bictegravir (GS-9883) / Gilead - LARVOL DELTA

Sex and gender differences in weight gain associated with second-generation integrase strand transfer inhibitors: A scoping review. (PubMed, HIV Med) - "Second-generation INSTIs, especially dolutegravir, appear to be associated with greater average and excessive weight gain among cis women, although this effect varies by setting, regimen and clinical context. Further research, especially in diverse populations, is needed to explore underlying mechanisms, determine risk factors and evaluate these trends in newer antiretroviral medications."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Exploring the impact of Cabotegravir-Rilpivirine long-acting on weight gain, body composition and quality of life in adults living with HIV. (PubMed, HIV Med) - "CAB + RPV LA was not associated with significant weight gain, clinically relevant changes in body composition or adverse metabolic effects over 48 weeks. Virologic suppression was maintained, renal laboratory parameters improved in prior INSTI users and treatment was well tolerated with increasing satisfaction. These findings support CAB + RPV LA as a safe, effective and metabolically neutral alternative to daily oral ART."

HEOR • Journal • Dyslipidemia • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease

Reversible Severe Hyperglycemia Without Ketoacidosis After Initiation of Bictegravir-containing Antiretroviral Therapy. (PubMed, AACE Endocrinol Diabetes) - "Incorporating metabolic monitoring (glycemia, weight, and lipid profile) and patient education for BIC into clinical practice, and utilizing a multidisciplinary team, can reduce the risk of acute hyperglycemia and glycemia-related hospitalization. Patients starting a BIC-containing ART who have a history of obesity and/or dysglycemia should be educated and monitored for risk of developing acute hyperglycemia, which can be reversed upon BIC discontinuation."

Journal • Diabetes • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Obesity • CD4

Bictegravir's effect on persistent low-level viraemia and immunological response: BELAIR study: a pilot prospective observational study (ESCMID Global 2026) - No abstract available

Clinical • Observational data • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Bictegravir concentrations in breastmilk of healthy, lactating women without HIV. (PubMed, J Antimicrob Chemother) - "Exposure to bictegravir through breastmilk is very low, with a relative infant dose below 1%. Even though metabolizing capacity in newborns is not yet fully developed, it is not expected to cause infant toxicity."

Journal • Human Immunodeficiency Virus • Infectious Disease

Resistance to second-generation integrase inhibitors in people with HIV following treatment failure on dolutegravir- or bictegravir-based ART in Taiwan. (PubMed, J Antimicrob Chemother) - "Although RAMs to second-generation INSTIs may be detected during treatment failure, the overall prevalence remains low for both dolutegravir- and bictegravir-based ART. Viral resuppression can be achieved through salvage therapy or continued use of second-generation INSTI-based regimens."

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

An ultra-long-acting dimeric bictegravir prodrug defined by a short pharmacokinetic tail. (PubMed, Nat Commun) - "NMXBIC's physicochemical properties and high BIC loading/unit mass of the prodrug contribute to its unique ULA PK profile. These results support its development as a ULA formulation for HIV-1 treatment and prevention."

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

Prediction of interactions between the SARS-CoV-2 ORF3a protein and small-molecule ligands using the ANDSystem cognitive platform, graph neural networks, and molecular modeling. (PubMed, Vavilovskii Zhurnal Genet Selektsii) - "Localization analysis showed that the binding sites of bictegravir and 4-(benzoylamino)benzoic acid lie in a cytosolic surface pocket of the protein that is solvent-exposed; L-threonine binds within the intersubunit cleft of the dimer; and austocystin D and N-acetyl-D-glucosamine are positioned at the boundary between the cytosolic surface and the transmembrane region. The accessibility of these binding sites may be reduced by the influence of the lipid bilayer. The binding energetics for bictegravirum were more favorable than for 4-(benzoylamino)benzoic acid (docking score -7.37 kcal/mol; MM/GBSA ΔG -14.71 ± 3.12 kcal/mol), making bictegravirum a promising candidate for repurposing as an ORF3a inhibitor."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Longitudinal analysis of metabolic changes in people with HIV on integrase inhibitor-based versus efavirenz-based therapy: a prospective real-world cohort study in China. (PubMed, BMC Infect Dis) - "INSTI-based ART was associated with sustained weight gain but did not worsen long-term dyslipidemia compared to an EFV-based regimen in a real-world setting. Hepatic steatosis correlated with metabolic parameters rather than INSTI exposure."

