Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead - LARVOL DELTA

BCL-2 inhibition in North American adult T-cell leukemia/lymphoma: Preclinical insights and early clinical outcomes (ASH 2025) - "Hence, we evaluated thepreclinical efficacy of BCL-2 inhibitors in NA ATLL cells and explored clinical outcomes in chemotherapy-refractory ATLL patients.Preclinical:A panel of well-characterized North American patient-derived ATLL cell lines [Pt-4a, Pt-5a, Pt-6a, Pt-15a]along with Japanese patient-derived ATLL cell lines [ATL43T (−)] (J-ATLL) were used to evaluate the efficacyof different BCL-2 inhibitors, including Venetoclax, Sonrotoclax, and Lisaftoclax. Both North American and Japanese ATLL cell lines have shown preclinical sensitivity to BCL-2inhibition using Venetoclax and other emerging inhibitors. Distinct molecular dependencies identifiedthrough BH3 profiling and transcriptional analyses. Venetoclax induces mitochondrial apoptosis anddownregulates key HTLV-1 viral oncogenes, targeting both survival pathways and viral factors."

Clinical data • IO biomarker • Preclinical • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • BCL2L1 • CASP3 • CD4 • MCL1 • NOTCH1 • TP53

Clarifying INSTINCT: Switching from DTG/3TC to BIC/FTC/TAF Shows Comparable Inflammatory and Weight Outcomes. (PubMed, Clin Infect Dis) - No abstract available

Journal

Efficacy of same-day initiation of antiretroviral therapy with coformulated bictegravir, emtricitabine and tenofovir alafenamide: Week 48 results of a single-arm, open-label, multicenter clinical trial. (PubMed, Int J Infect Dis) - P=N/A | "Initiation of BIC/FTC/TAF on the same day of HIV diagnosis is feasible, safe, and efficacious in achieving virologic suppression and engagement in care."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (clinicaltrials.gov) - P2/3 | N=570 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease

Fixed-dose combination bictegravir-emtricitabine-tenofovir alafenamide twice-daily for treatment of HIV during rifampicin-based tuberculosis treatment (INSIGHT Study): a phase 2b, open-label, randomised non-comparative trial. (PubMed, Lancet HIV) - P2 | "The INSIGHT trial provides evidence to support the use of twice-daily bictegravir-emtricitabine-tenofovir alafenamide in people with HIV taking rifampicin-based tuberculosis treatment."

Journal • P2b data • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

Integrase versus protease inhibitor therapy in advanced HIV disease (LAPTOP): a multicountry, randomised, open-label, non-inferiority trial. (PubMed, Lancet Infect Dis) - P3 | "In people with advanced HIV disease, bictegravir, emtricitabine, and tenofovir alafenamide was shown to be non-inferior to darunavir, cobicistat, emtricitabine, and tenofovir alafenamide and resulted in fewer adverse events, supporting its use as a preferred first-line antiretroviral regimen in this vulnerable population."

Head-to-Head • Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Canadian guideline on HIV pre- and postexposure prophylaxis: 2025 update. (PubMed, CMAJ) - "Multiple safe, effective PrEP and PEP regimens are now available in Canada, making it increasingly possible to find suitable options for all who could benefit. Implementation of this guideline should expand access to biomedical HIV prevention interventions for those at risk and decrease the incidence of HIV in Canada."

Clinical guideline • Journal • Human Immunodeficiency Virus • Infectious Disease

Effectiveness of B/F/TAF in adults with HIV who are viremic with M184V/I. (PubMed, AIDS Res Ther) - "For participants with data, 5/5 (100%) and 7/8 (88%) on B/F/TAF and 4/6 (67%) and 7/10 (70%) on alternate ART achieved virologic suppression at 3 and ≥ 6 months, respectively. Virologic suppression was achieved in most people with HIV who were viremic with M184V/I on B/F/TAF, as with alternate ART."

Journal • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

The effect of antacid and mineral supplements on bictegravir pharmacokinetics: results from a Phase 1, open-label, drug-drug interaction study. (PubMed, Antimicrob Agents Chemother) - P2/3, P3 | "B/F/TAF was well tolerated alone or in combination with metal cation-containing medications. Co-administration of BIC and calcium/iron-containing supplements with a meal and administration of BIC 2 hours or more before aluminum/magnesium-containing antacids are some of the effective strategies to mitigate chelation effects on BIC exposure.This study was registered at NCT05502341/NCT06333808."

Journal • P1 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in People Living with HIV Aged 50 Years and Older: A Retrospective Analysis of Naïve and Treatment-Experienced Individuals. (PubMed, Viruses) - "It demonstrates high efficacy in initiating treatment and is a safe, effective, and durable platform for treatment simplification. Its favorable metabolic and hepatic profile makes it particularly suitable for an aging population with a high burden of comorbidities, ensuring long-term treatment success."

