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Gilead Presents New Data From the Company’s HIV Clinical Development Program and Latest Findings on the Impact of HIV Pre-exposure Prophylaxis (PrEP) at IDWeek 2019

Published: 2019-10-04 12:30:00 ET

- Results from DISCOVER Trial Provide Bone and Renal Safety Profile Data from Participants who Switched from Truvada for PrEP® to Descovy for PrEP™ -

- Analysis Illustrates the Significant and Independent Impact of High PrEP Use on HIV Diagnoses Rate in Major U.S. Cities -

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced important findings from the DISCOVER trial evaluating Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for HIV pre-exposure prophylaxis (PrEP), showing significant improvements in key measures of bone and renal safety parameters in a subset of study participants who switched from Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP to Descovy for PrEP™. The company also released the latest data demonstrating that major metropolitan areas in the United States with the highest use of HIV PrEP experienced the greatest decreases in new diagnoses. The data will be presented at the IDWeek 2019 conference being held in Washington, D.C. from October 2-6.

“The results presented at IDWeek reflect Gilead’s ongoing commitment to expanding awareness of HIV prevention efforts and the impact of PrEP use in the United States, and continuing to research and develop new prevention options for people at risk for HIV,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “The data being shared at this year's meeting underscore the opportunity to reverse the HIV epidemic by supporting and accelerating the use of a broad range of prevention efforts.”

Descovy is approved for HIV-1 pre-exposure prophylaxis in at-risk adults and adolescents weighing at least 35 kg who are HIV-negative, excluding individuals at risk from receptive vaginal sex. The indication does not include use of Descovy in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Descovy and Truvada have Boxed Warnings in their U.S. product labels regarding the risk of drug resistance with use of Descovy for PrEP and Truvada for PrEP® in undiagnosed early HIV infection and the risk of post-treatment acute exacerbation of hepatitis B. See below for Indications and Important Safety Information. Descovy and Truvada do not prevent other sexually transmitted infections or cure HIV or AIDS.

DISCOVER Trial: Renal and Bone Safety Profile Data Among Participants Switching from Truvada to Descovy for HIV Pre-exposure Prophylaxis

Two sub-analyses of data from the DISCOVER trial, a multi-year global Phase 3 clinical study of HIV prevention in 5,387 men and transgender women who have sex with men (MSM, TGW) will be presented. These findings provide new bone and renal safety profile data from a subgroup of 905 study participants (17 percent) who were using Truvada for PrEP at baseline and were randomized 1:1 to either continue Truvada or to switch to Descovy for PrEP.

The first study (oral abstract 1962) reports 48-week renal safety parameters among 465 participants who switched from Truvada for PrEP to Descovy for PrEP after enrolling in the DISCOVER trial, finding statistically significant improvements in key prespecified laboratory measures of kidney function, including urine protein:creatinine (CR) ratio (UPCR), estimated glomerular filtration rate (eGFRCG) and markers of proximal tubular function (β2-microglobulin:Cr ratio [β2M:Cr] and retinol binding protein:Cr ratio [RBP Cr]). Improvements were statistically significant as early as Week 4 of the trial. At Week 48, eGFRCG increased by 3.9 mL/min from baseline for those randomized to F/TAF and decreased by 0.6 mL/min in those who continued to receive F/TDF (p

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Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.