SLC47 family of multidrug and toxin extrusion transporters

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data from its innovative HIV treatment portfolio and research pipeline, including a broad range of investigational and marketed agents with varied dosing frequencies and administration methods. The findings presented at the 25th International AIDS Conference (AIDS 2024) reflect a portfolio and future-looking pipeline focused on person-centered drug development strategies to help address unmet needs in HIV treatment. " People are at the center of all we do in HIV treatment research at Gilead. We strive to support people with HIV throughout their lifetimes, with research to maximize the impact of current treatment options and diligent work to develop treatment options for the future,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head. “ Durable viral suppression is the primary goal of HIV care and treatment, resulting in longer, healthier lives for people with HIV and, when undetectable, eliminating the risk of transmitting the virus to partners. Long-term success includes rigorous innovation so that each person can be on the right treatment for them that will support long-term treatment outcomes.” Five-Year Data Shows Biktarvy Maintains High Rates of Virologic Suppression in Hispanic/Latine People with HIV New research presented at AIDS 2024 demonstrated the durability and long-term safety profile of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in Hispanic/Latine people with HIV, who often experience disparities in health outcomes and are often under-represented in HIV clinical trials. Specifically, results of the subgroup analysis showed that at five years, Biktarvy treatment was generally well tolerated and maintained high virologic suppression. Based on a Missing=Excluded (M=E) analysis, 100% of the Hispanic/Latine participants and 98.1% of the non-Hispanic/Latine participants maintaining undetectable status and a viral load of less than 50 copies/mL at Week 240. No treatment-emergent resistance was detected. This analysis evaluating Biktarvy includes a pooled analysis of two Phase 3 randomized studies ( Study 1489 and Study 1490 ) in Hispanic/Latine people with HIV who were initiating treatment with Biktarvy in the 144-week randomization phase and in the 96-week open-label extension phase. “ HIV affects some communities more significantly and deeply than others, and the Hispanic/Latine community specifically needs the results of long-term studies that examine differences in outcomes and treatment nuances," said Santiago Moreno Guillen, MD, Head of the Infectious Diseases Service at the Ramón y Cajal Hospital in Madrid. " These long-term findings will help us determine the best treatment approach and can make a very big difference in the lives of our community. The robust efficacy shown in Hispanic/Latine participants at five years provides remarkable long-term insight and reinforces the role of Biktarvy as an effective treatment option for Hispanic/Latine people living HIV." Biktarvy was generally well tolerated in both groups, with similar metabolic and safety outcomes and few TEAEs leading to treatment discontinuation. The most common study drug-related TEAEs in Hispanic/Latine or non-Hispanic/Latine participants, respectively, were diarrhea (2%, 6%), headache (5%, 5%), and nausea (3%, 5%). Switch Data From Real-World BICSTaR Study Shows Biktarvy Maintains High Levels of Virologic Suppression in Older Adults With Comorbidities Additional new long-term data from the Bictegravir Single Tablet Regimen (BICSTaR) study evaluated the effectiveness and safety of Biktarvy in people aged 50 years and older with HIV who switched to the single-tablet regimen and currently have or have had at least one additional medical condition. Outcomes at two years included viral suppression rates, treatment-emergent resistance, drug-drug interactions and patient satisfaction (survey conducted 12 months after switching). BICSTaR ( NCT03580668 ) is an ongoing, multinational, observational single-arm, non-comparative real-world cohort study, which aims to evaluate the effectiveness, safety, tolerability, and patient-reported outcomes of treatment with Biktarvy in treatment‐naïve and treatment‐experienced people with HIV. Among the people with HIV enrolled in the BICSTaR study, there is a high baseline prevalence of comorbidities. Results showed high rates of effectiveness two years after switching to Biktarvy, with 96% (315/328) of individuals maintaining an undetectable viral load of less than 50 copies/mL based on a Missing=Excluded (M=E) analysis. Viral suppression rates at 24 months were similar regardless of age, sex and race at the time of the switch, ranging from 93-100% across subgroups. Patient-reported treatment satisfaction based on the HIVSTQc score increased through one year. No treatment-emergent resistance to Biktarvy was observed throughout the 24 months after switching. The BICSTaR population included 401 people with a median age of 56 years, with 86% male, 81% White and 18% aged 65 years or older. Most common baseline comorbidities were cardiovascular (48%), metabolism and nutrition disorders (48%), infections (34%), and psychiatric