An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.
The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.
The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.
The primary objectives of this study are:
Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.

Start Date29 Jul 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

NCT07476339

/ RecruitingPhase 4IIT

A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks

Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.
The REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B/F/TAF on the same day that they return to care. B/F/TAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.
Researchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.

Start Date17 Jun 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

[+1]

NCT07645287

/ RecruitingPhase 2

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.
The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Start Date15 Jun 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

100 Translational Medicine associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

100 Patents (Medical) associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

175

Literatures (Medical) associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

01 Aug 2026·JOURNAL OF INFECTION AND CHEMOTHERAPY

Results of three multicenter observational studies of regimens containing tenofovir alafenamide among people with HIV in Japan

Article

Author: Ohwaki, Ichiro ; Ohnishi, Makiko ; Lee, KuanYeh ; Serejo, Margarida ; Ishizaki, Akinobu ; Peters, Jami ; Taguchi, Nao

BACKGROUND:

Safety data on tenofovir alafenamide (TAF)-containing regimens with >2 years' follow-up in large cohorts of people with HIV (PWH) in Japan are limited. We evaluated the safety of TAF-containing regimens among PWH in Japan, including combinations with emtricitabine (F/TAF), elvitegravir/cobicistat/emtricitabine (E/C/F/TAF), and bictegravir/emtricitabine (B/F/TAF).

METHODS:

Data were collected from medical records for three separate single-arm studies from the HIV-Related Drugs multicenter observational joint cooperative surveillance. Data cut-off periods for each study were: F/TAF, January 2017-April 2025; E/C/F/TAF, July 2016-November 2024; and B/F/TAF, April 2019-February 2025. Each cohort was managed independently and analyzed descriptively as a separate observational cohort, without cross-cohort comparative analyses.

RESULTS:

Safety analyses for the studies included 1678 patients who received F/TAF, 659 who received E/C/F/TAF, and 1495 who received B/F/TAF; 22.2%-35.2% of patients were treatment-naïve across the three TAF-containing products. Median (quartile [Q]1, Q3) treatment duration was 5.12 (2.50, 6.89), 3.10 (2.38, 6.00), and 3.00 (1.28, 4.48) years. Adverse drug reactions (ADRs) occurred in 12.0%-18.6% of patients across studies. The most common ADRs by preferred term were: F/TAF, hypertension (23 [1.4%]) and hyperuricemia (22 [1.3%]); E/C/F/TAF, dyslipidemia (9 [1.4%]) and insomnia (6 [0.9%]); and B/F/TAF, weight increased (32 [2.1%]) and insomnia (18 [1.2%]). Most ADRs initially occurred within the first six months of treatment. The frequency of serious ADRs was <5%; 1.3%-2.9% discontinued treatment due to ADRs.

CONCLUSIONS:

The findings from these studies are consistent with the known safety profiles of the three TAF-containing products. No new safety issues emerged.

08 Jul 2026·Revista Espanola de Quimioterapia

Long-term persistence, effectiveness, safety, and metabolic impact of bictegravir/emtricitabine/tenofovir alafenamide fixed-dose combination in people living with HIV in the BICTARG cohort

Article

Author: Copertari, Gastón ; Brizuela, Martín ; Bottaro, Edgardo ; Roel, Macarena ; Cecchini, Diego ; Lamaizon, Cinthia ; Bacelar, Brenda ; Cassetti, Isabel

Introduction: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a preferred antiretroviral regimen in international guidelines, but long-term real-world data in Latin American people living with HIV (PLWH) are scarce. This study describes 48-month persistence, virological effectiveness, safety and metabolic changes in the Argentine BICTARG cohort. Material and methods: We conducted an observational, retrospective, open cohort study including treatment-naïve (TN) and treatment-experienced (TE) adults with HIV who initiated B/F/TAF between October 2019 and December 2022 at a large HIV centre. Persistence on B/F/TAF, virological suppression (VS, <50 copies/mL), B/F/TAF-related adverse events (AEs), and metabolic parameters (fasting glucose, cholesterol, and triglycerides) were assessed at 24, 36 and 48 months. Results: Overall, 3,057 PLWH were included: 425 TN (14%) and 2,632 TE (86%). In TN, persistence at 24, 36 and 48 months was 99%, 97% and 95%, and VS rates were 95%, 93% and 90%, respectively, with no AEs reported. In TE, persistence was 98%, 96%, and 88%, and VS rates were 96%, 98%, and 98%; AE rates were ≤0.4%, with no virological failure. Fasting glucose remained unchanged; TN participants showed increases in total, LDL, and HDL cholesterol, whereas in TE participants, lipid levels were stable and triglycerides decreased over time (p<0.001). Conclusions: In this large Argentine cohort, B/F/TAF demonstrated high persistence, sustained VS, low AE rates and an overall favourable metabolic profile over 48 months in both TN and TE PLWH, providing the first long-term real-world evidence from Latin America.

