Tension over generic entry sees Gilead donating 2.4m bottles of PrEP

The US Center for Disease Control and Prevention (CDC) will receive 2.4 million bottles of Truvada (emtricitabine and tenofovir disoproxil fumarate) from Gilead annually – the preventative treatment for HIV.

Truvada is indicated in combination with safe sex practices for HIV pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative.

A grassroots campaign against patent extensions and the continuation of the patent for Truvada is ongoing. With the campaign making ground tension over possible generics in the US intensifies.

On May 8, 2019, Gilead announced that a generic of Truvada will be available in September 2020, which is a year earlier than expected.

In its SEC filing​, Gilead stated that the possibility of decreasing sales from Truvada and its other HIV medications is possible. The company said that government reimbursement, resistance, and new branded or generic products introduced to the market may inhibit its ability to maintain pricing and affect its market share.

Gilead is facing generic competition in Europe currently, as its Truvada patent protection, which was extended by a supplementary protection certificate, was overturned last year, allowing for generic entry in certain countries.

Descovy approaches​

The donation from Gilead will allow the CDC to provide the treatment to uninsured Americans at risk of contracting HIV. Gilead’s donation initiative will continue to 2030, at which point it will transition to providing Descovy (emtricitabine). Descovy is approved in combination with antiretroviral agents for the treatment of HIV infection but has not yet been approved for PrEP.

Currently, Descovy for HIV PrEP is under investigational review and has not yet been proved to be safe or efficacious. Gilead submitted a supplemental new drug application (sNDA) for Descovy for PrEP to the US Food and Drug Administration (FDA) along with a priority review voucher in April 2019 and is anticipating a response in six months.

Both Truvada and Descovy carry boxed warning labels for a risk of post-treatment acute exacerbation of hepatitis B. Truvada also carries a boxed warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection.

Donation to end epidemic ​

Gilead stated that around 200,000 US citizens of the 1.1 million who are at risk for HIV receive Truvada for PrEP. However, many individuals who are at risk for contraction of the virus cannot receive the drug due to social and structural barriers, such as limited awareness of PrEP and lack of access.

Gregg Alton, chief patient officer at Gilead, said in a statement, “We believe today’s donation, combined with efforts to address the root causes of the epidemic, such as racism, violence against women, stigma, homophobia and transphobia, can play an important role in ending the HIV epidemic in the US, particularly in parts of the country with the highest burden of disease.”​

The donation is set to accelerate an effort to reach the at-risk population and create an opportunity for state and local partnerships to develop protocols for uninsured individuals at risk to receive PrEP at no cost.

Currently, the annual number of new HIV diagnoses in the US has remained stable since 2013, following a previous five-year decline. However, 48 ‘hotspot’ locations or concentrated regions with a large at-risk population have been determined.

Gilead has also made a 10-year, $100m (€89m) commitment to the HIV/AIDS epidemic in the southern region of the US and established a price freeze for all of its HIV medications for state AIDS Drug Assistance Programs in 2008, which remains in effect through 2019.