AHF Urges Gilead to Sharply Reduce Price of HIV PrEP Drug Descovy Following FDA Approval

Compiled by Fan Dongdong

On October 3, the U.S. FDA approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in high-risk adults and adolescents weighing more than 35 kg. Descovy is not recommended for individuals at risk of HIV-1 infection through receptive vaginal sex, as its efficacy in this population has not been evaluated.

In a randomized, double-blind, multinational trial, the safety and efficacy of Descovy as pre-exposure prophylaxis (PrEP) were evaluated in 5,387 HIV-negative men and transgender women who have sex with men and are at risk of HIV-1 infection. The trial compared the efficacy of once-daily Descovy with Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) over a period of 48 to 96 weeks, with the primary endpoint being the incidence of HIV-1 infection in each group.

Among 2,694 participants at risk of HIV-1 infection who received once-daily Descovy, 7 cases of HIV-1 infection were reported. Among 2,693 participants at risk of HIV-1 infection who received once-daily Truvada, 15 cases of HIV-1 infection were reported. The trial results showed that the average annualized incidence rate of HIV-1 infection was 0.16 per 100 person-years in the Descovy group, compared with 0.34 per 100 person-years in the Truvada group. Descovy met the criteria for non-inferiority compared with Truvada. Furthermore, the Descovy group demonstrated significantly better safety profiles in terms of bone mineral density and renal function than the Truvada group, meeting the prespecified secondary endpoints.

Dr. Jeffrey Murray, Deputy Director of the Division of Antiviral Products at the FDA’s Center for Drug Evaluation and Research, stated: “PrEP medications are highly effective in preventing HIV infection when taken as directed in the Descovy labeling. This approval provides additional prevention options for certain patients at risk of HIV infection and supports the ongoing efforts of the FDA and the U.S. Department of Health and Human Services to develop treatments and preventive measures for HIV/AIDS, thereby reducing new HIV infections.”

However, last Friday, the AIDS Healthcare Foundation called on Gilead to “do the right thing immediately” by lowering the price of its pre-exposure prophylaxis (PrEP) drug Descovy. In a press release, Michael Weinstein of the AIDS Healthcare Foundation stated, “Over the past decade, Gilead deliberately suppressed patient access to TAF-based therapy, forcing patients to purchase the more profitable TDF. However, Gilead’s greed and pursuit of profit have caused tremendous harm to people living with HIV, with many patients suffering permanent kidney and bone damage due to tenofovir use.”

This August, when the FDA advisory committee recommended approving Descovy for PrEP, the AIDS Healthcare Foundation requested Gilead to reduce the cost of Descovy to $1 per tablet. According to data from Drugs.com, Descovy currently costs approximately $1,800 for 30 tablets, equating to $60 per tablet. In its latest request, the AIDS Healthcare Foundation removed the specific price requirement and simply called on Gilead to significantly lower the drug’s price.

In May this year, a U.S. federal judge, in a class-action lawsuit involving 140 patients across 31 states, alleged that Gilead should have taken into account the safety issues of its older drugs and should not have blocked patients’ access to next-generation HIV medications. Gilead’s TDF-based drugs—Viread, Truvada, Atripla, Complera, and Stribild—were approved by the FDA in 2001, 2004, 2006, 2011, and 2012, respectively. The safer, next-generation TAF-based products entered the market starting with Genvoya in 2015, followed by Odefsey and Descovy in 2016.

When Gilead launched its new drug regimen featuring TAF, the company touted the safety profile of the new product, particularly its lower risk of renal and bone toxicity, and vigorously persuaded physicians to transition patients to the next-generation therapy. The lawsuit states that “Gilead could have and should have incorporated greater safety into its earlier product designs, yet concealed this from physicians and patients for more than a decade.”

Gilead’s rationale for launching its new drug was not primarily patient-centric; rather, it was largely driven by the anticipated fierce competition from generic versions of Truvada, expected to hit the market in September 2020, which prompted the company to recently intensify efforts to switch patients to its newer product. In a letter to clients last Thursday, Geoffrey Porges, an analyst at SVB Leerink, wrote that compared with Truvada, Descovy has a relatively milder side-effect profile, including lower risks of bone toxicity and renal impairment. Furthermore, Descovy demonstrates a faster onset of action and maintains therapeutic drug concentrations for a longer duration.

In May this year, Gilead Sciences pledged to donate 2.4 million bottles of Truvada to the U.S. government. However, some U.S. media outlets stated that the true purpose of this move was not to control HIV infections, but rather to stifle competition from generic drugs. Previously, Gilead had also committed to donating a certain quantity of Descovy to the U.S. government if the FDA approved it for pre-exposure prophylaxis (PrEP) against HIV. Although it remains uncertain whether Gilead will fulfill its pledge, the approval of Descovy for PrEP is undoubtedly good news for the company. Porges had previously predicted that peak sales of Descovy would reach $3.8 billion, sufficient to offset and compensate for future sales losses of Truvada due to generic competition.

Reference Sources:

1、FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

2、Gilead called on to 'significantly cut' HIV med Descovy's price in PrEP