– Data Provide New Clinical Insights on Use of Veklury for Treatment of COVID-19 –

– Research Examines Strategies to Enhance the Participation of Communities Underrepresented in HIV Clinical Trials –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new data from the company’s virology research and development programs at the virtual IDWeek 2021 conference, taking place September 29 – October 3. The findings in COVID-19 research, HIV treatment research and HIV prevention research are the latest example of Gilead’s ongoing commitment to help address the evolving COVID-19 pandemic and the needs of people affected by HIV.

“In partnership with the infectious disease community, we continue to monitor and respond to the devastating global viral pandemic, while simultaneously working to maintain the tremendous progress that has been made toward ending the HIV epidemic,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Our antiviral research program is not only expanding the scientific understanding of our current HIV and COVID-19 medicines, it also urgently pursues innovation to address the dynamic nature of these pandemics and evolving needs of the communities most impacted.”

COVID-19 Research

At IDWeek 2021, Gilead will present real-world analyses of Veklury, the antiviral standard of care for the treatment of hospitalized patients with COVID-19, to help inform real-time decision-making of clinicians and frontline healthcare workers. These data include a comparative retrospective analysis evaluating the impact of Veklury on mortality rates across the spectrum of baseline oxygen requirements. A second analysis, drawing on data from a large cohort study of U.S. hospitals, looks at the association of patients treated with Veklury and 30-day readmission rates. Further late-breaking data on Veklury in COVID-19 will also be presented at IDWeek.

HIV Research

HIV treatment research data at IDWeek include long-term results from the BRAAVE 2020 study evaluating the safety and efficacy of switching to the once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virally suppressed Black or African American adults with pre-existing resistance, viral blips and suboptimal adherence. Data from the ongoing BRAAVE 2020 study could help inform the design of future research programs in Black adults, who continue to be underrepresented in HIV clinical research despite being disproportionately affected by the epidemic.

As part of the company’s HIV prevention research program, Gilead will present long-term outcomes from an open-label extension phase of the DISCOVER trial, which is an ongoing, randomized, double-blind, multicenter, active-controlled, phase 3, non-inferiority clinical trial evaluating the efficacy and safety of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) for PrEP (pre-exposure prophylaxis). Additional HIV prevention research includes insights into improving the recruitment of historically underrepresented individuals for the PURPOSE 2 trial of the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir for PrEP – specifically, optimizing enrolment of Black and Hispanic or Latinx gay and other men who have sex with men, transgender women, transgender men and gender nonbinary individuals.

Additionally, to further inform HIV treatment strategies across a broad range of people and communities affected by HIV, Gilead will present results from an in vitro study evaluating the concept of regimen forgiveness with integrase strand transfer inhibitor (INSTI)-based regimens at drug concentrations simulating variable adherence. Gilead will also present a clinical study evaluating methods for measuring adherence in people taking antiretroviral therapy.

Gilead’s accepted abstracts are as follows:

For more information, including a complete list of abstracts, please visit https://idweek.org/program/.

Please see below for U.S. Indication and Important Safety Information for Veklury. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warnings, for Biktarvy and Descovy for PrEP®.

Veklury is the first and only U.S. Food & Drug Administration (FDA) approved antiviral treatment for adults and pediatric patients at least 12 years of age and weighing at least 40 kg requiring hospitalization for COVID-19 in the United States. Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide. Currently, multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of COVID-19, in different patient populations, and in combination with other therapies.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use; its safety and efficacy are not established. The FDA has granted Priority Review designation to Gilead’s new drug applications (NDAs) for lenacapavir for the treatment of multi-drug resistant HIV-1 infection in heavily treatment-experienced (HTE) patients in combination with other antiretroviral agents. The investigational, long-acting HIV-1 capsid inhibitor has been given a Prescription Drug User Fee Act (PDUFA) action date of February 28, 2022, accelerating the review goal from ten months to six months from the day of filing acceptance. Gilead also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lenacapavir as a potential treatment for HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. As announced in August 2021, the MAA has been fully validated and is now under evaluation with the EMA.

The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

There is currently no cure for HIV or AIDS.

U.S. Indication for Veklury

Veklury® (remdesivir 100 mg for injection) is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

U.S. Important Safety Information for Veklury

Contraindication

• Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.

Warnings and precautions

• Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of Veklury. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time ≤120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications).
• Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation.
• Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury.

Adverse reactions

• The most common adverse reaction (≥5% all grades) was nausea.
• The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Drug interactions

• Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans.

Dosage and administration

• Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes.
• Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.
• Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate.
• Renal impairment: Veklury is not recommended in individuals with eGFR