GILD Gilead Sciences Inc.

76.35
+0.29  (+0%)
Previous Close 76.06
Open 76.31
52 Week Low 60.89
52 Week High 85.97
Market Cap $95,771,409,090
Shares 1,254,373,400
Float 1,253,744,274
Enterprise Value $98,719,640,804
Volume 6,380,965
Av. Daily Volume 15,197,688
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Upcoming Catalysts

Drug Stage Catalyst Date
Axicabtagene ciloleucel - (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer
PDUFA priority review
PDUFA priority review
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Filgotinib
Rheumatoid arthritis (RA)
PDUFA
PDUFA
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Axicabtagene ciloleucel - (ZUMA-5)
Indolent B-Cell Non-Hodgkin Lymphoma
sNDA Filing
sNDA Filing
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Axicabtagene ciloleucel (ZUMA-7)
Refractory diffuse large B-cell lymphoma (DLBCL)
Phase 3
Phase 3
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Magrolimab + rituximab
Diffuse Large B-Cell Lymphoma
Phase 3
Phase 3
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Axicabtagene ciloleucel (ZUMA-8)
Chronic lymphocytic leukemia (CLL)
Phase 1
Phase 1
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Axicabtagene ciloleucel - (ZUMA-12)
Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2
Phase 2
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Magrolimab + Azacitidine
Higher risk-Myelodysplastic Syndrome (MDS)
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
Selonsertib (GS-4997) - STELLAR 3
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
Phase 3 data April 25, 2019 did not meet primary endpoint.
Filgotinib PENGUIN
Psoriatic arthritis
Phase 3
Phase 3
Phase 3 enrolment has been paused due to COVID-19,
Axicabtagene ciloleucel - (ZUMA-4)
Pediatric and young adult patients with r/r ALL - cancer
Phase 1/2
Phase 1/2
Phase 1/2 data released 2Q 2019.
Axicabtagene ciloleucel - (ZUMA-3)
Adult patients with r/r ALL - cancer
Phase 1/2
Phase 1/2
Phase 2 pivotal trial enrolment completed 3Q 2019.
Remdesivir - SIMPLE-Moderate study
COVID-19 - moderate disease
Phase 3
Phase 3
5-day treatment met primary endpoint. 10-day treatment did not meet primary endpoint.
Remdesivir (NIAID)
COVID-19 Coronavirus
Phase 3
Phase 3
Phase 3 data met primary endpoint - April 29, 2020 (placebo trial).
Remdesivir
Coronavirus / COVID-19 - severe patients
Phase 3
Phase 3
Phase 3 data from open-label trial released April 29, 2020 - 10-day course achieved similar improvement compared to 5-day course.
Actemra/RoActemra plus remdesivir
COVID-19
Phase 3
Phase 3
Phase 3 trial initiation announced May 28, 2020.
Filgotinib - SELECTION
Ulcerative colitis
Phase 2/3
Phase 2/3
Phase 2b/3 data released May 20, 2020. 200mg dose met primary endpoint. 100mg did not meet clinical remission endpoint.
Filgotinib - TORTUGA
Ankylosing spondylitis
Phase 2
Phase 2
Phase 3 trial to be initiated later in 2020.
Selonsertib (GS-4997) - STELLAR 4
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 11, 2019.
Filgotinib - DIVERSITY
Crohn’s disease
Phase 3
Phase 3
Phase 3 enrolment to be completed in 2021.
Axicabtagene ciloleucel and rituximab/lenalidomide (ZUMA-14)
Large B-cell Lymphoma
Phase 2
Phase 2
Phase 2 trial initiated 4Q 2019.
Axicabtagene ciloleucel - KTE-C19 and utomilumab (ZUMA-11)
Phase 1
Phase 1
Phase 1 trial ongoing.
Cilofexor (GS-9674)
Primary sclerosing cholangitis
Phase 3
Phase 3
Phase 3 enrolment to be completed 2H 2020.
Epclusa (sofosbuvir /velpatasvir)
Hepatitis C
Approved
Approved
sNDA FDA Approval announced March 19, 2020.
Cilofexor (GS-9674) and firsocostat (GS-0976) - ATLAS
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - December 16, 2019.
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint.
Filgotinib and GS-9876
Sjogren’s syndrome
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint.
GS-4875
Ulcerative Colitis
Phase 2
Phase 2
Phase 2 trial to be initiated 4Q 2019.
Selonsertib (GS-4997)
Diabetic kidney disease
Phase 3
Phase 3
Phase 3 trial initiated 3Q 2019.
GS-5734
Ebola
Phase 2
Phase 2
Phase 2 trial to complete enrolment 3Q 2019.
F/TAF (Descovy)
Pre-exposure prophylaxis
Approved
Approved
FDA Approval announced October 3, 2019.
Entospletinib
Chronic Graft Versus Host Disease (cGVHD)
Phase 2
Phase 2
Phase 2 ongoing.
GS-9674
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 data 4Q 2018.
Andecaliximab GS-5745
Gastric Cancer
Phase 3
Phase 3
Phase 3 futility analysis 3Q 2017. Trial to continue.
GS-9674
Primary biliary cholangitis
Phase 2
Phase 2
Phase 2 data released November 9, 2018.
Selonsertib (GS-4997)
Alcoholic Hepatitis
Phase 2
Phase 2
Phase 2 enrollment completed 1Q 2018.
Yescarta (axicabtagene ciloleucel)
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer
Phase 2
Phase 2
2-year data at ASH 2018 noted 39% of patients were in an ongoing response. OS not yet reached.
Bictegravir/F/TAF
HIV
Approved
Approved
Approved February 7, 2018.
Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
Hepatitis C virus (HCV)
Approved
Approved
Approval announced July 18, 2017.
GS-0976
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 data released October 24, 2017. Positive high dose data, low dose negative.
Yescarta (Axicabtagene Ciloleucel) and Utomilumab (PF-05082566)
Large B-Cell Lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated in 2018.

