Switch to Dolutegravir Plus Lamivudine Dual-therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)

This single-arm, open label study is aimed to assess efficacy and safety of dolutegravir plus lamivudine as a switch strategy among TGW with HIV receiving suppresive antiretroviral therapy.

Start Date01 May 2025

Sponsor / Collaborator

ViiV Healthcare Ltd.

[+1]

NCT06774872

/ Not yet recruitingPhase 2IIT

MODULO Trial: Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully Treated With Three-drug Regimens at Inclusion

The main objective of the MODULO trial is to compare (non-inferiority) the capacity of DOR/3TC and DTG/3TC two-drug regimens of maintain virological success at W48 in people living with HIV virus ( PLWH) with suppressed HIV plasma viral load (pVL) under three-drug regimen at inclusion.
The virological success is defined as no virological failure (2 consecutive pVL ≥50 copies/mL or one pVL ≥50 copies/mL followed with discontinuation of treatment or follow-up).

Start Date15 Feb 2025

Sponsor / Collaborator-

NCT06928090

/ Enrolling by invitationNot ApplicableIIT

A Retrospective Observational Study of Efficacy and Safety of DTG/3TC(Dolutegravir/Lamivudine) in Treatment-naïve HIV-1 Infected Patients From at Real-life Cohort in Korea

Non-interventional, retrospective, single arm study of individuals who have initiated a DTG/3TC regimen. Medical chart will be reviewed by the investigators. Naive subjects will be identified by the clinic database as having initiated DTG/3TC.

Start Date24 Jan 2025

Sponsor / Collaborator

Chungnam National University Hospital

100 Clinical Results associated with Dolutegravir Sodium/Lamivudine

100 Translational Medicine associated with Dolutegravir Sodium/Lamivudine

100 Patents (Medical) associated with Dolutegravir Sodium/Lamivudine

Literatures (Medical) associated with Dolutegravir Sodium/Lamivudine

01 Dec 2024·LIFE SCIENCES

Clinical efficacy and safety of new compound single tablet antiviral drugs in the treatment of HIV/AIDS

Article

Author: Li, Xin ; Zhu, Na ; Lin, Yingying ; Yi, Yunyun ; Cui, Xinyu

AIMS:

Genvoya, Biktarvy and Dovato are novel single-tablet antiretroviral therapy(ART). The aim of this study is to explore the therapeutic effects of these novel drugs on HIV/AIDS.

MAIN METHODS:

This retrospective cohort study, conducted at a single center, included a total of 200 HIV-treated patients who transitioned to these new antiretroviral drugs from July 2021 to August 2023. Data were extracted from electronic medical records at Ditan Hospital. The Genvoya group comprised 22 patients, and all subsequent switches in this group were to Biktarvy. The primary HAART group consisted of 178 patients initially treated with a first-line triple Highly Active Antiretroviral Therapy (HAART) regimen during the same period. This group was further subdivided into HAART+Dovato, HAART+Biktarvy, and HAART+Genvoya groups based on the switching regimen. The primary outcomes focused on changes in viral load and immune efficacy, while secondary safety indicators included blood/liver function, lipid parameters, renal function, blood glucose, blood uric acid, etc. KEY FINDINGS: The viral suppression rate was 100 % after the drug change treatment, and CD4+ T cell counts increased significantly across all four groups. Over the 6-month treatment period, there were increases in creatinine (Cr), low-density lipoprotein (LDL), high-density lipoprotein (HDL), erythrocyte count, and glomerular filtration rate (eGFR). Conversely, Alanine transaminase (ALT), Aspartate aminotransferase (AST), C-reactive protein (CRP), albumin (ALB), and blood glucose (Glu) levels decreased.

SIGNIFICANCE:

Genvoya, Biktarvy and Dovato are recommended for the treatment of HIV/AIDS and have a good safety profile.

02 May 2024·Antimicrobial agents and chemotherapy

Population pharmacokinetic modeling of dolutegravir/lamivudine to support a once-daily fixed-dose combination regimen in virologically suppressed adults living with HIV-1

Article

Author: Pene Dumitrescu, Teodora ; Singh, Rajendra ; Ait-Khaled, Mounir ; Adkison, Kimberly ; Chandasana, Hardik

ABSTRACT:

A fixed-dose combination (FDC) of 50 mg dolutegravir and 300 mg lamivudine is indicated for the treatment of HIV-1 infection. This analysis aimed to characterize the population pharmacokinetics (PK) of dolutegravir and lamivudine based on data from a phase 3 study (TANGO) in virologically suppressed adults living with HIV-1 switching to dolutegravir/lamivudine FDC. These analyses included 362 participants who contributed 2,629 dolutegravir and 2,611 lamivudine samples collected over 48 weeks. A one-compartment model with first-order absorption and elimination parameterized by apparent oral clearance (CL/F), apparent volume of distribution (V/F), and absorption rate constant (Ka) described dolutegravir PK. Covariate search yielded body weight, bilirubin, and ethnicity as predictors of CL/F, and weight was predictive for V/F. The estimates of CL/F, V/F, and Ka were 0.858 L/h, 16.7 L, and 2.15 h −1 , respectively. A two-compartment model with first-order absorption and elimination parameterized by CL/F, apparent intercompartmental clearance (Q/F), apparent central volume of distribution (V2/F), apparent peripheral volume of distribution (V3/F), and Ka described lamivudine PK. Covariate search yielded eGFR and race as predictors of CL/F, and weight was predictive for V2/F. The estimated parameter values were CL/F = 19.6 L/h, Q/F = 2.97 L/h, V2/F = V3/F = 105 L, and Ka = 2.30 h −1 . The steady-state prediction suggested that the effect of covariates dolutegravir and lamivudine exposures was small (<20%) and not clinically relevant. Therefore, no dose adjustments are recommended based on these analyses. The results support the use of dolutegravir/lamivudine FDC in the treatment of HIV-1 infection in adults.

