{"success":true,"data":{"pressRelease":{"id":"129925","rtpr_id":"nBwcrq1a","ticker":"GILD","exchange":"NASDAQ","all_tickers":["GILD"],"title":"U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens","author":"Business Wire","published_at":"2026-08-27T21:47:00.074Z","article_body":"U.S. FDA Approves Gilead’s Bixlenvo(™), a New Once-Daily Single Tablet\nOption for Virologically Suppressed Adults With HIV, Including Those on\nComplex Regimens\n\n– Novel Daily Oral Tablet Combines Bictegravir, a Guideline-Recommended\nINSTI with a High Barrier to Resistance, with Lenacapavir, a First-in-Class\nCapsid Inhibitor with No Cross-Resistance to Other Existing Antiretrovirals\n–\n\n– Bixlenvo Now the Smallest STR; First and Only STR for Most People on\nComplex HIV Treatment Regimens –\n\nGilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and\nDrug Administration (FDA) approved Bixlenvo(™) (bictegravir 75\nmg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for\nthe treatment of HIV in adults who are virologically suppressed. Bixlenvo is\nnow the first and only STR option for virologically suppressed people with HIV\nwho are on complex regimens and unable to take currently available STRs.\n\nThis press release features multimedia. View the full release here:\nhttps://www.businesswire.com/news/home/20260817093045/en/\n(https://www.businesswire.com/news/home/20260817093045/en/)\n\nThis novel HIV treatment pairs bictegravir, a global guideline-recommended\nintegrase strand transfer inhibitor (INSTI) with a high barrier to resistance,\nwith lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism\nof action with no cross-resistance to other antiretrovirals.\n\n“Bixlenvo offers a new once-daily STR designed for the evolving needs of\npeople with HIV,” said Chloe Orkin, MD, lead primary investigator for\nARTISTRY-1 and Clinical Professor of Infection and Inequities at Queen Mary\nUniversity of London. “The approval is a significant advancement in HIV\ntreatment, especially for individuals unable to benefit from\nguideline-recommended STRs due to challenges like pre-existing resistance or\ntolerability. It expands tailored, simplified dosing to people whose needs\nwere not fully met by existing single tablet therapies.\"\n\nThe FDA approval is based on results from the Phase 3 ARTISTRY-1 (NCT05502341\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05502341&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=NCT05502341&index=1&md5=40643373f169697197af436f7db6f6a2)\n) and ARTISTRY-2 (NCT06333808\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06333808&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=NCT06333808&index=2&md5=08814b50364c106327b0890fd91acdbd)\n) trials, with data\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2026%2Fgileads-single-tablet-regimen-of-bictegravir-and-lenacapavir-maintained-virological-suppression-in-people-with-hiv-who-switched-antiretroviral-therapy&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=data&index=3&md5=0fa4524b0f9cd9236dac6e637cb6c0b1)\npresented during late-breaker sessions at the 33rd Conference on Retroviruses\nand Opportunistic Infections (CROI 2026). The trials evaluated Bixlenvo in\nadults with HIV who are virologically suppressed, including those who switched\nfrom complex multi-tablet regimens or from Biktarvy(®) (bictegravir 50\nmg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). In both trials, Bixlenvo\ndemonstrated comparable efficacy in maintaining virologic suppression at Week\n48 and was generally well tolerated, with no significant or new safety\nconcerns identified. Most common adverse reactions reported in at least 2% of\nparticipants across the ARTISTRY program were headache, nausea, and diarrhea.\nDetailed ARTISTRY-1 results were published in The Lancet\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flancet%2Farticle%2FPIIS0140-6736%252826%252900307-7%2Ffulltext&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=The+Lancet&index=4&md5=0a66b023b7dc6b51fdbd847c68a0c2f4)\n, and ARTISTRY-2 results were published in Lancet HIV\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flanhiv%2Farticle%2FPIIS2352-3018%252826%252900078-0%2Fabstract&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=Lancet+HIV&index=5&md5=cf63b524d2bd691534676c52d2a7202e)\n.\n\n“Bixlenvo continues Gilead's long-term commitment to innovation in HIV.\nBringing together bictegravir with our first-in-class capsid inhibitor,\nlenacapavir, Bixlenvo offers a novel choice to people with HIV looking to\nswitch or simplify their treatment regimen,” said Daniel O’Day, Chairman\nand Chief Executive Officer of Gilead Sciences. “Our goal at Gilead is to\nprovide multiple options for HIV treatment and prevention and with a pipeline\nof potential daily, weekly and longer acting options, today’s approval could\nbe the first of many in the years ahead.”