Truvada Generics Enter Market Earlier Than Expected: Who Will Carry Gilead's HIV Flag?

For years, Gilead Sciences had claimed that its antiviral drug Truvada (Shufatai, F/TDF, emtricitabine/tenofovir), used for the treatment and prevention of HIV infection, would not face generic competition until 2021. However, the company has recently quietly moved this expectation forward by one year.

This will not only accelerate the onset of generic competition for Truvada in the U.S. market, but also shorten the window for Gilead to transition patients from Truvada to its new HIV medication, Descovy (emtricitabine/tenofovir alafenamide, F/TAF).

In its Q1 2019 securities filing, Gilead Sciences stated that Teva was preparing to launch a generic version of Truvada in the U.S. market on September 30, 2020. In February of this year, Gilead indicated that, based on an agreement signed with Teva in 2014, the generic Truvada would not enter the U.S. market until 2021. In the latest filing, Gilead cited the same agreement, yet the launch date for the generic drug has been advanced by one year.

The news of the generic drug’s market launch closely follows the release of new PrEP data for Descovy. Truvada, the previous-generation antiviral medication developed by Gilead Sciences, received FDA approval for use in HIV pre-exposure prophylaxis (PrEP). In March this year, Gilead announced results from the Phase III DISCOVER study, demonstrating that Descovy was non-inferior to Truvada for PrEP and exhibited significantly better bone and renal safety profiles than Truvada.

Some analysts pointed out that the above data laid the foundation for Gilead to transition Truvada's PrEP revenue of over $2 billion to Descovy. More importantly, before the exclusivity loss in September 2021, there was an opportunity for most of Truvada's revenue to shift to Descovy.

In April this year, based on data from the DISCOVER study, Gilead submitted a supplemental application to the FDA to expand the indication for Descovy for use as pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in HIV-negative individuals. A Priority Review Voucher (PRV) was also submitted with the application. This move indicates Gilead’s effort to bring Descovy as a PrEP therapy to populations at risk of HIV infection as soon as possible, thereby facilitating a rapid transition of the Truvada patient population to Descovy.

Currently, Truvada is increasingly being used among populations at elevated risk of HIV infection. Activists have pointed out that the drug’s high price tag has prevented many who could benefit from accessing it; thus, Teva’s early launch of a generic version is welcome news, although the outlook remains less than optimistic. Aaron Lord, an activist with PrEP4All at NYU School of Medicine, stated, “This news represents a victory for the LGBTQ+ community, HIV activists, and U.S. taxpayers, but it is only the beginning. Even though the generic drug entered the market in September 2020, Truvada still retains a 15-month exclusivity period, and Teva is the sole generic supplier, which will do little to lower prices and improve drug accessibility.”

In 2018, global sales of Truvada reached $3 billion. While facing generic competition in the European market, its sales in the United States have remained a significant growth contributor for Gilead Sciences. Due to intense market competition, sales from the company’s former “cash cow”—its hepatitis C franchise—have declined substantially.

On the other hand, Gilead Sciences is currently facing scrutiny over its patents for Truvada as pre-exposure prophylaxis (PrEP). Activists have pointed out that government funding supported early research into the drug’s PrEP applications and have questioned the legitimacy of Gilead’s patents. Last month, The Washington Post reported that the U.S. Department of Justice is investigating the matter. Former U.S. President Donald Trump has also proposed incorporating PrEP into the plan to combat the HIV epidemic in the coming years.

Gilead stated that the earlier launch date of Teva’s generic drug is unrelated to this review.

For Gilead’s investors, the past few years have been far from smooth. Since 2016, Gilead’s stock price has fallen by more than 30%, and the company is currently mired in financial difficulties. Earlier this year, Gilead appointed Dan O’Day as its next CEO. Given Mr. O’Day’s extensive experience in commercializing blockbuster anticancer drugs, many market observers believe that this appointment signals oncology is highly likely to become a key growth driver in Gilead’s next phase of development. (Compiled by Sina Medicine/newborn)

Reference Source:

[1]Gilead's $3B Truvada will face generics a year early. Can Descovy still win over its patients?

[2] Amid R&D Setbacks and Declining Revenue, Gilead’s New CEO Announces 20% Cut in Sales Force

https://med.sina.com/article_detail_103_2_64298.html

[3] Gilead Sciences Uses Priority Review Voucher to Accelerate the Launch of HIV Prevention Therapy

https://med.sina.com/article_detail_100_2_64044.html