Journal • Retrospective data • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease • Liver Cirrhosis • CD4 • CD8

Enhanced immune recovery with B/F/TAF compared with DTG/3TC in HIV patients: A prospective observational study. (PubMed, J Infect Public Health) - "These findings underscore the clinical advantages of the B/F/TAF regimen in promoting immune reconstitution among HIV patients. Future studies should investigate whether the observed differences in immune recovery translate into reduced morbidity and mortality rates over time."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease • CD4

Metabolomic Profile of Weight Gain of People Living with HIV Treated with Integrase Strand Transfer Inhibitor Regimens Reveals Dysregulated Lipid Metabolism and Mitochondrial Dysfunction. (PubMed, Metabolites) - P=N/A | "Sixty-six participants were randomized to receive INSTI-based regimens, either bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) or dolutegravir/abacavir/lamivudine (DTG/ABC/3TC), and followed for 18 months. In addition, accumulation of circulating medium-chain acylcarnitines, indicative of mitochondrial dysfunction, and insulin resistance were linked to weight gain in PWH on INSTI-based regimens after 18 months of therapy. This metabolomic study identified metabolites reflecting mitochondrial dysfunction, dysregulated lipid metabolism, and altered amino acid metabolism as key mechanisms underlying insulin resistance and weight gain in PWH on INSTI-based ART."

Clinical • Journal • Dyslipidemia • Human Immunodeficiency Virus • Hypertriglyceridemia • Infectious Disease • Metabolic Disorders

Clinical Efficacy and Safety of BIC/TAF/FTC in Elderly HIV-Infected Individuals in Southwest China: A Retrospective Observation Study. (PubMed, Immun Inflamm Dis) - "For elderly HIV/AIDS patients, B/F/TAF is a safe option to achieve and maintain virological suppression and immune recovery. In terms of lipid metabolism, the metabolic effects of BIC/FTC/TAF in the treated patients are not significant, and the effects in untreated patients require longer follow-up."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4 • CD8

A Comparison of the Risk of Viral Load Blips in Human Immunodeficiency Virus Patients on Two-Drug Versus Three-Drug Antiretroviral Regimens. (PubMed, Infect Dis Rep) - " A total of 121 patients were included, with 44 receiving two-drug regimens (e.g., dolutegravir/lamivudine) and 77 receiving three-drug regimens (e.g., bictegravir/tenofovir alafenamide/emtricitabine) at the time of analysis. No virologic failure was observed. These findings suggest that two-drug regimens provide virologic control comparable to three-drug regimens and may be a viable clinical option due to fewer drug interactions, lower toxicity, and reduced cost."

Journal • Human Immunodeficiency Virus • Infectious Disease

Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. (PubMed, Infect Dis Ther) - P, P=N/A | "In this large cohort of people with HIV who switched to B/F/TAF in routine clinical practice, mental and physical health scores improved or remained stable over time and treatment satisfaction improved. Further studies are required to elucidate the clinical relevance of PRO tools and how they relate to QoL in people with HIV. Video abstract available for this article."

HEOR • Journal • Observational data • Retrospective data • Infectious Disease

First-Line Switch to B/F/TAF for Treatment of HIV in Older Adults ≥60 Years in Kenya (the B/F/TAF-Elderly Study). (PubMed, Open Forum Infect Dis) - "More participants on B/F/TAF developed incident dyslipidemia compared with participants on CAR (23% on B/F/TAF; 14% on CAR; P .015). Switch to B/F/TAF was non-inferior to CAR and safe in an African population aged ≥60 years."

Clinical • Journal • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Osteoporosis • Rheumatology

Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1-Infected Pregnant Women: Real-Life Use. (PubMed, AIDS Res Hum Retroviruses) - "Reported tolerance was good. BIC/FTC/TAF might be a good option during pregnancy and particularly to simplify previous cART but it is necessary to counsel patients to ensure good adherence to this one."

Journal • Human Immunodeficiency Virus • Infectious Disease

Bone Mineral Density Changes in People with HIV Who had Immediate Switch Versus Deferred Switch from Tenofovir Disoproxil Fumarate-Based Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Multicenter, Open-Label, Randomized Clinical Trial. (PubMed, Infect Dis Ther) - P4 | "While both immediate and deferred switch from TDF-based regimens to B/F/TAF maintained virological suppression, early switch resulted in better improvement of BMD in the hip joint."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease • Osteoporosis • Rheumatology

Single high-dose liposomal amphotericin B plus B/F/TAF for AIDS-associated talaromycosis in China: a multicentre randomised controlled trial protocol. (PubMed, BMJ Open) - P=N/A | "This multicentre, randomised controlled phase II clinical trial compares the efficacy and safety of single high-dose L-AMB (10 mg/kg), followed by itraconazole capsule 200 mg every 12 hours for the remaining 13 days of induction therapy, versus AmBD (0.5 mg/kg/day for 14 days) as induction therapy for AIDS-associated talaromycosis in PLWH adults with microbiologically confirmed diagnosis. ClinicalTrials. gov NCT06926569."