01 Jul 2026·HIV MEDICINE

Bictegravir/emtricitabine/tenofovir alafenamide in viremic people with HIV harbouring nucleos(t)ide reverse transcriptase inhibitor resistance‐associated mutations

Article

Author: Chen, Yaling ; Ge, You ; Liu, Anni ; Hu, Zhiliang ; Chen, Wei ; Qin, Jiamin ; Qian, Zheng ; Yang, Jinjin ; Wei, Hongxia ; Zhong, Yandan

Abstract:

Introduction:

Accumulating evidence supports switching virologically suppressed people with HIV (PWH) harbouring nucleoside reverse transcriptase inhibitor (NRTI) resistance‐associated mutations (RAMs) to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). However, real‐world data on initiating B/F/TAF in individuals with NRTI RAMs and ongoing viremia remain limited.

Methods:

We retrospectively included adult PWH treated at the Second Hospital of Nanjing between June 2020 and November 2024 who had at least one NRTI RAM and an HIV‐1 RNA ≥200 copies/mL at B/F/TAF initiation. The primary outcome was virological suppression at 12 months (HIV‐1 RNA <50 copies/mL). Laboratory adverse events were assessed.

Results:

A total of 45 participants were included (97.8% male). At baseline, the median HIV‐1 RNA was 36 800 copies/mL (interquartile range [IQR]: 5130–243 000), and the median CD4 cell count was 53 cells/μL (IQR: 18–307). AIDS‐defining illnesses were documented in 13 participants (28.9%). M184V/I was present in 71.1% and K65R/N in 8.9%. At 12 months, 41/45 (91.1%) participants achieved HIV‐1 RNA <50 copies/mL, and 44/45 (97.8%) achieved <200 copies/mL, with high suppression rates across resistance subgroups, including those with K65R/N or thymidine analogue mutations. All participants without suppression at 12 months achieved virological suppression with extended follow‐up. Grade 3–4 laboratory adverse events occurred in 10/45 (22.2%) participants, most commonly severe bone marrow suppression. These events were frequently attributable to comorbidities and concomitant medications, with no discontinuations of B/F/TAF.

Conclusions:

B/F/TAF demonstrated high virological suppression and acceptable laboratory safety in viremic PWH with pre‐existing NRTI RAMs, supporting its use in this challenging clinical setting.

246

News (Medical) associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

28 Aug 2026

·firstwordpharma.com

FDA approves Bixlenvo, Gilead's daily pill to simplify HIV treatment

Gilead Sciences added another HIV treatment to its repertoire on Thursday with the FDA approval of Bixlenvo (bictegravir/lenacapavir), a single-tablet regimen (STR) for the infectious disease taken once a day. The pill is designed for adults who are virologically suppressed, but are juggling complicated treatment regimens. Bixlenvo comprises bictegravir, an integrase strand transfer inhibitor that serves as the main ingredient in Gilead's daily HIV treatment Biktarvy, and lenacapavir, a capsid inhibitor. The latter is already approved as Sunlenca for multi-drug resistant HIV and Yeztugo as a twice-yearly preventive shot."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," Gilead CEO Daniel O'Day said in a company release. Gilead plans to sell a 30-day supply of Bixlenvo at a wholesale acquisition cost of $4,595, according to a report from Reuters.Continued viral suppressionFriday's approval was based on data from a pair of Phase III trials presented at the Conference on Retroviruses and Opportunistic Infections (CROI) conference in February.In the 698-patient ARTISTRY-1 study, which enrolled people who were virologically suppressed on complex multi-tablet regimens, 0.8% of those who switched to Bixlenvo had viral loads rebound to 50 copies/mL or higher at week 48, compared to 1.1% who stayed on their existing regimens. A second trial, ARTISTRY-2, tested the same switch strategy in 577 patients suppressed at baseline, but this time against Gilead's blockbuster Biktarvy — which brought in $3.8 billion in sales for the year's second quarter. Among those randomised to Bixlenvo, 1.3% had viral loads at or above 50 copies/mL at week 48, versus 1% on Biktarvy. Treatment plus preventionBixlenvo's approval adds more momentum to Gilead's HIV portfolio, which has already seen a boost this year from its preventative options. During its second-quarter earnings report, the company said sales of its HIV prevention drugs crossed the $1-billion threshold for the first time, For the three-month period, sales of its pre-exposure prophylaxis (PrEP) products jumped 101% compared with the second quarter of 2025. Revenues from once-daily Descovy grew 60% to $801 million and the twice-yearly injection Yeztugo — first approved in the US in June last year — reached $232 million, up 40% and above analyst forecasts of $219 million.