CLINICAL TRIALS:

This study is registered with ClinicalTrials.gov as NCT03446573 .

28 Mar 2024·Open forum infectious diseases

Dolutegravir/Lamivudine Is Noninferior to Continuing Dolutegravir- and Non-Dolutegravir-Based Triple-Drug Antiretroviral Therapy in Virologically Suppressed People With Human Immunodeficiency Virus: DUALING Prospective Nationwide Matched Cohort Study

Author: Lowe, Selwyn H ; Brouwer, Annemarie E ; Leyten, Eliane M S ; Ammerlaan, Heidi S M ; Roukens, Anna H E ; Richel, Olivier ; Rijnders, Bart J A ; den Hollander, Jan G ; Bierman, Wouter F W ; Claassen, Mark A A ; Groeneveld, Paul H P ; Delsing, Corine E ; Jordans, Carlijn C E ; van den Berge, Marcel ; van Kasteren, Marjo E E ; Vasylyev, Marta ; van der Valk, Marc ; Wit, Ferdinand W N M ; Soetekouw, Robin ; van Lelyveld, Steven F L ; van den Berk, Guido E L ; Nellen, Jeannine F ; Hassing, Robert-Jan ; Rokx, Casper ; van Welzen, Berend J ; Kootstra, Gert-Jan

Abstract:

Background:

Confirming the efficacy of dolutegravir/lamivudine in clinical practice solidifies recommendations on its use.

Methods:

Prospective cohort study (DUALING) in 24 human immunodeficiency virus (HIV) treatment centers in the Netherlands. HIV RNA–suppressed cases were on triple-drug antiretroviral regimens without prior virological failure or resistance and started dolutegravir/lamivudine. Cases were 1:2 matched to controls on triple-drug antiretroviral regimens by the use of dolutegravir-based regimens, age, sex, transmission route, CD4+ T-cell nadir, and HIV RNA zenith. The primary endpoint was the treatment failure rate in cases versus controls at 1 year by intention-to-treat and on-treatment analyses with 5% noninferiority margin.

Results:

The 2040 participants were 680 cases and 1380 controls. Treatment failure in the 390 dolutegravir-based cases versus controls occurred in 8.72% and 12.50% (difference: −3.78% [95% confidence interval {CI}, −7.49% to .08%]) by intention-to-treat and 1.39% and 0.80% (difference: 0.59% [95% CI, –.80% to 1.98%]) by on-treatment analyses. The treatment failure risk in 290 non-dolutegravir-based cases was also noninferior to controls. Antiretroviral regimen modifications unrelated to virological failure explained the higher treatment failure rate by intention-to-treat. A shorter time on triple-drug antiretroviral therapy and being of non-Western origin was associated with treatment failure. Treatment failure, defined as 2 consecutive HIV RNA >50 copies/mL, occurred in 4 cases and 5 controls but without genotypic resistance detected. Viral blips occured comparable in cases and controls but cases gained more weight, especially when tenofovir-based regimens were discontinued.

Conclusions:

In routine care, dolutegravir/lamivudine was noninferior to continuing triple-drug antiretroviral regimens after 1 year, supporting the use of dolutegravir/lamivudine in clinical practice.

Clinical Trials Registration:

NCT04707326.

News (Medical) associated with Dolutegravir Sodium/Lamivudine

11 Nov 2024

·www.businesswire.com

ViiV Healthcare Announces Data Demonstrating Dovato (DTG/3TC) Is Highly Effective in Treatment-Naïve People With Advanced HIV

