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

Need for Medication Review and Deprescribing in People Living with HIV: A Longitudinal Observational Study. (PubMed, Pharmaceuticals (Basel)) - "Four were DDIs: cobicistat/alprazolam associated with sedation and dyspnoea, rilpivirine/hydroxychloroquine with QT prolongation, bictegravir/ursodeoxycholic acid with rising viremia, and atorvastatin/fenofibrate with myalgia...After medication review, alprazolam was replaced with zolpidem, rilpivirine-based HAART with bictegravir/emtricitabine/tenofovir alafenamide, and atorvastatin/fenofibrate with simvastatin/ezetimibe, and ursodeoxycholic acid and supplements were discontinued... This study highlights the importance of predicting DDIs/DSIs in PLWH undergoing polypharmacy. Medication review supports clinical decision-making, preventing avoidable adverse outcomes."

Journal • Observational data • Anesthesia • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Pain • Pain • Pulmonary Disease

Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels (clinicaltrials.gov) - P2 | N=125 | Not yet recruiting | Sponsor: Gilead Sciences

New P2 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Incidentally Discovered Large Duodenal Gastrointestinal Stromal Tumor in a HIV+ Patient With Concerning Postoperative Surveillance Findings (ACG 2026) - "Case Description/ A 69-year-old male with HIV on bictegravir, emtricitabine, tenofovir alafenamide (CD4 772 cells/µL), prior thyroid cancer, GERD, and tobacco use presented with acute right flank pain attributed to herpes zoster...Figure: Surveillance contrast-enhanced CT of the abdomen approximately 5 months following R0 duodenal resection and duodenojejunostomy, during which the patient had self-reduced adjuvant imatinib dosing...(B) Axial image through the mid-abdomen revealing a larger 21.7 Ã 18.7 mm heterogeneously enhancing hepatic lesion (calipers) with post-surgical changes in the duodenal bed. Neither lesion was present on preoperative imaging."

Clinical • Stroma • Gastric Cancer • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Hepatology • Herpes Zoster • Human Immunodeficiency Virus • Infectious Disease • Oncology • Sarcoma • Small Intestinal Carcinoma • Solid Tumor • Thyroid Gland Carcinoma • Varicella Zoster • CD4

Rare HCV-Associated IRIS Presenting as Acute Hepatitis Following ART Initiation in an HIV/HCV Coinfected Patient: A Case Report (ACG 2026) - "Case Description/ A 32-year-old ART-naïve male with advanced Human Immunodeficiency Virus (HIV) (CD4 274 cells/mm³, Viral load >10 million copies/mL) and untreated chronic Hepatitis C virus (HCV)(Viral load 15,094 IU/mL), complicated by bioprosthetic tricuspid valve endocarditis, was initiated on bictegravir/emtricitabine/tenofovir (Biktarvy) five weeks after achieving culture negativity with IV daptomycin...Prednisone 40 mg daily was initiated on day 7 without ART discontinuation, resulting in improvement in liver enzymes (AST 78, ALT 349 U/L within one week)...This case shows that HCV-IRIS does not mandate ART discontinuation and that it responds to corticosteroids, although this remains controversial. In these clinical scenarios, treating HCV before starting ART in coinfected patients may be a reasonable approach to help reduce the risk of hepatic IRIS."

Case report • Clinical • Autoimmune Hepatitis • Cardiovascular • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Failure • CD4

Hepatitis C Reactivation After Sustained Virologic Response in HIV-Positive Patient on Long-Acting Injectable Cabotegravir and Rilpivirine (ACG 2026) - "The patient was discontinued from the cabotegravir / rilpivirine and was started on oral bictegravir/emtricitabine/tenofovir alafenamide for treatment of his HIV. Additionally, the patient was prescribed 12 weeks of oral sofosbuvir/velpatasvir for treatment of his hepatitis C. The patient completed treatment and improved clinically...It is unsafe for patients to have long acting injectables without close follow up. Figure: Right Upper Quadrant Ultrasound showing "starry sky" appearance of the liver."

Clinical • Autoimmune Hepatitis • Genetic Disorders • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Movement Disorders

Gastrointestinal Kaposi Sarcoma Presenting as Iron Deficiency Anemia With Variable HHV-8 Immunostaining in the Setting of HIV-AIDS (ACG 2026) - "Case Description/ A 27-year-old man with recently diagnosed HIV (initial CD4 242 cells/µL) was started on bictegravir/emtricitabine/tenofovir alafenamide...(C) CD34 immunostain (4x) demonstrating diffuse positivity within a proliferation of spindle-shaped vascular cells infiltrating the colonic lamina propria. (D) Human herpesvirus-8 (HHV-8) immunostain (4x) showing diffuse nuclear positivity in the spindle cell population, confirming the diagnosis of Kaposi sarcoma."

Anemia • Colorectal Cancer • Epstein-Barr Virus Infections • Gastrointestinal Disorder • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Kaposi Sarcoma • Sarcoma • Solid Tumor • Spindle Cell Sarcoma • CD34

A Decade Undiagnosed: Colonic Spirochetosis Masquerading as Refractory IBS and Misidentified as Syphilis Colitis in an HIV-Positive Patient (ACG 2026) - "Case Description/ A 40-year-old HIV-positive male (CD4 776â1053 cells/μL, undetectable viral load on Biktarvy) with recurrent syphilis and gonorrhea presented with a decade-long history of chronic diarrhea, bloating, and up to eight bowel movements daily, attributed to irritable bowel syndrome (IBS)...Doxycycline 100 mg BID for 28 days yielded only partial symptomatic improvement...Third, persistent GI symptoms despite adequate treatment, confirmed by spirochetosis on repeat colonoscopy, should prompt diagnostic reconsideration. Metronidazole achieved near-complete resolution after a decade of delay."

