GILD Gilead Sciences Inc

– Full Results From PURPOSE 2 Study Exploring Lenacapavir as a Potential Twice-Yearly HIV Prevention Option Among a Broad and Geographically Diverse Range of Cisgender Men and Gender-Diverse People –

– Four-Year Outcomes From Real-World BICSTaR Study Further Demonstrate the Consistent Efficacy and Safety Profile of Biktarvy, Providing Insights for HIV Clinical Care –

– Late-Breaking Oral Presentation From Phase 2 Study Evaluating an Investigational Once-Weekly Oral Combination Treatment Regimen of Islatravir/Lenacapavir –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of HIV research findings at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2024), taking place from November 10-13. The results from more than 40 studies across HIV treatment and prevention include late-breaking data and seven oral presentations. These findings reflect a robust portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV and help end the epidemic.

“We look forward to presenting new research from our broad and innovative HIV portfolio and pipeline as we strive to help end the epidemic through continuous scientific discovery,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Our contributions to HIV Glasgow 2024 demonstrate that people are at the center of all we do at Gilead. The breadth and depth of Gilead’s work underscore our commitment to driving the next wave of transformational innovations in HIV research.”

HIV Prevention Research

A late-breaking oral presentation at HIV Glasgow will be the first in-depth look at the full results from the PURPOSE 2 trial (NCT04925752), including data not presented last month at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 2 is a pivotal Phase 3 trial evaluating twice-yearly lenacapavir, Gilead’s injectable HIV-1 capsid inhibitor for the investigational use of HIV prevention, among a broad and geographically diverse range of cisgender men and gender-diverse people. The trial is part of a comprehensive program assessing lenacapavir in a variety of populations who need or want pre-exposure prophylaxis (PrEP) and, if approved, would be the first and only twice-yearly HIV prevention choice.

Prevention research presented at HIV Glasgow will also include a systematic review and meta-analysis of real-world data mapping HIV prevalence against PrEP uptake, health economic data on the impact of PrEP in France and the return on investment that HIV prevention has yielded for the French healthcare system. Data will also be presented from a study examining same-day PrEP initiation and its effect on PrEP uptake at a Canadian clinic.

HIV Treatment Research

Continuous scientific discovery in HIV treatment is a pillar of Gilead’s commitment to help end the epidemic. At HIV Glasgow, 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 provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir. Additionally, late-breaking data from the Phase 2 study (NCT05052996) evaluating an investigational once-weekly oral combination regimen of lenacapavir and islatravir will be presented during an oral session.

Specifically, Biktarvy presentations will include four-year outcomes from BICSTaR, (NCT03580668) an ongoing global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. As the average age of people with HIV increases, the management of comorbid conditions is an important consideration in HIV clinical care. BICSTaR helps to inform what the future of coordinated person-centered HIV care could look like.

Additional research studies evaluating Biktarvy include three-year outcomes from ALLIANCE, an ongoing Phase III study (NCT03547908) evaluating the efficacy and safety of the single-tablet regimen versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV/hepatitis B (HBV) coinfection who were initiating therapy.

Gilead will also present outcomes from the Phase 2 portion of the ARTISTRY-1 study (NCT05502341) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily regimen of lenacapavir and bictegravir.

Additional lenacapavir data to be presented at HIV Glasgow 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.

HIV treatment research pipeline findings also include a presentation of new pharmacokinetic and resistance data on GS-1720, a selective integrase strand transfer inhibitor (INSTI). The agent is being evaluated as a component of a novel, investigational, once-weekly oral INSTI/capsid-inhibitor combination regimen with GS-4182 aimed at providing new long-acting treatment options for people with HIV.

A late-breaker presentation will compare the rate of treatment emergent resistance associate mutations (TE-RAMs) in people with HIV taking three-drug single tablet regimens and cabotegravir+rilpivirine. A separate late-breaker oral presentation will explore clinical features and resistance patterns during second-generation INSTI failure from the ROSETTA-registry.

Overview of Scientific Presentations

HIV TREATMENT RESEARCH (B/F/TAF)

Oral Presentation

Randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from dolutegravir/lamivudine to bictegravir/emtricitabine/tenofovir alafenamide in people with HIV, good virologic control and neuropsychiatric comorbidities: Week 24 results from the MIND Study.

Poster

Four-year outcomes from the BICSTaR study: Observational analysis of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV in Canada, France and Germany

Poster

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve people with both HIV-1 and hepatitis B: 3-year outcomes from ALLIANCE

Poster

Global survey to evaluate engagement in care and treatment experiences of people with HIV

Poster

Rapid Start (RS) with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with HIV-1 (PWH): A systematic literature review (SLR) of clinical and patient-reported outcomes (PROs)

Poster

Persistence, safety, and virologic outcomes of B/F/TAF as a baseline or switch regimen in HIV-infected people living with advanced HIV disease in the real world: the BIC-CD4 study.

Poster

Real-world effectiveness in treatment-experienced (TE) people with HIV (PWH) switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) with distinct patterns of self-reported adherence

Poster

Multicentre, prospective cohort study of same-day initiation of antiretroviral therapy with BIC/FTC/TAF among antiretroviral-naïve people with HIV

Poster

Real-World Persistence of Bictegravir- versus Dolutegravir-based Single Tablet Regimens in a Large Urban Canadian HIV Centre

Poster

Incidence of comorbidities over 18 months with BIC/FTC/TAF, DTG/ABC/3TC or DTG/3TC in real life settings in the ANRS-CO3 - AquiVIH-NA cohort.

