An influential panel of experts has issued its highest recommendation for an expanded range of HIV prevention strategies for adults and adolescents, a move that will make that happen require private insurers to cover the medication without a co-payment or deductible under the Affordable Care Act.
The recommendation comes as the Biden administration is struggling to maintain free coverage of all prevention services under the ACA after a Texas judge ruled the mandate unconstitutional.
The ruling specifically targeted drugs approved as pre-exposure prophylaxis (or PrEP) for HIV prevention, arguing that the obligation to cover them violated employers' religious rights.
In the new recommendations, published Tuesday in JAMA, the US Preventive Services Task Force gave three drugs approved for PrEP their highest, or “Grade A,” recommendation.
The new ruling updates the previous recommendation of a single daily pill, Truvada or generic equivalents, for PrEP. The task force now included Descovy, another pill, and cabotegravir (marketed as Apretude), an injectable drug given every two months.
Generic Truvada is generally $1 a day, while the new options can cost upwards of $20,000 a year.
An estimated 1.2 million Americans are living with HIV. Thanks to effective drugs, the virus is not the death sentence it once was. However, apart from a few exceptional examples, there is still no cure for HIV and preventing new cases is a public health priority.
In 2020, nearly 31,000 people contracted HIV, and nearly 70 percent of those cases occurred in adolescents and adult men who have sex with men. That's what a 2018 study estimated more than 12 percent of men who have sex with men in the United States are living with HIV
“We're already doing a very, very poor job of providing prevention services in our country,” said Dr. Thomas Dobbs, Dean of the John D. Bower School of Population Health at the University of Mississippi.
“If we don't have free access to some of the most important prevention services, our poor health will only worsen.”
The new guidelines recommend physicians routinely ask patients about their history of sexual and injecting drug use. Doctors should offer PrEP to anyone who has an HIV-infected sex partner, has had a bacterial sexually transmitted infection in the past six months, uses condoms irregularly or never, injects drugs or has a drug-injecting partner with HIV, or has transgender sex, the task force said .
The CDC, on the other hand, recommends doctors Discuss PrEP with all sexually active adults and adolescents and prescribe PrEP to anyone who asks.
“It's hard to figure out who might be a risk, and certainly these conversations are a bit tricky at times,” said Dr. Dobbs. “If people think they need it, that's all we need to hear to say yes.”
In June 2019, the Task Force recommended the only drug available for PrEP at the time, Truvada. (Generic versions are now available.)
In October 2019, the Food and Drug Administration approved another daily pill, Descovy, for HIV prevention in men and transgender women; The drug is currently only being studied in cisgender women. Descovy is considered safer than Truvada for people with kidney disease or osteoporosis.
And in December 2021 the agency approved the long-term effect Syringe, cabotegravir, for PrEP. Cabotegravir is given every two months and offers an alternative for people who are unable or unwilling to take a daily HIV prevention pill. In two studies, the injection seemed to help more effective at thwart HIV as were Truvada and its generic equivalents.
To update their recommendations in 2019, the task force commissioned a systematic review of 32 studies, most of which clearly showed the benefits of PrEP.
The task force sometimes moves slowly, but in this case it “acted fairly quickly and updated the recommendation,” said Amy Killelea, adviser to the PrEP4All advocacy group. The new stance “consistent with the evidence base we currently have for PrEP.”
Several studies have also shown that cisgender men who have sex with men can use generic Truvada for “on-demand” PrEP. Two tablets are taken two to 24 hours before sex, one tablet 24 hours after the double dose, and another 24 hours later. The International AIDS Society and the World Health Organization endorse this approach as effective.
The 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 if insurance companies will overcome hurdles to the new therapies, such as offering generic Truvada as first-line prevention and requiring prior approval for the other options.
“These prioritizations and so forth are a real barrier to choice,” said Dr. Dobbs.
Physicians also need to address striking racial disparities in PrEP use. In 2021, it was black Americans around 40 percent new HIV diagnoses. This year, only 11 percent of blacks expected to benefit from PrEP received it, compared to 78 percent of whites who met the criteria.
The task force's recommendation does not make access easier for those who are not insured either.
“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 nationwide PrEP program would help solve this problem.”
PrEP does not reduce the risk of other sexually transmitted infections. Doctors should advise patients to take their medications on time, practice safe sex, including using condoms, and get tested regularly for HIV and other STDs, the task force said.