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced 48-week findings from the DOLCE study, sponsored by Fundación Huésped and the Bahiana Foundation of Infectiology, showing the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) achieved similar results to 3-drug therapy in viral suppression in a population of adults with advanced HIV. A post-hoc analysis of the study showed DTG/3TC was non-inferior to 3-drug therapy regardless of the participant’s baseline viral load. These data were presented at HIV Glasgow 2024 , being held in Glasgow, Scotland from 10 – 13 November. Harmony P. Garges, M.D., Chief Medical Officer, at ViiV Healthcare, said: “We know taking fewer medicines is an important consideration for many in the HIV community, and these new data continue to reinforce the efficacy and safety of Dovato, a 2-drug regimen. The findings from the DOLCE study build on the robust body of evidence supporting its use in treatment-naïve adults living with HIV and shows comparable efficacy to a 3-drug regimen, even in people with low CD4 counts and high viral loads.” DOLCE is a randomised, open-label, multicentre study assessing the efficacy and safety of DTG/3TC in 230 antiretroviral treatment (ART)-naïve people with advanced HIV (low CD4 counts [≤200 cells/mL]). 1 In the clinical trial, participants were randomised in a 2:1 ratio to receive DTG/3TC (n=152) or DTG+TDF/XTC (n=77). The baseline characteristics of the participants were similar between the two treatment groups and represented a population of people with severe immunosuppression – 43% of participants having baseline CD4 counts less than 100 cells/mL, 69% having baseline viral load (VL) greater than 100,000 copies (c)/mL, and 23% having a very high baseline VL, greater than 500,000 copies (c)/mL. The primary endpoint of the study was the proportion of subjects with VL <50 copies/ml at week 48. At week 48 comparable efficacy was observed, with 82% of individuals in the DTG/3TC group and 80% in the 3-drug regimen group achieving a VL<50. Furthermore, a post-hoc analysis showed that Dovato was non-inferior to the 3-drug regimen in achieving a VL<50. Prof. Pedro Cahn, Scientific Director of Fundación Huésped study investigator of the DOLCE study, said : “It’s encouraging to see additional new data that continue to support the efficacy and safety of 2-drug regimens compared to traditional 3-drug regimens. The results from DOLCE provide healthcare providers with further confidence in prescribing DTG/3TC and are important findings for people living with HIV taking medicines to suppress their virus.” A post-hoc analysis reported that DTG/3TC was non-inferior to 3-drug therapy (adjusted risk difference of 2.0%, 95% CI -8.6; 12.8%). 1 The study also showed that secondary efficacy measures of viral load decline, time to viral suppression, and CD4 recovery were similar between arms. Efficacy by baseline viral load categories was similar across both arms, including those with baseline viral load greater than 500,000 copies with 74% in the DTG/3TC arm, and 67% in the DTG+TDF/XTC arm achieving virologic success. The change in median CD4 count from baseline to Week 48 showed an increase of 200 cells/mL in the DTG/3TC arm and an increase of 177 cells/mL in the triple therapy arm. Safety through Week 48 was comparable across both arms and consistent with known safety profiles and showed similar rates of serious adverse events (SAEs) and immune reconstitution inflammatory syndrome across arms. The rate of discontinuation in both arms was also similar (DTG/3TC = 12.8%; DTG+TDF/XTC = 6.8%). About DOLCE The DOLCE (NCT04880395) randomised clinical trial is a phase IV, open-label, multicentre clinical trial assessing the efficacy of DTG/3TC for the treatment of HIV-1 in treatment-naïve adults 18 years or older with CD4+ T-cell count ≤200 c/mm3 and HIV-1 RNA >1,000 copies/mL with no known ART-resistance or HBV co-infection, conducted in 11 sites across Argentina and Brazil. The primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 48 (FDA snapshot for ITT-E population) and secondary outcomes included, among others, efficacy, resistance, safety, and tolerability. About Dovato Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato . Dovato is approved in the US, Europe, Japan, Australia, and other countries worldwide. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets . Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Fundación Huésped Fundación Huésped is an Argentine organisation with a regional reach that has been working in public health since 1989, aiming to ensure the right to health and the control of diseases are guaranteed. Our comprehensive approach includes the development of research, practical solutions, and communications related to public health policies in our country and the region. Our mission is to conduct scientific research and implement preventive actions and rights-promotion initiatives to ensure access to healthcare and reduce the impact of diseases, with a focus on HIV/AIDS, viral hepatitis, vaccine-preventable diseases, and other transmissible diseases, as well as sexual and reproductive health. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1 M. I. Figueroa, et al . Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm3: the DOLCE study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. For media and investors only

Clinical ResultDrug Approval

07 Nov 2024

·www.businesswire.com

ViiV Healthcare expands on real-world data supporting use of long-acting therapies in diverse patient populations at HIV Glasgow