disorders (34%), and 22% were taking five or more comedications. Switching to Biktarvy was generally well tolerated. Treatment-related adverse events (TRAEs) occurred in 13% (54/401) of patients, with serious TRAEs occurring in 0.2% (1/401). Discontinuation due to TRAEs occurred in 7% (27/401) of patients. Those who switched to Biktarvy remained clinically stable, with no significant worsening in lipid, kidney or liver measures. The data presented at AIDS 2024 complement those observed in multiple Phase 3 clinical trials, which demonstrated the sustained efficacy, safety profile, and high barrier to resistance of Biktarvy. Once-Daily Oral Combination of Bictegravir and Lenacapavir Demonstrates Sustained Viral Suppression ARTISTRY-1 ( NCT05502341 ) is an ongoing, open-label, multicenter Phase 2/3 study being conducted to compare the investigational once-daily combination of bictegravir, an integrase strand transfer inhibitor, and lenacapavir, a first-in-class capsid inhibitor, versus current therapy in people with HIV who require a complex treatment regimen to maintain virologic suppression, primarily due to a history of resistance. It is estimated that up to 8% of people with HIV take a complex treatment regimen, defined as two or more pills each day, although single-tablet regimens have become standard of care for HIV treatment due to their simplified dosing and potential benefits for adherence. In ARTISTRY-1, 128 participants on a stable baseline regimen for six or more months prior to screening were randomly allocated in a 2:2:1 ratio to receive once-daily oral bictegravir 75 mg + lenacapavir 25 mg, bictegravir 75 mg + lenacapavir 50 mg or continue their current stable baseline regimen (n=25). The 24-week primary efficacy and safety outcomes for bictegravir + lenacapavir in people with HIV who are virologically suppressed on a complex regimen have been previously presented and demonstrated that all three treatment groups had robust virologic suppression at six months, with consistently low viral loads throughout the study. Week 48 outcomes presented at AIDS 2024 show that 90% of participants (n=52) treated with once-daily oral bictegravir 75 mg + lenacapavir 50 mg and 92% of participants (n=51) treated with once-daily oral bictegravir 75mg + lenacapavir 25 mg were virologically suppressed (HIV viral load <50 copies/mL per FDA Snapshot). Changes in CD4 counts were comparable among groups. In the higher lenacapavir dose group, only one participant had a viral load above the threshold, which was later suppressed after changing the regimen. In the lower lenacapavir dose group, two participants had a viral load above the threshold, with both individuals later suppressed without regimen change. Bictegravir + lenacapavir was generally well tolerated, with few treatment-emergent adverse events (TEAEs) leading to premature treatment discontinuation. Up to Week 48, the most common TEAEs in the higher dose bictegravir + lenacapavir group were COVID (10%), upper respiratory tract infection (8%) and diarrhea (4%). Drug-related TEAEs leading to discontinuation were reported in 2% of participants in the higher dose lenacapavir group, 2% in the lower dose lenacapavir group and none in the stable baseline regimen group. These latest findings support the continued evaluation of the combination of bictegravir and lenacapavir for use in people with HIV who are virologically suppressed on complex ART regimens. This investigational combination of bictegravir 75 mg + lenacapavir 50 mg is being further evaluated as a single-tablet regimen in the Phase 3 portion of the ARTISTRY-1 study as well as in ARTISTRY-2 ( NCT06333808 ) a Phase 3 study comparing the same combination of bictegravir 75 mg + lenacapavir 50 mg versus Biktarvy in virologically suppressed people with HIV. New Data Support Ongoing Clinical Development of an Investigational, First-in-Class, Once-Weekly Oral Combination HIV Treatment Regimen GS-4182 is a novel, oral prodrug of lenacapavir that is under development for the treatment of HIV. Results from a nonclinical pharmacology study showed GS-4182 was generally well tolerated with a favorable safety profile. Additionally, a first-in-human Phase 1a study assessed the safety and pharmacokinetics (PK) of GS-4182 in participants without HIV. This randomized, blinded, placebo-controlled study included single ascending doses and multiple ascending doses, and demonstrated that GS-4182 reached mean LEN concentrations rapidly, achieving target efficacy levels. No Grade ≥3 TEAEs, serious TEAEs or discontinuations due to TEAEs occurred. Nine Grade ≥3 treatment-emergent laboratory abnormalities were reported. Both datasets support the future development of GS-4182 as a component of a once-weekly oral combination HIV treatment regimen. GS-1720 is a selective integrase strand transfer inhibitor (INSTI) being evaluated as a novel, investigational once-weekly antiretroviral agent in combination with long-acting agents with the goal of providing people with HIV with new long-acting options. Previously presented data demonstrated the first proof of concept that GS-1720 has a pharmacokinetic profile suitable for evaluation as a weekly dosing interval. In new nonclinical data