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

No DDI between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (EASL 2025) - "BEM/RZR and B/FTC/TAF, alone and co-administered, were well tolerated in healthy subjects with no clinically relevant PK DDI. These results support the enrollment of HCV/HIV-co- infected subjects receiving B/FTC/TAF in BEM/RZR clinical trials."

Human Immunodeficiency Virus • Infectious Disease

“It made me feel like I was going to be okay…[but] is a daily reminder that I have HIV“ Perspectives on Treatment Needs of Youth with HIV from the Biktarvy Outcomes in Baltimore Youth Study (B.O.B.Y) (PAS 2025) - "There were 629 YHIV between ages 12 and 30 who were on Biktarvy between March 2022 and September 2024; 34 YHIV completed the survey, (mean age 24; range 16-30) 94% were Black/African American. Preliminary findings reveal a spectrum of experiences among participants. Among YHIV, 76% who switched to Biktarvy were satisfied, compared to 92% satisfaction among those for whom Biktarvy was their first regimen."

Human Immunodeficiency Virus • Infectious Disease

Accelerated ART Initiation for PWHIV Who Are Out of Care (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: University of Missouri-Columbia | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: May 2025 ➔ May 2026

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

Dissolved Bictegravir/Emtricitabine/Tenofovir Alafenamide Improves Medication Adherence. (PubMed, J Pediatr Health Care) - "To support medication adherence, caregivers dissolved low-dose bictegravir/emtricitabine/tenofovir alafenamide, with follow-up showing maintenance of virologic suppression, no adverse side effects, and improved adherence to medication based on parental report and pharmacy refill history. This is the first known published case report of dissolved low-dose bictegravir/emtricitabine/tenofovir alafenamide in a pediatric patient."

Journal • CNS Disorders • Developmental Disorders • Epilepsy • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) After A Viremic Event: A Pooled Analysis of Studies in People with HIV. (PubMed, Infect Dis Ther) - "Most participants receiving B/F/TAF experienced no viremic events. The vast majority of viremic events resolved with B/F/TAF continuation, without the need for treatment change."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis (clinicaltrials.gov) - P=N/A | N=116 | Not yet recruiting | Sponsor: Shanghai Public Health Clinical Center

New trial • Human Immunodeficiency Virus • Infectious Disease

Long-term metabolic changes with bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir-containing regimens for HIV. (PubMed, AIDS Res Ther) - P3 | "No significant difference in weight change from baseline to Week 144 was found between bictegravir and DTG, or between B/F/TAF and a non-TAF-containing regimen, in these two randomized trials. Furthermore, weight gain following treatment initiation was greatest in the first year of treatment and most pronounced in individuals with more advanced HIV at baseline, supporting the hypothesis that weight gain following initial treatment is linked to a "return to health" in people with advanced HIV."

Clinical • Journal • Cardiovascular • Diabetes • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • CD4

Efficacy and persistence of same-day re-start with B/F/TAF among patients with HIV who experienced discontinuation from previous NNRTI based regimens in China (ChiCTR) - P4 | N=250 | Not yet recruiting | Sponsor: National center for AlDS/STD control and prevention, China CDC; National center for AlDS/STD control and Pprevention, China CDC

New P4 trial • Human Immunodeficiency Virus • Infectious Disease

COMPARATIVE CARDIOVASCULAR RISK IN HIV: A RETROSPECTIVE ANALYSIS OF DUAL VS TRIPLE THERAPY OUTCOMES - Joshua Chang (ACC 2025) - "Dolutegravir/Lamivudine (DTG/3TC) is the only dual ART approved for treatment-naive patients while Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) is a commonly used single-tablet, triple ART. We conducted a retrospective cohort study utilizing data from the TriNetX database, which covers 60 healthcare organizations providing real-world electronic health records. Our study contradicts Greenberg et al. (2021), which found no difference in cardiovascular events between dual vs triple therapy, and support Pulido et al. (2017) and Hung et al."

Retrospective data • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Human Immunodeficiency Virus • Infectious Disease • Ischemic stroke • Myocardial Infarction

Comparison of malignant melanoma development in people living with HIV/AIDS (EADO-WCM 2025) - "Both patients were treated antiviral medicine Biktarvy containing the active substances bictegravir, emtricitabine and tenofoviralafenamide...Oncology treatment for both patients included dabrafenib and trametinib... The co-occurrence of HIV infection and MMposes a major threat to patient survival. Delayed diagnosis of melanoma in PLWHA leads to rapid metastasis formation and significantly impedes the cancer treatment process. The location of MM metastases in PLWHA is an individual feature."

Human Immunodeficiency Virus • Infectious Disease • Melanoma • Oncology • Solid Tumor • BRAF

BICTECAPS: Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret

New trial • Human Immunodeficiency Virus • Infectious Disease

Effectiveness and safety of tenofovir alafenamide/emtricitabine/bictegravir as a first-line regimen in people with HIV: A retrospective observational study. (PubMed, IJID Reg) - "The estimated durabilities of TAF/FTC/BIC at 12 and 24 months were 84.8% (95% CI 78.6-89.3%) and 75.5% (95% CI 67.6-82.6%), respectively. In our cohort of newly diagnosed PWH treated with TAF/FTC/BIC, the low occurrence of virological failure and discontinuation related to drug toxicities underscores the effectiveness and tolerability of the regimen."