Latest News

  1. Gilead Sciences, Inc. (NASDAQ:GILD) today announced data from an ongoing Phase 1 study, which showed that a sustained-delivery subcutaneous formulation of the company's investigational, novel inhibitor of HIV-1 capsid function, lenacapavir (GS-6207), sustained predicted therapeutic concentrations for at least six months following a single 900 mg dose. In the study, lenacapavir was generally well-tolerated, and no serious adverse events were reported. These data were presented at the 23rd International AIDS Conference (AIDS 2020: Virtual).

    "Long-acting antiretroviral therapy may help address challenges with treatment adherence and treatment fatigue, providing additional options to people living with HIV," said Eric S. Daar, MD, Chief of the…

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced data from an ongoing Phase 1 study, which showed that a sustained-delivery subcutaneous formulation of the company's investigational, novel inhibitor of HIV-1 capsid function, lenacapavir (GS-6207), sustained predicted therapeutic concentrations for at least six months following a single 900 mg dose. In the study, lenacapavir was generally well-tolerated, and no serious adverse events were reported. These data were presented at the 23rd International AIDS Conference (AIDS 2020: Virtual).

    "Long-acting antiretroviral therapy may help address challenges with treatment adherence and treatment fatigue, providing additional options to people living with HIV," said Eric S. Daar, MD, Chief of the Division of HIV Medicine at the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine at UCLA. "The promising safety and pharmacokinetic profiles of lenacapavir support continued evaluation of an every six-month dosing interval and further demonstrate the potential for a single subcutaneous injection of lenacapavir to be part of a long-acting HIV treatment regimen."

    Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Lenacapavir disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

    "There is a compelling unmet need for interventions that can potentially improve treatment adherence to chronic HIV therapy, including the development of long-acting formulations, which can be administered less frequently," said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. "We hope to make HIV a more manageable part of people's lives through continued treatment innovations, including the exploration of dosing intervals that coincide with regularly scheduled visits with healthcare providers."

    The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies, and have not yet been established. Initial data from Phase 1 studies that assessed the antiviral activity of lenacapavir were presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland in 2019 and presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020 in Boston, Mass.

