Gilead Wants to PrEP a Truvada Substitute

Gilead Sciences, Inc. has earned a reputation for playing dirty to maintain its stronghold upon the antiretroviral drug market, has shown a blatant disregard for the health and finances of HIV patients, and has even been taking advantage of legal loopholes to give insurers and patients no choice but to buy their product at a premium price.

In July 2023, the New York Times reported that internal documents at Gilead Sciences, Inc. revealed that the company decided to delay the release of an updated tenofovir formula that was potentially less toxic to patients’ kidneys and bones than the previous formula to prolong its patent protections specifically in order to maintain a monopoly on the market, prevent competitors from producing less expensive alternatives, and keep the prices for its tenofovir-based drugs at a premium. 

Deborah Williams, founder of patient advocacy group Health Policy Insights, LLC, states, “This [practice] is what is called lifecycle planning where a company can maintain the value of the original patents through spinoffs.”

As a result of Gilead’s lifecycle planning with its tenofovir-based drugs, some 26,000 patients have sued Gilead as a result of being exposed to bone and kidney problems and as of June 2024, the company has paid $40 million in settlements.

Unreported so far, Gilead has found a way to profit from amendments to the California State Health Code.

California Senate Bill 159, drafted by State Senator Scott Weiner (D-San Francisco) and Assembly member Todd Gloria (D-San Diego) and passed in May 2019, states, “…a health care service plan shall not subject antiretroviral drugs that are medically necessary for the prevention of AIDS/HIV, including preexposure prophylaxis or postexposure prophylaxis, to prior authorization or step therapy, except as provided in paragraph…If the United States Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of AIDS/HIV, this section does not require a health care service plan to cover all of the therapeutically equivalent versions without prior authorization or step therapy, if at least one therapeutically equivalent version is covered without prior authorization or step therapy.”

Effectively, this means that the law pushes patients onto Gilead’s Descovy over cheaper, similar generic versions of the same drug. Descovy currently has a list price of $2,202 per month; less expensive generic tenofovir formulas, like Truvada, can cost as low as $84 per month. “Step therapy,” which is a practice used by pharmacy benefit managers (PBMs) to encourage patients try the less expensive drug first so long as it is not a clinical “no-go,” could help keep costs down and keeps patients safe. But SB 159 effectively banned PBMs from doing step therapy. The problem is, the more expensive drugs used by a given patient are, the more expensive premiums become. Higher premiums are borne by individual insurees and taxpayers. While tons of people need access to PrEP medication, higher premiums give everyone a reason to care.

It’s worth noting that according to the San Francisco AIDS Foundation, both Truvada and Descovy are over 99 percent effective in preventing HIV. However, Truvada is a better fit for many patients. For example, the San Francisco AIDS Foundation states that Descovy should not be used by transgender men, heterosexuals, cis women, or users of injected drugs. Even worse, Gilead’s justification for obtaining a new patent on Descovy was that a change in sodium salt would positively impact bone minerality and renal function, but a 2024 randomized controlled trial showed that compared to generic Truvada, Descovy had a higher risk of increased cholesterol and weight gain. On the other hand, Truvada can result in weight loss. All in all, this means pushing patients onto Descovy over Truvada may not only be expensive, but also dangerous for some patients.

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According to a study conducted by the National Institutes of Health from 2019 to 2022, 47.1 percent of insurers surveyed overpaid $83 million on Descovy and $14 million on Truvada. Had step therapy been allowed, insurance costs would have been reduced by $98 million.

That data tracks with what Williams has observed. She says, “overall the growth in high cost specialty drugs according to AAA (actuaries) for 2025 premiums is a top problem.” But what is the solution?

According to her,“if [private insurers] were able to substitute drugs that authorities such as USPTF (U.S. Preventive Services Task Force) find therapeutically similar but lower cost that would be grand for private employers.” Presumably, it would also be better for everyone paying in whole or in part for their health insurance, too, which means plenty of PrEP patients.

With ongoing outrage at continued high drug prices and a need for PrEP drugs to remain widely accessible and affordable, there is an argument for looking at a language tweak to SB 159 to preserve PBMs ability to manage costs and protect patients. Expert legislative draftsmen should be more than capable of ensuring that California is neither steering everyone who could take a generic form of PrEP to higher-priced Descovy, nor preventing those for whom Descovy really is the only solution from accessing it. 

by James Conrad.