John Epling, a member of the task force and a professor of community medicine at the Virginia Tech Carilion School of Medicine and the Carilion Clinic, said routine discussion of the medication has not permeated primary care. He said he suspects that some doctors are not having conversations with patients who should be considered high-risk.
“It’s just one of those things that haven’t diffused all the way through primary care yet,” Epling said in an interview. “The more familiar territory is in using condoms and avoiding multiple sexual partners.”
The task force’s draft recommendations are aimed at persuading more doctors to bring up the subject of preventive drugs with their patients, he said.
If the recommendations become final, most insurance companies would be required by law to cover the medication without imposing a co-payment on patients.
Pre-exposure prophylaxis, known as PrEP, is a combination of two drugs — tenofovir disoproxil fumarate and emtricitabine — made by Gilead Sciences and marketed as Truvada. Taken daily in a single pill, the FDA-approved medication greatly reduces the chance of acquiring HIV, according to research cited by the task force. The Centers for Disease Control and Prevention says that PrEP cuts the risk of contracting HIV through sex by more than 90 percent and reduces the risk for intravenous drug users by more than 70 percent.
Side effects — mainly nausea and mild, reversible kidney problems — are minor, but patient adherence to the drug program varied between 30 percent and 100 percent in research considered by the task force, an independent panel of experts on preventive medicine.
The drug also is very expensive — according to Gilead, nearly $1,676 for a 30-day supply. Most insurance covers the drugs, but critics have cited out-of-pocket costs as perhaps the biggest obstacle to staying on the medication.
In a statement, a Gilead spokesman disagreed, adding that “the CDC estimates that less than one percent of people who are indicated for Truvada for PrEP have an unmet need for financial assistance. . . . Beginning September 1 of this year, we increased our patient support programs by raising the annual co-pay assistance from $4,800 to $7,200 and doubling patient eligibility for the Medication Assistance Program from six months to 12 months.”
The AIDS research foundation amfARcalled the new recommendation “encouraging,” saying the organization welcomes “any effort to increase its uptake among populations at high risk for HIV. . . . Today is a good day for HIV science and prevention.”
Growth in the use of PrEP has been rapid, according to a 2018 study led by epidemiologists at the Rollins School of Public Health at Emory University in Atlanta. Its use rose from 3.3 people per 100,000 population in 2012 to 36.7 people in 2017.
But use of the medication is more than twice as frequent in the Northeast than it is in the South, the researchers found, even though a disproportionate number of new HIV diagnoses occur in Southern states.
The development of effective therapies and better prevention have changed HIV from a death sentence to a manageable disease that people can live with for decades. The CDC estimates that 1.1 million people in the United States are infected with HIV, an estimated 15 percent of whom don’t know they have it, the task force reported.
According to the CDC, new HIV diagnoses are disproportionately concentrated among injection drug users and black and Latino men who have sex with other men.
The task force delineated four groups of people it considers to be at high risk for HIV:
●Men who have sex with other men and have a partner with HIV, a recent sexually transmitted infection or inconsistently use condoms;
●Heterosexuals who have a partner with HIV, a recent sexually transmitted infection or inconsistent condom use with a partner whose HIV status is unknown and is at high risk for contracting the virus;
●Injection drug users who share needles or are at risk of acquiring HIV through sexual activity.
●Sex workers or people trafficked for sex.
As it did in 2013, the task force also recommended that all people ages 15 to 65 and all pregnant women be screened for HIV.
The proposed recommendations are open for public comment until Dec. 26.