    Data presented on lenacapavir at AIDS 2020: Virtual:

    Virtual Poster PEB0265: GS-6207 Sustained Delivery Formulation Supports 6-Month Dosing Interval

    In this ongoing, randomized, blinded, placebo-controlled, single-ascending dose (SAD) Phase 1 study, 30 participants were randomized (4:1) to receive 300 mg/mL of subcutaneous lenacapavir (n=eight per cohort) or placebo (n=two per cohort), at 300 mg (1 x 1.0 mL) or 900 mg (3 x 1.0 mL or 2 x 1.5 mL). All study participants completed dosing, and pharmacokinetic and safety data were collected through approximately 64 weeks post-dose.

    A slow initial release of lenacapavir was observed, and therapeutic plasma concentrations were sustained for at least six months following a single 900 mg dose, administered as 3 x 1.0 mL injections. Similar results were observed following a 900 mg dose administered as 2 x 1.5 mL injections. Lenacapavir exposures increased in a generally dose-proportional manner from 300 mg to 900 mg, with maximum concentrations achieved 11 to 14 weeks post-dose and an apparent half-life of roughly 15 weeks.

    Lenacapavir was generally well-tolerated; no serious or grade 3 or 4 adverse events (AEs) related to study drug or leading to study discontinuation occurred. The most common AEs were injection site induration (87 percent), pain (63 percent) and erythema (70 percent), all of which were mild. There were no clinically relevant laboratory abnormalities of grade 3 or higher.

    Lenacapavir is an investigational compound and is not approved by the U.S. Food and Drug Administration or any other regulatory authority and the safety and efficacy are not yet known. There is no cure for HIV or AIDS.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

    For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it's estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company's manufacturing partners.

    Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.

    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 the possibility of unfavorable results from ongoing and additional clinical trials involving lenacapavir, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all.

    In addition, it is possible that Gilead may make a strategic decision to discontinue development of lenacapavir, and as a result, lenacapavir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    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 Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-300

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  2. – Older Adults With Diabetes, Hypertension, Cardiovascular Disease, and Dyslipidemia Maintained High Rates of Virologic Suppression After Switching to Biktarvy –

    – Additional Data Presented Suggest the Presence of Pre-Existing Resistance in Virologically Suppressed Patients Switching to Biktarvy, Including Those With History of Treatment Failure –

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced data demonstrating the safety and efficacy of the once-daily, single tablet regimen Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults ages 65 and older (n=140), including those with common comorbidities such as diabetes (22 percent), hypertension (55 percent), cardiovascular…

    – Older Adults With Diabetes, Hypertension, Cardiovascular Disease, and Dyslipidemia Maintained High Rates of Virologic Suppression After Switching to Biktarvy –

    – Additional Data Presented Suggest the Presence of Pre-Existing Resistance in Virologically Suppressed Patients Switching to Biktarvy, Including Those With History of Treatment Failure –

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced data demonstrating the safety and efficacy of the once-daily, single tablet regimen Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults ages 65 and older (n=140), including those with common comorbidities such as diabetes (22 percent), hypertension (55 percent), cardiovascular disease (24 percent), and dyslipidemia, which is an abnormal amount of lipids in the blood (59 percent). At 48 weeks, 92 percent of those who switched to Biktarvy maintained virologic suppression, achieving HIV RNA<50 copies/mL. Across the studies, Biktarvy was generally well tolerated. These data were evaluated as part of a pooled analysis of four international trials and will be presented during the 23rd International AIDS Conference (AIDS 2020: Virtual).

    "As the number of older adults living with HIV grows, it's critical to optimize therapy to fit the unique needs of this key population, including those with chronic conditions who may be on multiple medications," said Moti Ramgopal, MD, FACP, FIDSA, Medical Director, Midway Immunology and Research Center. "By 2030, it is projected that up to 70 percent of people living with HIV will be 50 years or older, the majority of whom will have at least one other comorbidity. The data presented at AIDS 2020: Virtual showed that adults 65 years and older who switched to Biktarvy maintained viral suppression without a significant impact on lipid levels such as cholesterol, weight, or interactions with other drugs they may be taking for comorbidities."

    Gilead also announced a new data analysis from multiple studies evaluating drug resistance, including the first study to investigate a switch to Biktarvy in virologically suppressed study participants (n=565) in which some of the participants had a history of treatment failure or suspected pre-existing nucleoside reverse transcriptase inhibitor resistance (NRTI-R). The study showed infrequent and similar viral blips (when study participants experienced a temporary viral load at or above 50 copies/mL) among study participants switching to Biktarvy, as compared to the comparator arm. The results support further evaluation of whether the once-daily, single tablet regimen Biktarvy may potentially be an effective and well-tolerated option for adults with a history of treatment failure or pre-existing resistance. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.

