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Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Key Findings from HIV Treatment Research Studies Evaluating Biktarvy® and Investigational Long-Acting Combination Regimens Affirm Commitment to Continuous Biomedical Innovation

– Latest Real-World Evidence Analyses Evaluate Impact of Veklury® on Mortality and Long-COVID –

New Data Evaluating the Safety and Efficacy of Hepcludex® in People with HIV/HBV/HDV Coinfection to Be Presented

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new clinical data and real-world evidence (RWE) from its antiviral research and development programs at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) taking place from March 3-6. The data from nearly eighty studies across HIV, COVID-19 and viral hepatitis include late-breaking data, four oral presentations, and reflect Gilead’s commitment to address the evolving needs of a diverse range of people and communities affected by some of the world’s most challenging viruses.


“At CROI 2024, we look forward to sharing new research that highlights the breadth of our antiviral portfolio and expanding pipeline as we strive to treat, prevent, cure and help eradicate viral diseases worldwide,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “The data selected for presentation at CROI is a reflection of our unwavering commitment to advancing person-centered biomedical innovation in virology, aimed at fulfilling urgent global needs.”

HIV Treatment Research

Scientific discovery in HIV treatment is a pillar of Gilead’s commitment to help end the epidemic. At CROI 2024, presented study results and analyses will include further evaluation of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a long-term treatment option for a broad range of people with HIV who may also have common comorbidities and other specific health needs. Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir. Additionally, key findings from a study evaluating the investigational combination of lenacapavir with broadly neutralizing antibodies (bNAbs) will be featured in a late-breaker oral presentation. A late-breaker oral presentation of Week 24 data from the ongoing Phase 2 study evaluating an investigational once-weekly oral combination regimen of islatravir and lenacapavir will also be presented.

Specifically, Biktarvy presentations will include a two-year analysis of data from the Phase 3 ALLIANCE trial evaluating factors associated with hepatitis B (HBV) treatment response in adults with HIV-1/HBV co-infection initiating treatment. Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.

Gilead will also present outcomes from the ARTISTRY-1 Phase 2/3 study investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily single-tablet regimen of lenacapavir and bictegravir. Additional lenacapavir data presented at CROI 2024 will evaluate the efficacy and safety of the novel antiviral agent in combination with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) as a potential long-acting treatment regimen with twice-yearly dosing.

Additional HIV treatment research pipeline findings include an oral presentation of new proof-of-concept data on GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI) and PRESTIGIO registry data evaluating sensitivity to broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) in people with multi-drug resistant HIV.

COVID-19 Research

Gilead remains committed to understanding the COVID-19 treatment landscape and will present multiple RWE analyses, including on the impact of Veklury® (remdesivir) in reducing mortality in immunocompromised people hospitalized for COVID-19 during the Omicron period (Dec’21 – April’23). Gilead will also present a study on the disparities in COVID-19 treatment initiation by race and ethnicity among hospitalized patients and one on the effect of Veklury on long-COVID among people hospitalized with COVID-19. Additional presentations will include RWE of Veklury in combination with dexamethasone for the treatment of COVID-19, and study results from kidney transplant patients hospitalized with COVID-19.

Viral Hepatitis Research

Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV). The aim of this 96-week analysis from the Phase 3 MYR301 study is to evaluate the safety and efficacy of Hepcludex (2 mg or 10 mg) in patients with HIV/HBV/HDV coinfection. A separate analysis of RWE will examine liver-related events in people living with HIV/HBV coinfection with and without HDV. Since limited data is available to describe the natural history of triple infection with HBV/HIV/HDV, this retrospective cohort study, conducted using HealthVerity claims data from the US, evaluates baseline liver health, HDV prevalence, and the risk of liver-related events in individuals with HBV/HIV with or without HDV.

Select accepted abstracts are as follows:

HIV Treatment Research (B/F/TAF)

Disposition

Factors associated with HBV response to B/F/TAF vs. DTG + F/TDF at W96 in people with HIV-1 and HBV

Poster

Efficacy, safety and PK of BIC/FTC/TAF in adults with HIV and Tuberculosis on rifampicin at Week 24

LB Oral

Inflammatory profile of B/F/TAF, DTG/ABC/3TC, and DTG+F/TAF over 5-years and effects of viral blips

Poster

Longitudinal analysis of preexisting resistance-associated mutations prior to B/F/TAF switch

Poster

Safety of tenofovir alafenamide in individuals with a history of proximal renal tubulopathy on TDF