\n\nARTISTRY-1 enrolled the oldest study population in a Phase 3 registrational\ntrial for HIV-1 treatment to date, with a median participant age of 60 years.\nParticipants were taking between two and 11 pills per day at baseline, with\napproximately 40% taking antiretroviral therapy more than once daily.\nAdditionally, the trial participants had extensive HIV treatment experience,\nwith a median treatment duration of 28 years, a high level of historical\nantiretroviral resistance (67% with NRTI resistance) and a high proportion of\nparticipants on a complex regimen because of antiretroviral resistance (81%).\nThe Phase 3 results demonstrated that switching from complex multi-tablet\nregimens to Bixlenvo was associated with improvements in certain fasting lipid\nparameters and participant-reported treatment satisfaction. ARTISTRY-2 showed\nthat switching to Bixlenvo had no significant impact on weight.\n\nBixlenvo requires a two-day initiation dose with Sunlenca(® )(lenacapavir),\nthereafter only Bixlenvo is taken orally once a day.\n\nBictegravir and lenacapavir in combination are not approved by any regulatory\nauthority outside of the United States.\n\nThere is currently no cure for HIV or AIDS.\n\nPlease see below for the U.S. Indication and Important Safety Information for\nBixlenvo.\n\nAbout Bixlenvo\n\nBixlenvo is a once-daily, single tablet regimen that combines bictegravir, a\nglobal guideline-recommended integrase strand transfer inhibitor (INSTI) with\na high barrier to resistance, and lenacapavir, a first-in-class capsid\ninhibitor with a multi-stage mechanism of action. Together, bictegravir and\nlenacapavir target multiple stages of the HIV life cycle. Developed for adults\nwith HIV who are virologically suppressed, including those on complex\nregimens, Bixlenvo expands treatment choice with a simple daily oral option\nsupported by results from the Phase 3 ARTISTRY clinical program.\n\nFor more information, visit www.BIXLENVO.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.BIXLENVO.com&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=www.BIXLENVO.com&index=6&md5=0d0a9e6577df4810974ecdb50e9d4f05)\n.\n\nU.S. Indication for Bixlenvo\n\nBixlenvo is indicated as a complete regimen for the treatment of human\nimmunodeficiency virus type 1 (HIV-1) infection in adults to replace the\ncurrent antiretroviral regimen in those who are virologically suppressed\n(HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with\nno known or suspected resistance to the individual components of Bixlenvo.\n\nIMPORTANT SAFETY INFORMATION\n\nContraindications\n\n\n * Coadministration: Concomitant administration of Bixlenvo is contraindicated\nwith dofetilide and strong CYP3A inducers.\n\nWarnings and precautions\n\n\n * See Contraindications and Drug Interactions sections. Consider the potential\nfor drug interactions prior to and during Bixlenvo therapy and monitor for\nadverse reactions.\n\nAdverse reactions\n\n\n * Most common adverse reactions (incidence >2%; all grades) reported in\nclinical trials were headache (4%), nausea (3%), and diarrhea (2%).\n\nDrug interactions\n\n\n * Prescribing Information: Consult the full Prescribing Information for Bixlenvo\nfor more information on contraindications, warnings, and potentially\nsignificant drug interactions, including clinical comments.\n\n * Enzymes/transporters: Drugs that are both a strong inducer of CYP3A and induce\nUGT1A1 can substantially decrease the concentration of components of Bixlenvo.\nDrugs that are strong or moderate inducers of CYP3A may significantly decrease\nthe concentrations of components of Bixlenvo. Drugs that are both a strong\nCYP3A inhibitor and a UGT1A1 inhibitor, or combined P-gp, UGT1A1, and strong\nCYP3A inhibitors can significantly increase concentrations of components of\nBIXLENVO.\n\nDosage and administration\n\n\n * Dosage: Two-day initiation regimen of Bixlenvo 1 tablet plus Sunlenca 2\ntablets taken orally daily, followed by a maintenance regimen of Bixlenvo 1\ntablet orally once daily. Tablets may be taken with or without food.