Clinical • Gastroenterology • Gastrointestinal Disorder • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Concurrent Pan-Gastrointestinal Kaposi Sarcoma and Multicentric Castleman Disease Presenting With Hemodynamic Shock in a Newly Diagnosed HIV Patient (ACG 2026) - "Antiretroviral therapy (ART) was initiated with Biktarvy under multidisciplinary care...Early tissue sampling via both lymph node biopsy and endoscopy is imperative to guide targeted immunomodulatory and oncologic regimens alongside rapid ART initiation. Generative AI assisted with text formatting limits."

Clinical • Acute Kidney Injury • Cardiovascular • Colorectal Cancer • Cough • Epstein-Barr Virus Infections • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Human Immunodeficiency Virus • Immunology • Infectious Disease • Kaposi Sarcoma • Nephrology • Rare Diseases • Renal Disease • Respiratory Diseases • Sarcoma • Septic Shock • Solid Tumor • CD4

A Rare Case of Isolated Gastric Kaposi Sarcoma in Advanced HIV/AIDS (ACG 2026) - "He was inconsistently adherent to bictegravir/emtricitabine/tenofovir alafenamide and otherwise relied on homeopathic remedies...Figure: Figure 2A: Atypical vascular proliferation in gastric mucosa in between normal crypts. Figure 2B: 40X magnification CD31 immunostain highlights atypical neoplastic vessels."

Clinical • Metastases • Epstein-Barr Virus Infections • Gastrointestinal Disorder • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Kaposi Sarcoma • Sarcoma • Solid Tumor • CD31 • CD4 • PECAM1

Gastrointestinal Kaposi Sarcoma: An Underdiagnosed Manifestation of Advanced HIV (ACG 2026) - "He was diagnosed with Pneumocystis jirovecii pneumonia and disseminated histoplasmosis and was treated with trimethoprim-sulfamethoxazole and voriconazole...Biopsies confirmed GI-KS, and he was started on bictegravir/emtricitabine/tenofovir alafenamide and doxorubicin for advanced KS...F. Normal-appearing duodenum."

Metastases • Cardiovascular • Epstein-Barr Virus Infections • Gastrointestinal Disorder • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Kaposi Sarcoma • Pneumonia • Pulmonary Disease • Respiratory Diseases • Sarcoma • Septic Shock • Solid Tumor • CD4

The Double-Hit DILI: Drug-Induced Liver Injury Leading to Acute Liver Failure Following Antiretroviral Therapy With Therapeutic Acetaminophen Use (ACG 2026) - "He started BIC/FTC/TAF two weeks prior to presentation while also taking 2 grams of acetaminophen daily over this time due to a toothache...The patient was started on N-acetylcysteine and underwent three sessions of PLEX...Figure: Table 1. Trend of liver function tests and lactic acid throughout hospital admission"

Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Failure • Metabolic Disorders

When Dysphagia Signals More: A Case of Lymphocytic Esophagitis With Esophageal Stricture (ACG 2026) - "Case Description/ A 61 year old male with HIV on Biktarvy, GERD, chronic dysphagia, and a history of esophageal stricture treated with balloon dilation, as well as previously eradicated H. pylori infection, presented for evaluation of persistent dysphagia...He was started on omeprazole 40 mg twice daily for three months, with consideration of topical steroids if symptoms persisted...Figure: Figure A: Esophageal biopsy showing increased intraepithelial lymphocytes (up to 70 per high power field), spongiosis, and basal cell hyperplasia in low power. Figure: Figure B: Esophageal biopsy showing increased intraepithelial lymphocytes (up to 70 per high power field), spongiosis, and basal cell hyperplasia in high power."

Clinical • Celiac Disease • Eosinophilic Esophagitis • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (clinicaltrials.gov) - P2/3 | N=177 | Active, not recruiting | Sponsor: Gilead Sciences | Trial completion date: Nov 2026 ➔ Jun 2027

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

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

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

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

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

2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial (clinicaltrials.gov) - P4 | N=134 | Completed | Sponsor: University Hospital, Ghent | Recruiting ➔ Completed | Trial completion date: Apr 2027 ➔ Mar 2026 | Trial primary completion date: Jun 2026 ➔ Mar 2026

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

24-Month Outcomes of Bictegravir/Emtricitabine/Tenofovir Alafenamide in People with HIV from the Italian BICSTaR Cohort. (PubMed, Curr HIV Res) - "B/F/TAF was well tolerated, with high levels of viral suppression and treatment persistence over 24 months. HIV symptom burden remained stable or improved, while treatment satisfaction increased."

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 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2030 ➔ Dec 2031

Trial completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Differences in Demographics and HIV Risk Exposures Among People Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) vs. Other Post-exposure Prophylaxis Regimens in the United States, 2016-2025 (IDWeek 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Incidence of resistance-associated mutations among people with HIV receiving bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based regimens (IDWeek 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Virological Effectiveness of B/F/TAF Despite Suboptimal Adherence Measured by Electronic Monitoring in a Socially Vulnerable Real-World Cohort (IDWeek 2026) - No abstract available

Adherence • Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Patient-Reported Outcomes With Doravirine/Islatravir (100/0.25 mg) Once Daily Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Previously Untreated Adults Living With HIV-1: Phase 3 Week 48 Results (IDWeek 2026) - No abstract available

Clinical • P3 data • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease

Week 48 Efficacy and Safety of Doravirine/Islatravir (100/0.25 mg) vs Bictegravir/Emtricitabine/Tenofovir Alafenamide in Previously Untreated Adults Living with HIV-1 with Renal Impairment (IDWeek 2026) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease