Pharmaceutical giant Gilead Sciences announced Oct. 3 that it had received FDA approval for its medication Descovy to be used as a pre-exposure prophylaxis ( PrEP ) intervention to reduce the chances of HIV transmission. The new medication, according to the company, would offer fewer potential complications to kidneys or bone density than Truvada, the oral medication that has been used for PrEP for several years.
The approval comes shortly before Truvada is scheduled to become available in a less expensive, generic form. A month's supply of Truvada costs well over $1,500; while many states, cities and health organizations have implemented programs to ease access to the drug, and several insurers cover its use, the cost nevertheless has proven to be a barrier to widespread PrEP adoption. Foster City, California-based Gilead also offered copay assistance for Truvada patients. Descovy is expected to be similarly priced.
"Descovy for PrEP provides a new HIV prevention option that matches Truvada's high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time," said Daniel O'Day, chairman and CEO of Gilead Sciences in a statement. "This is a reflection of Gilead's continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum."
The approval also comes at a time when many advocates and stakeholders have been questioning the ethics of pharmaceutical pricing by Gilead and other drug companies. Earlier in 2019, many advocates noted that research and development for Truvada as PrEP was essentially paid for from federal funding, not Gilead, calling into question why the medication was so highly priced, when the company did not have to recover those costs. Activist and writer Mark S. King also recently accused Gilead of "duping" him into writing a Medicare-related editorial that he later determined was ultimately in the service of a company marketing initiative.
King's account of the experience with Gilead is at marksking.com/my-fabulous-disease/gilead-duped-me-into-being-their-mouthpiece-heres-how/ .