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

Kaposi Sarcoma Masquerading as Methicillin-Resistant Staphylococcus aureus Soft Tissue Infection of the Foot in an Immunocompromised Transgender Female. (PubMed, Cureus) - "Here, we present the case of a 28-year-old homeless transgender female with untreated HIV (CD4 count = 175 cells/μL, HIV RNA = 221,000 copies/mL), latent syphilis, and methamphetamine use disorder, who presented with a five-month history of progressive left foot pain, ulceration, and swelling...The patient was initiated on antiretroviral therapy with Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and treated with linezolid and amoxicillin-clavulanate for MRSA...Furthermore, this case emphasizes the impact of social determinants of health, such as homelessness and substance use, on disease progression and treatment outcomes. Addressing these barriers is essential for improving care in vulnerable populations with complex, multifactorial conditions."

Journal • Dermatology • Epstein-Barr Virus Infections • Human Immunodeficiency Virus • Infectious Disease • Kaposi Sarcoma • Oncology • Pain • Sarcoma • Solid Tumor • CD4

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (clinicaltrials.gov) - P3 | N=643 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Metabolic Complications After Initiating BIC/FTC/TAF Versus DTG + 3TC in ART-naive Adults With Human Immunodeficiency Virus (HIV): A Multicenter Prospective Cohort Study. (PubMed, Clin Infect Dis) - "In this nationwide cohort of ART-naive individuals, initiation of BIC/FTC/TAF or DTG + 3TC resulted in similar modest increases in weight and lipid levels after 96 weeks, with no significant differences in metabolic outcomes or clinical events. These findings suggest that the metabolic profile of TAF should not be a deciding factor when choosing between 2- and 3-drug ART regimens."

Journal • Cardiovascular • Diabetes • Dyslipidemia • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders

Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide Introduced at the First Clinical Visit: A Real-Life Single-Arm Single-center Retrospective Cohort Study. (PubMed, Infect Dis Ther) - "In our real-life clinical setting, same-day treatment with BIC/FTC/TAF was an efficacious and feasible option for achieving viral suppression in treatment-naïve PLWH."

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

Real-world effectiveness and safety of BIC/FTC/TAF in comparison with other regimens in people with HIV starting therapy with AIDS-defining conditions. Results from the CORIS Cohort: The ACTUAS II Study. (PubMed, Clin Infect Dis) - "In the light of our results, BIC/FTC/TAF is an effective and well tolerated option for starting ART in people with AIDS."

Journal • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • CD4

Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate Regimen and Its Effect on Liver Steatosis Assessed by Fibroscan. (PubMed, Viruses) - "bictegravir-based regimens are a valid therapeutic option for people living with HIV, particularly for those with metabolic comorbidities."

Journal • Observational data • Retrospective data • Cardiovascular • Dyslipidemia • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • CD4

Glecaprevir/Pibrentasvir in HIV/HCV-coinfected patients treated with bictegravir (APASL 2025) - "One of the most commonly used highly active antiretroviral therapy (HAART) is bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF). It has been proven that coadministration of B/FTC/TAF and sofosbuvir/velpatasvir (SOF/VEL) is unlikely to induce clinically significant interactions, however, coadministration of B/FTC/TAF with gelcaprevir/pibrentasvir (GLE/PIB) has not been studied...Of these, 38 were treated with GLE/PIB and 101 were treated with SOF/VEL ± ribavirin (RBV)... To our knowledge, this is one of the first studies to assess the real-life effectiveness and safety of GLE/PIB in HIV/HCV-positive patients treated with bictegravir. The study showed that real-life results of therapy with GLE/PIB or SOF/VEL did not differ significantly in HIV/HCV-coinfected patients treated with B/FTC/TAF. Both regimens allowed encouraging SVR12 rates and treatment safety, as well as tolerability, were also comparable between the study groups."

Clinical • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Liver Failure

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060) (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Human Immunodeficiency Virus • Infectious Disease

Systematic Literature Review and Meta-Analysis (SLR/MA) of Integrase Strand Transfer Inhibitors (INSTI)-based Single-Tablet Regimens (STR) versus Multiple-Tablet Regimens (MTR) for the Treatment of Adult People with HIV (PWH) (ISPOR 2025) - "INSTI-based STR compared to MTR performed similarly in clinical trials but demonstrated significantly better outcomes in real-world settings."

Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease

Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in Black and Hispanic/Latine adults with HIV-1 initiating first-line therapy: 5-year follow-up from two phase III studies. (PubMed, HIV Med) - P3 | "These results demonstrate the durability and long-term safety of B/F/TAF in Black and Hispanic/Latine people with HIV."

Journal • P3 data • Cardiovascular • Diabetes • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • CD4

PASO-DOBLE: DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: (clinicaltrials.gov) - P4 | N=554 | Completed | Sponsor: Fundacion SEIMC-GESIDA | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

The case of a bloody mess - Bictegravir/emtricitabine/tenofovir alafenamide induced colitis. (PubMed, Clin Biochem) - "This case highlights how anti-retroviral therapies such as Biktarvy may elicit medication-induced gastrointestinal symptoms, which may underlie the cause of bloody diarrhea and pancolitis, and consequently a grossly elevated fecal calprotectin."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pain • Ulcerative Colitis • CRP

Pharmacokinetics of Twice-Daily TAF in Adults With HIV-Associated TB on BIC/FTC/TAF and Rifampicin (CROI 2025) - P2 | "Conclusions Twice-daily TAF achieved sufficient exposures to overcome RIF enzyme-inducing effects in adults with HIV and TB, achieving TFV-DP intracellular concentrations above those previously reported with TDF. These data support the use of TAF in a fixed dose combination of BIC/FTC/TAF in PWH and TB."

Clinical • Late-breaking abstract • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases • Tuberculosis