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, will share new data from its industry-leading HIV treatment and prevention portfolio and pipeline at HIV Glasgow 2024, being held in Glasgow, Scotland from 10 – 13 November 2024. Spanning 42 abstracts, the data showcases long-acting and two-drug regimens as care options for diverse populations in the face of a continuing HIV epidemic. Harmony P. Garges, MD, Senior Vice President and Chief Medical Officer at ViiV Healthcare, said: “ViiV Healthcare is the first company to develop and launch long-acting options and two-drug regimens, and these therapies are transforming how physicians and providers treat and prevent HIV today. We continue evaluating how diverse populations living with or impacted by HIV respond to our therapies in the real world. Data from these studies include more than 10,000 people using Vocabria + Rekambys , more than 50,000 people using Dovato and more than 1,300 people using Apretude 1 . At HIV Glasgow, ViiV Healthcare is showcasing new, compelling data from our portfolio that reinforces how our medicines impact health outcomes and contribute to ending the HIV epidemic. ” Key data to be presented at HIV Glasgow 2024 by ViiV Healthcare and its study partners will include: Analysis of cabotegravir + rilpivirine long-acting (CAB+RPV LA) in the real-world and across phase 3/3b studies : Findings from a large-scale post hoc analysis of the complete long-acting HIV treatment regimen CAB+RPV LA will be presented. The analysis, which pooled data from over 2,500 participants across four major phase 3/3b clinical trials (FLAIR, ATLAS, ATLAS-2M, and SOLAR), will compare virologic outcomes and isolated viraemic events between daily oral HIV treatment and CAB+RPV LA. 2 Furthermore, the real-world utilisation of CAB+RPV LA will be explored in an analysis of adherence and persistence in a Canadian patient support program. These analyses will add to the growing body of clinical and real-world evidence for CAB+RPV LA and offer additional insights to healthcare providers on outcomes for CAB+RPV LA in diverse populations. Data exploring the use of dolutegravir/lamivudine (DTG/3TC) in antiretroviral-naïve people living with HIV: Findings will be presented from the Fundación Huésped-sponsored DOLCE study. This is the first study to fully focus on evaluating the efficacy and safety of the 2-drug regimen DTG/3TC in people living with HIV with CD4 ≤ 200 cells/mm³. 3 Additionally, data will be shared from the phase IV D2ARLING study, which compared the efficacy and safety of DTG/3TC against a 3-drug regimen in an antiretroviral-naïve population that did not have baseline drug-resistance testing results available. 4 Many guidelines recommend baseline drug resistance testing prior to antiretroviral therapy (ART) initiation, that may not always be readily accessible, reinforcing the need and impact of these data in an antiretroviral-naïve population. Cost-effectiveness and usage patterns for long-acting HIV prevention: Findings from a cost-effectiveness study examining the economic and public-health impact of cabotegravir long-acting (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in Canada will be presented. Researchers will compare the impact of the introduction of CAB LA for PrEP against daily oral PrEP (TDF/FTC) and no PrEP usage on cost savings and quality-adjusted life years. 5 New findings from the PROTECT survey will be shared, exploring differences in interest and intention to use long-acting PrEP among men who have sex with men and heterosexual men and women in 20 European countries. 6,7 Advancing novel mechanisms of action in HIV research: New findings from the BANNER study of VH3810109 (N6LS), an investigational, broadly neutralising antibody (bNAb), will be presented. Previously presented phase IIa proof-of-concept findings from the BANNER study suggested VH109 was well-tolerated and efficacious in people living with HIV. 8 Researchers will share new findings exploring the correlation between baseline phenotypic sensitivity to N6LS and virologic response after treatment with N6LS. 9 Additional research evaluating N6LS will focus on administration and dose responsiveness, adding to the growing body of evidence supporting the bNAb as a potential new approach to treating HIV. 10 ViiV Healthcare-sponsored or supported studies to be presented at HIV Glasgow 2024: Title First Author Presentation Cabotegravir + rilpivirine long-acting Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies J. Thornhill Poster Presentation Real-world utilization of cabotegravir/rilpivirine: an observational analysis of adherence and persistence using a patient support program in Canada, preliminary results C. LaForty Poster Presentation Feasibility and satisfaction of interventions measures (FIM and HIVTISQ) of implementation long-acting (LA) CAB+RPV administration out of HIV units: the IMADART study A. Cabello Poster Presentation Cabotegravir and rilpivirine concentrations and HIV-1 RNA suppression in male and female genital fluids and rectal tissue in people with HIV on antiretroviral therapy with long-acting intramuscular cabotegravir plus rilpivirine A. Fernández Oral Presentation Use of long-acting cabotegravir and rilpivirine in a real-life setting: 12-month results of virological outcome, adherence, safety, durability, in the ANRS CO3 AquiVIH-NA cohort-France M. Hessamfar Poster Presentation Results at month 7 of CABO-CHANCE study: real-world-evidence (RWE) on the use of intramuscular cabotegravir plus rilpivirine long-acting (CAB+RPV LA) dosed every 2 months in viral suppressed people with HIV (PWH) C. H. Tenorio Poster Presentation Re-suppression regimens and outcomes after virological failure in randomised controlled trials and real-world evidence studies evaluating cabotegravir and rilpivirine (CAB+RPV) A. Elias Poster Presentation Virological failure rate and emergent resistance in real-world studies evaluating long-acting cabotegravir and rilpivirine in people with baseline viral suppression M. Smuk Poster Presentation Cabotegravir long-acting for PrEP PrEP-associated stigma in Europe: findings from a real-world survey M. Schroeder Poster Presentation Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada A. Adelakun Poster Presentation Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used pre-exposure prophylaxis in Europe; the PrEPaRe study V. Cambiano Poster Presentation Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis H. Wang Oral Presentation Preparing for long-acting PrEP delivery: provider preferences for the provision of long-acting PrEP differ between MSM and heterosexual individuals in Europe H. M. L. Zimmerman Poster Presentation Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey K. Jonas Poster Presentation Dolutegravir Two-year long-term data on the efficacy and tolerability of dolutegravir-based regimens from the prospective multi-centre TESLA cohort study in ART-naive and pre-treated people living with HIV in Russia A. Basova Poster Presentation The analysis of metabolic parameters