In 2012, Gilead Sciences, Inc. was granted approval by the FDA for a HIV preventative medication, but there continues to be a problem of getting PrEP to the people that need it most.
Two medications, sold under the brand names Truvada® and Descovy® are approved for daily use as PrEP (Pre-Exposer Prophylaxis) to help prevent a person without HIV from getting the virus from sex or injection drug use. Studies have shown that PrEP is highly effective for preventing HIV if it is used as prescribed on a daily basis—up to 99% effective against sexually transmitted HIV.
But PrEP, can cost from $2,000 for a 30-day supply to $0 under certain insurance policies and cost support programs. Those without insurance, however, are less likely to have access to the drug or even hear about it.
“There’s a gap in getting PrEP to the people who need it most,” says Helen Koenig, MD, MPH, associate professor of clinical medicine and medical director of the MacGregor Infectious Diseases Practice at University of Pennsylvania (Penn).
Far too many Americans with HIV are unaware that they have it. Far too few have the virus under control through effective treatment. These findings—showing that progress in reducing new HIV infections in the United States has stalled in recent years—come in a new CDC Vital Signs report published December 3, 2019.
In 2018, only about 18% (219,700) of the 1.2 million people who could benefit from PrEP had received a prescription for the medication. Coverage was especially low among young people, African Americans, and Latinos who could benefit from PrEP, according to HIV.gov.
Those at Risk
“PrEP is for anyone who may be at risk for HIV; in fact, one in five new HIV diagnoses occurs in women,” Koenig says. But at highest risk are women of color, young gay men of color and injection drug users.
“Because of the opioid epidemic and use of fentanyl, which has a short half-life, many people are injecting more frequently, so the old ways people had been protecting themselves, now just isn’t enough for many” says David Metzger, research professor and director of the HIV Prevention Research Division at the Perelman School of Medicine.
Barriers and Stigmas
“We often have primary care [providers] not familiar with PrEP even though it’s now a Grade A [ U.S. Preventive Services Task Force] recommendation in the same prestigious boat as mammograms for women and hearing screenings for kids,” according to Koenig.
Stigma—which can be a debilitating barrier preventing people living with, or at risk for, HIV from receiving the health care, services, and respect they need and deserve—still tragically surrounds HIV. Responding to HIV is not just a biomedical issue but a social challenge, too.
Some, especially adolescents, just don’t want to talk about sex or recreational drug use with their doctors, or have their prescriptions show up on their parent’s insurance coverage.
“I don’t think the stigma is within the drug-using community, but I think there are a lot of people who inappropriately feel that drug users won’t be interested, willing, or able to adhere to the medication,” says Metzger, who also cites access to insurance as a major barrier to getting high-risk individuals on PrEP.
Programs in Place
The U.S. Department of Health and Human Services (HHS) launched Ready, Set, PrEP, a nationwide program that makes PrEP medications available at no cost to individuals who lack prescription drug coverage.
Koenig, who is also the medical director of Philadelphia FIGHT’s PrEP program, which provides HIV prevention services to patients in the city for low or no cost regardless of insurance status, says one of the hurdles for getting high-risk individuals on PrEP is insurance. To address this, she says Penn is in the early stages of piloting a program in Infectious Diseases that will allow medical professionals to see uninsured PrEP patients and test its long-term financial feasibility. That program has yet to roll out officially.
Plans for Future
On February 5, 2019, President Donald Trump announced his Administration’s goal to end the HIV epidemic in the United States within 10 years. To achieve this goal and address the ongoing public health crisis of HIV, the proposed Ending the HIV Epidemic: A Plan for America, will leverage the powerful data and tools now available to reduce new HIV infections in the United States by 75 percent in five years and by 90 percent by 2030 (Of note, the Trump administration recently filed a lawsuit against Gilead for patent infringement).
Meanwhile, Penn continues to be a site for ongoing research regarding new forms of and approaches for PrEP. The Penn Prevention Clinical Research Site is part of a global network of National Institutes of Health (NIH)-funded research sites that are testing new strategies for HIV prevention; one strategy being worked on is a new formulation of PrEP. “Importantly,” explains Metzger, “most of them are long-acting versions of PrEP.”