\n\n\n* Day 1: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300\nmg orally (600 mg dose)\n\n * Day 2: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300\nmg orally (600 mg dose)\n\n * Day 3 and once daily thereafter: Bixlenvo 1 tablet of 75 mg/50 mg orally once\ndaily\n\n\n\n\n * Missed dose: If the initiation doses of Bixlenvo or Sunlenca are missed,\npatients should take them as soon as possible. Patients should not take both\nDay 1 and Day 2 doses of Sunlenca on the same day. Patients should take missed\nmaintenance doses as soon as possible. If more than 7 days have elapsed since\nthe last maintenance dose, restart initiation dosage regimen from Day 1, if\nclinically appropriate to continue treatment.\n\nPregnancy and lactation\n\n\n * Pregnancy: Lower exposures of bictegravir were observed in clinical studies\nwith a bictegravir-containing regimen; therefore, viral load should be\nmonitored closely in pregnant individuals. An Antiretroviral Pregnancy\nRegistry (APR) has been established.\n\n * Lactation: Individuals with HIV-1 should be informed of the potential risks of\nbreastfeeding.\n\nAbout Gilead HIV\n\nFor almost 40 years, Gilead has been a leading innovator in the field of HIV,\ndriving advances in treatment, prevention and cure research. Gilead\nresearchers have developed 13 HIV medications, including the first\nsingle-tablet regimen to treat HIV, the first antiretroviral for pre-exposure\nprophylaxis (PrEP) to help reduce new HIV infections, and the first\nlong-acting injectable HIV prevention medication administered twice-yearly.\nOur advances in medical research\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fscience%2Fresearch&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=medical+research&index=7&md5=4dac7025fd1b82a98417679aebf3dc25)\nhave helped to transform HIV into a treatable, preventable, chronic condition\nfor millions of people.\n\nGilead is committed to continued scientific innovation to provide solutions\nfor the evolving needs of people affected by HIV around the world. Through\npartnerships\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fresponsibility%2Fgiving-at-gilead%2Fcorporate-giving%2Fstrategic-initiatives&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=partnerships&index=8&md5=a0c9ba227bbd3de294e596ea0e96498c)\n, collaborations and charitable giving, the company also aims to improve\neducation, expand access\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fresponsibility%2Fglobal-health-and-access&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=access&index=9&md5=ff2ae16f784c27267ea643e3762ca981)\nand address barriers to care, with the goal of ending the HIV epidemic\nworldwide. Gilead has been repeatedly recognized\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2023%2Fgilead-named-number-one-overall-philanthropic-funder-of-hiv-related-programs-for-second-year-in-a-row-by-funders-concerned-about-aids&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=recognized&index=10&md5=c01adc4225a20cc3255f2e010aefebf9)\nas the top two leading philanthropic funders of HIV-related programs in a\nreport released by Funders Concerned About AIDS.\n\nDiscover more about Gilead’s unique collaborations worldwide and the work to\nhelp end the HIV epidemic.\n\nAbout Gilead Sciences\n\nGilead Sciences, Inc. is a biopharmaceutical company that has pursued and\nachieved breakthroughs in medicine for more than three decades, with the goal\nof creating a healthier world for all people. The company is committed to\nadvancing innovative medicines to prevent and treat life-threatening diseases,\nincluding HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025,\nGilead announced a planned $32 billion investment to further strengthen its\nU.S. footprint to power the next era of discovery, job creation and public\nhealth preparedness – while continuing to invest globally to ensure patients\neverywhere benefit from its scientific innovation. Gilead operates in more\nthan 35 countries worldwide, with headquarters in Foster City, Calif.\n\nForward-Looking Statements\n\nThis press release includes forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995 that are subject to\nrisks, uncertainties and other factors, including Gilead’s ability to\ninitiate, progress or complete clinical trials or studies within currently\nanticipated timelines or at all, and the possibility of unfavorable results\nfrom ongoing and additional clinical trials or studies, including those\ninvolving bictegravir and lenacapavir (such as ARTISTRY-1 and ARTISTRY-2);\nuncertainties relating to regulatory applications and related filing and\napproval timelines, including potential applications for programs and/or\nindications currently under evaluation, and the risk that any regulatory\napprovals, if granted, may be subject to significant limitations on use or\nsubject to withdrawal or other adverse actions by the applicable regulatory\nauthority; the possibility that Gilead may make a strategic decision