Truvada, with its distinct blue color, was the first drug to be approved by the FDA for PrEP use. [Credit: NIAID | CC BY 2.0]
Much has changed for the better since the peak of the HIV/AIDS epidemic in the mid-1980s. The number of new annual HIV infections is less than one-third of what it was. In addition, more HIV-prevention drugs are reaching the marketplace and giving consumers options beyond Truvada, which was approved by the Food and Drug Administration in 2012 and is close to 99% effective when taken daily, as prescribed.
PrEP is a HIV-prevention strategy, which requires a HIV-negative person to take medication. It is “one of the most important tools we have to end the HIV epidemic in the U.S. and around the globe,” says Dr. Douglas Krakower, an infectious disease specialist at Boston’s Beth Israel Deaconess Medical Center. An acronym for pre-exposure prophylaxis, “PrEP is highly effective. It’s very safe in the vast majority of people who use it.”
Despite the benefits, PrEP drugs continue to be underutilized by people who need them the most, such as gay and bisexual men, transgender women and injection drug users. Only 4% of gay and bisexual men in the U.S. use PrEP drugs, according to a 2018 study. And among gay and bisexual men, the least likely to use it are obese people, Black people and people from the Southern states, another research paper found in 2019.
Not all people are aware of PrEP drugs, so here are some questions and answers about these highly effective preventive medications for HIV/AIDS.
How do PrEP drugs work?
When a person takes a PrEP pill, it interrupts the HIV virus from replicating inside the body by interfering with proteins that the virus uses to make copies of itself, explains Krakower. Obstructing those proteins means that even if the HIV virus enters a body, it won’t spread.
What are the PrEP options?
For more than seven years, Truvada was the only option for consumers. However, in 2019 the FDA approved Descovy for PrEP use, and a generic version of Truvada hit the market in October 2020.
Because Truvada has been available for so long, its safety and effectiveness have been well-tested, including in people who are at high risk of contracting HIV through sex or intravenous drug use. It is not without side effects, however, which can include headaches, abdominal pain and weight loss, as well as possible long-term side effects like bone density decrease and kidney problems. In comparison, Descovy — as it is newer to the market — is not for everyone. The drug has only been tested in cisgender gay and bisexual men and transgender women; others in at-risk groups should use Truvada or its generic version.
As an alternative to a daily pill, a strategy called on-demand or intermittent PrEP is also an option. It involves taking either Truvada or its generic before and after having sex. On-demand use is about 86% effective in preventing HIV for cisgender men who have sex with other cisgender men (it has not been tested for transgender men and cisgender women.) While the World Health Organization recommends this strategy, the FDA has so far only approved Truvada and its generic for daily use. This does not mean that the strategy is unsafe; rather, it only means that the drug companies may not advertise on-demand use for their drugs.
There is also a PrEP injection in development that can protect a user for eight weeks instead of just one day. The trial for the injection is in its final phase, and the results so far show that the injection is even more effective at preventing HIV infection than daily pills. The injection would also be the most effective method for cisgender women — but it is not yet available to consumers.
If PrEP is so effective, why aren’t more people using it?
One big hurdle is cost. The list price for a month’s supply of Truvada is almost $2,000. Generic drugs often cost less than brand name drugs, but the generic version of Truvada costs $1,455 — only about 25% less than the branded drug. A more substantial price drop is expected in early 2021 as more drug companies enter the generic drug market.
To ease the burden on consumers, local and federal governments offer programs that help with the cost. The Ready, Set, PrEP program from the U.S. Department of Health and Human Services, for example, offers PrEP at no cost to people who qualify. Some states — such as New York, California, Massachusetts and Washington — provide similar assistance through programs like PrEP-AP or PrEP DAP.
In addition, Gilead — the manufacturer of Truvada and Descovy — offers a patient assistance program for uninsured people, as well as a co-pay card that covers up to $7,200 in patient out-of-pocket costs per year.
What are other hurdles besides PrEP’s high price tag?
There are cultural and behavioral barriers, too.
A big one is shame. “There’s a lot of stigma about HIV and PrEP,” Krakower says. “In some communities, that can make people afraid to seek it out or talk to their health care providers about it.” He also says many health care providers are reluctant to talk about HIV and PrEP, which “makes them less likely to seek out patients who may benefit from using PrEP and less likely to prescribe it.”
Another barrier is that people are likely to underestimate the risk of contracting HIV. Even though people know that the risk of infection exists, some potential patients don’t associate that with their own personal risk, says Kevin Robert Frost, the chief executive of amfAR, one of the world’s largest AIDS research foundations. For example, people in monogamous relationships may downplay the risk of HIV, and think that they don’t need PrEP, he adds.
However, according to Frost, the biggest hurdle is the inequity in the U.S. healthcare system. Thinking about who has healthcare access and who doesn’t, “you begin to understand why we haven’t been able to drive the HIV epidemic down to zero,” he says. “The very communities that need [PrEP] the most are the ones who are getting this the least.” For patients in Black and Latino communities in particular, “[t]heir doctors aren’t prescribing it or they don’t have healthcare access. And that’s why we’re not able to drive those infections down in those communities.”
So, will PrEP end the HIV epidemic?
The U.S. government has set a goal to end the HIV epidemic by 2030, and PrEP is an important part of the strategy to get there. But Frost argues that there are “other examples of tools that have been at our disposal for some time now, of which we’re not really fully able to take advantage.”
Syringe exchanges are one such tool. They provide clean needles to injection drug users and have been shown to be effective in protecting users against HIV transmission, as shown in a 2013 review of needle and syringe exchange programs. In 2018, one in 15 people diagnosed with HIV were injection drug users, according to a 2018 report from the Centers for Disease Control and Prevention. Yet needle and syringe exchange programs remain controversial, as they are sometimes seen as encouraging drug use. According to a 2007 publication by the Institute of Medicine, however, such programs do not lead to increased drug use.
Ultimately, ending the HIV/AIDS epidemic will require a multi-pronged strategy, including a bigger push for PrEP drugs. “All these things are solvable if you have political will and community investment and healthcare provider participation,” Krakower says. “I’m optimistic that we’ll sort this out.”