HIV continues to be associated with health disparities in the United States and around the world. The virus remains an epidemic despite a notable reduction in new infections. According to the Centers for Disease Control and Prevention (CDC), in 2018 there were an estimated 37,832 Americans newly infected with HIV. Although effective preventive medications known as preexposure prophylaxis (PrEP) are available, major barriers to accessing them include prohibitive costs, perceived stigma, and limited access to medical care. New policy initiatives are needed to ensure access to PrEP as well as to screening and preventive care and education.
The two prophylactic agents approved by the Food and Drug Administration (FDA) for reducing new HIV infection in high-risk populations are Truvada (emtricitabine and tenofovir disoproxil fumarate) and the newer Descovy (emtricitabine and tenofovir alafenamide), both once-daily medications. When used by high-risk populations in conjunction with safe sexual practices, Truvada is more than 90% effective in preventing new HIV infection. However, there are still only about 200,000 PrEP users in the United States, despite CDC estimates that over 1 million at-risk individuals would benefit from it. Those most at risk are Blacks and Latinos, who constitute two-thirds of those likely to benefit from PrEP but account for the smallest percentage of PrEP prescriptions.
Since its approval by the FDA in 2012, Truvada has increased in price by 45%. The list price of a one-month supply is about $2,000. Gilead Sciences (which manufactures Truvada and Descovy) earned $3 billion in profit from sales of Truvada in 2018. The patent for Truvada is due to expire soon, but while a generic form is expected sometime this fall, it is not likely to cost significantly less.
Patients have difficulty accessing preventive care, including PrEP, for reasons that include poverty, lack of education on HIV prevention, associated medical costs, and being uninsured. The U.S. Preventive Services Task Force recently gave PrEP its grade A recommendation. This will require the majority of health insurers to cover the cost of PrEP. However, associated medical costs such as copays, routine provider visits, clinical lab work, and ancillary services lead to high out-of-pocket costs, which can be prohibitive. Furthermore, millions of Americans do not have health care coverage, which makes accessing and paying for PrEP and its associated costs nearly impossible. These barriers often undermine patient follow-up with providers and lead to medication nonadherence.
Among policymakers, there is no current substantive action to address the rising cost of drugs like Truvada. This is a multifactorial issue involving drug manufacturers, insurance companies, and federal and state legislators. Innovative policies have been implemented regionally to increase high-risk groups' access to PrEP. Several states, including Florida, California, New York, Colorado, Ohio, and Washington, have initiated programs that provide high-risk patients with access to Truvada for limited to no cost. Additionally, the Department of Health and Human Services launched the nationwide program Ready, Set, PrEP (http://www.getyourprep.com) to provide PrEP to those who qualify. However, such programs typically have income and eligibility restrictions.
Every year millions of dollars are spent on treating HIV and HIV-related conditions in the United States. Policy initiatives that target at-risk populations continue to be needed in many areas. A multifactorial approach would include making PrEP and associated medical care available and accessible to all Americans, regardless of insurance or income status. According to the CDC's national HIV/AIDS strategy (http://www.cdc.gov/hiv/policies/nhas.html), priorities include increasing prevention initiatives in communities where HIV is more prevalent, increasing the use of evidence-based preventive treatments, increasing education for all Americans regarding HIV prevention, and providing access to quality HIV care. Preventive care is the gold standard in public health. As providers it is imperative that we remain up to date regarding HIV prophylaxis and the resources available to our patients.