– Results Continue to Demonstrate Statistically Significant Advantages of Descovy® Over Truvada® for Study Measurements of Bone and Renal Safety –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced 96-week results from the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for HIV pre-exposure prophylaxis (PrEP) compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for PrEP, in men and transgender women who have sex with men and are at risk for sexually acquired HIV infection. Descovy demonstrated non-inferior efficacy to Truvada through 96 weeks and statistically significant differences over Truvada for certain key measurements of bone and renal safety assessed in the study, which were pre-specified secondary endpoints. These data are being presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland.

“The 96-week data from the DISCOVER trial further support the comparable efficacy of Descovy and Truvada for PrEP and offer new insights into the improved renal and bone safety profile of Descovy as measured by key bone and renal markers,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “As more at-risk people use PrEP for longer periods of time, the data affirm the value of Descovy for PrEP as a new HIV prevention option.”

In the United States, Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Descovy has a Boxed Warning in its U.S. product label regarding the risk of drug resistance when used for PrEP in undiagnosed early HIV infection, and the risk of post-treatment acute exacerbation of hepatitis B. See below for Indication and Important Safety Information.

In the DISCOVER trial, 5,387 study participants were randomized in a 1:1 ratio to receive either Descovy or Truvada once-daily. The primary endpoint was the incidence rate of HIV infection when 100 percent of participants completed 48 weeks, and at least 50 percent of participants completed 96 weeks. As a secondary endpoint analysis, the incidence rate ratio (IRR) of Descovy to Truvada was evaluated when 100 percent of participants completed 96 weeks. Among the 2,670 participants who received Descovy over 96 weeks, eight acquired HIV (incidence rate: 0.16/100 person-years (PY)). Among the 2,665 participants who received Truvada for the duration of the study, 15 acquired HIV (incidence rate: 0.30/100 PY). These results confirm the continued non-inferiority of Descovy versus Truvada (IRR: 0.54; 95 percent CI 0.23, 1.26). After the primary analysis, there was one new HIV infection in the Descovy arm in a study participant with significantly reduced adherence for several months.

Bone and Renal Safety Outcomes

Bone mineral density (BMD) was measured in a subset of 375 participants at 96 weeks. For measurements of both spine and hip BMD, differences between the Descovy and Truvada arms were statistically significant. At Week 96, lumbar spine BMD increased by 0.95 percent in the Descovy group and decreased by 1.39 percent in the Truvada group (p