    Biktarvy is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients weighing at least 25 kg who have no antiretroviral (ART) treatment history. While it is also indicated for adults and pediatric patients weighing at least 25 kg who are virologically suppressed and on a stable antiretroviral regimen, these people must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Please see below for U.S. Important Safety Information for Biktarvy, including a Boxed Warning on the risk of post-treatment acute exacerbation of hepatitis B.

    "These data presented at AIDS 2020: Virtual further reinforce the potential of Biktarvy for use in a wide range of people living with HIV, including those with treatment resistance, older adults and those with certain common chronic conditions," said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. "At Gilead, we are focused on continuing to advance the scientific understanding of HIV treatment in a way that will have a truly meaningful impact on the daily lives of those affected by the epidemic, from young children to the growing number of older adults who are living longer, healthier lives with HIV."

    Key abstracts for HIV treatment data presented at AIDS 2020: Virtual include:

    Oral Presentation OAB0403: Pooled Analysis of 4 International Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged 65 or Older Demonstrating Safety and Efficacy: Week 48 Results

    A pooled analysis of four international trials (Studies 1844, 1878, 4030 and 4449) of virologically suppressed (HIV-1 RNA<50 copies/mL), treatment-experienced adults 65 years and older evaluated the efficacy and safety of switching to Biktarvy. The primary endpoint was HIV-1 RNA<50 copies/mL at week 48 as defined by the U.S. Food and Drug Administration Snapshot algorithm. Across the studies, 140 study participants with a median age of 68 years were evaluated; 14 percent were female, and 88 percent were white. Medical history at baseline was significant for diabetes (22 percent), hypertension (55 percent), cardiovascular disease (24 percent), and dyslipidemia, which is an abnormal amount of lipids in the blood (59 percent).

    At week 48, the proportion with HIV RNA<50 copies/mL was 92 percent (129/140), showing that Biktarvy in older adults maintained high rates of virologic suppression. In the studies, Biktarvy was generally well-tolerated; 11 study participants experienced a grade 1 or 2 study drug-related adverse event (AE), four of which discontinued the study. No participant experienced a grade 3 or 4 drug-related AE or virologic failure. Most common AEs were nasopharyngitis and arthralgia (7 percent each).

    Virtual Poster PEB0257: Baseline NRTI Resistance in Suppressed Participants Did Not Lead to Viral Blips on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) or Dolutegravir (DTG)+F/TAF Through Week 48 in Study 380-4030

    Study 4030 was the first study to prospectively investigate switching to Biktarvy in virologically suppressed study participants (n=565) in which some of the participants (25 percent) had a history of treatment failure and/or known or suspected pre-existing NRTI resistance. The aim of this additional analysis of the 48-week study data was to analyze the occurrence of viral blips in 565 suppressed study participants switching from DTG+F/TAF or DTG+F/tenofovir disoproxil fumarate to Biktarvy or DTG+F/TAF. A blip was defined as a post-baseline HIV-1 RNA value ≥50 c/mL preceded and followed by HIV-1 RNA <50 c/mL.

    In total, 15 study participants (2.7 percent) experienced a blip through week 48 with similar blip frequencies between treatment arms. No participant with blips qualified for genotypic and phenotypic testing for emergent resistance. Viral blips were infrequent and similar among study participants switching to Biktarvy or DTG+F/TAF, and baseline NRTI resistance did not result in a higher rate of blips. Blips did not lead to virologic failure or resistance development using these triple therapy regimens.

    Virtual Poster PEB0254: Prevalence and Risk Factors of Pre-Existing NNRTI Resistance Among Suppressed PLWH in B/F/TAF Switch Studies

    This analysis investigated the prevalence of pre-existing non-nucleoside reverse-transcriptase inhibitor resistance (NNRTI-R) and associated risk factors across four clinical trials evaluating the safety and efficacy of switching stably suppressed adults with HIV-1 infection to Biktarvy.

