The U.S. Preventive Services Task Force (USPSTF) issued a recommendation today calling on health care providers to offer pre-exposure prophylaxis, or PrEP, to men and women at high risk of acquiring HIV.
The recommendation received an A grade, meaning it is well supported by scientific evidence. This is important because the Affordable Care Act (ACA) requires private insurers to cover preventive services recommended by the USPSTF with an “A” or “B” rating.
The task force recommended once-daily Truvada (tenofovir disoproxil fumarate/emtricitabine) for all at-risk groups. But it also gave the nod to tenofovir disoproxil fumarate (TDF) alone—available as an inexpensive generic—for heterosexual men and women and people who inject drugs.
The task force also released a recommendation for routine HIV screening for people ages 15 to 65 and for all pregnant women, also with an “A” grade.
“The new recommendation for PrEP is enormously important news for the struggle against HIV,” said Robert Grant, MD, of the University of California, San Francisco, lead investigator for iPrEx, one of the key studies showing that PrEP is highly effective for men who have sex with men (MSM). “This grade A recommendation reflects the available evidence, which strongly supports the use of PrEP as a safe, effective method of HIV prevention.”
Based on a review of medical studies, the task force found “convincing evidence” that PrEP is of substantial benefit in decreasing the risk of HIV infection in people at high risk—with protection highly dependent on adherence—along with “adequate evidence” that PrEP is associated with only small harms, including kidney and gastrointestinal side effects.
On balance, the recommendation’s authors write in the Journal of the American Medical Association, “The USPSTF concludes with high certainty that the magnitude of benefit of PrEP with oral tenofovir disoproxil fumarate-based therapy to reduce the risk of acquisition of HIV infection in persons at high risk is substantial.”
But advocates caution that pressure may be needed to make sure insurers add PrEP to their coverage.
"The decision of the USPSTF to grant PrEP a Grade A recommendation is an excellent, if long overdue, step to ensuring universal access to this vital public health tool," said James Krellenstein of the PrEP4All collaboration. "Activists will now need to ensure that when this rule is implemented, all plans are not only charging zero cost sharing for access to the drug, but also to the vital clinical services that people on PrEP need to stay healthy."
The USPSTF authors note that more than 38,000 new HIV diagnoses were reported in 2017—an annual figure that hasn’t changed much since the FDA approved Truvada for PrEP in 2012.
The Centers for Disease Control and Prevention (CDC) estimates that in 2015, over 1.1 million people in the United States were at substantial risk of acquiring HIV. But only 8% of eligible individuals were using PrEP, falling to just 3% among Latinos and 1% among African-Americans—the group with the highest rate of new infections. More recent research shows that the proportion of gay and bisexual men who use PrEP has risen but still remains lower among Black and Latino men compared with white men.
The new recommendation—which was issued as a draft for public comment last November—say clinicians should offer PrEP to the following groups:
- Men who have sex with men who are sexually active and have one of the following:
- A sex partner living with HIV
- Inconsistent use of condoms during receptive or insertive anal sex
- A sexually transmitted infection (STI)—syphilis, gonorrhea or chlamydia—within the past six months
- Sexually active heterosexual women and men who have one of the following:
- A sex partner living with HIV
- Inconsistent use of condoms during sex with a partner whose HIV status is unknown and who is at high risk
- An STI within the past six months
- People who inject drugs who have one of the following:
- Shared use of needles or other drug injection equipment
- Risk of sexual acquisition of HIV, as described above
The recommendation highlights certain groups, including sex workers, bisexual men and transgender women and men, who may be at increased risk for HIV and should be considered for PrEP based on the same criteria.
The CDC estimates that approximately a quarter of trans women—and more than half of Black trans women—are living with HIV. The authors note that few transgender people have been included in trials of PrEP, but because PrEP has been shown to reduce the risk of HIV acquisition during receptive or insertive anal or vaginal sex, it can be considered for both cisgender and transgender people.
The authors state that consistent use of condoms decreases the risk of HIV acquisition by around 80%—and also protects against other STIs—but acknowledge that sexually active people often use condoms inconsistently. They also point to studies showing that when HIV-positive people are on effective antiretroviral therapy with an undetectable viral load, their risk of transmitting HIV is essentially zero; it’s unclear whether PrEP further lowers the risk.