Poster

Weight gain in people with HIV (PWH) vs people without HIV (PWoH) over a 3-year period

Poster

A randomized trial switching adults ≥ 60 years old from first-line ART to B/F/TAF: week 48 results

Poster

Long-Acting HIV Treatment Research (Lenacapavir)

 

Efficacy and safety of weekly islatravir plus lenacapavir in PWH at 24 weeks: a Phase 2 study

LB Oral

Lenacapavir efficacy in CAPELLA patients with no fully active agents in optimized background regimen

Poster

Lenacapavir plus bNAbs for people with HIV and sensitivity to either teropavimab or zinlirvimab

Oral

HIV Pipeline Research

 

Phase 2 study of switch to daily BIC + LEN in individuals on a multi-tablet HIV treatment regimen

Poster

Preclinical characterization of GS-5894, a potent NNRTI with once-weekly oral dosing potential

Poster 

Antiviral activity, safety, and pharmacokinetics of GS-1720, a novel weekly oral INSTI

Oral

Teropavimab and zinlirvimab sensitivity in people living with MDR HIV-1: PRESTIGIO registry data

Poster

Type I IFN signaling and regulation in vesatolimod-treated virally suppressed adults with HIV-1

Poster

HIV Prevention Research

 

Sexual health outcomes among daily and on-demand oral PrEP users in China

Oral

HIV Cure Research

 

Immune profile during ATI in AELIX-002 HTI vaccine trial and its role in post-intervention control

Oral

COVID-19 Research

 

Remdesivir reduces mortality in immunocompromised patients hospitalized for COVID-19 during Omicron

LB Poster

Effect of remdesivir on post-COVID conditions among individuals hospitalized with COVID-19 by age

LB Poster

Disparities in treatment initiation by race and ethnicity among patients hospitalized for COVID-19

Poster

Remdesivir+dexamethasone vs. dexamethasone for the treatment of COVID-19: real-world study in the US

LB Poster

Characteristics and outcomes of kidney transplant patients hospitalized for COVID-19 in the United States

Poster

Viral Hepatitis Research

 

Risk of liver-related events in individuals with HBV/HIV coinfection with and without HDV

Poster

Efficacy and safety of BLV 2 or 10 mg for 96 weeks in CHD including two patients with HIV/HBV/HDV

Poster

For more information, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://www.croiconference.org.

Teropavimab, zinlirvimab, vesatolimod, GS-5894 and GS-1720 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown.

Lenacapavir, marketed as Sunlenca®, is approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom and the United States for the treatment of people with multi-drug resistant HIV in combination with other antiretroviral(s).

Lenacapavir is being studied in multiple ongoing early and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment and prevention that could uniquely fit into the lives of people living with HIV and people who would benefit from pre-exposure prophylaxis (PrEP).

The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program.

Islatravir, alone or in combination with lenacapavir, is investigational and not approved anywhere globally. Their safety and efficacy have not been established.

Bictegravir is an investigational compound and is not approved by any regulatory authority for use as a single-agent; its safety and efficacy are not established. ​

Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not yet been established.

The use of Biktarvy in individuals with HIV-1/HBV co-infection is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

Hepcludex (bulevirtide) has received full marketing authorization from the European Commission for the treatment of adults with chronic HDV and compensated liver disease. In the United States and other areas outside of the European Union and European Economic Area, bulevirtide is an investigational product and its safety and efficacy have not been established.

Please see below for the U.S. Indication and Important Safety Information for Veklury and Sunlenca®. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. There is currently no cure for HIV or AIDS.

About Biktarvy

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.

About Sunlenca

Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option.

The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir for HIV prevention is investigational, and its safety and efficacy for this use have not been established. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV.

About Veklury

Veklury (remdesivir) is a nucleotide analog prodrug invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and limited known drug interactions in diverse populations. It plays an important role in reducing disease progression across a spectrum of disease severity and enabling patients to recover faster. Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components. Please see below for the U.S. Indication and Important Safety Information for Veklury.

Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including XBB, XBB.1.5 and CH.1.1. Veklury continues to be evaluated against emerging variants of interest and concern, including EG.5, EG.5.1 and BA.2.86.

Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 14 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead’s voluntary licensing program.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

U.S. Indication for Sunlenca

Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

U.S. Important Safety Information for Sunlenca

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pr

Contacts

Jacquie Ross, Investors

investor_relations@gilead.com

Meaghan Smith, Media

public_affairs@gilead.com

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