Journal • Real-world evidence • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Switch to BIC/TAF/FTC or DTG + TDF/FTC in virologically suppressed PWH: outcomes in real-world setting with and without tenofovir resistance. (PubMed, Clin Infect Dis) - P | "in a real-world setting, switching to BIC/TAF/FTC or DTG + TDF/FTC in PWH with virological success was associated with a non-significant risk of VF, but M184V or M184I mutations and tenofovir resistance had no effect on VF. Most VF were blips or related to unmeasured adherence issues."

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

Real-Life Long-Term Weight Trends After Switching to INSTI-Based Therapy in People Living with HIV: A 12-Year Retrospective Cohort Study. (PubMed, New Microbiol) - "Switching from PI- to INSTI-based cART in virologically suppressed PLWH is associated with modest but sustained increases in body weight and BMI over time, without evident deterioration in metabolic health. These results support the favourable safety profile of INSTIbased regimens while underscoring the need for routine anthropometric monitoring and preventive lifestyle interventions during long-term therapy."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

Localized inflammasome inhibition mitigates foreign body response to subcutaneous long-acting antiretroviral therapy for HIV. (PubMed, J Control Release) - "In this study, we incorporated MCC950, a selective NLRP3 (NOD-, LRR-, and pyrin domain-containing protein 3) inhibitor, into a subcutaneous nanofluidic implant co-delivering TAF and bictegravir (BIC)...Sustained plasma levels of both drugs were maintained for up to 45 days, and imaging mass cytometry and histological analyses confirmed localized immunomodulation. These findings establish inflammasome inhibition as a viable strategy to improve the safety and tolerability of subcutaneous LA-ART and lay the groundwork for future immunomodulatory-enhanced drug delivery systems."

Journal • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • NLRP3

Despite increasing use of integrase inhibitors to treat HIV infection, resistance to this class remains stable. (PubMed, J Antimicrob Chemother) - "Although the use of INSTIs has increased over time with differences in the duration of use, we did not observe a corresponding increase in the proportion of ARV-treated PLWHIV who experienced virological failure with INSTI-resistant viruses during the study period."

Journal • Human Immunodeficiency Virus • Infectious Disease

Bictegravir's effect on persistent low-level viremia and immunological response. BELAIR study: A pilot prospective observational study. (PubMed, Int J STD AIDS) - "A significant gradual elevation of CD4/CD8 ratio was also observed (0.51 ± 0.30 before switch vs 0.69 ± 0.35 at 12 months, p < 0.001).ConclusionThe results of the present study indicate that BIC/TAF/FTC may improve the immunological response and reduce the proportion of PWHIV experiencing persistent LLV. Further studies in larger patient series are needed to determine the full beneficial role of bictegravir."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

AI-driven discovery of antiretroviral drug bictegravir and etravirine as inhibitors against monkeypox and related poxviruses. (PubMed, Commun Biol) - "These findings support the repurposing of bictegravir and etravirine for treating mpox, especially for patients co-infected with HIV, warranting follow-up clinical investigation. The established AI pipeline and our antiviral drug discovery strategies bear major implications for responding to the ongoing mpox emergency and preparing for future poxvirus epidemics."

Journal • Human Immunodeficiency Virus • Infectious Disease

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

Differential adipose tissue remodeling and metabolic effects of dolutegravir and bictegravir: implications for HIV therapy. (PubMed, Biomed Pharmacother) - "Collectively, these findings demonstrate that DTG and BIC exert distinct yet overlapping influences on adipogenesis and WAT biology that might contribute to metabolic alterations in PWH. Understanding these mechanisms is essential for optimizing long-term HIV treatment strategies and mitigating the cardiometabolic risk associated with modern antiretroviral regimens."