in people living with HIV using dolutegravir-based regimens in routine clinical practice in Russia A. Basova Poster Presentation Outcomes following prenatal exposure to DTG-containing antiretroviral therapy regimens: data from the DOLOMITE-EPPICC study R. Sconza Poster Presentation Incident hypertension with antiretroviral therapy: real-world evidence from the OPERA cohort P. Lackey Poster Presentation A multicentre observational study to determine the safety and effectiveness of dolutegravir (DTG) use during pregnancy: data from DOLOMITE-NEAT ID Network study J. D. Kowalska Poster Presentation Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia E. Tusch Poster Presentation Mental health in PWH: Patient-reported outcomes in the DUALIS study E. Wolf Poster Presentation Evaluating the cardiovascular risk and the achievement of target levels in low-density lipoprotein cholesterol in PLWH: Insights from the DUALIS study F. Voit Poster Presentation Dolutegravir-based antiretroviral therapy does not reduce plasma levonorgestrel or medroxyprogesterone acetate concentrations among contraceptive users living with HIV compared with HIV-negative controls R. Ryan Poster Presentation Efficacy and safety of dolutegravir (DTG)-based antiretroviral treatment (ART) in patients with HIV and solid organ transplantation (SOT): A single-arm clinical trial (DTG-SOT) J. Miro Poster Presentation Dolutegravir/lamivudine PAIRED - PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine (DTG/3TC): a sub-analysis of people with HIV (PWH) switching from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in the United States (US) J. Slim Poster Presentation Treatment-emergent integrase strand transfer inhibitor (INSTI) resistance-associated mutations among people living with HIV-1 treated with dolutegravir (DTG) + lamivudine (3TC) with pre-existing M184V/I from real-world and interventional studies D. Fox Poster Presentation An EYEWITNESS to successful diversity in antiretroviral switch studies C. V. Dam Poster Presentation CARAVEL: evaluation of real-world effectiveness and sustainability of the 2-drug regimen dolutegravir/lamivudine fixed-dose combination in treatment-naive adults and pre-treated adults who are virologically suppressed, in routine clinical care, in France. Two-year interim analysis results P. Philibert Poster Presentation Real world experience of DTG+3TC regimen: results from the French Dat'AIDS cohort (2015-2022) C. Allavena Poster Presentation Changes in patient-reported neuropsychological outcomes in virologically suppressed persons with HIV switching to DTG/3TC or BIC/FTC/TAF: a substudy of the PASO-DOBLE randomized clinical trial L. Garcia-Fraile Poster Presentation Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm 3 : the DOLCE study M. I. Figueroa Oral Presentation RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF S. Degroote Poster Presentation Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study E. Cordova Poster Presentation Long-term efficacy and safety of Dolutegravir/Lamivudine in virologically suppressed persons with resistance to Lamivudine: Week 96 results of VOLVER clinical trial - GESIDA 11820 M. De Lagarde Poster Presentation Fostemsavir CD4 T-cell, CD4/CD8 ratio improvement and a general reduction in inflammatory biomarkers with low-level viremia (LLV) up to Week 192 with fostemsavir (FTR)-based regimens in individuals with multidrug-resistant (MDR) HIV-1 V. Spagnuolo Encore Poster Presentation Similar efficacy, safety and CD4 T-cell increase up to Week 96 observed with fostemsavir (FTR)-based regimens in the BRIGHTE study and dolutegravir (DTG)-based regimens in the VIKING-3 study in individuals with multidrug-resistant (MDR) HIV-1 A. Castagna Encore Poster Presentation Pipeline Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER M. Gartland Poster Presentation VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models M. Keegan Encore Poster Presentation Additional Studies Mortality and clinical outcomes after common cancers in people A. Timiryasova Poster Presentation The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study S. Deb Poster Presentation Comparison of 4 frailty scores to predict adverse health outcomes and mortality in people living with HIV aged 70 years and more (ANRS EP66 SEPTAVIH study) C. Allavena Poster Presentation The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period L. Sukumaran Poster Presentation About Dovato Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato . Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets . About Vocabria Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class. Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for: oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection. oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection. Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing. Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets About Rekambys Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class. Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection). Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection About Apretude Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Fundación Huésped Fundación Huésped is an Argentine organisation with a regional reach that has been working in public health since 1989, aiming to ensure the right to health and the control of diseases are guaranteed. Our comprehensive approach includes the development of research, practical solutions, and communications related to public health policies in our country and the region. Our mission is to conduct scientific research and implement preventive actions and rights-promotion initiatives to ensure access to healthcare and reduce the impact of diseases, with a focus on HIV/AIDS, viral hepatitis, vaccine-preventable diseases, and other transmissible diseases, as well as sexual and reproductive health. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com . About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com . Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References: 1 Data on file 2 J. Thornhill, et al . Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 3 M. I. Figueroa, et al . Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm3: the DOLCE study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 4 E. Cordova, et al . Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 5 A. Adelakun, et al . Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 6 H. Wang, et al . Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 7 K. Jonas, et al. Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 8 P. Leone, et. al . VH3810109 (N6LS) Reduces Viremia Across a Range of Doses in ART-Naive Adults Living with HIV: Proof of Concept Achieved in the Phase IIa BANNER (207959, NCT04871113) Study. Presented at HIV Glasgow 2022, 23 – 26 October, Glasgow, Scotland. 9 M. Gartland, et al . Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 10 M. Keegan, et al . VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. For media and investors only