Clinical protocol • Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Effectiveness and safety of dolutegravir/lamivudine/abacavir versus bictegravir/emtricitabine/tenofovir alafenamide as first-line regimens in real-world settings (MICTLAN study). (PubMed, Int J STD AIDS) - "BIC/FTC/TAF was more effective in patients with low baseline CD4 + counts, while DTG/3TC/ABC performed better with higher viral loads. DTG/3TC/ABC had more neuropsychiatric AEs and rare hypersensitivity reactions."

Clinical • Journal • Real-world evidence • CNS Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Insomnia • Psychiatry • Sleep Disorder • CD4

Venetoclax Alone or in Combination Shows Promising Activity in Preclinical Models and Clinical Cases of Relapsed/Refractory North American Adult T-Cell Leukemia Lymphoma (ASH 2024) - "Venetoclax has shown activity in other T-cell malignancies, alone or in combination with hypomethylating agents (HMA), AZT (Zidovudine) with Interferon-alpha has been the backbone of acute ATLL treatment for the past three decades...Results : Preclinical : We observed that both the J-ATLL and NA-ATLL cells are sensitive to BCL-2 inhibitors (Venetoclax & Sonrotoclax) with IC50s in the 1-10uM range...To determine synergy between drugs we tested the combination of Decitabine (hypomethylating agent)-Venetoclax as well as between Biktarvy-Venetoclax...TP53 mutated patients had poorer responses. Given the encouraging preclinical and clinical activity of this agent, a prospective clinical trial is being developed using these agents."

IO biomarker • Preclinical • Adult T-Cell Leukemia-Lymphoma • Endocrine Disorders • Fatigue • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock • IFNA1

Promising Safety and Efficacy Data for Peginterferon Alfa-2a (PEG-IFN) and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) in a North American Adult T-Cell Leukemia Lymphoma (NA-ATLL) Cohort of Patients (ASH 2024) - "Zidovudine (AZT) with Interferon-alpha has been the backbone of acute ATLL treatment for the past three decades...This backbone was combined with Venetoclax in one patient and mogamulizumab in another...We propose integrating Biktarvy and PEG-IFN as part of induction or maintenance strategies in ATLL, possibly in combination with other agents. A prospective clinical trial is being designed to evaluate the effect of PEG-IFN and Biktarvy in a larger standardized patient cohort."

Clinical • Adult T-Cell Leukemia-Lymphoma • Fatigue • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock • CD4 • IFNA1

Mogamulizumab Shows Significant Activity with Tolerable Toxicity in a Real-World North American Adult T-Cell Leukemia/Lymphoma (ATLL) Cohort (ASH 2024) - "In our long-term survivors, mogamulizumab was combined with Peg-IFN/Biktarvy, venetoclax, and lenalidomide. Compared to our historical control group, OS in the mogamulizumab-treated group was 309 days versus an OS of 33 days in our control group (p-value=0.0013).Overall, our data supports the use of mogamulizumab in heavily pre-treated ATLL patients. Further studies, using mogamulizumab alone or in combination with other agents, are necessary to elucidate the role of this agent in ATLL."

Clinical • IO biomarker • Real-world • Real-world evidence • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Cutaneous T-cell Lymphoma • Fatigue • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CCR4 • CD4

Tenofovir Alafenamide Fumarate-Associated Fanconi Syndrome (KIDNEY WEEK 2025) - "The patient had been stable on darunavir, ritonavir, and raltegravir, but this was changed to a combined bictegravir-emtricitabine-tenofovir alafenamide for simplicity just prior to his presentation. His development of acute and severe electrolyte disturbances after initiation of TAF is concerning for acute worsening of preexisting Fanconi syndrome. This case highlights that while TAF is generally considered safer, there is still risk of renal toxicity, particularly when renal tubular dysfunction is already present."

Chronic Kidney Disease • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Renal Disease

HIV Mimicking Lupus Nephritis: A Diagnostic Challenge (KIDNEY WEEK 2025) - "The patient was treated with pulse methylprednisolone and mycophenolate mofetil...Immunosuppression was discontinued, antiretroviral therapy (Biktarvy) was initiated, and prednisone was tapered...Early HIV testing is crucial to avoid misdiagnosis and unnecessary immunosuppression, which can be harmful in immunocompromised patients. Management of HIV-related GN should prioritize antiretroviral therapy over immunosuppressive regimens."

Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Renal Disease • Systemic Lupus Erythematosus • CD4