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

October 4, 2019 8:30 AM

- 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<0.001). Greater declines in RBP:CR and β2M:Cr were observed among participants randomized to F/TAF compared with those who received F/TDF. Additional renal outcomes data from the 5,387 DISCOVER trial participants through 48 weeks will also be presented, including that study participants randomized to F/TAF for PrEP had fewer study drug-related renal adverse effects (AEs) and fewer discontinuations due to renal AEs compared with study participants randomized to F/TDF. Common adverse reactions (≥2 percent; all grades) in the DISCOVER trial included diarrhea, nausea, headache, fatigue, and abdominal pain.

“These latest findings from the DISCOVER trial continue to support the clinical and public health potential of Descovy for PrEP,” said Tony Mills, MD, Assistant Professor of Clinical Medicine, UCLA and Chief Medical Officer, SoCal Men’s Medical Group and lead author of the DISCOVER study. “The improvements observed in these important markers of kidney health in the overall study population and in those who switched from Truvada to Descovy point to the potential for Descovy to be a preventive option for appropriate people at risk for HIV who may require longer-term PrEP use, including those who have previously taken Truvada for PrEP.”

A second presentation (abstract 1288) reports 48-week data on bone mineral density (BMD) outcomes among a subgroup of DISCOVER trial participants who received additional bone strength evaluations. Of these individuals (n=383), 53 participants were on baseline F/TDF PrEP at enrollment, 26 of whom were randomized to F/TAF. Participants who were randomized to switch to F/TAF experienced statistically significant improvements in BMD of the hip and spine compared with those randomized to continue F/TDF. In addition, participants taking F/TAF for PrEP were significantly less likely to develop osteopenia of the spine. The prevalence of osteopenia among the 2,694 study participants who took F/TAF for PrEP was 0.4 percent. The prevalence of osteopenia among the 2,693 study participants who took F/TDF for PrEP was 0.6 percent. Rates of fracture incidence were similar across the F/TAF and F/TDF groups. Among the subset of participants who were taking F/TDF for PrEP prior to randomization to F/TAF, significant improvements in hip BMD compared with baseline were observed, while spine BMD was unchanged.

“Maintaining bone mineral density is important when considering the potential impact of longer-term PrEP for people at risk for HIV infection,” David Alain Wohl, MD, Professor of Medicine, Division of Infectious Diseases, the University of North Carolina at Chapel Hill and lead author of the DISCOVER study. “These results provide valuable insight into the potential impact of Descovy for PrEP on important measures of bone strength in a diverse population over the course of nearly a year.”

Increased PrEP Use Associated with Significant Reductions in New HIV Diagnoses in Major U.S. Metropolitan Areas

A new analysis (abstract 1963) demonstrates the significant impact of PrEP for reducing new HIV diagnoses since the approval of the biomedical intervention, finding that between 2012 and 2017 metropolitan statistical areas (MSAs) in the United States with the highest rates of PrEP use experienced the greatest decreases in HIV diagnoses. Importantly, this effect was independent of the impact of treatment as prevention (TasP).

The analysis evaluates U.S. Centers for Disease Control and Prevention (CDC) HIV surveillance data collected between 2012 and 2017 from 105 MSAs, national pharmacy and medical claims databases and proxy data for TasP from HIV-suppressed individuals in 38 states and Washington, D.C. Between 2012 and 2017, the rate of PrEP use among at-risk individuals increased by greater than nine-fold, at an average rate of 2.95 percent per year, and HIV viral suppression increased by 1.34 percent per year during the same period. Overall, from 2012 to 2017, there was a 15.2 percent decline in the total rate of new HIV diagnoses. In MSAs with the highest rates of PrEP use, HIV diagnoses decreased by as much as 4.24 percent per year, whereas in MSAs with the lowest rates of PrEP use, HIV diagnoses decreased by 0.23 percent per year; these declines were statistically significant and independent of TasP. Comparatively, TasP independent of PrEP contributed to a 2.87 percent decline in HIV diagnoses for each percent increase in the proportion of HIV-infected people achieving viral suppression.

Projecting out five years, the analysis suggests that if PrEP utilization among individuals at high risk of HIV could reach 50 percent by 2022 in the MSAs analyzed, a 40.7 percent decline in the rate of new HIV diagnoses is possible.

These data support a multi-prong approach to reducing the number of new HIV diagnoses, combining TasP and PrEP.

Important U.S. Safety Information and Indication for Descovy for PrEP

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindication

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

INDICATION

DESCOVY for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Important U.S. Safety Information and Indication for Truvada for PrEP

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindications

Warnings and precautions: Comprehensive risk reduction strategies

Warnings and precautions

Adverse reactions

Drug interactions

Pregnancy and lactation

Dosage and administration

INDICATION

Truvada for PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation

Individuals at risk for sexually acquired HIV-1 may include those:

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that FDA and other regulatory agencies may not approve Descovy for PrEP in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Descovy for PrEP may never be successfully commercialized. There is also the possibility of unfavorable results from additional studies involving Descovy for PrEP. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full Prescribing Information for Descovy and Truvada, including BOXED WARNINGS, is available at www.gilead.com

Descovy, Descovy for PrEP, Truvada, Truvada for PrEP and Gilead are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Sung Lee, Investors

(650) 524-7792



Ryan McKeel, Media

(650) 377-3548

Source: Gilead Sciences, Inc.

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