Abacavir sulfate/Dolutegravir sodium/Lamivudine

Lupin has been granted tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, to market a generic equivalent of Triumeq PD® Tablets for Oral Suspension, of ViiV Healthcare Company. This product would be manufactured at Lupin’s Nagpur facility in India. The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, (RLD Triumeq PD) had an estimated annual sale of USD 1.3 million in the US. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the US across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals.

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new findings from its antiviral research and development programs at IDWeek 2024 , taking place from October 16-19. The data from 31 presentations across HIV treatment and prevention, COVID-19 and viral hepatitis include one late breaker abstract and six oral presentations, reflecting Gilead’s commitment to helping address the evolving needs of a diverse range of people and communities affected by some of the world’s most challenging viruses. “ 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 Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head at Gilead Sciences. “ The data reflect our unwavering commitment to advance scientific innovations in virology, aimed at addressing urgent global needs.” HIV Research Continuous scientific discovery in HIV is a pillar of Gilead’s commitment to help end the HIV epidemic. Presented studies’ 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 (PWH). Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including new data on GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI), and a late-breaker oral presentation of Week 48 data from the Phase 2 study evaluating an investigational once-weekly oral combination regimen of islatravir and lenacapavir will also be presented. Gilead will present an overview of results from its pivotal Phase 3 PURPOSE 1 ( NCT04994509 ) and PURPOSE 2 ( NCT04925752 ) trials, which studied the efficacy and safety of lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention in a broad, diverse range of people globally. The trials were unblinded in June and September, respectively. Additionally, Gilead will present five-year outcomes in new subgroup analyses from Studies 1489 ( NCT02607930 ) and 1490 ( NCT02607956 ), which assessed the safety and efficacy of Biktarvy compared to Triumeq (ABC/DTG/3TC) and dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, DTG+F/TDF. The first analysis evaluated the safety and efficacy of Biktarvy in treatment naïve PWH aged 50 or older, providing data to inform treatment decisions in this increasing proportion of PWH with a greater burden of age-related comorbidities. The second analysis evaluated the safety and efficacy of Biktarvy in treatment-naïve Black adults, a population that has historically been underrepresented in clinical studies despite the disproportionate impact of HIV on Black communities. Gilead will also present three-year outcomes from the CAPELLA study ( NCT04150068 ), which evaluated twice-yearly subcutaneous dosing of Sunlenca ® (lenacapavir) in combination with an optimized background regimen in people with multi-drug resistant HIV. HIV prevention data will include an analysis of newly initiated pre-exposure prophylaxis (PrEP) use in priority populations with unmet needs for PrEP in the U.S. Additional HIV research findings include a presentation of survey data reporting current real-world trends for PWH with ART resistance mutations and utilization of healthcare resources in addition to the impact on efficacy, safety and clinical outcomes. COVID-19 Research Across Gilead’s 14 presentations in COVID-19, key data will highlight the dynamic nature of the SARS-CoV-2 virus and address the needs of those most susceptible to severe outcomes from COVID-19. A real-world evidence analysis will feature outcomes following treatment with Veklury ® (remdesivir, 100mg for injection), for people hospitalized with COVID-19 who have leukemia, lymphoma and multiple myeloma. Additionally, a presentation of in vitro data will demonstrate the ongoing antiviral activity of Veklury against recent Omicron subvariants. An oral presentation will discuss how investigational obeldesivir reduced SARS-CoV-2 infectious viral titers in people with COVID-19. Gilead will also present full data results from the obeldesivir BIRCH ( NCT05603143 ) and OAKTREE ( NCT05715528 ) clinical trials. Previously, Gilead announced the early termination of the BIRCH trial due to lower-than-expected COVID-19 incidence rates and related hospitalizations or all-cause death by Day 29, which were primary endpoints in the study. The decision did not reflect any safety or efficacy concerns. Gilead also previously announced top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint in people without risk factors, obeldesivir was found to have a generally well tolerated safety profile. The detailed data add to the breadth of safety data on