to\ndiscontinue development of these programs and, as a result, these programs may\nnever be successfully commercialized for the indications currently under\nevaluation; the risk that physicians and patients may not see the advantages\nof Bixlenvo for the treatment of HIV in adults who are virologically\nsuppressed; and any assumptions underlying any of the foregoing. These and\nother risks, uncertainties and factors are described in detail in Gilead’s\nQuarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed\nwith the U.S. Securities and Exchange Commission. These risks, uncertainties\nand other factors could cause actual results to differ materially from those\nreferred to in the forward-looking statements. All statements other than\nstatements of historical fact are statements that could be deemed\nforward-looking statements. The reader is cautioned that any such\nforward-looking statements are not guarantees of future performance and\ninvolve risks and uncertainties and is cautioned not to place undue reliance\non these forward-looking statements. All forward-looking statements are based\non information currently available to Gilead, and Gilead assumes no obligation\nand disclaims any intent to update any such forward-looking statements.\n\nBixlenvo(™), Sunlenca(®), Gilead and the Gilead logo are trademarks of\nGilead Sciences, Inc., or its related companies.\n\nU.S. Prescribing Information for Bixlenvo is available at www.gilead.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.gilead.com%2F&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=www.gilead.com&index=11&md5=d28c45feda0c14ddd3c67645f1649e94)\n.\n\nFor more information about Gilead, please visit the company’s website at\nwww.gilead.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2F&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=www.gilead.com&index=12&md5=e19d76ab726fa1474356dd239b6fbe7a)\n, follow Gilead on X (@Gilead Sciences\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2FGileadSciences&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=%28%40Gilead+Sciences&index=13&md5=3dff1194341e4170b868e6ccc5b68d33)\n) and LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fgilead-sciences%2F&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=LinkedIn&index=14&md5=ddfe3d0587a12a010165fbf101cfd710)\n, or contact\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fcontact-us&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=contact&index=15&md5=16045ba86e0ff273179fb80c3283767d)\nGilead Public Affairs.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260817093045/en/\n(https://www.businesswire.com/news/home/20260817093045/en/)\n\nPriscilla White, Media\n\npublic_affairs@gilead.com (mailto:public_affairs@gilead.com)\n\nJacquie Ross, Investors\n\ninvestor_relations@gilead.com (mailto:investor_relations@gilead.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBwcrq1a","title":"U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens","author":"Business Wire","ticker":"GILD","created":"2026-08-27T21:47:00.074Z","tickers":["GILD"],"exchange":"NASDAQ","article_body":"U.S. FDA Approves Gilead’s Bixlenvo(™), a New Once-Daily Single Tablet\nOption for Virologically Suppressed Adults With HIV, Including Those on\nComplex Regimens\n\n– Novel Daily Oral Tablet Combines Bictegravir, a Guideline-Recommended\nINSTI with a High Barrier to Resistance, with Lenacapavir, a First-in-Class\nCapsid Inhibitor with No Cross-Resistance to Other Existing Antiretrovirals\n–\n\n– Bixlenvo Now the Smallest STR; First and Only STR for Most People on\nComplex HIV Treatment Regimens –\n\nGilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and\nDrug Administration (FDA) approved Bixlenvo(™) (bictegravir 75\nmg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for\nthe treatment of HIV in adults who are virologically suppressed. Bixlenvo is\nnow the first and only STR option for virologically suppressed people with HIV\nwho are on complex regimens and unable to take currently available STRs.\n\nThis press release features multimedia. View the full release here:\nhttps://www.businesswire.com/news/home/20260817093045/en/\n(https://www.businesswire.com/news/home/20260817093045/en/)\n\nThis novel HIV treatment pairs bictegravir, a global guideline-recommended\nintegrase strand transfer inhibitor (INSTI) with a high barrier to resistance,\nwith lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism\nof action with no cross-resistance to other antiretrovirals.