Expert panel recommends all types of PrEP

  • by Liz Highleyman, BAR Contributor
  • Friday August 25, 2023
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A new recommendation by the U.S. Preventive Services Task Force adds PrEP medications Descovy, left, and long-acting Apretude to its 2019 recommendation for Truvada and generic versions of the drug for people at risk for HIV. Photos: Courtesy Gilead Sciences Inc. and ViiV Healthcare
A new recommendation by the U.S. Preventive Services Task Force adds PrEP medications Descovy, left, and long-acting Apretude to its 2019 recommendation for Truvada and generic versions of the drug for people at risk for HIV. Photos: Courtesy Gilead Sciences Inc. and ViiV Healthcare

The U.S. Preventive Services Task Force released a recommendation this week calling on health care providers to prescribe all approved PrEP options for people at increased risk for HIV.

The new recommendation adds tenofovir alafenamide/emtricitabine pills (Descovy) and long-acting injectable cabotegravir (Apretude) to its 2019 recommendation of tenofovir disoproxil fumarate/emtricitabine pills (Truvada and generic equivalents).

The recommendation, released August 22, received an "A" grade, meaning it is well supported by scientific evidence. The national Affordable Care Act requires private insurers to fully cover USPSTF-recommended prevention services with an "A" or "B" grade and provides financial incentives for state Medicaid programs to do so. This requirement will apply to the additional forms of PrEP in early 2025.

Public health officials and advocates hope the expanded USPSTF recommendation will help increase PrEP uptake, but the coverage requirement is jeopardized by an ongoing lawsuit by conservative business owners who claim it violates their religious freedom. As the Bay Area Reporter previously reported, a Texas judge blocked the requirement in March, but it remains in effect while the U.S. government appeals the decision.

"Expanding PrEP is a priority if we are to end the HIV epidemic," Dr. Carlos del Rio, president of the Infectious Diseases Society of America, and Dr. Michelle Cespedes, chair of the HIV Medicine Association, said in a statement. "Unfortunately, the current court challenge to the preventive services coverage requirement, if successful, would put more people at risk for HIV and other serious infectious diseases and would be a major setback to efforts to end HIV as an epidemic."

The task force recommended daily Truvada or Descovy pills or Apretude injections administered every other month; it did not address on-demand PrEP taken before and after sex. All three PrEP options are highly effective, reducing the risk of HIV acquisition by more than 99% if used consistently. All are generally well tolerated, but Truvada can cause kidney and bone problems in susceptible people, while Descovy has been linked to weight gain and elevated cholesterol.

Truvada and Apretude are approved for all individuals at risk for HIV. However, due to a lack of evidence from clinical trials, Descovy is not approved for people who are at risk for acquiring the virus via vaginal sex, such as cisgender women and transgender men.

Based on a review of medical studies, published this week in JAMA, the Journal of the American Medical Association, the expert panel concluded "with high certainty" that all three PrEP options offer "substantial net benefit" in reducing HIV acquisition for adolescents and adults at increased risk.

To determine whether people are at increased risk, the task force advises providers to talk with patients about their sexual history and injection drug use "in an open and nonjudgmental manner." Factors that increase risk include having sex with a person who has HIV, having a recent sexually transmitted infection, not using condoms consistently, engaging in transactional sex, and sharing needles to inject drugs. Transgender women are at especially high risk for HIV acquisition, the panel noted.

"PrEP is an essential tool to help reduce rates of HIV in our nation," task force member Dr. John Wong of Tufts University School of Medicine said in a statement. "To prevent HIV, it's important that healthcare professionals prescribe PrEP to patients at increased risk and discuss which form of this medication would be best for them."

Cost and access

More than 36,000 people were newly diagnosed with HIV in 2021, most of them gay and bisexual men, according to the federal Centers for Disease Control and Prevention. While white gay and bisexual men in San Francisco and other cities have eagerly adopted PrEP, uptake has been slow among gay men of color and cisgender women. The CDC estimates that about a third of the 1.2 million people who could benefit from PrEP are using it, but this ranges from just 11% of Black people and 21% of Latino people to nearly 80% of White people. Uptake of injectable PrEP has been particularly low.

"We're still seeing that many people who could benefit from PrEP aren't receiving this highly effective medication, particularly in Black, Hispanic, and Latino communities," said task force member Dr. James Stevermer of the University of Missouri. "It's critical for health care professionals to keep these disparities in mind and to have conversations with patients who are at risk about proven ways to prevent HIV, including taking PrEP."

Truvada was approved by the U.S. Food and Drug Administration in July 2012, and generic versions have been available since 2020. But Descovy (approved in October 2019) and Apretude (approved in December 2021) are still under patent, and the cost — approximately $23,000 per year for each — can be prohibitive. Gilead Sciences Inc., which makes Descovy, and ViiV Healthcare, which makes Apretude, offer patient assistance programs and copay cards for people with private insurance, but they do not always fully cover out-of-pocket costs for the medications and associated care, which includes regular lab tests.

"The USPSTF recommendation and coverage requirement will mean that long-acting injectable PrEP clients will not have to depend on pharmaceutical copay assistance," Reina Hernandez, associate director of navigation services at the San Francisco AIDS Foundation, told the B.A.R. "Because oral PrEP's effectiveness depends on daily adherence, it is critical that we have affordable injectable options for folks who may struggle with adherence. We know that people affected by mental health issues, housing instability, anti-Black racism, transphobia, and lack of access to employment or other resources may have more difficulty with adherence. That is why ensuring equitable access to all PrEP options is a matter of racial and health justice."

In California, Medi-Cal already covers all approved PrEP, a new state law requires most commercial health plans to cover PrEP without prior authorization, and the state has a PrEP Assistance Program as a payer of last resort. But people seeking PrEP often need patient navigators to help them negotiate the complex payment system, and those living in other states have fewer options.

"It is critical to address medication cost and insurance coverage, especially for the recently approved long-acting injectable cabotegravir and in states that have not adopted Medicaid expansion," Drs. Albert Liu, Hyman Scott, and Susan Buchbinder of the San Francisco Department of Public Health wrote in a JAMA editorial accompanying the recommendation.

"Several groups have advocated for a National PrEP Program that provides nationwide coverage for PrEP medication, follow-up visits, and laboratory costs," they added. "Such a comprehensive, federally funded program would be transformative in eliminating PrEP access barriers and ensuring access to PrEP for all who need it."

Updated, 8/25/23: This article was updated with an expanded quote from Reina Hernandez at the San Francisco AIDS Foundation.

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