obeldesivir. Based on results from BIRCH and OAKTREE, as well as results from preclinical studies in Respiratory Syncytial Virus (RSV), Gilead has launched a Phase 2 trial to study obeldesivir as a potential treatment for non-hospitalized adults with acute RSV. The study will evaluate if obeldesivir can help participants' symptoms improve faster. Overview of Scientific Presentations HIV Treatment Research Late Breaker Week 48 Results of a Phase 2 Study Evaluating Once-weekly Oral Islatravir Plus Lenacapavir Oral Presentation Abstract 155 Long-Acting Subcutaneous Lenacapavir in People With Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study Oral Presentation Abstract 154 Pharmacokinetics and Safety of GS-1720 Following Multiple Ascending Doses in a Phase 1a Study in People Without HIV-1 P-547 Efficacy and Safety of B/F/TAF in Treatment-Naïve People With HIV Aged ≥ 50 Years: 5-Year Follow-Up from Two Phase 3 Studies P-550 Efficacy and Safety of B/F/TAF in Black Adults With HIV who are Treatment Naïve: 5-Year Follow-Up from Two Phase 3 Studies P-474 Effects of Antiretroviral Resistance on Outcomes and Healthcare Resource Use of People With HIV in the United States and Europe – A Real-world Survey P-590 Impact of Pharmacoenhancers on the Pharmacokinetics and Safety of Lenacapavir in People With HIV P-473 Health Care Resource Use Burden Among People with HIV (PWH) and Concurrent Mental Health Disorders (MHDs): Claims Analysis of Treatment-Naïve Medicaid Population Initiating Multi-Tablet Regimens (MTRs) vs. Single-Table Regimens (STRs) P-529 Comparison of Renal Outcomes by Tenofovir Alafenamide Fumarate (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) Containing Regimens for Prevention, and Treatment of HIV and/or HBV Treatment: A Systematic Literature Review and Meta-Analysis HIV Prevention Research Oral Presentation Abstract 507 Trajectories of Newly Initiated Pre-Exposure Prophylaxis (PrEP) Use Among Priority Populations With Unmet Needs for PrEP in the USA P-512 Changes in Renal Function After Switching from Emtricitabine/Tenofovir Disoproxil Fumarate to Emtricitabine/Tenofovir Alafenamide Fumarate for HIV Pre Exposure Prophylaxis (PrEP): A Real-World Study COVID-19 Research Oral Presentation Abstract 92 Obeldesivir Reduced SARS-CoV-2 Infectious Titers in the BIRCH Phase 3 Clinical Trial (GS-US-611-6273) P-2036 The OAKTREE Study: Obeldesivir for Treatment of COVID-19 in Adults and Adolescents Without Risk Factors for Progression to Severe Disease P-2026 The BIRCH Study: Obeldesivir for the Treatment of COVID-19 in People With Comorbid Risk Factors for Progression to Severe Disease P-2030 Remdesivir and Obeldesivir Retain Potent Activity Against SARS-CoV-2 Omicron Variants P-1925 Incidence of Long COVID Symptoms During the Year Post Admission Among Patients Hospitalized for COVID-19 P-1939 Health Status and Symptom Perceptions Among Patients Diagnosed with Long COVID in the United States: An Online Survey Study P-1938 Impact of Race and Ethnicity on Patient Perspectives of Health and Symptoms Following COVID-19 Diagnosis P-2033 Patient Characteristics and Management of COVID-19 Diagnosed in the Outpatient Setting P-2020 Combination Therapy with Remdesivir and Corticosteroids is Associated With Lower Mortality Risk vs. Corticosteroids Monotherapy in Patients Hospitalised for COVID-19 P-1913 Characteristics, Clinical Management, and Outcomes of Leukemia, Lymphoma and Multiple Myeloma Patients Hospitalized With a Primary Diagnosis of COVID-19: Insights from Hospitals Across the United States P-1973 Characteristics, Clinical Management, and Outcomes of Immunocompromised Patients Diagnosed with COVID-19 in the Outpatient Setting in France P-2021 How Have COVID-19 Treatment Guidelines and the Scientific Evidence Evolved Throughout the Pandemic and Endemic Era? P-2031 Thorough QT/QTc Clinical Study to Evaluate the Effect of Remdesivir on Cardiac Repolarization in Healthy Male and Female Participants P-2025 Resistance Analyses from the Remdesivir Phase 2/3 Caravan Study in Pediatric and Neonatal Participants with COVID-19 Viral Hepatitis Research Oral Presentation Abstract 83 Predictors of Undetectable HDV RNA 48 Weeks After Completion of Finite Treatment With Bulevirtide and Pegylated-Interferon Alpha 2a P-2191 Efficacy and Safety of Bulevirtide Monotherapy for Chronic Hepatitis D in Patients With and Without Cirrhosis: Results from the Week 144 Interim Analysis of a Phase 3 Randomized Study P-2185 Community Health Worker-led Intervention to Increase Hepatitis Delta Virus Screening Among Immigrants in the Metropolitan-DC Area P-2180 Linkage to Care, Treatment Initiation, and Outcomes in Individuals with Hepatitis B Virus Infection With and Without Cirrhosis P-2322 Screening Rates and Clinical Outcomes for Hepatitis Delta in Individuals with HBV Coinfection P-2188 Hepatitis C Screening: Before and After Study of Hepatitis C Risk Score Alerts in CHORUS For more information about Gilead at IDWeek 2024, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://idweek.org/program/ . GS-1720 is an investigational compound and not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. The use of the compound alone or in combination with other antiretrovirals is investigational. Its safety and efficacy are unknown. Lenacapavir is presently marketed as Sunlenca and approved for the treatment of adults with multi-drug resistant HIV in combination with an optimized background regimen. 