Some patients are discontinuing the HIV prevention drug, Gilead Sciences Inc.'s Truvada, or asking their doctors to switch them to a newer drug over safety concerns prompted by ads on social media, medical professionals and public health officials said.
The anxiety over Truvada’s safety is coming from patients who are seeing advertisements on Instagram and Facebook that could be read to imply that the drug has harmful side effects. Some examples of the ads include statements like, “Anyone who suffered Kidney or Bone Damage after Truvada/PrEP may be entitled to Financial Compensation.”
Truvada, also known as pre-exposure prophylaxis or PrEP, is the key to the Trump administration’s initiative to stem the spread of HIV. The drug reduces the risk of getting HIV from sex by about 99% when taken consistently, the Centers for Disease Control and Prevention said.
Serious side effects haven’t been observed in HIV-negative people using Truvada for prevention. Confusion arises because there are documented side effects for HIV-positive patients who are taking a different version of the drug to treat their condition.
The fears prompted by the social media ads could blunt Trump’s HIV initiative, which is based on dispensing PrEP to at-risk populations. The question of side effects could also exacerbate already existing medical mistrust within the communities that could benefit most from PrEP—black and Latino gay and bisexual men, transgender people, and black women.
These populations “have well-established and well-reasoned reasons for medical mistrust for Truvada” because of a history of mistreatment by doctors and researchers, said Megan Coleman, a family nurse practitioner at the Whitman-Walker Health clinic in Washington D.C. The community health center focuses on care for LGBT patients and people with HIV/AIDS.
The advertisements are working against public health messaging that encourages people to use PrEP for HIV prevention, Demetre Daskalakis, deputy commissioner for the Division of Disease Control at the New York City Department of Health and Mental Hygiene, said.
The administration launched a program Dec. 3 to give Truvada to patients who are uninsured.
Descovy is the only other drug approved for HIV prevention, also produced by Gilead. Since the FDA cleared it in October, Coleman said almost all of her patients at the Whitman-Walker Health clinic have asked about switching, fearing Truvada’s side effects, and about half have switched or are considering doing so.
Daskalakis said he’s regularly receiving messages on social media from patients asking if it’s OK for their doctors to switch them to Descovy. He said doctors are getting caught up in the fears as well and switch patients to Descovy.
Patients also have stopped taking Truvada, both for HIV prevention and treatment, or don’t want to start taking it, Coleman said. Patients who used Truvada for prevention in the past have asked how that previous use could affect them now, she added.
The anxiety around the safety of Truvada could raise costs for prevention. Truvada is set to go generic in September, which should lead to a decline in cost from the current $20,000 per patient per year. Gilead is seeking to extend two of its patents on Descovy until 2025. If that request is granted, there wouldn’t be a generic version of the newer drug for years.
To get more people on PrEP with “any hope of cost-effectiveness, we’re going to need to use generic PrEP,” which means using Truvada, Christopher Morten, a patent attorney and teaching fellow at New York University School of Law Technology Law & Policy Clinic, said. This fear will “undermine the effort of the Trump administration to end the epidemic.”
“If we do not get ahead of this and have a clear and consistent message of the safety, tolerability, and efficacy of both these medications, we’ll already be behind the gate.” Coleman said.
These ads could also lead to an inability to “scale up PrEP the way we need to to make an impact,” Coleman said.
The differences between Truvada and Descovy are clinically insignificant, Daskalakis said. But he said he isn’t sure how to fix the damage already done the social media ads except making it clear that Truvada is safe.
One component of PrEP, tenofovir disoproxil fumarate (TDF), has been shown to affect bone density or kidney function when used as a treatment for HIV. However, PrEP for HIV-negative patients has been shown to cause those problems in exceedingly rare cases, a CDC spokesperson said.
A few patients had slight declines in their kidney function early in PrEP use, but it stabilized and didn’t affect overall health, the spokesperson said. There have been rare cases of small changes in bone density, but they weren’t associated with an increase in fractures.
When patients stopped taking PrEP, both kidney function and bone density returned to initial levels.
The CDC has advised doctors to monitor kidney function regularly in patients who use PrEP and decline to prescribe PrEP to patients with abnormally low kidney function or pre-existing bone conditions, such as osteoporosis, the CDC spokesperson said.