Among the myriad challenges facing HIV/AIDS advocates and healthcare providers has been increasing use of pre-exposure prophylaxis, or PrEP, among persons at risk for HIV transmission. A PrEP intervention, which usually consists of taking the oral medication Truvada, has been shown to decrease the risk of transmission by more than 90 percent.
Truvada was approved for PrEP use by the Food and Drug Administration in 2012 and, since then, has been widely prescribed by physicians to help at-risk patients prevent HIV transmission (it was earlier used to treat persons living with HIV). But Truvada's patent expiration in 2020 means both generic options for consumers are forthcoming and that a competing drug, Descovy, by the same manufacturer, is already on the market.
Some advocates are looking forward to having lower-cost options available. AIDS Foundation of Chicago (AFC) Senior Director of Prevention Advocacy and Gay Men's Health Jim Pickett suspects that "lower drug costs will lower the cost of access and alleviate some pressure on the system."
He added, "With PrEP, the costs are not just about the drug. There are costs affiliated with seeing your doctor, having blood work done, being tested for HIV and STI's. It's important to remember that services that come along with PrEP are part of the programPrEP isn't just a prescription. If our system can spend less on the drug, there's arguably more money to cover those other things which can be prohibitive for people."
The cost of Truvadawhich is a combination of the drugs known generically as tenofovir disoproxil fumarate and emtricitabinehas indeed been a key deterrent to widespread PrEP implementation. A month's supply of the medication is often $1,500-2,000. Nevertheless, many insurers cover Truvada in their formularies, and the medication's manufacturer, Foster City, California-based Gilead Sciences, provides consumer assistance for monthly co-payments their plans require.
Various public health agencies have also made PrEP access a central component to long-term strategies that eliminate new HIV transmissions, such as the Getting to Zero initiative launched in Illinois in late 2018. The federal government announced a similar program with PrEP interventions playing a central role in early 2019.
Nevertheless, PrEP adoption numbers remain far behind where advocates and providers want to see them. Getting the message about PrEP to white gay men has been a relatively minimal challenge, but communicating that same message to diverse audiences at risk, such as transgender women or young Black men, remains problematic. Usage in the southern United States, where a large number of new HIV transmissions take place, is also low.
In late 2019, Gilead announced it would donate a five-year supply of Truvada to 200,000 people. Their Truvada patent expired in late 2020. The company reached an exclusivity agreement for six months Israeli pharmaceutical manufacturer Teva for a generic version of tenofovir disoproxil fumarate and emtricitabine. Starting in spring 2021, Teva's exclusivity window expires and any manufacturer can produce a generic version of tenofovir disoproxil fumarate and emtricitabine.
Gilead still intends to remain a player in manufacturing and distributing medications for PrEP, however. In 2019, it received approval for use of Descovy as a PrEP intervention and has aggressively marketed the new drug as a replacement for Truvada. Google users who search "Truvada generic" will likely spot an advertisement for Descovy toward the top of their results.
Among the advantages of Descovy, according to Gilead, are reduced chances of complications to kidneys or bone density, which are stated side-effects to Truvada. But Descovy shares the same high cost as Truvada, about $16,600-20,000 a year, according to aidsmap.com .
Many advocates and providers say that there is no need for a "mass exodus" from Truvada to Descovy for PrEP users, Pickett said.
"In terms of prescribing for PrEP, the vast majority of people using Truvada for PrEP have absolutely zero clinical need to switch over to Descovy," he added. "The only clinical reason to switch would be if you have some underlying kidney or bone disease, or if Truvada is giving your kidneys a hard time."
Gilead could not provide a spokesperson to comment on Descovy by this article's deadline. Shortly after Descovy was approved for PrEP in October 2019, Daniel O'Day, Gilead's chairman and CEO, said the new medication nevertheless "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."
Prior to her appointment as director of the Centers for Disease Control and Prevention, Rochelle Walensky, MD, was lead author on a March 2020 Annals of Internal Medicine study which concluded that mitigating for Truvada's side-effects with a new medication was outweighed by the benefits of a lower-cost generic substitute for Truvada. Other researchers also have expressed concern that Descovy has not been tested on as diverse a population as Truvada has been.
"We already are seeing insurance companies pointing people to the generic alternativewhen you are prescribed PrEP, the insurance company might cover the generic form of Truvada," Pickett said. "They may or may not be inclined to cover Truvada itself. We are also seeing insurance companies put in utilization-management for Descovy, so if you are prescribed Descovy, the doctor has to show clinical need."
Gilead has also been involved in extensive litigation with the federal government regarding the PrEP-related patents. The CDC sued the company in 2019, maintaining that it had not been properly compensated for federal researchers' contributions to Truvada and Descovy's development. In January 2021, a federal judge rejected the Justice Department's motion to dismiss Gilead's counterclaims that the federal government had been in breach of key contracts, so the litigation will continue.
But for now, a key challenge for stakeholders remains getting the costs under control. Using PrEP represents a collective commitment of time and money for patients, providers and insurers.
In the years ahead, the PrEP landscape will likely change even further. An injectable version of the intervention has proven to be as effective as oral applications. In such a scenario, the medication cabotegravir could be injected and offer two months' worth of protection for patients who don't wish to take a pill every day.
Pickett said he didn't foresee injectable PrEP completely replacing pills however, noting that compliance challenges might only shift for some consumers. While the injection saves the patient from the responsibility of taking a pill, they'd still need a bimonthly appointment to receive it.
"I don't see it as replacing [oral medication]I see it as being additive," Pickett said. "I see it drawing in people who struggle with PrEP because it is a pill, or aren't interested because it's a pill. Overall, if we do it right and create support systems that make it easy for people to get their shotsimagine being able to do it at WalgreensI'll be super-excited about it. It means people having more options and more protection."