\n\n“Bixlenvo offers a new once-daily STR designed for the evolving needs of\npeople with HIV,” said Chloe Orkin, MD, lead primary investigator for\nARTISTRY-1 and Clinical Professor of Infection and Inequities at Queen Mary\nUniversity of London. “The approval is a significant advancement in HIV\ntreatment, especially for individuals unable to benefit from\nguideline-recommended STRs due to challenges like pre-existing resistance or\ntolerability. It expands tailored, simplified dosing to people whose needs\nwere not fully met by existing single tablet therapies.\"\n\nThe FDA approval is based on results from the Phase 3 ARTISTRY-1 (NCT05502341\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05502341&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=NCT05502341&index=1&md5=40643373f169697197af436f7db6f6a2)\n) and ARTISTRY-2 (NCT06333808\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06333808&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=NCT06333808&index=2&md5=08814b50364c106327b0890fd91acdbd)\n) trials, with data\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2026%2Fgileads-single-tablet-regimen-of-bictegravir-and-lenacapavir-maintained-virological-suppression-in-people-with-hiv-who-switched-antiretroviral-therapy&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=data&index=3&md5=0fa4524b0f9cd9236dac6e637cb6c0b1)\npresented during late-breaker sessions at the 33rd Conference on Retroviruses\nand Opportunistic Infections (CROI 2026). The trials evaluated Bixlenvo in\nadults with HIV who are virologically suppressed, including those who switched\nfrom complex multi-tablet regimens or from Biktarvy(®) (bictegravir 50\nmg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). In both trials, Bixlenvo\ndemonstrated comparable efficacy in maintaining virologic suppression at Week\n48 and was generally well tolerated, with no significant or new safety\nconcerns identified. Most common adverse reactions reported in at least 2% of\nparticipants across the ARTISTRY program were headache, nausea, and diarrhea.\nDetailed ARTISTRY-1 results were published in The Lancet\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flancet%2Farticle%2FPIIS0140-6736%252826%252900307-7%2Ffulltext&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=The+Lancet&index=4&md5=0a66b023b7dc6b51fdbd847c68a0c2f4)\n, and ARTISTRY-2 results were published in Lancet HIV\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flanhiv%2Farticle%2FPIIS2352-3018%252826%252900078-0%2Fabstract&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=Lancet+HIV&index=5&md5=cf63b524d2bd691534676c52d2a7202e)\n.\n\n“Bixlenvo continues Gilead's long-term commitment to innovation in HIV.\nBringing together bictegravir with our first-in-class capsid inhibitor,\nlenacapavir, Bixlenvo offers a novel choice to people with HIV looking to\nswitch or simplify their treatment regimen,” said Daniel O’Day, Chairman\nand Chief Executive Officer of Gilead Sciences. “Our goal at Gilead is to\nprovide multiple options for HIV treatment and prevention and with a pipeline\nof potential daily, weekly and longer acting options, today’s approval could\nbe the first of many in the years ahead.”\n\nARTISTRY-1 enrolled the oldest study population in a Phase 3 registrational\ntrial for HIV-1 treatment to date, with a median participant age of 60 years.\nParticipants were taking between two and 11 pills per day at baseline, with\napproximately 40% taking antiretroviral therapy more than once daily.\nAdditionally, the trial participants had extensive HIV treatment experience,\nwith a median treatment duration of 28 years, a high level of historical\nantiretroviral resistance (67% with NRTI resistance) and a high proportion of\nparticipants on a complex regimen because of antiretroviral resistance (81%).\nThe Phase 3 results demonstrated that switching from complex multi-tablet\nregimens to Bixlenvo was associated with improvements in certain fasting lipid\nparameters and participant-reported treatment satisfaction. ARTISTRY-2 showed\nthat switching to Bixlenvo had no significant impact on weight.\n\nBixlenvo requires a two-day initiation dose with Sunlenca(® )(lenacapavir),\nthereafter only Bixlenvo is taken orally once a day.\n\nBictegravir and lenacapavir in combination are not approved by any regulatory\nauthority outside of the United States.\n\nThere is currently no cure for HIV or AIDS.\n\nPlease see below for the U.S. Indication and Important Safety Information for\nBixlenvo.