    Pre-existing drug resistance was assessed by historical genotypes and/or retrospective proviral DNA genotyping. Stepwise selection was used to identify potential risk factors for NNRTI-R in a multivariate logistic regression model with variables including participant demographics and baseline characteristics, HIV disease measures, ART history, and other pre-existing HIV drug resistance substitutions.

    Baseline genotypic data were available for 1,995 study participants. Altogether, 38 percent (754/1,995) of study participants were previously treated with NNRTIs, and 7 percent (145/1,995) were on a NNRTI-based regimen at baseline. NNRTI resistance was the most frequently observed resistance class in these studies. The high prevalence of NNRTI resistance among suppressed people living with HIV and the risk factors associated with NNRTI resistance underscore the importance of comprehensive resistance assessments and medical history prior to switching to NNRTI containing regimens.

    The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational; this use is not approved by the U.S. FDA, and the safety and efficacy of Biktarvy for this use has not been established. Please see below for the U.S. Indication for Biktarvy.

    Biktarvy does not prevent other sexually transmitted infections or cure HIV or AIDS.

    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: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. 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: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
    • Renal impairment: 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: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
    • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

    U.S. Indication for Biktarvy

    Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 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 history of treatment failure and no known resistance to any component of Biktarvy.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

    For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it's estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company's manufacturing partners.

    Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.

    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 the possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    U.S. Prescribing Information for Biktarvy including BOXED WARNING, is available at www.gilead.com.

    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 Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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  3.  -- Veklury is the First Approved Treatment Option for COVID-19 in the European Union --

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional marketing authorization was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting data that began in April 2020.

    Under this authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.

    "We appreciate the European Medicines…

     -- Veklury is the First Approved Treatment Option for COVID-19 in the European Union --

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional marketing authorization was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting data that began in April 2020.

    Under this authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.

    "We appreciate the European Medicines Agency's rapid review of remdesivir in recognition of the unprecedented nature of this pandemic," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "This conditional marketing authorization is an important step forward as we work together to address the treatment needs of patients across Europe."

    Veklury has been studied in hospitalized COVID-19 patients spanning a range of disease severity. The conditional marketing authorization for Veklury is supported by the U.S. National Institute of Allergy and Infectious Diseases' global Phase 3 trial of remdesivir. A conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data.

    Ongoing clinical trials continue to evaluate the safety and efficacy of remdesivir, including studies of remdesivir in combination with anti-inflammatory medicines and in special populations including pediatric patients. Research is also being conducted on new, investigational formulations of remdesivir that may enable studies of remdesivir in earlier stages of disease.

    About Veklury

    Veklury (remdesivir) is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of SARS-CoV-2, the virus that causes COVID-19. In recognition of the current public health emergency and based on available clinical data, remdesivir has been approved as a treatment for patients with severe COVID-19 in Japan, Taiwan, India, Singapore, the United Arab Emirates and the European Union. Outside of these regions, remdesivir is an investigational, unapproved drug.

    Important Information about Remdesivir in the United States

    In the United States, remdesivir (GS-5734™) is authorized for use under an Emergency Use Authorization (EUA) only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate, as remdesivir must be administered intravenously.

    Remdesivir is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 have not been established. This authorization is temporary and may be revoked, and it does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the United States, please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.

    There are limited clinical data available for remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of remdesivir. The use of remdesivir is contraindicated in patients with known hypersensitivity to remdesivir. Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received remdesivir. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy. Do not initiate remdesivir in patients with ALT ≥5x ULN or with an eGFR <30 mL/min. The decision to continue or discontinue remdesivir therapy after development of an adverse event should be made based on the clinical risk/benefit assessment for the individual patient.

    Due to a risk of reduced antiviral activity, coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended.

    Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during remdesivir treatment and considered to be potentially attributable to remdesivir. These events must be reported within 7 calendar days from the onset of the event. MedWatch adverse event reports can be submitted to FDA online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

    Gilead 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 the risk that the European Commission may not extend or convert the conditional marketing authorization into an unconditional marketing authorization for Veklury as a treatment for COVID-19. Remdesivir is an investigational drug that has not been approved by the FDA for any use, including for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    Veklury, 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 Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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  4. Gilead Sciences, Inc. (NASDAQ:GILD) today announced that new data from the company's HIV research and development program will be presented at the 23rd International AIDS Conference (AIDS 2020: Virtual) from July 6-10. The breadth of data presented at the meeting, along with Gilead-led symposia and workshops, reflect the company's commitment to advancing the scientific understanding of HIV prevention, treatment and cure strategies.

