Expert Panel Recommends New Drugs for HIV Prevention

By John Mercury August 22, 2023

An influential expert panel has given its highest recommendation to an expanded menu of H.I.V. prevention strategies for adults and adolescents, a move that will require private insurers to cover the drugs without a co-pay or deductible under the Affordable Care Act.

The recommendation arrives as the Biden administration is fighting to preserve no-cost coverage of all preventive services under the A.C.A., after a Texas judge ruled the mandate to be unconstitutional.

The ruling was aimed in particular at medications approved for use as pre-exposure prophylaxis (or PrEP) to prevent H.I.V., arguing that requiring its coverage violated the religious rights of employers.

In the new recommendations, published on Tuesday in JAMA, the U.S. Preventive Services Task Force gave its highest or “grade A” recommendation to three medications approved for PrEP.

The new ruling updates the earlier endorsement of a single daily pill, Truvada or generic equivalents, for PrEP. The task force now has included Descovy, another pill, and cabotegravir (marketed as Apretude), an injectable drug given every two months.

Generic Truvada generally costs $1 per day, while the new options may cost more than $20,000 per year.

An estimated 1.2 million Americans are living with H.I.V. Thanks to powerful medications, the virus is not the death sentence it once was. Still, H.I.V. is not yet curable, save for a handful of extraordinary examples, and preventing new cases is a public health priority.

Nearly 31,000 people acquired H.I.V. in 2020, and nearly 70 percent of those cases occurred among adolescents and adult men who have sex with men. A 2018 study estimated that more than 12 percent of men who have sex with men in the United States are living with H.I.V.

“We already do a really, really crummy job in our country of providing preventive services,” Dr. Thomas Dobbs, dean of the University of Mississippi’s John D. Bower School of Population Health, said.

“If we don’t have no-cost access to some of the most essential preventive services, our poor health standing is only going to deteriorate.”

The new guidelines recommend that clinicians routinely ask patients about their sexual and injection drug use history. Doctors should offer PrEP to anyone who has a sexual partner with H.I.V., has had a bacterial sexually transmitted infection within the past six months, uses condoms inconsistently or never, injects drugs or has a drug-injecting partner with H.I.V., or engages in transactional sex, the task force said.

The C.D.C., on the other hand, recommends that clinicians discuss PrEP with all sexually active adults and adolescents, and prescribe PrEP to anyone who asks for it.

“It’s hard to tease out who might be a risk, and certainly sometimes those conversations are kind of tricky,” Dr. Dobbs said. “If people think that they need it, that’s all that we have to hear to say yes.”

In June 2019, the task force recommended the only drug available for PrEP at the time, Truvada. (Generic versions have since become available.)

In October 2019, the Food and Drug Administration approved another daily pill, Descovy, to prevent H.I.V. in men and transgender women; the drug is only now being studied in cisgender women. Descovy is thought to be safer than Truvada for people with kidney disease or osteoporosis.

And in December 2021, the agency approved the long-acting shot, cabotegravir, for PrEP. Cabotegravir is administered every two months and offers an alternative to people who are unable or unwilling to take a daily pill to prevent H.I.V. In two trials, the injection appeared to be more effective at thwarting H.I.V. than Truvada and its generic equivalents were.

To update its recommendations in 2019, the task force commissioned a systematic review of 32 studies, most of which clearly showed PrEP’s benefits.

The task force sometimes moves slowly, but in this case it “acted fairly swiftly to update the recommendation,” Amy Killelea, a consultant to the advocacy organization PrEP4All, said. The new stance “matches the evidence base that we have right now for PrEP.”

Several studies have also shown that cisgender men who have sex with men can use generic Truvada for “on-demand” PrEP. Two pills are taken two to 24 hours before sex, one pill 24 hours after the double dose and another 24 hours later. The International AIDS Society and World Health Organization endorse this approach as effective.

Adoption of PrEP has been slow for a number of reasons, including a lack of awareness and unwillingness to take the daily pills. It’s not yet clear whether insurance companies will stand up hurdles to the new regimens, such as offering generic Truvada as the first-line preventive and requiring prior authorization for the other options.

“Those prioritizations and stuff are a real impediment to having choice,” Dr. Dobbs said.

Clinicians will also need to combat striking racial disparities in PrEP use. In 2021, Black Americans accounted for roughly 40 percent of new H.I.V. diagnoses. That year, only 11 percent of Black people who were expected to benefit from PrEP received it, compared with 78 percent of white people who met the criteria.

The task force’s recommendation also does not ease access for uninsured people.

“We have a huge access problem for people who are uninsured in this country, and we have a growing health equity crisis,” Ms. Killelea said. “A federal national PrEP program would help to solve that problem.”

PrEP does not reduce the risk of other sexually transmitted infections. Clinicians should counsel patients about taking their medications on time, practicing safe sex, including condom use, and testing regularly for H.I.V. and other sexually transmitted diseases, the task force said.

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