Drug ApprovalPhase 3AcquisitionClinical ResultFinancial Statement

27 Aug 2026

·www.biospace.com

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

– Novel Daily Oral Tablet Combines Bictegravir, a Guideline-Recommended INSTI with a High Barrier to Resistance, with Lenacapavir, a First-in-Class Capsid Inhibitor with No Cross-Resistance to Other Existing Antiretrovirals – – Bixlenvo Now the Smallest STR; First and Only STR for Most People on Complex HIV Treatment Regimens – FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo ™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs. This novel HIV treatment pairs bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism of action with no cross-resistance to other antiretrovirals. “Bixlenvo offers a new once-daily STR designed for the evolving needs of people with HIV,” said Chloe Orkin, MD, lead primary investigator for ARTISTRY-1 and Clinical Professor of Infection and Inequities at Queen Mary University of London. “The approval is a significant advancement in HIV treatment, especially for individuals unable to benefit from guideline-recommended STRs due to challenges like pre-existing resistance or tolerability. It expands tailored, simplified dosing to people whose needs were not fully met by existing single tablet therapies." The FDA approval is based on results from the Phase 3 ARTISTRY-1 ( NCT05502341 ) and ARTISTRY-2 ( NCT06333808 ) trials, with data presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026). The trials evaluated Bixlenvo in adults with HIV who are virologically suppressed, including those who switched from complex multi-tablet regimens or from Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). In both trials, Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified. Most common adverse reactions reported in at least 2% of participants across the ARTISTRY program were headache, nausea, and diarrhea. Detailed ARTISTRY-1 results were published in The Lancet , and ARTISTRY-2 results were published in Lancet HIV . “Bixlenvo continues Gilead's long-term commitment to innovation in HIV. 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,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Our goal at Gilead is to provide multiple options for HIV treatment and prevention and with a pipeline of potential daily, weekly and longer acting options, today’s approval could be the first of many in the years ahead.” ARTISTRY-1 enrolled the oldest study population in a Phase 3 registrational trial for HIV-1 treatment to date, with a median participant age of 60 years. Participants were taking between two and 11 pills per day at baseline, with approximately 40% taking antiretroviral therapy more than once daily. Additionally, the trial participants had extensive HIV treatment experience, with a median treatment duration of 28 years, a high level of historical antiretroviral resistance (67% with NRTI resistance) and a high proportion of participants on a complex regimen because of antiretroviral resistance (81%). The Phase 3 results demonstrated that switching from complex multi-tablet regimens to Bixlenvo was associated with improvements in certain fasting lipid parameters and participant-reported treatment satisfaction. ARTISTRY-2 showed that switching to Bixlenvo had no significant impact on weight. Bixlenvo requires a two-day initiation dose with Sunlenca ® (lenacapavir), thereafter only Bixlenvo is taken orally once a day. Bictegravir and lenacapavir in combination are not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. Please see below for the U.S. Indication and Important Safety Information for Bixlenvo. About Bixlenvo Bixlenvo is a once-daily, single tablet regimen that combines bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with a multi-stage mechanism of action. Together, bictegravir and lenacapavir target multiple stages of the HIV life cycle. Developed for adults with HIV who are virologically suppressed, including those on complex regimens, Bixlenvo expands treatment choice with a simple daily oral option supported by results from the Phase 3 ARTISTRY clinical program. For more information, visit . U.S. Indication for Bixlenvo Bixlenvo is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of Bixlenvo. IMPORTANT SAFETY INFORMATION Contraindications Coadministration: Concomitant administration of Bixlenvo is contraindicated with dofetilide and strong CYP3A inducers. Warnings and precautions See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Bixlenvo therapy and monitor for adverse reactions. Adverse reactions Most common adverse reactions (incidence > 2%; all grades) reported in clinical trials were headache (4%), nausea (3%), and diarrhea (2%). Drug interactions Prescribing Information: Consult the full Prescribing Information for Bixlenvo for more information on contraindications, warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that are both a strong inducer of CYP3A and induce UGT1A1 can substantially decrease the concentration of components of Bixlenvo. Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentrations of components of Bixlenvo. Drugs that are both a strong CYP3A inhibitor and a UGT1A1 inhibitor, or combined P-gp, UGT1A1, and strong CYP3A inhibitors can significantly increase concentrations of components of BIXLENVO. Dosage and administration Dosage: Two-day initiation regimen of Bixlenvo 1 tablet plus Sunlenca 2 tablets taken orally daily, followed by a maintenance regimen of Bixlenvo 1 tablet orally once daily. Tablets may be taken with or without food. Day 1: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300 mg orally (600 mg dose) Day 2: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300 mg orally (600 mg dose) Day 3 and once daily thereafter: Bixlenvo 1 tablet of 75 mg/50 mg orally once daily Missed dose: If the initiation doses of Bixlenvo or Sunlenca are missed, patients should take them as soon as possible. Patients should not take both Day 1 and Day 2 doses of Sunlenca on the same day. Patients should take missed maintenance doses as soon as possible. If more than 7 days have elapsed since the last maintenance dose, restart initiation dosage regimen from Day 1, if clinically appropriate to continue treatment. Pregnancy and lactation Pregnancy: Lower exposures of bictegravir were observed in clinical studies with a bictegravir-containing regimen; therefore, viral load should be monitored closely in pregnant individuals. An Antiretroviral Pregnancy Registry (APR) has been established. Lactation: Individuals with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead HIV For almost 40 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV prevention medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving bictegravir and lenacapavir (such as ARTISTRY-1 and ARTISTRY-2); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; the risk that physicians and patients may not see the advantages of Bixlenvo for the treatment of HIV in adults who are virologically suppressed; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Bixlenvo ™ , Sunlenca ® , Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Bixlenvo is available at . For more information about Gilead, please visit the company’s website at , follow Gilead on X ( @Gilead Sciences ) and LinkedIn , or contact Gilead Public Affairs. Contacts Priscilla White, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