Phase 2Clinical ResultPhase 3

07 Nov 2024

·www.businesswire.com

Late-Breaking Clinical Data and Real-World Evidence Presented at HIV Glasgow as Gilead Extends Leadership Efforts Toward Ending the Epidemic

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of HIV research findings at the International Congress on Drug Therapy in HIV Infection ( HIV Glasgow 2024 ), taking place from November 10-13. The results from more than 40 studies across HIV treatment and prevention include late-breaking data and seven oral presentations. These findings reflect a robust portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV and help end the epidemic. “ We look forward to presenting new research from our broad and innovative HIV portfolio and pipeline as we strive to help end the epidemic through continuous scientific discovery,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “ Our contributions to HIV Glasgow 2024 demonstrate that people are at the center of all we do at Gilead. The breadth and depth of Gilead’s work underscore our commitment to driving the next wave of transformational innovations in HIV research.” HIV Prevention Research A late-breaking oral presentation at HIV Glasgow will be the first in-depth look at the full results from the PURPOSE 2 trial ( NCT04925752 ), including data not presented last month at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 2 is a pivotal Phase 3 trial evaluating twice-yearly lenacapavir, Gilead’s injectable HIV-1 capsid inhibitor for the investigational use of HIV prevention, among a broad and geographically diverse range of cisgender men and gender-diverse people. The trial is part of a comprehensive program assessing lenacapavir in a variety of populations who need or want pre-exposure prophylaxis (PrEP) and, if approved, would be the first and only twice-yearly HIV prevention choice. Prevention research presented at HIV Glasgow will also include a systematic review and meta-analysis of real-world data mapping HIV prevalence against PrEP uptake, health economic data on the impact of PrEP in France and the return on investment that HIV prevention has yielded for the French healthcare system. Data will also be presented from a study examining same-day PrEP initiation and its effect on PrEP uptake at a Canadian clinic. HIV Treatment Research Continuous scientific discovery in HIV treatment is a pillar of Gilead’s commitment to help end the epidemic. At HIV Glasgow, presented study results and analyses will include further evaluation of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a long-term treatment option for a broad range of people with HIV who may also have common comorbidities and other specific health needs. Outcomes from pipeline research studies will provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir. Additionally, late-breaking data from the Phase 2 study ( NCT05052996 ) evaluating an investigational once-weekly oral combination regimen of lenacapavir and islatravir will be presented during an oral session. Specifically, Biktarvy presentations will include four-year outcomes from BICSTaR, ( NCT03580668 ) an ongoing global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. As the average age of people with HIV increases, the management of comorbid conditions is an important consideration in HIV clinical care. BICSTaR helps to inform what the future of coordinated person-centered HIV care could look like. Additional research studies evaluating Biktarvy include three-year outcomes from ALLIANCE, an ongoing Phase III study ( NCT03547908 ) evaluating the efficacy and safety of the single-tablet regimen versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV/hepatitis B (HBV) coinfection who were initiating therapy. Gilead will also present outcomes from the Phase 2 portion of the ARTISTRY-1 study ( NCT05502341 ) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily regimen of lenacapavir and bictegravir. Additional lenacapavir data to be presented at HIV Glasgow will evaluate the efficacy and safety of the novel antiviral agent in combination with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) as a potential long-acting treatment regimen with twice-yearly dosing. HIV treatment research pipeline findings also include a presentation of new pharmacokinetic and resistance data on GS-1720, a selective integrase strand transfer inhibitor (INSTI). The agent is being evaluated as a component of a novel, investigational, once-weekly oral INSTI/capsid-inhibitor combination regimen with GS-4182 aimed at providing new long-acting treatment options for people with HIV. A late-breaker presentation will compare the rate of treatment emergent resistance associate mutations (TE-RAMs) in people with HIV taking three-drug single tablet regimens and cabotegravir+rilpivirine. A separate late-breaker oral presentation will explore clinical features and resistance patterns during second-generation INSTI failure from the ROSETTA-registry. Overview of Scientific Presentations HIV TREATMENT RESEARCH (B/F/TAF) Oral Presentation Randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from dolutegravir/lamivudine to bictegravir/emtricitabine/tenofovir alafenamide in people with HIV, good virologic control and neuropsychiatric comorbidities: Week 24 results from the MIND Study. Poster Four-year outcomes from the BICSTaR study: Observational analysis of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV in Canada, France and Germany Poster Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve people with both HIV-1 and hepatitis B: 3-year outcomes from ALLIANCE Poster Global survey to evaluate engagement in care and treatment experiences of people with HIV Poster Rapid Start (RS) with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with HIV-1 (PWH): A systematic literature review (SLR) of clinical and patient-reported outcomes (PROs) Poster Persistence, safety, and virologic outcomes of B/F/TAF as a baseline or switch regimen in HIV-infected people living with advanced HIV disease in the real world: the BIC-CD4 study. Poster Real-world effectiveness in treatment-experienced (TE) people with HIV (PWH) switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) with distinct patterns of self-reported adherence Poster Multicentre, prospective cohort study of same-day initiation of antiretroviral therapy with BIC/FTC/TAF among antiretroviral-naïve people with HIV Poster Real-World Persistence of Bictegravir- versus Dolutegravir-based Single Tablet Regimens in a Large Urban Canadian HIV Centre Poster Incidence of comorbidities over 18 months with BIC/FTC/TAF, DTG/ABC/3TC or DTG/3TC in real life settings in the ANRS-CO3 - AquiVIH-NA cohort. Poster Effectiveness of switching to B/F/TAF in virologically suppressed people with HIV and with preexisting resistance-associated mutations in Italy: the BIC-BARRIER Study Poster Evaluation of T-cell immunosenescence