    "Continued scientific innovation is essential to better understanding and addressing the evolving needs of people living with or at risk for HIV," said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. "Gilead is actively pursuing innovative cure and long-term viral…

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced that new data from the company's HIV research and development program will be presented at the 23rd International AIDS Conference (AIDS 2020: Virtual) from July 6-10. The breadth of data presented at the meeting, along with Gilead-led symposia and workshops, reflect the company's commitment to advancing the scientific understanding of HIV prevention, treatment and cure strategies.

    "Continued scientific innovation is essential to better understanding and addressing the evolving needs of people living with or at risk for HIV," said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. "Gilead is actively pursuing innovative cure and long-term viral suppression strategies, while seeking to optimize antiretroviral and prevention therapies for all individuals impacted by HIV. Through the data presented at AIDS 2020: Virtual, we aim to advance care in a transformative way and contribute to the shared goal of ending the HIV/AIDS epidemic."

    Phase 1 trial results supporting further evaluation of a six-month dosing interval for a sustained delivery formulation of Gilead's novel, investigational HIV-1 capsid inhibitor, lenacapavir (GS-6207), will be presented. Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Lenacapavir disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

    HIV treatment data to be presented includes a pooled analysis of four international trials evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; B/F/TAF) in adults aged 65 or older. Additionally, data evaluating the safety and efficacy of an investigational low-dose formulation of E/C/F/TAF (elvitegravir 90 mg/cobicistat 90 mg/emtricitabine 120 mg/tenofovir alafenamide 6 mg) in virologically suppressed children two years or older and weighing 14 to less than 25 kg who are living with HIV will be shared in a late-breaking presentation.

    Prevention data around the impact of COVID-19 shelter-in-place orders on pre-exposure prophylaxis (PrEP) access and usage and HIV risk behavior in the United States will be shared in a late-breaking presentation. Data from the ongoing DISCOVER multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg; F/TAF) for PrEP® will also be presented.

    Insights from Gilead's cure research program include an oral presentation on vesatolimod, a toll-like receptor 7 (TLR7) agonist, and dose-dependent immune responses induced in HIV controllers.

    Select accepted abstracts are as follows:

    Investigational Long-Acting HIV Therapy

    E-posters – Track B

     

    PEB0265: Lenacapavir/GS-6207 Sustained Delivery Formulation Supports 6-Month Dosing Interval

    HIV Treatment Research

    OAB04 – Antiretrovirals session 2

     

    OAB0403: Pooled Analysis of 4 International Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged >65 or Older Demonstrating Safety and Efficacy: Week 48 Results

    E-posters – Track B

     

    PEB0257: Baseline NRTI Resistance in Suppressed Participants Did Not Lead to Viral Blips on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) or Dolutegravir (DTG)+F/TAF Through Week 48 in Study 380-4030

    E-posters – Track B

     

    PEB0254: Prevalence and Risk Factors of Pre-Existing NNRTI Resistance Among Suppressed PLWH in B/F/TAF Switch Studies

    E-posters – Track B

     

    PEB0229: The BICSTaR Prospective Cohort: Real-World Effectiveness, Safety and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Routine Clinical Practice in People Living with HIV (PLWH)

    Prime channel live sessions – Track D late-breaker abstracts

     

    OABLB01: Safety, PK, and Efficacy of Low-dose E/C/F/TAF in Virologically Suppressed Children ≥2 Years Old Living with HIV

    HIV Prevention Research

    Prime channel live sessions – Track D late-breaker abstracts

     

    OADLB01: Impact of COVID-19 Related Shelter-in-Place Orders on PrEP Access, Usage and HIV Risk Behaviors in the United States

    E-posters – Track B

     

    PEB0165: DISCOVER: Study for HIV Pre-Exposure Prophylaxis (PrEP): No Evidence of Risk Compensation in Participants Taking F/TDF or F/TAF for PrEP Through 96 Weeks

    PDB04 – Resistance

     