Phase 3Clinical ResultDrug Approval

04 Aug 2026

·www.biospace.com

Gilead Sciences Announces Second Quarter 2026 Financial Results

Product Sales Excluding Veklury Increased 10% Year-Over-Year to $7.6 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.8 billion Diluted Loss Per Share was $(8.45) and Non-GAAP Diluted Loss Per Share was $(6.75) Reflecting $(9.08) Per Share Acquired IPR&D and Tax Expenses Associated with Recent Acquisitions FOSTER CITY, Calif.--(BUSINESS WIRE)-- #Earnings --Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the second quarter 2026. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Gilead delivered a very strong second quarter, with 10% year-over-year revenue growth in our base business driven by our HIV portfolio, Trodelvy and Livdelzi. HIV sales grew 12%, reflecting continued strength in treatment and the rapid expansion of our PrEP business, supporting an increase in our base business revenue expectations for 2026,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “We also made significant clinical progress with three FDA approvals and three positive Phase 3 updates. We look forward to delivering on our many opportunities in the second half of the year including another two potential launches in oncology and HIV.” Second Quarter 2026 Financial Results Total second quarter 2026 revenues increased 10% to $7.8 billion compared to the same period in 2025, primarily driven by: Higher sales of HIV products, Trodelvy® (sacituzumab govitecan-hziy) and Livdelzi® (seladelpar), partially offset by lower sales of Veklury® (remdesivir) as well as Cell Therapy and chronic hepatitis C virus (“HCV”) products; and Higher royalty, contract and other revenues related to a previous sale of intellectual property. Diluted (loss) earnings per share (“EPS”) was $(8.45) in the second quarter 2026 compared to $1.56 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired in-process research and development (“IPR&D”) expenses associated with our acquisitions of Arcellx, Inc. (“Arcellx”), Tubulis GmbH (“Tubulis”) and Ouro Medicines, LLC (“Ouro Medicines”), net of the impact of our collaboration with Lakefront Biotherapeutics NV (“Lakefront”) and the related taxes, as well as an IPR&D impairment related to assets previously acquired from Immunomedics, Inc. (“Immunomedics”) and higher operating expenses. The decrease was partially offset by higher revenues, lower income tax expense, and higher net gains from equity securities. Non-GAAP diluted (loss) EPS was $(6.75) in the second quarter 2026 compared to $2.01 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired IPR&D and tax expenses discussed above, as well as higher non-GAAP selling, general and administrative (“SG&A”) expenses and non-GAAP income tax expense, partially offset by higher revenues. As of June 30, 2026, Gilead had $3.2 billion of cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025. The decrease was primarily driven by year-to-date cash outflows of $11.3 billion related to acquisitions, $2.8 billion of debt repayments, $2.1 billion of dividend payments and $774 million of common stock repurchases, partially offset by $4.1 billion of net proceeds from debt financing and $6.1 billion of operating cash flow. During the second quarter 2026, Gilead generated $3.6 billion in operating cash flow. During the second quarter 2026, Gilead paid dividends of $1.0 billion and repurchased $355 million of common stock. Second Quarter 2026 Product Sales Total second quarter 2026 product sales increased 8% to $7.6 billion compared to the same period in 2025. Total second quarter 2026 product sales excluding Veklury increased 10% to $7.6 billion compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Cell Therapy and HCV products. HIV product sales increased 12% to $5.7 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 7% to $3.8 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price, favorable inventory dynamics and higher demand. Descovy® (FTC 200mg/TAF 25mg) sales increased 48% to $967 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand. The Liver Disease portfolio sales increased 10% to $877 million in the second quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, as well as chronic hepatitis B virus (“HBV”) products