A mere decade ago, 45,000 Americans a year were contracting HIV. Since the Centers for Disease Control and Prevention started collecting data on HIV-related deaths just over 30 years ago, more than half a million of those people have died from AIDS.
And yet, today, the struggle against HIV may be undergoing a sea change.
U.S. health officials and HIV experts are beginning to talk about a future in which transmission in the United States could be halted. And that future, they say, could come not within a generation, but in the span of just a few years.
“We have the science to solve the AIDS epidemic,” Dr. Robert Redfield, the director of the CDC, himself a longtime HIV researcher and clinician, told STAT in a recent interview. “We’ve invested in it. Let’s put it into action.‘’
Other leaders in the HIV field have been musing about the idea, buoyed by the astonishing impact effective HIV medications have wrought, both on the lives of people infected with or at risk of contracting the virus, and on the trajectory of the epidemic.
“It’s certainly doable in the United States,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a researcher whose study focused on HIV from the earliest days of the AIDS epidemic.
Fauci and other health experts are quick to point out that the goal of stopping transmission entirely is largely theoretical. There will always be some new cases, and the barriers to providing treatment to existing cases remain significant. There are still just under 40,000 people in the U.S. each year contracting HIV. As Fauci put it: “We live in a real world, we don’t live in a theoretical world.”
But “if we implement all the tools that we have and if we can theoretically, conceptually, get everybody who’s HIV infected on antiretroviral drug so that they will not transmit the infection to anyone else, theoretically you could end the epidemic tomorrow by doing that,” he added.
In the absence of a highly effective vaccine — and likely, even, in the presence of one — consigning the global HIV/AIDS epidemic to the history books would be impossible. And at the moment, that’s moot: Despite decades of research on HIV vaccines, the holy grail of HIV control remains an unmet goal.
Still, even without a vaccine, experts believe transmission could be largely stopped in this country — a goal that until the past few years would have been unthinkable.
In March, Redfield told CDC staff that he believed HIV transmission in the United States could be halted over the next three to seven years.
The foundation of the dream is the realization that, if taken correctly, today’s potent antiretroviral drugs will drive down the amount of virus in an HIV-infected person’s system to undetectable levels. People who reach that state, known as viral suppression, are not contagious — even, it seems, if they have unprotected sex.
Accumulated data from several studies show that in nearly 80,000 condomless sex acts between pairs of men who had discordant HIV status — one was negative, the other was positive, but virally suppressed — not a single new infection occurred.
In the HIV world, that finding has given rise to a slogan: U = U, or undetectable equals untransmissible. To maximize the benefits of viral suppression, though, people must know their HIV status and start treatment if they are infected. Currently the CDC estimates that 15 percent of infected Americans are unaware they are HIV positive.
“People with HIV infection need to be diagnosed, getting care, stay in care, get on antiretrovirals, and get their viral load down to undetectable,” Redfield said.
Pairing the power of viral suppression with another tool further increases the chances of stopping spread of the virus. That other tool is PrEP, pre-exposure prophylaxis — antiretroviral drugs used to prevent infection in people who are at high risk of contracting the virus.
Taken correctly, PrEP reduces the risk of contracting HIV from an infected partner by 95 percent. If the infected partner is virally suppressed, the risk is lower still.
But the benefits of PrEP can only be reaped if people use it. Currently too few do. The CDC estimates that about 1.1 million people in the U.S. should be taking PrEP, including men who have sex with men, sex workers, and transgender women, a population with a highly elevated risk of contracting HIV. But only about 200,000 are actually using it, Redfield said.
Paradoxically, doctors bear part of the blame for that gap.
“There is a large number of people who are not comfortable prescribing PrEP or have not been taught how to prescribe PrEP, whether it be in their residency, fellowship, or post-graduate training,” said Dr. Robert Goldstein, medical director of the transgender health program at Massachusetts General Hospital and an instructor at Harvard Medical School.
“We’re limited by stigma within the medical community and within the LGBT community. We’re limited by lack of provider knowledge. We’re limited by awareness among those at highest risk of HIV infection,” Goldstein said. “And those limitations result in rising rates of new HIV infections in men who have sex with men while we see across the country actually dropping rates of new HIV infections year after year.”
In some cases, the problem of too little PrEP prescribing is due to a lack of training, and in other cases, something else may be at play, suggested Dr. Demetre Daskalakis, the New York Department of Health’s deputy commissioner of disease control.
“We still have to sell this to [clinicians] who are like, ‘Why would I be offering people PrEP, if it’s going to encourage them to have condomless sex?’” he said. “And our answer tends to be, ‘They’re already having condomless sex and this prevents HIV.’”
New York is one of several cities — San Francisco and Washington, D.C., among them — that have moved aggressively to harness the power of the treatment and prevention, working to actively identify people who are HIV-positive but who haven’t yet been tested, or haven’t yet started taking antiretroviral drugs, as well as people who should be using PrEP, but are not.