in +60 years PLWH virologically suppressed on 3DR with BIC/FTC/TAF or 2DR with DTG/3TC: the Collateral-2 study. LONG-ACTING HIV TREATMENT & PREVENTION RESEARCH (LENACAPAVIR) Oral Presentation (late breaker) Once-Weekly Islatravir Plus Lenacapavir in Virologically Suppressed PWH: Week 48 Safety, Efficacy, and Metabolic Changes Oral Presentation (late breaker) Persistence in use of twice-yearly lenacapavir versus daily oral PrEP in the PURPOSE 1 Phase 3 trial Oral Presentation (late breaker) Twice-yearly lenacapavir PrEP in cisgender gay men, transgender women and men, and gender-diverse people (PURPOSE 2) Poster Pharmacokinetic/Pharmacodynamic and Resistance Analyses of GS-1720, a Once-Weekly Oral Integrase Strand Transfer Inhibitor Poster Pharmacokinetics of oral islatravir (ISL) plus lenacapavir (LEN) given once weekly in an open-label, active-controlled, phase 2 study of virologically suppressed people with HIV HIV TREATMENT PIPELINE RESEARCH Oral Presentation Efficacy and safety analysis of lenacapavir with broadly neutralising antibodies, teropavimab and zinlirvimab, in people with HIV-1 highly sensitive to one or both broadly neutralising antibodies Poster Pharmacokinetic (PK) analysis of oral once-daily bictegravir (BIC) plus lenacapavir (LEN) administered separately (BIC 75mg + LEN 25mg; BIC 75mg + LEN 50mg) and as a single-tablet BIC/LEN 75/50mg fixed-dose combination (FDC) to support Phase 3 dose selection Poster Effect of acid reducing agents on the pharmacokinetics of oral GS-4182 Poster Safety and immunogenicity of GS-1966+GS-1144 vaccines in virally suppressed adults living with HIV-1: a phase 1b, randomised, placebo-controlled study Poster Metabolic changes at 48 weeks in virologically suppressed people with HIV switching from complex antiretroviral regimens to bictegravir plus lenacapavir: ARTISTRY-1 trial HIV PREVENTION RESEARCH Poster Estimating return on investment (ROI) with increased utilisation of HIV pre-exposure prophylaxis (PrEP) among key populations in France from a national health payer perspective Poster PrEP cascade improvement through same-day PrEP initiation Poster Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used Pre-exposure Prophylaxis in Europe; the PrEPaRe study. Poster HIV-1 prevalence and pre-exposure prophylaxis uptake among key populations in high-income economies (2017-2023): a systematic review and meta-analysis of real-world studies ADDITIONAL HIV RESEARCH Oral Presentation (late breaker) Clinical features and resistance patterns during second-generation INSTI failure: The ROSETTA-registry Oral Presentation (late breaker) Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia Poster (late breaker) Comparison of treatment-emergent resistance associated mutations among three-drug single tablet regimens and cabotegravir+rilpivirine for the treatment of virologically suppressed people with HIV: A Systematic Literature Review and Network Meta-Analysis Poster (late breaker) The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period Poster Replication-competent HIV-1 harbouring resistance-associated mutations is present in the viral reservoir Poster Treatment Patterns in Virologically Suppressed, Treatment-Experienced People with HIV; a US Real-World Database Study Poster Demographic and clinical characteristics of treatment naïve people with HIV, and their healthcare professionals’ reasons for treatment choice: findings from a real-world survey in five European countries Poster Understanding knowledge and attitudes regarding HIV amongst secondary care healthcare professionals in the United Kingdom: A national survey Poster The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study For more information about Gilead at HIV Glasgow 2024, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://hivglasgow.org/programme/ . The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally. Islatravir in combination with lenacapavir is investigational and not approved anywhere globally. The safety and efficacy of the combination of islatravir and lenacapavir have not been established. Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1. Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established. The use of Biktarvy in individuals with HIV/HBV co-infection is investigational and the safety and efficacy of this use have not been established. GS-5423, GS-2872, GS-1720 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning , for Biktarvy. There is currently no cure for HIV or AIDS. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. About Biktarvy ® Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. U.S. Indication for Biktarvy Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration : Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions Drug interactions : See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Immune reconstitution syndrome , including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment : Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis : Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information : Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters : Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function : Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage : Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment : For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment : Not recommended in patients with severe hepatic impairment. Prior to or when initiating : Test patients for HBV infection. Prior to or when initiating, and during treatment : As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy : BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. Lactation : Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead Sciences in HIV Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications , including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead is recognized as one of the leading funders of HIV-related programs in a report released by Funders Concerned About AIDS. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy, bictegravir, lenacapavir, teropavimab, zinlirvimab and GS-1720 (such as the ALLIANCE, ARTISTRY, BICSTaR, PURPOSE 2 and NCT05052996 studies); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation, such as regulatory applications for lenacapavir for PrEP, 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 programs for indications that are currently under evaluation, including bictegravir, lenacapavir and GS-1720, and, as a result, these programs may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s). U.S. full Prescribing Information for Biktarvy, including BOXED WARNING , and U.S. full Prescribing Information for lenacapavir are available at www.gilead.com . For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter ( @Gilead Sciences ) and LinkedIn , or contact Gilead Public Affairs at public_affairs@gilead.com , 1-800-GILEAD-5 or 1-650-574-3000.