and Hepcludex® (bulevirtide-gmod), partially offset by lower sales for HCV products. Veklury sales decreased 81% to $23 million in the second quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations. Cell Therapy product sales decreased 14% to $417 million in the second quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds. Yescarta® (axicabtagene ciloleucel) sales decreased 12% to $346 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in- and out-of-class competition. Tecartus® (brexucabtagene autoleucel) sales decreased 24% to $70 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in-class competition. Trodelvy® (sacituzumab govitecan-hziy) sales increased 26% to $457 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher demand. Second Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin remained relatively flat at 79.3% in the second quarter 2026 compared to 78.7% in the same period in 2025. Non-GAAP product gross margin also remained flat at 86.9% in the second quarter 2026 compared to the same period in 2025. Research and development (“R&D”) expenses were $1.8 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily due to integration costs and other acquisition-related expenses, partially offset by lower oncology clinical study activity. Non-GAAP R&D expenses were $1.4 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily driven by lower oncology clinical study activity. Acquired IPR&D expenses were $11.2 billion in the second quarter 2026, primarily related to $7.0 billion for the Arcellx acquisition, $3.1 billion for the Tubulis acquisition and $1.0 billion for the Ouro Medicines acquisition, net of the impact of the Lakefront collaboration. SG&A expenses were $1.9 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily driven by integration costs related to the acquisitions and higher HIV promotional activities. Non-GAAP SG&A expenses were $1.5 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily due to higher HIV promotional activities. The effective tax rate (“ETR”) was (2.4)% in the second quarter 2026 compared to 19.3% in the same period in 2025. The non-GAAP ETR was (11.4)% in the second quarter 2026 compared to 18.8% in the same period in 2025. These changes primarily reflect the non-deductible acquired IPR&D expenses related to our acquisitions of Arcellx, Tubulis, and Ouro Medicines. Guidance and Outlook For the full year 2026, Gilead now expects: (in millions, except per share amounts) August 4, 2026 Guidance Comparison to May 7, 2026 Guidance Low End High End Product sales $ 30,100 $ 30,400 Previously $30,000 to $30,400 Product sales excluding Veklury $ 29,800 $ 30,100 Previously $29,400 to $29,800 Veklury ~ $300 Previously ~ $600 Diluted loss per share $ (3.75) $ (3.40) Previously $(3.25) to $(2.85) Non-GAAP diluted loss per share $ (0.65) $ (0.30) Previously $(1.05) to $(0.65) Our full year 2026 GAAP and non-GAAP diluted loss per share guidance includes the impact of approximately $9.08 due to acquired IPR&D charges of $11.1 billion related to the Arcellx, Tubulis and Ouro Medicines transactions, net of the impact of the Lakefront collaboration and related taxes. Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Announced U.S. Food and Drug Administration (“FDA”) accepted a supplemental New Drug Application submission for Yeztugo® (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis (“PrEP”), with a Prescription Drug User Fee Act target action date of February 2, 2027. Announced positive Phase 3 results from the ISLEND-1 and ISLEND-2 trials, in partnership with Merck, evaluating an investigational long-acting oral treatment regimen of islatravir 2 mg and lenacapavir 300 mg in adults with HIV who are virologically suppressed and switched from Biktarvy (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2) to the once-weekly combination. Received FDA accelerated approval for Hepcludex for the treatment of chronic hepatitis delta virus (“HDV”) infection in adults without cirrhosis or with compensated cirrhosis, which is now the first and only FDA-approved treatment for HDV in the U.S. Announced a donation of 2,000 vials of remdesivir to the Republic of Uganda to support response efforts to the current outbreak of Ebola Bundibugyo virus disease (“BVD”). Remdesivir