With regard to which medications to use for PrEP, the authors point out that once-daily Truvada is the only regimen approved by the Food and Drug Administration (FDA) for HIV prevention. This regimen reduced the risk of HIV acquisition by 92% among the mostly gay and bi men in Grant’s iPrEx study; further research shows that the regimen is around 99% effective when used consistently.
Trials that enrolled heterosexual men and women and people who inject drugs showed that TDF alone is also effective for lowering the risk of HIV, and the recommendation includes this as an option for these groups. No randomized clinical trials have tested TDF monotherapy in MSM—and the task force is hesitant to make recommendations without such evidence—but there’s no reason to believe it wouldn’t be effective for this group as well.
Although no randomized trials have evaluated PrEP in teens at high risk for HIV, the FDA has approved Truvada for adolescents, and young gay and bi men are at particularly high risk for HIV acquisition. The authors advise providers to consider PrEP for teens on an individual basis.
Finally, the recommendation says little about intermittent or “event-driven” PrEP taken on a fixed schedule before and after sex (dubbed PrEP 2-1-1). Studies have shown that this approach is effective, but many participants had sex often enough that they took Truvada four or more times a week—the threshold for effectiveness of daily PrEP—and it remains uncertain whether the findings would apply to those having sex less frequently.
Implications of the Recommendation
The USPSTF recommendation has the potential to substantially expand access to PrEP. Many private insurers already cover Truvada for HIV prevention but cost sharing is common. Gilead Sciences, which manufactures Truvada, offers a co-pay card that people with private insurance can use to cover out-of-pocket costs, although some claim this benefit is inadequate. The new recommendation could have the effect of shifting the cost of Truvada from Gilead to insurance companies.
“Make no mistake about it—a Grade A from the U.S. Preventive Services Task Force is a huge win for people vulnerable to HIV infection and a key facet in the national effort to end the epidemic,” said Tim Horn, director of medication access and pricing for the National Alliance of State and Territorial AIDS Directors. “This will ultimately translate into access, without cost sharing, for thousands of commercial insurance and Medicaid clients alike. We’ll begin working with insurers, in earnest, to ensure that equitable access to PrEP and its related services is prioritized.”
HIV Medicine Association chair W. David Hardy, MD, concurs, emphasizing that coverage of associated services is important along with the medication itself.
“The recommendation, once implemented in 2021, will require insurers to cover PrEP with no cost sharing to patients,” he said. “The [CDC] recommends that individuals taking PrEP receive medical services every three months that include HIV and STD screening, laboratory monitoring and adherence counseling. Health insurer coverage of these clinical services as essential components of PrEP, without cost sharing, will be critical.”
“In addition to addressing insurance coverage issues, the USPSTF’s strong support of PrEP provides needed impetus to increase medical provider awareness of this essential prevention tool and to address providers’ reluctance to prescribe PrEP,” Hardy added.
But the recommendation won’t silence calls for lowering the cost of Truvada—currently about $1,600 a month—or making generic versions available. These demands have gotten louder since advocates discovered earlier this year that the CDC appears to hold patents on the use of Truvada for HIV prevention.
While people with access to the health care system and public or private insurance can generally find a way to obtain Truvada—especially those in cities where AIDS organizations and public health departments employ PrEP navigators to help them—the bigger issue is people who aren’t engaged in care and don’t have coverage. The ACA requirement that insurers cover USPSTF-recommended prevention services won’t be much help to those who aren’t insured.
Many state Medicaid programs cover Truvada for PrEP, but at the current cost this amounts to a substantial financial burden when funds are also needed for other health concerns. For example, Massachusetts Medicaid spends around $22 million and California spends about $50 million on PrEP, Kaiser Health News reports.
The cost also falls heavily on public health programs that provide starter packs of Truvada while clients work out other payment methods. Gilead recently announced it would donate more than 2 million bottles of Truvada for uninsured individuals through the CDC. But some advocates say this isn’t enough to close the PrEP gap.
“The two new USPSTF recommendation statements underscore the remarkable progress in preventing and treating HIV infection,” Hyman Scott, MD, of the San Francisco Department of Public Health, and Paul Volberding, MD, of the UCSF AIDS Research Institute, wrote in an accompanying editorial. “Together, the health gains in HIV treatment, the resulting reduction in transmission and PrEP provide the necessary tools to end the HIV epidemic. Success in the next chapter in confronting this epidemic demands that these tools be widely accessible and used.”
This article has been updated to include additional comments.
Ben Ryan assisted with reporting for this article.
Click here to read the full USPSTF PrEP recommendation.
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