    PDB0404: Deep Sequencing with Unique Molecular Identifiers for Evaluation of HIV-1 Drug Resistance in the DISCOVER Pre-exposure Prophylaxis Trial

    PDB03 – Opportunistic infections

     

    PDB0303: Persistently High Rates of Sexually Transmitted Infections in the DISCOVER HIV PrEP Trial

    HIV Cure Research

    OAB02 – ARV, cure and testing strategies

     

    OAB0205: Vesatolimod, a Toll-Like Receptor 7 (TLR7) Agonist, Induces Dose-Dependent Immune Responses in HIV Controllers

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

    Lenacapavir (GS-6207), vesatolimod, and the low-dose formulation of E/C/F/TAF are investigational compounds and are not approved by the U.S. Food and Drug Administration or any other regulatory authority. Their safety and efficacy have not been established. In May 2019, FDA granted Breakthrough Therapy Designation for the development of lenacapavir (GS-6207) for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance.

    Biktarvy and Descovy do not prevent other sexually transmitted infections or cure HIV or AIDS.

    U.S. Important Safety Information and Indication 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: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. 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: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
    • Renal impairment: 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: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
    • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

    U.S. Indication for Biktarvy

    Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 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 history of treatment failure and no known resistance to any component of Biktarvy.

    U.S. Important Safety Information and Indication for Descovy for PrEP

    BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

    • Descovy for PrEP must be prescribed only to patients confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed.
    • Severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of Descovy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue Descovy. If appropriate, anti-hepatitis B therapy may be warranted.

    Contraindication:

    • Descovy for PrEP is contraindicated in patients with unknown or positive HIV status.

    Comprehensive management to reduce risks:

    • Use Descovy for PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
    • HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to: condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network.
    • Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner's HIV-1 viremic status, regular testing for STIs).
    • Reduce potential for drug resistance: Only prescribe Descovy for PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking Descovy, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only Descovy because Descovy alone is not a complete regimen for treating HIV-1.
      • Some HIV tests may not detect acute HIV infection. Prior to initiating Descovy for PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection.
      • If HIV-1 infection is suspected or if symptoms of acute infection are present while taking Descovy for PrEP, convert the Descovy for PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection.
    • Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling.

    Warnings and precautions:

    • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. Do not initiate Descovy in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Descovy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients (see Dosage and Administration section).
    • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue use 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 (≥2%) in the Descovy for PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain.

    Drug interactions:

    • Prescribing information: Consult the full Prescribing Information for Descovy for more information, warnings, and potentially significant drug interactions, including clinical comments.
    • Metabolism: Drugs that inhibit P-gp can increase the concentrations of tenofovir alafenamide (TAF), a component of Descovy. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy.
    • Drugs affecting renal function: Coadministration of Descovy 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: One tablet taken once daily with or without food.
    • HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section).
    • HBV screening: Test for HBV infection prior to or when initiating Descovy.
    • Renal impairment and monitoring: Not recommended in patients with creatinine clearance (CrCl) <30 mL/min. Prior to or when initiating Descovy, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

    U.S. Indication for Descovy for PrEP

    Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

    Limitation of Use:

    • Descovy for PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

    For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it's estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company's manufacturing partners.

    Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.

    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 the possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy, Descovy for PrEP, the low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all. In addition, it is possible that Gilead may make a strategic decision to discontinue development of the low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod, and as a result, the low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements.

    These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    U.S. full Prescribing Information for Biktarvy, and Descovy for PrEP, including BOXED WARNINGS, is available at www.gilead.com

    Biktarvy, Descovy, Descovy for PrEP, 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 Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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  5. In the weeks since we learned of remdesivir's potential against COVID-19, one topic has attracted more speculation than any other: what price we might set for the medicine. This degree of speculation is understandable. Remdesivir, our investigational treatment, is the first antiviral to have demonstrated patient improvement in clinical trials for COVID-19 and there is no playbook for how to price a new medicine in a pandemic. We are aware of the significant responsibility that comes with pricing remdesivir, and the need to be transparent on our decision. After giving this the considerable care, time and amount of discussion that it merits, we are now ready to share our decision and explain how we reached it.