is not approved for the treatment of Ebola virus disease, including BVD, anywhere globally, and the safety and efficacy of this use is not known. Oncology Received FDA approval of Trodelvy for the first-line (“1L”) treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (“mTNBC”) as either a single agent for patients who are not candidates for PD-1/PD-L1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) for patients whose tumors express PD-L1 (CPS ≥10). Announced European Commission marketing authorization for Trodelvy as a monotherapy for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitor therapy. Received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Trodelvy in combination with Keytruda® (pembrolizumab) for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 (CPS≥10). Announced the discontinuation of the Phase 3 EVOKE-03 study, in partnership with Merck, evaluating Trodelvy in combination with Keytruda® for the investigational treatment of 1L metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%). The decision was based on the recommendation of the external Data Monitoring Committee, following review of data from a pre-specified final analysis of progression-free survival and interim analysis of overall survival. Presented new analyses at the 2026 American Society of Clinical Oncology meeting from the Phase 3 ASCENT-03 and ASCENT-04 studies evaluating Trodelvy with or without Keytruda® in 1L mTNBC, as well as new data on investigational anitocabtagene-autoleucel (“anito-cel”) clinical trial manufacturing experience in patients with newly diagnosed or relapsed/refractory multiple myeloma. Presented updated Phase 1 results for KITE-753, an investigational bicistronic autologous CD19/CD20 CAR T-cell therapy for relapsed or refractory B-cell lymphoma at the 2026 European Hematology Association meeting. Completed the acquisition of Tubulis for $3.15 billion in upfront consideration. This acquisition brings Gilead next-generation antibody-drug conjugate (“ADC”) assets, including GS-8824, a NaPi2b-directed topoisomerase-I inhibitor ADC, and a platform to develop novel ADCs. Inflammation Completed the acquisition of Ouro Medicines for $1.675 billion in upfront consideration, which brings Gilead gamgertamig, an investigational clinical stage BCMAxCD3 T cell engager for autoimmune diseases. The acquisition was completed in collaboration with Lakefront, which equally shared the upfront payment and will equally share contingent milestone payments, subject to customary adjustments. Announced positive results from the Phase 3 IDEAL study, supporting the potential of Livdelzi to help people living with primary biliary cholangitis (“PBC”) with elevated alkaline phosphatase (“ALP”) levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with ursodeoxycholic acid (“UDCA”), or who are intolerant to UDCA. Presented data from the open-label Phase 3 ASSURE study at the 2026 European Association for the Study of the Liver Congress evaluating the long-term safety and tolerability pro Livdelzi in people living with PBC with elevated ALP levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with UDCA, or who are intolerant to UDCA. Corporate Issued $3.0 billion aggregate principal amount of senior unsecured notes and borrowed $1.1 billion aggregate principal amount under a one-year term loan facility. Announced a renewed 5-year collaboration with the World Health Organization to commit funding, strategic support and AmBisome donations toward eliminating visceral leishmaniasis. The Board declared a quarterly dividend of $0.82 per share of common stock for the third quarter of 2026. The dividend is payable on September 29, 2026, to stockholders of record at the close of business on September 15, 2026. Future dividends will be subject to Board approval. