The United States Preventive Services Task Force (USPSTF) on Tuesday for the first time recommended that doctors should offer pre-exposure prophylaxis (PrEP) to healthy people at risk of HIV infection.
More than one million U.S. residents are living with HIV, and an estimated 40,000 new U.S. residents are infected with HIV each year. About 1.2 million U.S. residents are eligible for PrEP, which research has shown is more than 90% effective at preventing HIV infection when taken daily. However, only about 78,360 U.S. residents took PrEP in 2016.
USPSTF in November 2018 issued a draft statement recommending that health care providers offer PrEP with antiretroviral therapy to all patients at high risk for HIV infection, including those who are otherwise healthy.
USPSTF said the draft recommendation was based on evidence showing PrEP decreases an individual's risk of contracting HIV. USPSTF reviewed data from 12 randomized clinical trials comparing PrEP with a placebo or no PrEP. Each of the clinical trials evaluated a risk-prediction tool designed to identify patients at high risk for HIV infection.
A meta-analysis of the clinical trials found PrEP was associated with a reduced risk of HIV infection when compared with a placebo or no PrEP after patients took PrEP for four months to four years, according to USPSTF. The task force said the evidence showed the drug's effectiveness was correlated with a patient's adherence to the drug's daily regimen.
In addition, USPSTF said evidence showed the use of an antiretroviral therapy reduces the risk of transmitting HIV to an uninfected individual, and early detection of an HIV infection reduces the risk of an AIDS-related death.
However, USPSTF found inadequate evidence to support the use of specific risk-assessment tools to identify patients at high risk for HIV infection. In addition, USPSTF said evidence showed PrEP potentially could cause renal and gastrointestinal adverse effects, as well as preterm births in pregnant women.
Ultimately, USPSTF concluded the overall risks associated with using PrEP are minimal and gave an "A" grade recommendation for providers to offer PrEP with antiretroviral therapy to all men and women who are at a high risk for HIV infection. Under the Affordable Care Act, insurers are required to cover preventive services that receive a "B" grade or higher form USPSTF without cost sharing.
USPSTF finalizes recommendation
USPSTF on Tuesday finalized the recommendation, which was published in JAMA. USPSTF in the final recommendation said PrEP is intended only for individuals at a high risk of HIV infection, which includes those with an HIV-positive sex partner, those who have sex without a condom with someone at a high risk of HIV infection, and those who share needles while injecting drugs.
Anthony Fauci, director of NIH's National Institute on Allergy and Infectious Diseases, said PrEP is key to accomplishing the Trump administration's goal of eliminating new transmissions of HIV/AIDS in the United States within the next 10 years. "If we're going to try and end the HIV epidemic in the way [President Trump] talked about in February of this year, then we've got to get a lot more people using PrEP," he said.
Many physicians have been hesitant to prescribe PrEP to healthy patients because of the drug's side effects, but those side effects are rare. In addition, not all health insurers currently cover PrEP, though USPSTF's recommendation likely will convince more payers to cover the drug.
"I consider this a significant advance toward our quest to get as many people on prevention as we possibly can," Fauci said, adding, "We are not going to bring the incidence of new infections down significantly unless PrEP is maximally utilized."
Hyman Scott and Paul Volberding, physicians and researchers at the University of California-San Francisco (UCSF), in an editorial accompanying the recommendation noted that, "[c]urrently, less than 10% of individuals with an indication for PrEP are receiving this medication." They added that the new recommendation "should serve to promote policies to expand PrEP access to those at risk."
PrEP's price is also a significant concern, Diane Havlir and Susan Buchbinder, both from UCSF, wrote in a separate editorial published Tuesday in JAMA Internal Medicine. Currently, the price of Truvada, the FDA-approved brand name version of PrEP, has a list price of almost $2,000 a month, they wrote. "How this recommendation will be implemented is of critical importance because cost is a major barrier," Havlir and Buchbinder said (Park, TIME, 6/11; AP/STAT News, 6/11; Aubrey, "Shots," NPR, 6/11).
Here are 8 clinical technologies that could transform health care delivery
Our new report explores the clinical technology pipeline to help health care leaders become more conversant in the major vectors of innovation, leading applications of new technologies, and the business implications for established providers. Read on to unpack the new innovation agenda.