Poster

Effectiveness of switching to B/F/TAF in virologically suppressed people with HIV and with preexisting resistance-associated mutations in Italy: the BIC-BARRIER Study

Poster

Evaluation of T-cell immunosenescence in +60 years PLWH virologically suppressed on 3DR with BIC/FTC/TAF or 2DR with DTG/3TC: the Collateral-2 study.

LONG-ACTING HIV TREATMENT & PREVENTION RESEARCH (LENACAPAVIR)

Oral Presentation (late breaker)

Once-Weekly Islatravir Plus Lenacapavir in Virologically Suppressed PWH: Week 48 Safety, Efficacy, and Metabolic Changes

Oral Presentation (late breaker)

Persistence in use of twice-yearly lenacapavir versus daily oral PrEP in the PURPOSE 1 Phase 3 trial

Oral Presentation (late breaker)

Twice-yearly lenacapavir PrEP in cisgender gay men, transgender women and men, and gender-diverse people (PURPOSE 2)

Poster

Pharmacokinetic/Pharmacodynamic and Resistance Analyses of GS-1720, a Once-Weekly Oral Integrase Strand Transfer Inhibitor

Poster

Pharmacokinetics of oral islatravir (ISL) plus lenacapavir (LEN) given once weekly in an open-label, active-controlled, phase 2 study of virologically suppressed people with HIV

HIV TREATMENT PIPELINE RESEARCH

Oral Presentation

Efficacy and safety analysis of lenacapavir with broadly neutralising antibodies, teropavimab and zinlirvimab, in people with HIV-1 highly sensitive to one or both broadly neutralising antibodies

Poster

Pharmacokinetic (PK) analysis of oral once-daily bictegravir (BIC) plus lenacapavir (LEN) administered separately (BIC 75mg + LEN 25mg; BIC 75mg + LEN 50mg) and as a single-tablet BIC/LEN 75/50mg fixed-dose combination (FDC) to support Phase 3 dose selection

Poster

Effect of acid reducing agents on the pharmacokinetics of oral GS-4182

Poster

Safety and immunogenicity of GS-1966+GS-1144 vaccines in virally suppressed adults living with HIV-1: a phase 1b, randomised, placebo-controlled study

Poster

Metabolic changes at 48 weeks in virologically suppressed people with HIV

switching from complex antiretroviral regimens to bictegravir plus lenacapavir: ARTISTRY-1 trial

HIV PREVENTION RESEARCH

Poster

Estimating return on investment (ROI) with increased utilisation of HIV pre-exposure prophylaxis (PrEP) among key populations in France from a national health payer perspective

Poster

PrEP cascade improvement through same-day PrEP initiation

Poster

Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used Pre-exposure Prophylaxis in Europe; the PrEPaRe study.

Poster

HIV-1 prevalence and pre-exposure prophylaxis uptake among key populations in high-income economies (2017-2023): a systematic review and meta-analysis of real-world studies

ADDITIONAL HIV RESEARCH

Oral Presentation (late breaker)

Clinical features and resistance patterns during second-generation INSTI failure: The ROSETTA-registry

Oral Presentation (late breaker)

Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia

Poster (late breaker)

Comparison of treatment-emergent resistance associated mutations among three-drug single tablet regimens and cabotegravir+rilpivirine for the treatment of virologically suppressed people with HIV: A Systematic Literature Review and Network Meta-Analysis

Poster (late breaker)

The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period

Poster

Replication-competent HIV-1 harbouring resistance-associated mutations is present in the viral reservoir

Poster

Treatment Patterns in Virologically Suppressed, Treatment-Experienced People with HIV; a US Real-World Database Study

Poster

Demographic and clinical characteristics of treatment naïve people with HIV, and their healthcare professionals’ reasons for treatment choice: findings from a real-world survey in five European countries

Poster

Understanding knowledge and attitudes regarding HIV amongst secondary care healthcare professionals in the United Kingdom: A national survey

Poster

The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study

For more information about Gilead at HIV Glasgow 2024, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://hivglasgow.org/programme/.

The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally.

Islatravir in combination with lenacapavir is investigational and not approved anywhere globally. The safety and efficacy of the combination of islatravir and lenacapavir have not been established. Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1.

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

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

GS-5423, GS-2872, 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.

Please 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 Lenacapavir

Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir 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 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 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 F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.

U.S. Indication for Biktarvy

Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

• Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

• Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
• New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
• Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

• Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

• Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
• Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
• Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

• Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
• Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
• Hepatic impairment: Not recommended in patients with severe hepatic impairment.
• Prior to or when initiating: Test patients for HBV infection.
• Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

• Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy.
• Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding.

About Gilead Sciences in HIV

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead is recognized as one of the leading funders of HIV-related programs in a report released by Funders Concerned About AIDS.

Forward-Looking Statements

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 Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy, bictegravir, lenacapavir, teropavimab, zinlirvimab and GS-1720 (such as the ALLIANCE, ARTISTRY, BICSTaR, PURPOSE 2 and NCT05052996 studies); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation, such as regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of programs for indications that are currently under evaluation, including bictegravir, lenacapavir and GS-1720, and, as a result, these programs may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).

U.S. full Prescribing Information for Biktarvy, including BOXED WARNING, and U.S. full Prescribing Information for lenacapavir are available at www.gilead.com.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs at public_affairs@gilead.com, 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241107836956/en/

Meaghan Smith, Media public_affairs@gilead.com

Jacquie Ross, Investors investor_relations@gilead.com