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on and will be archived on for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets, restructuring charges and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities, the related tax charges or benefits associated with such exclusions and other discrete tax charges or benefits not representative of underlying trends such as changes in tax laws, transfers of intangible assets between certain legal entities, and effects of legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its full year 2026 financial guidance, including as a result of the uncertainty of the amount and timing of Veklury revenues, the impact from Medicare Part D pricing reform in the Inflation Reduction Act, the expiration of subsidies related to the Affordable Care Act, our most-favored-nation pricing agreement with the U.S. government, changes in U.S. regulatory or legislative policies, and changes in U.S. trade policies, including tariffs; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology, inflammation and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the arrangements with Arcellx, Immunomedics, Lakefront, Merck, Ouro Medicines, The World Health Organization and Tubulis; the risk that Gilead’s U.S. manufacturing and R&D investment may not achieve their intended benefits; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Livdelzi, Trodelvy, anito-cel, KITE-753 and lenacapavir (such as ASCENT-03, ASCENT-04, ASSURE, IDEAL, ISLEND-1 and ISLEND-2), and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to resolve the issues cited by the FDA in pending clinical holds to the satisfaction of the FDA and the risk that FDA may not remove such clinical holds, in whole or in part, in a timely manner or at all; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, and the risk that any such approvals, if granted, may be subject to significant limitations on use and may be subject to withdrawal or other adverse actions by the applicable regulatory authority, including those involving Hepcludex, Trodelvy and once-weekly oral Yeztugo; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies, including Hepcludex and Trodelvy; Gilead’s ability to effectively manage the access strategy relating to lenacapavir for HIV PrEP, subject to necessary regulatory approvals; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended June 30, 2026 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Additional information is available on our Investor Relations website, . Among other things, an estimate of Acquired IPR&D expenses is expected to be made available on the Quarterly Results page within the first ten (10) days after the end of each quarter. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE®, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, JYSELECA®, LIVDELZI®/LYVDELZI®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA®, TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA®, YEZTUGO®/YEYTUO® and ZYDELIG®. Other trademarks and trade names are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except per share amounts) 2026 2025 2026 2025 Revenues: Product sales $ 7,627 $ 7,054 $ 14,574 $ 13,668 Royalty, contract and other revenues 176 27 189 81 Total revenues 7,803 7,082 14,763 13,749 Costs and expenses: Cost of goods sold 1,579 1,501 3,023 3,041 Research and development expenses 1,764 1,491 3,136 2,870 Acquired in-process research and development expenses 11,183 61 11,290 315 In-process research and development impairments 1,750 190 1,750 190 Selling, general and administrative expenses 1,921 1,365 3,372 2,623 Total costs and expenses 18,197 4,608 22,571 9,038 Operating (loss) income (10,394 ) 2,474 (7,808 ) 4,711 Interest expense 247 254 487 513 Other (income) expense, net (387 ) (208 ) (621 ) 120 (Loss) income before income taxes (10,254 ) 2,429 (7,674 ) 4,077 Income tax expense 242 468 801 802 Net (loss) income $ (10,496 ) $ 1,960 $ (8,475 ) $ 3,275 Basic (loss) earnings per share $ (8.45 ) $ 1.57 $ (6.82 ) $ 2.63 Diluted (loss) earnings per share $ (8.45 ) $ 1.56 $ (6.82 ) $ 2.61 Shares used in basic (loss) earnings per share calculation 1,243 1,245 1,243 1,246 Shares used in diluted (loss) earnings per share calculation 1,243 1,255 1,243 1,257 Supplemental Information: Cash dividends declared per share $ 0.82 $ 0.79 $ 1.64 $ 1.58 Product gross margin 79.3 % 78.7 % 79.3 % 77.7 % Research and development expenses as a % of revenues 22.6 % 21.1 % 21.2 % 20.9 % Selling, general and administrative expenses as a % of revenues 24.6 % 19.3 % 22.8 % 19.1 % Operating margin (133.2 )% 34.9 % (52.9 )% 34.3 % Effective tax rate (2.4 )% 19.3 % (10.4 )% 19.7 % Contacts Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com Read full story here