\n\nAbout Bixlenvo\n\nBixlenvo is a once-daily, single tablet regimen that combines bictegravir, a\nglobal guideline-recommended integrase strand transfer inhibitor (INSTI) with\na high barrier to resistance, and lenacapavir, a first-in-class capsid\ninhibitor with a multi-stage mechanism of action. Together, bictegravir and\nlenacapavir target multiple stages of the HIV life cycle. Developed for adults\nwith HIV who are virologically suppressed, including those on complex\nregimens, Bixlenvo expands treatment choice with a simple daily oral option\nsupported by results from the Phase 3 ARTISTRY clinical program.\n\nFor more information, visit www.BIXLENVO.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.BIXLENVO.com&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=www.BIXLENVO.com&index=6&md5=0d0a9e6577df4810974ecdb50e9d4f05)\n.\n\nU.S. Indication for Bixlenvo\n\nBixlenvo is indicated as a complete regimen for the treatment of human\nimmunodeficiency virus type 1 (HIV-1) infection in adults to replace the\ncurrent antiretroviral regimen in those who are virologically suppressed\n(HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with\nno known or suspected resistance to the individual components of Bixlenvo.\n\nIMPORTANT SAFETY INFORMATION\n\nContraindications\n\n\n * Coadministration: Concomitant administration of Bixlenvo is contraindicated\nwith dofetilide and strong CYP3A inducers.\n\nWarnings and precautions\n\n\n * See Contraindications and Drug Interactions sections. Consider the potential\nfor drug interactions prior to and during Bixlenvo therapy and monitor for\nadverse reactions.\n\nAdverse reactions\n\n\n * Most common adverse reactions (incidence >2%; all grades) reported in\nclinical trials were headache (4%), nausea (3%), and diarrhea (2%).\n\nDrug interactions\n\n\n * Prescribing Information: Consult the full Prescribing Information for Bixlenvo\nfor more information on contraindications, warnings, and potentially\nsignificant drug interactions, including clinical comments.\n\n * Enzymes/transporters: Drugs that are both a strong inducer of CYP3A and induce\nUGT1A1 can substantially decrease the concentration of components of Bixlenvo.\nDrugs that are strong or moderate inducers of CYP3A may significantly decrease\nthe concentrations of components of Bixlenvo. Drugs that are both a strong\nCYP3A inhibitor and a UGT1A1 inhibitor, or combined P-gp, UGT1A1, and strong\nCYP3A inhibitors can significantly increase concentrations of components of\nBIXLENVO.\n\nDosage and administration\n\n\n * Dosage: Two-day initiation regimen of Bixlenvo 1 tablet plus Sunlenca 2\ntablets taken orally daily, followed by a maintenance regimen of Bixlenvo 1\ntablet orally once daily. Tablets may be taken with or without food.\n\n\n* Day 1: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300\nmg orally (600 mg dose)\n\n * Day 2: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300\nmg orally (600 mg dose)\n\n * Day 3 and once daily thereafter: Bixlenvo 1 tablet of 75 mg/50 mg orally once\ndaily\n\n\n\n\n * Missed dose: If the initiation doses of Bixlenvo or Sunlenca are missed,\npatients should take them as soon as possible. Patients should not take both\nDay 1 and Day 2 doses of Sunlenca on the same day. Patients should take missed\nmaintenance doses as soon as possible. If more than 7 days have elapsed since\nthe last maintenance dose, restart initiation dosage regimen from Day 1, if\nclinically appropriate to continue treatment.\n\nPregnancy and lactation\n\n\n * Pregnancy: Lower exposures of bictegravir were observed in clinical studies\nwith a bictegravir-containing regimen; therefore, viral load should be\nmonitored closely in pregnant individuals. An Antiretroviral Pregnancy\nRegistry (APR) has been established.\n\n * Lactation: Individuals with HIV-1 should be informed of the potential risks of\nbreastfeeding.\n\nAbout Gilead HIV\n\nFor almost 40 years, Gilead has been a leading innovator in the field of HIV,\ndriving advances in treatment, prevention and cure research. Gilead\nresearchers have developed 13 HIV medications, including the first\nsingle-tablet regimen to treat HIV, the first antiretroviral for pre-exposure\nprophylaxis (PrEP) to help reduce new HIV infections, and the first\nlong-acting injectable HIV prevention medication administered twice-yearly.\nOur advances in medical research\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fscience%2Fresearch&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=medical+research&index=7&md5=4dac7025fd1b82a98417679aebf3dc25)\nhave helped to transform HIV into a treatable, preventable, chronic condition\nfor millions of people.