Phase 2Phase 3Clinical ResultPhase 1Drug Approval

100 Deals associated with Dolutegravir Sodium/Lamivudine

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KEGG	Wiki	ATC	Drug Bank
-	-	J05AR	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	United States	ViiV Healthcare Co.	08 Apr 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 3	Brazil	ViiV Healthcare Ltd.	14 Jun 2025
Tuberculosis	Phase 3	Brazil	ViiV Healthcare Ltd.	14 Jun 2025
HIV Seropositivity	Phase 3	United States	ViiV Healthcare Ltd.	18 Jan 2018
HIV Seropositivity	Phase 3	Japan	ViiV Healthcare Ltd.	18 Jan 2018
HIV Seropositivity	Phase 3	Australia	ViiV Healthcare Ltd.	18 Jan 2018
HIV Seropositivity	Phase 3	Belgium	ViiV Healthcare Ltd.	18 Jan 2018
HIV Seropositivity	Phase 3	Canada	ViiV Healthcare Ltd.	18 Jan 2018
HIV Seropositivity	Phase 3	France	ViiV Healthcare Ltd.	18 Jan 2018
HIV Seropositivity	Phase 3	Germany	ViiV Healthcare Ltd.	18 Jan 2018
HIV Seropositivity	Phase 3	Netherlands	ViiV Healthcare Ltd.	18 Jan 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04585737 (DYAD, CTgov)	Phase 4	HIV Infections	222	Dolutegravir / Lamivudine Pill (Treatment Group 1)	tlflfodbni = ffmspbroom kroprvjcad (rvbxryedxt, xmucgkxnsc - vduneekwrs) View more	-	17 Oct 2024
				Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill (Treatment Group 2)	tlflfodbni = fpqxknshus kroprvjcad (rvbxryedxt, piwjvsttop - lwxbjimdyz) View more
PASO DOBLE (NEWS) Manual	Phase 4	HIV Infections Maintenance	-	Dovato (dolutegravir/lamivudine)	bsrqydqito(rtvxcamicm) = Dovato demonstrating non-inferior efficacy in maintaining viral suppression after 48 weeks of treatment compared to Biktarvy. eauizoahsl (fzrylqwirx ) Met	Non-inferior	24 Jul 2024
				Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
NCT03446573 (TANGO, Pubmed \| Antimicrob Agents Chemother) Manual	Phase 3	HIV Infections	362	Dolutegravir/lamivudine FDC	uytbjgyiqh(exvsgtpfvl) = rcjzktnbzr ntvdvqvjss (zvaitpolgl ) View more	Positive	08 Apr 2024
NCT04707326 (DUALING, Pubmed \| Open Forum Infect Dis) Manual	Not Applicable	HIV Infections	2,040	Dolutegravir/lamivudine	hetfnrvxrp(iakkhhgfdo) = gnhlsyvnqg cpnqvyqlqx (svnmxymkwj ) View more	Positive	01 Apr 2024
				Continuing triple-drug antiretroviral regimens	hetfnrvxrp(iakkhhgfdo) = kacwzdruic cpnqvyqlqx (svnmxymkwj ) View more
NCT04021290 \| NCT03446573 (SALSA, Pubmed) Manual	Phase 3	HIV Infections	1,234	Switch to dolutegravir/lamivudine (DTG/3TC)	yuwfbrjsvi(pbgbcwiogv) = In the DTG/3TC group, incidence of adverse events (AEs) was similar across age groups. vurcynrqbt (hszmslsbho ) View more	Positive	21 Mar 2024
				Continuing current antiretroviral regimen (CAR)
NCT03682848 (CTgov)	Phase 3	HIV Infections	32	3TC FDC+DTG	tpqgvqfwym = etcraxzxgm wavomnociv (uqgilmnpgw, ryvtlqecvj - gzpnelxbka) View more	-	08 Aug 2022
NCT04021290 (SALSA, CTgov)	Phase 3	HIV Infections	493	3TC FDC+DTG (Randomized Phase-Participants Who Received DTG/3TC FDC)	orzorwuerb = nrvfbosviw acnmxqawkv (gvcbczurjk, tscyhypivr - mjmxueobgv) View more	-	01 Jul 2022
				atazanavir (Randomized Phase-Participants Who Received CAR)	orzorwuerb = yudfldgzvc acnmxqawkv (gvcbczurjk, bhgqkpwrmr - pkbggvykjl) View more
IAS2022	Not Applicable	-	-	Dolutegravir/Lamivudine (D/L)	unxzbnajgb(yuqjnknaad) = vregpmnxjx vzpqbsocca (wjseuavjhj ) View more	-	01 Jan 2022
				Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/T)	unxzbnajgb(yuqjnknaad) = mgztlxsqgv vzpqbsocca (wjseuavjhj ) View more
NCT03945981 (CTgov)	Phase 3	HIV Infections	131	DTG+3TC	qcyhbypexa = mqnukbwrkl tkaxcjgcts (lgagukjgad, wmkljqqgpq - yfnzxuhefz) View more	-	28 Apr 2021

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Dolutegravir Sodium/Lamivudine

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