100 Deals associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

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KEGG	Wiki	ATC	Drug Bank
D11039	-	J05AR	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Gilead Sciences, Inc.	07 Feb 2018

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Fasting	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Aug 2022
Metabolic Syndrome	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Aug 2022
Obesity	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Aug 2022
Hepatitis B	Phase 3	United States	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	China	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Japan	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Dominican Republic	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	France	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Greece	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Hong Kong	Gilead Sciences, Inc.	30 May 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


BICSTaR (IAS2026)	Not Applicable	HIV Infections	107	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)	ypbgntgghd(ifizbtgwgz) = mcpnebrkyp ljbqeokrcr (iamenawafj, −25 - 205) View more	Positive	26 Jul 2026
NCT05979311 (VOGUE, IAS2026)	Phase 3	HIV Infections	509	dolutegravir/lamivudine (DTG/3TC)	vapbrpzeen(jogriielyb) = jfckfwdcjr hrpdozppxh (otoemxtzka ) View more	Positive	26 Jul 2026
NCT05979311 (VOGUE, IAS2026)	Phase 3	HIV Infections	509	bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)	vapbrpzeen(jogriielyb) = kfhmlgfuom hrpdozppxh (otoemxtzka ) View more	Positive	26 Jul 2026
IAS2026	Not Applicable	HIV Infections	281	Bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC)	tmtzhttedt(iebjqvxnrx) = Hepatic parameters improved significantly over time. bacxdqcijs (mksmwfqwea )	Positive	26 Jul 2026
IAS2026	Not Applicable	HIV Infections	297	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)	nrhusnktjq(hzltzptrtw) = lntolrkurc maugfefoog (scbvmgiajk ) View more	Positive	26 Jul 2026
IAS2026	Not Applicable	HIV Infections	137	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)	vteqoshdxo(ycltyrvwkv) = jpyrblwqdh vhaxprcobl (lszmilpuwt ) View more	Positive	26 Jul 2026
NCT02881320 (IAS2026)	Phase 2/3	HIV Infections	122	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg	ipqpdahsks(femvvspojl) = gtrchwmjfb xgbbkakcke (spoenbmmzk ) View more	Positive	26 Jul 2026
NCT02881320 (IAS2026)	Phase 2/3	HIV Infections	122	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg	ipqpdahsks(femvvspojl) = sgwzuudinn xgbbkakcke (spoenbmmzk )	Positive	26 Jul 2026
IAS2026	Not Applicable	HIV Infections	117	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)	zgyzwjdlud(niduepjtmc) = cnvrxjxvto dzrdkvppfi (zhrmksbuab ) View more	Positive	26 Jul 2026
NCT04483674 (IAS2026)	Phase 3	HIV Infections	116	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) (PHI (overall))	rsryhpbnvq(fzerityrmz) = ivxmhtlxjh brdeeionxc (vrfzbjbfzr, 517 - 870) View more	Positive	26 Jul 2026
NCT04483674 (IAS2026)	Phase 3	HIV Infections	116	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) (Chronic)	rsryhpbnvq(fzerityrmz) = nhbewhbpqr brdeeionxc (vrfzbjbfzr, 341 - 753) View more	Positive	26 Jul 2026
IAS2026	Phase 4	HIV Infections	60	BIC/FTC/TAF plus DRV/cob	dvtogojqil(xmltvhujfv) = vcmugddptk mvsoitiahr (ltwyqbswzn ) View more	Non-inferior	26 Jul 2026
IAS2026	Phase 4	HIV Infections	60	DRV/r, RAL, TDF	dvtogojqil(xmltvhujfv) = undhhaprrk mvsoitiahr (ltwyqbswzn ) View more	Non-inferior	26 Jul 2026
NCT05405751 (SIMPLIFIED, CTgov)	Phase 4	HIV Infections	101	Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]	fitjrsvgmf = yemxnzbnsx jrhjkvrbjb (ulrzgcfzho, jwrqrfgkwp - odocqoyszf) View more	-	30 Jun 2026

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