presented at AIDS 2024, the safety pharmacology and toxicology profiles of GS-1720 were evaluated in vitro and in animals following oral administration of the agent. Results showed significantly improved antiviral potency compared to bictegravir in vitro and a similar nonclinical virology, pharmacology, and safety profile. Additionally, in a first-in-human study, the safety and PK of single-ascending doses of GS-1720 were evaluated in participants without HIV. Results showed that GS-1720 was generally well tolerated across the doses tested and exhibited a half-life that may be supportive of once-weekly oral dosing. These data support the ongoing clinical development of GS-1720 and GS-4182 as the components of an investigational, first-in-class, once-weekly oral capsid-inhibitor/INSTI combination regimen for HIV treatment. Long-Acting, Twice-Yearly Regimen of Lenacapavir and Broadly Neutralizing Antibodies (bNAbs) Results of a resistance analysis from a previously presented study evaluating the investigational combination of lenacapavir with bNAbs [teropavimab (GS-5423, TAB) + zinlirvimab (GS-2872, ZAB)] showed that high rates of virologic suppression were maintained for six months with twice-yearly dosing during treatment with lenacapavir and bNAbs, including among participants highly susceptible to only one bNAb (n=30), according to the study screening criteria. Three participants experienced virologic rebound, with emergent lenacapavir resistance detected for one participant, who had no resistance to bNAbs and resuppressed with resumption of oral ART. These results reinforce the potential of this long-acting combination treatment regimen with twice-yearly dosing and of the continued development of lenacapavir as a foundational agent for future long-acting combination HIV treatment options. Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established in combination. GS-5423, GS-2872, GS-1720, GS-4182 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 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 that could uniquely fit into the lives of people with HIV. Please see below for the U.S. Indication and Important Safety Information for Sunlenca. Please see below for U.S. Indications and Important Safety Information for Biktarvy, including Boxed Warning . There is currently no cure for HIV or AIDS. 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 Coadministration : Concomitant administration of Sunlenca is contraindicated with strong CYP3A inducers. Warnings and precautions Immune reconstitution syndrome , including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy. Long-acting properties and potential associated risks with Sunlenca : Residual concentrations of Sunlenca may remain in the systemic circulation of patients for up to 12 months or longer. Sunlenca may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing Sunlenca, begin alternate suppressive ARV regimen within 28 weeks from last injection. Injection site reactions may occur, and nodules and indurations may be persistent. Adverse reactions Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%). Drug interactions Prescribing information : Consult the full prescribing information for Sunlenca for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters : Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of Sunlenca. Sunlenca may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of Sunlenca, which may increase the potential risk of adverse reactions. Dosage and administration Dosage : Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food. Initiation Option 1 : Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Initiation Option 2 : Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection. Maintenance : 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection. Missed Dose : During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue Sunlenca treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2. 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. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population. Lactation : Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. 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. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population. Lactation : Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead 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, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. 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 for everyone, everywhere. 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 or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy, lenacapavir, teropavimab, zinlirvimab, GS-1720 and GS-4182; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; 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 March 31, 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. U.S. full Prescribing Information f or Sunlenca is available at www.gilead.com . U.S. full Prescribing Information for Biktarvy, including BOXED WARNING , is available at www.gilead.com . Sunlenca, Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X ( @Gilead Sciences ) and LinkedIn , or contact Gilead Public Affairs at public_affairs@gilead.com , 1-800-GILEAD-5 or 1-650-574-3000.