New York has expanded the remit of its sexual health clinics to help identify these patients and get them into treatment, said Daskalakis, who explained it’s about “snagging” the people most at risk “where they come for service.”
Anyone who is newly diagnosed with HIV is offered antiretroviral drugs immediately. No waiting for a follow-up appointment, which increases the possibility the patient won’t return. And it’s working “with just staggering success,” said Daskalakis.
“What we’re finding is that they get virally suppressed faster,” he said. “It’s sort of the dream, that when you start people on medicines for infections they have on the day of their diagnosis, all of a sudden you see that they’re interested in connecting to care and actually follow through.”
Likewise, people who test negative for HIV but who are deemed at risk of becoming infected are offered a starter pack of PrEP. The efforts led to a sharp upswing in the number of people taking PrEP — and a swift decline in the number of new HIV diagnoses. In 2016, new infections dropped 10 percent overall, and 15 percent among men who have sex with men, Daskalakis said.
The cost of PrEP is steep — $1,500 a month without insurance or assistance from the manufacturer. But New York state has an assistance program that helps with the cost of the medical care PrEP use requires, and there’s a patient assistance program for those who can’t pay for the drug. At the end of the day, Daskalakis said, with a combination of programs, most patients can access PrEP.
“In New York, the answer is yes. But I would be more worried about talking to someone in Mississippi,” he said.
That isn’t an insignificant consideration. The epidemic in the United States is currently being driven, in large part, by infections among African-American and Latino men who have sex with men in several Southern states.
Fauci is a believer in the active style of HIV interventions New York and other cities are employing. “You can’t do business as usual,” he said. “You’ve got to have an aggressive approach.”
But he’s always cognizant that translating the successes of Washington or New York to less urban settings — where access to care is more limited and stigma may be greater — likely won’t be as simple as changing some wording on some brochures.
“Is that going to work in Alabama? In Georgia? In Mississippi and Louisiana? That’s where we’ve got to put the focus on,” Fauci said.
Another challenge that likely won’t be easily overcome relates to the opioid epidemic. The growth in the use of injectable drugs — specifically the sharing of syringes — has driven up HIV and hepatitis C rates in people using illicit substances.
Research shows that needle exchange programs reduce those infections. Separately, a number of cities — San Francisco, Philadelphia, New York, and Seattle, among them— have been exploring opening safe injection sites.
“We’ll never get to a place where we can stop the spread of HIV unless we are willing to rethink the way we take care of, and our policy towards people who use drugs in this country.”
Dr. Sarah Wakeman, Massachusetts General Hospital
But just as some doctors associate PrEP prescription with enabling unsafe behavior, the notion of sanctioned injection sites and syringe programs draws the ire of people who believe they encourage illegal activity.
In an opinion piece in the New York Times, Deputy Attorney General Rod Rosenstein warned the Department of Justice would take swift action against cities that open such facilities, calling them illegal.
“Americans struggling with addiction need treatment and reduced access to deadly drugs. They do not need a taxpayer-sponsored haven to shoot up,” he wrote.
Public health experts counter that criminalizing drug use hasn’t worked. Officials can’t “punish people into getting well,” said Dr. Sarah Wakeman, medical director of the substance use disorder program at Mass. General.
“At the highest levels of our government, there’s a lot of opposition and antipathy to the idea of harm reduction,” Wakeman said of Rosenstein’s commentary. “And in fact, in that op-ed, it was very clearly stated that these efforts are ‘enabling’ — which I think is one of the many kind of myths around harm reduction.”
“We’ll never get to a place where we can stop the spread of HIV unless we are willing to rethink the way we take care of, and our policy towards people who use drugs in this country,” she said.
Needle exchange programs have some high-profile supporters, including top officials who have had up-close experience with the problem. The CDC’s Redfield has a son who has struggled with opioid addiction; Surgeon General Jerome Adams has a younger brother who has fought addiction for two decades.
“We believe there is clear evidence that needle exchange programs can reduce the risk of transmission of HIV infection,” said Redfield. Adams told STAT last week: “When I see a [needle exchange] program close, what that says to me is that we haven’t done a good enough job communicating to the community why this program is important and the value that it provides.”
The hardest sell yet may be to convince authorities that successfully containing the spread of HIV in the U.S. requires addressing transmission in prisons. Prisons, in theory, “should be easy, because it’s a confined population,” said Fauci. He acknowledged, however, the gap is wide here between theory and reality.
“You’ve just got to get really flexible in what you do and recognize that there is sex going on, there is injection drug use going on. And if you really want to address it, you really have to address it in those settings,” he said. “And that, I know, is going to raise a lot of eyebrows. But it’s got to be done.”