\n\nGilead is committed to continued scientific innovation to provide solutions\nfor the evolving needs of people affected by HIV around the world. Through\npartnerships\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fresponsibility%2Fgiving-at-gilead%2Fcorporate-giving%2Fstrategic-initiatives&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=partnerships&index=8&md5=a0c9ba227bbd3de294e596ea0e96498c)\n, collaborations and charitable giving, the company also aims to improve\neducation, expand access\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fresponsibility%2Fglobal-health-and-access&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=access&index=9&md5=ff2ae16f784c27267ea643e3762ca981)\nand address barriers to care, with the goal of ending the HIV epidemic\nworldwide. Gilead has been repeatedly recognized\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2023%2Fgilead-named-number-one-overall-philanthropic-funder-of-hiv-related-programs-for-second-year-in-a-row-by-funders-concerned-about-aids&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=recognized&index=10&md5=c01adc4225a20cc3255f2e010aefebf9)\nas the top two leading philanthropic funders of HIV-related programs in a\nreport released by Funders Concerned About AIDS.\n\nDiscover more about Gilead’s unique collaborations worldwide and the work to\nhelp end the HIV epidemic.\n\nAbout Gilead Sciences\n\nGilead Sciences, Inc. is a biopharmaceutical company that has pursued and\nachieved breakthroughs in medicine for more than three decades, with the goal\nof creating a healthier world for all people. The company is committed to\nadvancing innovative medicines to prevent and treat life-threatening diseases,\nincluding HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025,\nGilead announced a planned $32 billion investment to further strengthen its\nU.S. footprint to power the next era of discovery, job creation and public\nhealth preparedness – while continuing to invest globally to ensure patients\neverywhere benefit from its scientific innovation. Gilead operates in more\nthan 35 countries worldwide, with headquarters in Foster City, Calif.\n\nForward-Looking Statements\n\nThis press release includes forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995 that are subject to\nrisks, uncertainties and other factors, including Gilead’s ability to\ninitiate, progress or complete clinical trials or studies within currently\nanticipated timelines or at all, and the possibility of unfavorable results\nfrom ongoing and additional clinical trials or studies, including those\ninvolving bictegravir and lenacapavir (such as ARTISTRY-1 and ARTISTRY-2);\nuncertainties relating to regulatory applications and related filing and\napproval timelines, including potential applications for programs and/or\nindications currently under evaluation, and the risk that any regulatory\napprovals, if granted, may be subject to significant limitations on use or\nsubject to withdrawal or other adverse actions by the applicable regulatory\nauthority; the possibility that Gilead may make a strategic decision to\ndiscontinue development of these programs and, as a result, these programs may\nnever be successfully commercialized for the indications currently under\nevaluation; the risk that physicians and patients may not see the advantages\nof Bixlenvo for the treatment of HIV in adults who are virologically\nsuppressed; and any assumptions underlying any of the foregoing. These and\nother risks, uncertainties and factors are described in detail in Gilead’s\nQuarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed\nwith the U.S. Securities and Exchange Commission. These risks, uncertainties\nand other factors could cause actual results to differ materially from those\nreferred to in the forward-looking statements. All statements other than\nstatements of historical fact are statements that could be deemed\nforward-looking statements. The reader is cautioned that any such\nforward-looking statements are not guarantees of future performance and\ninvolve risks and uncertainties and is cautioned not to place undue reliance\non these forward-looking statements. All forward-looking statements are based\non information currently available to Gilead, and Gilead assumes no obligation\nand disclaims any intent to update any such forward-looking statements.\n\nBixlenvo(™), Sunlenca(®), Gilead and the Gilead logo are trademarks of\nGilead Sciences, Inc., or its related companies.\n\nU.S. Prescribing Information for Bixlenvo is available at www.gilead.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.gilead.com%2F&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=www.gilead.com&index=11&md5=d28c45feda0c14ddd3c67645f1649e94)\n.\n\nFor more information about Gilead, please visit the company’s website at\nwww.gilead.