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 PWH and individuals who need or want PrEP. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. 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 and Veklury. There is currently no cure for HIV or AIDS. All uses of obeldesivir are investigational and have not been determined to be safe or efficacious and is not approved by the FDA. Bulevirtide 2 mg remains the only approved treatment for adults with chronic HDV and compensated liver disease in the European Economic Area (EEA), Great Britain and Switzerland and is not approved in the U.S. Bulevirtide 10 mg is an investigational product and is not approved anywhere. 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 (lenacapavir), 300 mg tablet and 463.5 mg/1.5 mL injection, 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. 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 is the only antiviral studied in hospitalized COVID-19 patients in clinical trials and large real-world analyses that has demonstrated reduced time to recovery, as well as disease progression, mortality and readmission. 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 XBF, XBB.1.16, FL.22, E.G.5.1 and BA.2.86. Veklury continues to be evaluated against emerging variants of interest and concern. Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to approximately 14.5 million patients around the world, including more than 8.1 million people in middle- and low-income countries through Gilead’s voluntary licensing program. 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. 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 informed of the potential risks of breastfeeding. U.S. Indication for Veklury Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (weighing ≥1.5 kg) who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. For more information, please see the U.S. full Prescribing Information available at www.gilead.com . U.S. Important Safety Information for Veklury Contraindication Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components. Warnings and precautions Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury; most occurred within one hour. Monitor patients during infusion and observe for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications). Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation. Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury. Adverse reactions The most common adverse reaction (≥5% all grades) was nausea. The most common lab abnormalities (≥5% all grades) were increases in ALT and AST. Drug interactions Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. Dosage and administration Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Treatment duration: For patients who are hospitalized, Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19. For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days. For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use. Testing prior to and during treatment: Perform hepatic laboratory, and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate. Renal impairment: No dose adjustment of Veklury is recommended in patients with any degree of renal impairment, including patients on dialysis. Veklury may be administered without regard to the timing of dialysis. Pregnancy and lactation Pregnancy: A pregnancy registry has been established for Veklury. Available clinical trial data for Veklury in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of Veklury exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy. Lactation: Veklury can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Veklury and any potential adverse effects on the breastfed child from Veklury or from an underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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, cancer and inflammation. 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. 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, Sunlenca, Veklury, bulevirtide, lenacapavir, obeldesivir and GS-1720 (such as the BIRCH, CAPELLA and OAKTREE trials and Studies 1489 and 1490); 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 programs for indications that are currently under evaluation, including lenacapavir, obeldesivir 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, Sunlenca, Veklury, 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 , U.S. full Prescribing Information for Sunlenca, and U.S. full Prescribing Information for Veklury 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 (@Gilead-Sciences).