- The influential U.S. Preventive Services Task Force now recommends people at high risk of acquiring HIV take Gilead Sciences' Truvada, which is approved as a preventive therapy for the viral disease.
- In its recommendation, the expert advisory group found "convincing evidence" that PrEP, or preexposure prophylaxis, provides a "substantial benefit" when it comes to decreasing the risk of HIV.
- The task force designates a letter grade to each of its recommendations based on medical evidence and the treatment's potential benefits. For Truvada, the group assigned an "A," meaning commercial plans must cover the drug under an Affordable Care Act requirement linked to the task force's grading.
The task force's recommendation could potentially expand access to PrEP, as its endorsement carries weight and requires many insurers to cover prescriptions at no cost to the patient, said Lindsey Dawson, an assistant director for HIV policy at the Kaiser Family Foundation, in an interview.
Adoption of PrEP is not yet widespread among those who stand to benefit the most, according to the Centers for Disease Control and Prevention. About 1 million could take PrEP, but only 90,000 prescriptions were filled in 2015, according to the CDC. The FDA approved Truvada (emtricitabine/tenofovir) for PrEP in 2012.
Numerous barriers contribute to the low uptake, including the stigma surrounding HIV and AIDS as well as the drug's high cost.
"We know that there are really significant access issues to PrEP right now," Dawson said.
Truvada is the only FDA-approved drug used to prevent acquisition of HIV. An agreement between Gilead and Teva means generic versions of Truvada will be available as soon as next fall, earlier than what was previously expected.
Gilead, though, plans to secure an approval for use of its newer drug Descovy (emtricitabine/tenofovir alafenamide) for HIV prevention as well.
Truvada generated sales of nearly $3 billion in 2018, while Descovy — currently approved as an HIV treatment — earned $1.5 billion.
Gilead has faced backlash for Truvada's price tag, which lists at about $1,780 per month. Most recently, company CEO Daniel O'Day was pressured on Truvada's pricing at a congressional hearing.
Though the task force's recommendation is a step forward, Kaiser's Dawson noted important caveats.
In particular, the recommendation is geared toward covering the drug regimen, rather than the ancillary services associated with obtaining a PrEP prescription, including lab work, doctors visits and other related costs.
In May, Gilead announced plans to donate enough of Truvada to treat as many as 200,000 uninsured Americans at risk for the virus each year.