Journal • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

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

Deep sequencing reveals underestimated burden of integrase inhibitor resistance mutations in people living with HIV: a global individual patient data meta-analysis. (PubMed, Emerg Microbes Infect) - "IPD analysis of 394 mutation-positive individuals revealed 8.52% low-frequency resistance to dolutegravir and bictegravir in treatment-naïve populations, while treated patients exhibited significantly increased intermediate/high-level resistance to first-generation INSTIs, including raltegravir and elvitegravir. Although second-generation INSTIs maintain lower resistance rates, cross-resistance risks necessitate clinical vigilance. Optimized resistance surveillance strategies incorporating low-frequency mutation detection offer critical evidence for advancing global HIV control efforts."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

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

Emerging patterns in HIV integrase resistance. (PubMed, AIDS) - "Resistance was more frequent in non-B subtypes and often co-occurred with resistance to other antiretroviral classes. Though prevalence remains low, the findings highlight the need for continued surveillance to inform treatment decisions, especially as integrase inhibitors like dolutegravir, bictegravir and cabotegravir become more widely used."

Journal • Human Immunodeficiency Virus • Infectious Disease

Rare Case of Dual Pathology: Methamphetamine-Associated Acute Interstitial Nephritis and HIV/Hepatitis C Virus-Associated Fibrillary Glomerulonephritis (KIDNEY WEEK 2025) - "The patient received a 2-week course of 20 mg oral prednisone. Antiviral therapies (bictegravir/emtricitabine/tenofovir and glecaprevir/pibrentasvir) were initiated...His IVDA status could be linked to both methamphetamine AIN and HCV/HIV-related GN. This case highlights the diagnostic and therapeutic challenges in patients with dual renal pathology and coexisting infections."

Clinical • Cardiovascular • Glomerulonephritis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Lupus Nephritis • Nephrology • Renal Disease

Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in People With HIV-1 Who Are Virologically Suppressed on Complex Antiretroviral Regimens at Baseline. (PubMed, Open Forum Infect Dis) - "ARTISTRY-1 is a phase 2/3 trial of bictegravir (BIC; 75 mg) plus lenacapavir (LEN; 25 mg or 50 mg) versus complex antiretroviral therapy regimens in 128 virologically suppressed people with HIV-1. At 48 weeks, BIC + LEN (at either LEN dose) was highly effective at maintaining virologic suppression and was well tolerated."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

NRTI-Induced Pancreatitis Second to Viral-Induced Acute Liver Failure (ACG 2025) - "Initiation of antiviral therapy with tenofovir or entecavir monotherapy as well as evaluation for liver transplant is the standard of care.Case Description/ A 47 year old woman with no PMH presented for one week history of worsening malaise, nausea, vomiting, and worsening jaundice...Vitamin K, lactulose, Tenofovir, and NAC were initiated...Further workup was halted due to acceptance to transplant institute. NRTI-induced pancreatitis has been described in HIV patient's receiving combination NRTI regimens including didanosine + tenofovir and bictegravir, emtricitabine, and tenofovir...Common, alternative etiologies were ruled out. We see here an interesting presentation of NRTI-induced pancreatitis in the setting of ALF.Figure: Massively inflamed body and tail of pancreas on CT with infiltration of the surrounding fat"

CNS Disorders • Gastroenterology • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Lipodystrophy • Liver Failure • Metabolic Disorders • Myositis • Pancreatitis

Colonic Clue to a Hidden Diagnosis: Isolated GI Histoplasmosis in an Unaware HIV Patient (ACG 2025) - "Empiric vancomycin and piperacillin-tazobactam were started for suspected sepsis. Due to pancytopenia and transaminitis, doxycycline was added for possible tick-borne disease which is endemic to the patient's region, and IV fluconazole was added to cover for candidiasis...Subsequently, the patient was started on antiretroviral therapy (bictegravir, emtricitabine, tenofovir) and Amphotericin B, followed by itraconazole...Abnormal Laboratory Findings on Admission.WBC- White Blood Cell count/ AST- Aspartate Aminotransferase/ ALT - Alanine Aminotransferase/ ALP - Alkaline phosphatase/ HIV- Human Immunodeficiency Virus Figure: Figure 1. Endoscopic and histopathologic findingsA-B: Colonoscopy images showing inflamed, erythematous mucosa with ulceration.C-D: Periodic acid–Schiff (PAS) staining demonstrating intracellular yeast forms within necrotizing granulomas and Grocott's methenamine silver (GMS) stain highlighting numerous fungal organisms consistent with..."

Clinical • Candidiasis • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pancreatitis • Septic Shock • CD4