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced its program for the upcoming 25th International AIDS Conference ( AIDS 2024 ), taking place in Munich, Germany, and virtually, from July 22-26. As the leading innovator in HIV, Gilead will share new data from its research and development programs and Gilead-supported collaborations that unite leading scientific innovation and partnership aimed at ending the HIV epidemic. " The AIDS 2024 conference convenes the global HIV community – scientists, advocates, and partners from the public and private sectors," said Jared Baeten, MD, PhD, Senior Vice President, Virology Clinical Development, Gilead Sciences. " Our contributions to this year's meeting demonstrate Gilead's leadership in person-centered innovations across HIV prevention, treatment, and cure. Our scientific advancements are grounded in collaboration with community and research partners around the world. I look to a future where every person has options to help obtain their own HIV prevention or treatment success and where we've come together to end the HIV epidemic." Gilead’s AIDS 2024 program highlights include: Late-breaking: Full data from pivotal PURPOSE 1 trial: Data evaluating lenacapavir, an investigational, twice-yearly medicine for HIV prevention, will be presented at the Co-Chairs’ Choice session on July 24, 10:30 a.m.-noon, CEST. Developed in partnership with communities affected by HIV around the world, the PURPOSE clinical trials comprise the most comprehensive and diverse HIV prevention trial program ever conducted. PURPOSE 1 is the first HIV prevention trial to intentionally include pregnant and lactating women. In June, the topline results from an interim analysis of the Phase 1 trial were announced , demonstrating 100% efficacy for the investigational use of HIV prevention in cisgender women. Oral presentation: Week 48 outcomes from ARTISTRY-1: The latest data from an ongoing Phase 2/3 study ( NCT05502341 ) designed to evaluate an investigational once-daily single-tablet regimen of bictegravir and lenacapavir in virologically suppressed people with HIV who are on a complex regimen. Two-year outcomes from BICSTaR : The latest findings from an ongoing global, observational study evaluating the effectiveness, safety and tolerability of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. Additional research studies evaluating Biktarvy include five-year outcomes from the pivotal trials evaluating Biktarvy as a long-term treatment option in older adults with a high burden of comorbidities and the Hispanic/Latine community, respectively. HIV treatment research pipeline findings will also include new data on GS-1720 and GS-4182. Both investigational agents are being clinically evaluated as part of potential future once-weekly oral HIV treatment options. Additionally, resistance analyses from a study evaluating the investigational combination of lenacapavir + teropavimab (GS-5423, TAB) + zinlirvimab (GS-2872, ZAB) will be presented to support previously presented data demonstrating the potential of this combination as a novel, long-acting, twice-yearly treatment option. Symposia focused on addressing barriers to HIV care and prevention: Two symposia to discuss the latest progress in policies and practical solutions from around the world to help achieve more equitable access to HIV care and services. What’s Preventing Us From Preventing? Pushing Together Towards the UNAIDS 2030 HIV Prevention Goals (July 24, 7-8 a.m., CEST) will convene experts and community members to strategize about working to achieve UNAIDS 2030 goals. Topics include forward-thinking policies, person-centered care and innovative solutions for health equity. How Treatment Selection Can Support Long-Term Success (July 25, 12-1 p.m., CEST) will bring together providers and the HIV community to explore ways to help achieve long-term success in HIV management. Discussions will focus on the importance of treatment selection from the outset, aiming for long-term, durable viral suppression. Gilead-supported initiatives highlighting collaboration to advance health equity: To help end the HIV epidemic, it is essential to extend beyond science. Gilead will highlight two initiatives that aim to bridge gaps in HIV awareness and improve linkage to and retention in care: The Person-Centered Care (PCC) Program with the International AIDS Society (IAS) is a multidisciplinary, integrated and long-term, focused approach to care for people with and affected by HIV that is responsive to their evolving needs, priorities and preferences. RADIAN ® – a groundbreaking partnership between Gilead and the Elton John AIDS Foundation (EJAF) – will host a community exchange event, led by community leaders from Eastern Europe and Central Asia (EECA), to discuss how RADIAN-supported innovation and services are elevating efforts to end the HIV crisis in EECA. Overview of Scientific Presentations HIV TREATMENT RESEARCH (B/F/TAF) Efficacy and Safety of B/F/TAF in Hispanic/Latine Adults With HIV-1 Initiating First-Line Therapy: 5-Year Follow-Up From Two Phase 3 Studies Switching To B/F/TAF in A Real-World Cohort of Older People With HIV And High Burden of Non AIDS-Related Comorbidities (BICSTaR) LONG-ACTING HIV TREATMENT & PREVENTION RESEARCH (LENACAPAVIR) Centring Community