and public health programming that target gay and bisexual men. But one community has been largely absent from the prevention conversation: people who inject drugs.
People who inject drugs and their partners were included in the CDC's historic May 2014 guidelines. But relatively few public health dollars and little research funding has targeted people who inject drugs for PrEP interventions.
"People who use drugs are often last to get these tools. That has been a problem throughout the entire history of the epidemic," said Jose A. Benitez, executive director of Prevention Point Philadelphia (PPP), a multi-service harm reduction and public health organization. PPP is the only syringe exchange program in Philadelphia and eastern Pennsylvania.
"We have seen a fair amount of demand for PrEP implementation, public health leadership, research and awareness campaigns. It's primarily been focused around gay men, although some women have advocated to be included," said Daniel Raymond, policy director for the New York City-based Harm Reduction Coalition. "Men who have sex with men (MSM) who use drugs have not been included. So are these campaigns meaningful to gay and bisexual men who inject drugs? There are a number of gay and bisexual men who may 'slam' crystal but do not see themselves as an ideal candidate for PrEP. We believe this group should be targeted."
People who inject drugs remain the most underserved population in the global response to the epidemic. There is a significant gap in prevention and treatment services for drug users.
At the same time, there has been a surge in heroin and injectable opioid drug use across the United States. The epidemic has been most noticeable in rural areas, Appalachia, New England and the Midwest. The increase in injection drug use has fueled a surge in hepatitis C infections. African Americans and Latinos have historically been disproportionately represented among those who inject drugs and seroconvert. But the relatively newer opioid, heroin and hepatitis epidemics have been concentrated in white communities.
About 1.2 million Americas are living with HIV, according to the CDC. MSM account for about two-thirds of that population. People who inject drugs account for about 15%. People who inject drugs can experience health disparities after seroconverting and are more likely not to achieve viral suppression.
New infections among people who use drugs have dramatically declined since the 1990s. The total number of new infections in this country has plateaued at about 47,000 per year. People who inject drugs account for about 8% of all new infections. Another 4% are MSM who also inject drugs.
"Of those new infections from MSM who inject drugs, how many were from drug use and how many were from sex?" asked Raymond. "There is some reason to believe that those numbers are probably skewed towards sex."
Only one major clinical research trial has studied PrEP as an HIV-prevention option for people who inject drugs. The Bangkok Tenofovir Study of 2013 enrolled more than 2400 adults who inject drugs in Bangkok, Thailand. The participants were randomized to either daily oral tenofovir (Viread) or a placebo. "Daily oral PrEP ... was found to reduce the risk of acquiring HIV by approximately 49 percent," reports the CDC. Those who took the medication with higher levels of consistency and adherence saw their risk reduced by 74%.
The results were published in The Lancet on June 13, 2013. Based on those findings, that same day the CDC published guidelines recommending PrEP "as one of several prevention options for persons at very high risk for HIV acquisition through the injection of illicit drugs."
Costs Versus Benefits?
"If you are running a harm reduction program -- syringe exchange -- you are not seeing many new HIV infections from the population that you are serving. Our problem is scaling it up and making it available everywhere," said Harm Reduction's Daniel Raymond.
Raymond referenced a 2014 mathematical model and cost-benefit analysis on the efficacy of PrEP among various populations in New York City. The modeling found that PrEP could be cost effective among MSM if the price were halved and if the highest risk groups had near universal uptake and adherence. There was almost no cost-effective scenario if it were offered to people who inject drugs.
The monthly price of Truvada is about $1300 to $1500. On the other hand, syringe exchange is very inexpensive. Syringes and needles cost less than fifty cents. At least 33 states, the District of Columbia, Puerto Rico and almost 200 U.S. cities allow syringe exchange, according to the Kaiser Family Foundation. At least 37 states and the District of Columbia allow some form of sale of non-prescription sterile syringes.
Increasing PrEP Access
"Just because new HIV infections among people who inject drugs has dropped, that does not mean [they should] not be targeted for this intervention," said PPP's Jose Benitez. "PrEP needs to be available to everyone who is HIV negative. It doesn't matter if they use drugs or share needles. It needs to be available to their [sexual] partners, too."
"PrEP is about empowering people to take control of their lives," said Caitlin Conyngham, the director of PrEP programs at Philadelphia FIGHT, a comprehensive health services organization providing primary care, treatment and prevention for people living with HIV and those at high risk of becoming HIV positive.
An estimated 30,000 people are living with HIV in metropolitan Philadelphia. The citywide infection rate is five times the national average.
Philadelphia FIGHT was an "early adopter of PrEP," said Conyngham. "We wrote our first prescription in early 2013 after enrolling people in December 2012." FIGHT is providing PrEP at three locations, including a youth health center and a clinic for those who were formerly incarcerated.
Timely access to PrEP is critical, said Conyngham. "That means less red tape, such as reducing the length of time it takes someone to get an appointment or the results of their labs. We need to demystify PrEP and include it among primary health. We want to provide that in a space that is free of shame and free of stigma. There is a spectrum of what people consider to be 'acceptable' drug use. Injecting drugs tends to be on the far end of the spectrum of stigmatized drug use."
The influence of stigma and discrimination as a driver in the epidemic cannot be overestimated, according to many experts. The Obama Administration's historic National HIV/AIDS Strategy -- first released in 2010 and updated in 2015 -- includes a section on reducing stigma.
"There are multiple layers of stigma," said PPP's Jose Benitez. "People who are HIV positive are stigmatized. Men who have sex with men are stigmatized. Drug users are consistently stigmatized. MSM and drug users stigmatize each other. Even within the drug using community, people who may smoke or inhale drugs will stigmatize people who inject drugs."
Physicians, nurses and health care workers also stigmatize and discriminate against people who use drugs. This has become a significant barrier to treatment and prevention. It could become a major obstacle to accessing PrEP.
"We've conducted several surveys" on stigma from health care workers, added Benitez. "Many of our clients say they have a difficult time going into an emergency room or primary care clinic. They feel that health care workers think they are drug seeking. They may have a visible wound but the assumption is they are looking for pain medication."
Benitez, Conyngham, Raymond and harm reduction advocates across the globe stress the importance of framing drug use as a public health issue. It's also critical that health care workers be caring and culturally competent. Otherwise, those who need them the most won't trust them and access services.
"Our organization is located in an area with high poverty, high drug use and high drug trafficking. It has one of the highest community HIV viral loads in Philadelphia," added Benitez. "PrEP provides an additional tool so that we can help end this epidemic. The science is there; we just have to make it happen."
Rod McCullom has written and produced for ABC News and NBC, Scientific American, The Atlantic, The Nation, Ebony, Poz and many others. Rod is a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.