9 April 2019 - - US-based Gilead Sciences, Inc. (NASDAQ: GILD) has submitted a supplemental New Drug Application to the US Food and Drug Administration for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV, the company said.

A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months.

The filing is based on the results of the Phase 3 DISCOVER trial which evaluated the safety and efficacy of Descovy compared to Truvada in men and transgender women who have sex with men at high-risk for sexually acquired HIV infection.

Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) for PrEP is currently the only FDA approved product indicated to reduce the risk of sexually acquired HIV-1 in individuals (≥35 kg) who are HIV-negative and at risk for HIV.

Results from the DISCOVER trial, presented at the 2019 Conference on Retroviruses and Opportunistic Infections, demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at substantial and sustained risk of HIV acquisition.

Additionally, statistically significant improvements in renal and bone laboratory parameters were observed for participants receiving Descovy versus those receiving Truvada.

In the United States, Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ≥25 kg and is not indicated for PrEP.

Truvada is indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative and weigh ≥35 kg.

Descovy and Truvada each have a Boxed Warning in their respective product labels regarding the risk of post-treatment acute exacerbation of hepatitis B; the Truvada label also carries a Boxed Warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection.

Among DISCOVER trial participants, Descovy and Truvada were well tolerated and had low discontinuation rates due to adverse events of 1.3% and 1.8%, respectively. The most common (≥5% in the Descovy group) drug-related adverse event was diarrhea.

The use of Descovy for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally.

Descovy is not approved for the treatment of chronic hepatitis B virus infection and the safety and efficacy of Descovy have not been established in patients coinfected with HIV-1 and HBV.