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2F&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=www.gilead.com&index=12&md5=e19d76ab726fa1474356dd239b6fbe7a)\n, follow Gilead on X (@Gilead Sciences\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2FGileadSciences&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=%28%40Gilead+Sciences&index=13&md5=3dff1194341e4170b868e6ccc5b68d33)\n) and LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fgilead-sciences%2F&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=LinkedIn&index=14&md5=ddfe3d0587a12a010165fbf101cfd710)\n, or contact\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.gilead.com%2Fcontact-us&esheet=54590652&newsitemid=20260817093045&lan=en-US&anchor=contact&index=15&md5=16045ba86e0ff273179fb80c3283767d)\nGilead Public Affairs.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260817093045/en/\n(https://www.businesswire.com/news/home/20260817093045/en/)\n\nPriscilla White, Media\n\npublic_affairs@gilead.com (mailto:public_affairs@gilead.com)\n\nJacquie Ross, Investors\n\ninvestor_relations@gilead.com (mailto:investor_relations@gilead.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-08-27T21:47:00.14648762Z","server_sent_at_ms":1787867220146},"received_at":"2026-08-27T21:47:00.333Z","source_url":"https://www.businesswire.com/news/home/20260817093045/en/"},"analysis":{"id":"118839","press_release_id":"129925","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"The FDA approved Gilead's Bixlenvo, a new once-daily single tablet regimen for virologically suppressed adults with HIV, including those on complex regimens.\n\nApproval is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 trial data demonstrating comparable efficacy to existing regimens with no significant new safety concerns.\n\nThis launch targets a difficult-to-treat population with the smallest STR available, combining bictegravir and the first-in-class capsid inhibitor lenacapavir.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Gilead secures FDA approval for Bixlenvo, expanding its HIV dominance with the smallest STR designed for complex patient cases."},"keyFigures":{"drugName":"Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg)","phaseOfTrial":"Phase 3"},"quotedText":"Bringing together bictegravir with our first-in-class capsid inhibitor, lenacapavir, Bixlenvo offers a novel choice to people with HIV looking to switch or simplify their treatment regimen","namedEntities":{"people":[{"name":"Daniel O’Day","role":"Chairman and Chief Executive Officer"},{"name":"Chloe Orkin","role":"MD, Clinical Professor of Infection and Inequities at Queen Mary University of London"}],"products":["Bixlenvo","Biktarvy","Sunlenca"],"companies":[{"name":"Gilead Sciences, Inc.","ticker":"GILD"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":5,"reasoning":"FDA approval of Bixlenvo, a novel single-tablet regimen for HIV, represents a binary regulatory event. It expands Gilead's core HIV franchise into the complex regimen population with a first-in-class combination."},"tickerRelevance":{"others":[],"primary":"GILD"},"globalImportance":65,"audienceRelevance":55,"eventTypeSecondary":["product_launch"],"importanceComponents":{"tickerTier":"Large-cap Pharma","eventGravity":"FDA approval of major franchise drug","sectorWeight":"Health Care","householdBrandBoost":false}},"event_type":"fda_approval","event_type_secondary":["product_launch"],"sentiment":"bullish","material_impact_score":5,"narrative":"The FDA approved Gilead's Bixlenvo, a new once-daily single tablet regimen for virologically suppressed adults with HIV, including those on complex regimens.\n\nApproval is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 trial data demonstrating comparable efficacy to existing regimens with no significant new safety concerns.\n\nThis launch targets a difficult-to-treat population with the smallest STR available, combining bictegravir and the first-in-class capsid inhibitor lenacapavir.","key_figures":{"drugName":"Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg)","phaseOfTrial":"Phase 3"},"named_entities":{"people":[{"name":"Daniel O’Day","role":"Chairman and Chief Executive Officer"},{"name":"Chloe Orkin","role":"MD, Clinical Professor of Infection and Inequities at Queen Mary University of London"}],"products":["Bixlenvo","Biktarvy","Sunlenca"],"companies":[{"name":"Gilead Sciences, Inc.","ticker":"GILD"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-27T21:51:05.016Z","global_importance":65,"audience_relevance":55,"importance_components":{"tickerTier":"Large-cap Pharma","eventGravity":"FDA approval of major franchise drug","sectorWeight":"Health Care","householdBrandBoost":false}},"durationMs":61342,"modelName":"glm-4.7"}}