Leadership With Purpose: Inclusion Of Adolescents, Ciswomen, and Pregnant And Lactating Individuals in a Phase 3 Clinical Trial Evaluating Lenacapavir and F/TAF For PrEP Twice-Yearly Lenacapavir or Daily Emtricitabine/Tenofovir Alafenamide for HIV Prevention in Cisgender Women: Interim Analysis Results from the PURPOSE 1 Study Experiences and Quality of Life with Long-Acting Lenacapavir from People With Multidrug-Resistant HIV-1 Enrolled in the Phase 2/3 CAPELLA Study Injection Site Reactions with Subcutaneous Lenacapavir Administration at Alternate Injection Sites Resistance Analyses During Treatment of Lenacapavir With Broadly Neutralizing Antibodies in PWH HIV PIPELINE RESEARCH Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in Virologically Suppressed People With HIV-1 on Complex ART Regimens at Baseline (Artistry-1) Phase 1a PK and Safety of Single Ascending Doses of GS-1720 in Healthy Participants Supports Oral Weekly Administration and Phase 1b Dose Selection Nonclinical Pharmacology Profile of GS-1720, a Novel, Highly Potent Once-Weekly Oral HIV-1 INSTI Inhibitor in Clinical Development Safety and PK Profile of Single and Multiple Ascending Doses of GS-4182, an Oral Prodrug of Lenacapavir, in Participants Without HIV-1 Nonclinical Profile of GS-4182, a Once-Weekly Oral Prodrug of the HIV-1 Capsid Inhibitor Lenacapavir in Clinical Development ADDITIONAL HIV PREVENTION RESEARCH Real-World Adherence of HIV-1 Oral PrEP Regimens in the United States: A Group-Based Trajectory Modeling Approach HIV CURE RESEARCH GS-8588, a Novel Envelope-Targeting Bispecific T-Cell Engager for HIV Cure For more information, including a complete list of abstracts and their corresponding oral and poster session titles, please visit: https://programme.aids2024.org/ Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established. GS-5423, GS-2872, GS-1720, GS-4182 and GS-8588 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 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 with HIV and individuals who need or want 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. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning , for Biktarvy. Please also see below for the U.S. Indication and Important Safety Information for Sunlenca. 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 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 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. 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. 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 Coadministration : Concomitant administration of Sunlenca is contraindicated with strong CYP3A inducers. Warnings and precautions Immune reconstitution syndrome , including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy. Long-acting properties and potential associated risks with Sunlenca : Residual concentrations of Sunlenca may remain in the systemic circulation of patients for up to 12 months or longer. Sunlenca may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing Sunlenca, begin alternate suppressive ARV regimen within 28 weeks from last injection. Injection site reactions may occur, and nodules and indurations may be persistent. Adverse reactions Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%). Drug interactions Prescribing information : Consult the full prescribing information for Sunlenca for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters : Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of Sunlenca. Sunlenca may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of Sunlenca, which may increase the potential risk of adverse reactions. Dosage and administration Dosage : Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food. Initiation Option 1 : Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Initiation Option 2 : Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection. Maintenance : 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection. Missed Dose : During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue Sunlenca treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2. Pregnancy and lactation Pregnancy : There is insufficient human data on the use of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Lactation : Individuals infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission. 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, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. 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. Learn more about Gilead’s unique collaborations worldwide and the work to help end the global HIV epidemic. 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 or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy, lenacapavir, teropavimab, zinlirvimab, GS-1720, GS-4182 and GS-8588; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; 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 March 31, 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. U.S. Prescribing Information for Biktarvy, including BOXED WARNING , and U.S. full Prescribing Information for Sunlenca are available at www.gilead.com Biktarvy, Descovy, Sunlenca, RADIAN, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X ( @Gilead Sciences ) and LinkedIn , or contact Gilead Public Affairs at public_affairs@gilead.com , 1-800-GILEAD-5 or 1-650-574-3000.