    As with all our actions on remdesivir…

    In the weeks since we learned of remdesivir's potential against COVID-19, one topic has attracted more speculation than any other: what price we might set for the medicine. This degree of speculation is understandable. Remdesivir, our investigational treatment, is the first antiviral to have demonstrated patient improvement in clinical trials for COVID-19 and there is no playbook for how to price a new medicine in a pandemic. We are aware of the significant responsibility that comes with pricing remdesivir, and the need to be transparent on our decision. After giving this the considerable care, time and amount of discussion that it merits, we are now ready to share our decision and explain how we reached it.

    As with all our actions on remdesivir, we approached this with the aim of helping as many patients as possible, as quickly as possible and in the most responsible way. This has been our compass point throughout, from collaborating to find rapid answers on safety and efficacy, to scaling up manufacturing and donating our supply of remdesivir through the end of June. In each case, we recognized the need to do things differently to reflect the exceptional circumstances of the pandemic. Now, as we transition beyond the donation period and set a price for remdesivir, the same principle applies.

    In normal circumstances, we would price a medicine according to the value it provides. The first results from the NIAID study in hospitalized patients with COVID-19 showed that remdesivir shortened time to recovery by an average of four days. Taking the example of the United States, earlier hospital discharge would result in hospital savings of approximately $12,000 per patient. Even just considering these immediate savings to the healthcare system alone, we can see the potential value that remdesivir provides. This is before we factor in the direct benefit to those patients who may have a shorter stay in the hospital.

    We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient.

    Part of the intent behind our decision was to remove the need for country by country negotiations on price. We discounted the price to a level that is affordable for developed countries with the lowest purchasing power. This price will be offered to all governments in developed countries around the world where remdesivir is approved or authorized for use. At the current price of $390 per vial, remdesivir is positioned to achieve the aim of providing immediate net savings for healthcare systems.

    In the U.S., the same government price of $390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be $520 per vial. At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access.

    Gilead has entered into an agreement with the U.S. Department of Health and Human Services (HHS) whereby HHS and states will continue to manage allocation to hospitals until the end of September. After this period, once supplies are less constrained, HHS will no longer manage allocation.

    In the developing world, where healthcare resources, infrastructure and economics are so different, we have entered into agreements with generic manufacturers to deliver treatment at a substantially lower cost. These alternative solutions are designed to ensure that all countries in the world can provide access to treatment.

    Our work on remdesivir is far from done. We continue to explore its potential to help in this pandemic in various ways, such as evaluating treatment earlier in the course of the disease, in outpatient settings, with an inhaled formulation, in additional patient groups and in combination with other therapies. As we accumulate more data from global clinical trials and initiate many additional studies, we will understand more about the full value of remdesivir over time. Our teams also remain focused on increasing supplies to meet the high global demand. By the end of this year, we expect our investment on the development and manufacture of remdesivir to exceed $1 billion (U.S.) and our commitment will continue through 2021 and beyond.

    In making our decision on how to price remdesivir, we considered the full scope of our responsibilities. We started with our immediate responsibility to ensure price is in no way a hindrance to ensuring rapid and broad treatment. We also balanced that with our longer-term responsibilities: to continue with our ongoing work on remdesivir, to maintain our long-term research in antivirals and to invest in scientific innovation that might help generations to come. As with many other aspects of this pandemic, we are in unchartered territory in pricing remdesivir. Ultimately, we were guided by the need to do things differently. As the world continues to reel from the human, social and economic impact of this pandemic, we believe that pricing remdesivir well below value is the right and responsible thing to do.

    About Remdesivir

    Remdesivir is an antiviral product that is being studied in multiple ongoing international clinical trials. In recognition of the current public health emergency and based on available clinical data, the approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir have not been established.

    Remdesivir has not been approved by the U.S. Food and Drug Administration (FDA) for any use. In the U.S., the FDA granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

    Forward-Looking Statement

    This statement 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. Remdesivir is an investigational agent that has not been approved by the FDA for any use, and it has not been demonstrated to be safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. In addition, Gilead may face challenges related to the allocation and geographical distribution of existing and future supply of remdesivir. If Gilead is unable to sufficiently scale up production of remdesivir in the currently anticipated timelines, Gilead may be unable to meet future supply needs. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

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