– Additional Data in Pregnant Adults Who Are Virologically Suppressed Reinforce Safety and Tolerability Pro Biktarvy in Broad Range of People With HIV – – Perinatal Guidelines Recognize Biktarvy as Alternative Regimen for Use During Pregnancy and for Those Trying to Conceive – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc., (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy pro Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. These additional data stem from Study 5310, which evaluated the pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who have suppressed viral loads and no known resistance to any components of Biktarvy in their second and third trimesters and through a median of 16 weeks postpartum. This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant. The U.S. Department of Health and Human Services (DHHS) perinatal guidelines recognize Biktarvy as having sufficient data to support being recommended as an alternative complete regimen for use in pregnancy and for people who are trying to conceive. Additionally, guidelines recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant. “This label update marks an important milestone for Biktarvy, reinforcing its efficacy pro pregnant PWH, an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant. We continue to keep people at the center of our tireless commitment to HIV treatment research and development so that our medicines address the needs of the broad range of communities that we serve.” The updated label now includes additional data from Study 5310, a Phase 1b, open-label, single-arm, multicenter clinical trial evaluating the pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who were virologically suppressed (HIV-1 RNA < 50 copies/mL) and had no known resistance to the components of Biktarvy. Participants were administered Biktarvy once daily from the second or third trimester through postpartum. Lower plasma exposures of Biktarvy were observed during pregnancy as compared to postpartum; all 32 participants who completed the study maintained viral suppression during pregnancy, at delivery and through week 18 postpartum. The median CD4+ cell count at baseline was 558 cells/μL, and the median change in CD4+ cell count from baseline to week 12 postpartum was 159 cells/μL. All 29 newborn participants had negative/nondetectable HIV-1 PCR results at birth and/or at four to eight weeks post birth. Further, the study did not identify any new safety or tolerability concerns for people who use Biktarvy during pregnancy and postpartum as the overall incidence and types of adverse events observed were consistent with those expected for the population studied. This label update marks a significant milestone in Gilead’s efforts to address the individual needs of all people impacted by HIV, as these data can help to provide assurance for people of childbearing potential to remain on Biktarvy if they were to become pregnant. The Biktarvy label was also updated in February 2024 to align with Centers for Disease Control and Prevention (CDC) guidance on breastfeeding, which encourages a dialogue between a person and their healthcare provider regarding breastfeeding. “As an OB-GYN and a longtime women’s health advocate, I’m incredibly passionate about helping end health disparities among women, and especially Black women who are disproportionately impacted by HIV,” said Yolanda M. Lawson, MD, President, National Medical Association. “I’m encouraged by the tremendous progress made in personalizing HIV treatment over the years, including this milestone that further supports the safety pro Biktarvy use during pregnancy. Together, we can help bring all PWH the care they need, including those who are or may become pregnant, so they can continue to live longer, healthier lives while on HIV treatment.” “These additional data can help to better inform treatment decisions between pregnant PWH and their providers and mark an incredible step forward in addressing the unique needs PWH have when they are pregnant or planning to become pregnant,” said William R. Short, MD, Associate Professor of Medicine, Perelman School of Medicine at the University of Pennsylvania. “As experts in perinatal care, we will continue to recommend ways pregnant PWH can maintain undetectable viral loads so they can stay healthy and prevent transmission to their baby.” Please see below for U.S. Indications and Important Safety Information for Biktarvy, including Boxed Warning. There is 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. 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 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, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. For 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. 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 Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy; the risk that physicians may not see the benefits of prescribing Biktarvy to treat pregnant people with HIV with suppressed viral loads; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2023, 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, Descovy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Biktarvy, including BOXED WARNING, is available at . For more information about Gilead, please visit the company’s website at , follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).