bictegravir (GS-9883) / Gilead - LARVOL DELTA

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

Integrase Strand Transfer Inhibitors for Treatment-experienced Young Adults With Perinatal HIV in the US: Immunologic, Virologic, and Anthropometric Outcomes. (PubMed, Clin Infect Dis) - "Individual INSTI-based regimens among treatment-experienced AYAPHIV had moderate effectiveness with respect to viral suppression. Continued average weight gain across INSTIs raises concerns about long-term cardiometabolic sequalae."

Journal • Human Immunodeficiency Virus • Infectious Disease • Obesity • Pediatrics • CD4

Drug-Drug Interaction (DDI) Liability of Bictegravir/Lenacapavir (BIC/LEN) Compared With Representative Complex Antiretroviral Therapy (ART) Regimens in the Phase 3 Portion of ARTISTRY-1 (EACS 2025) - P2/3 | "Purpose : People with HIV (PWH) who are on complex ART regimens often also take concomitant medications to treat comorbidities. A larger number of DDIs were identified for ART regimens containing boosted DRV compared with BIC/LEN, due to strong inhibition of drug-metabolism pathway components cytochrome P450 3A (CYP3A) and P-glycoprotein by pharmacokinetic enhancers cobicistat and ritonavir, in comparison with moderate CYP3A inhibition and weak P-glycoprotein inhibition by LEN. Conclusions : DDI liability of ART regimens varies, with advantages for BIC/LEN compared with pharmacokinetic enhancer–containing complex regimens."

Late-breaking abstract • P3 data • Human Immunodeficiency Virus • Infectious Disease

Differences in ART regimen initiation among people with recently acquired HIV: 2015-2021 (EACS 2025) - "INSTIs were classified as first-generation (raltegravir, elvitegravir) or second-generation (dolutegravir, bictegravir). However, women and individuals from Africa remain less likely to receive these regimens despite early care engagement. Qualitative research with prescribers is needed to understand these disparities to inform more equitable ART initiation."

Human Immunodeficiency Virus • Infectious Disease • CD4

Impact of continental spread of HIV-1 integrase resistance on progress toward the WHO’s 2030 elimination goals (EACS 2025) - "Resistance to dolutegravir and bictegravir occurred in 1.5% of sequences. Molecular surveillance is essential for tracking resistant lineages and informing treatment strategies. Monitoring circulation within and beyond Europe is critical to preserving the efficacy of antiretroviral classes and achieving WHO’s 2030 targets."

Human Immunodeficiency Virus • Infectious Disease

Nucleocapsid mutations at time of virological failure with an integrase inhibitor (EACS 2025) - "Results : Sequences were available for 61 PLWH-1 receiving either elvitegravir (n=3), raltegravir (n=4), cabotegravir (n=4), dolutegravir (n=18), or bictegravir (n=32). Conclusions : Our study confirms that mutations in the nucleocapsid are observed in a small number of individuals with VF with an INSTI-based regimen. Phenotypic data are needed to decipher the impact of the new mutations (F16Y, N27D, and N27H), and the frequency of nucleocapsid mutations should be explored in larger cohorts."

Human Immunodeficiency Virus • Infectious Disease

High in vitro resistance barrier for the bictegravir/lenacapavir combination (EACS 2025) - "Conclusions : The BIC+LEN combination exhibited synergistic antiviral activity and a high barrier to emergence of resistance in vitro . These data support further clinical investigation of BIC+LEN as a potentially effective regimen for the treatment of HIV."

Preclinical • Human Immunodeficiency Virus • Infectious Disease

Real-World Effectiveness of Bictegravir- versus Dolutegravir-Based Triple regimens in High-Viremia HIV Infection: The BicDol Study (EACS 2025) - "Conclusions : Although both drugs are highly effective, our data shows faster virological control with DTG- compared to BIC-based 3-drugs regimens in high-HIV-viremia PWH, including AHI population. This result should be supported by dedicated studies."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • CD4

Metformin prevents weight gain in non-diabetic adults with HIV: results from a randomized, placebo-controlled trial (EACS 2025) - "Baseline characteristics were balanced between groups; 86% were receiving dolutegravir or bictegravir, and 31% were on TAF-containing regimen. The inverse correlation with GDF-15, in the absence of changes in glucose, HbA1c or HOMA-IR, supports a weight-regulating mechanism independent of glycemic control, likely related to appetite modulation. Further studies of metformin as a metabolic intervention in aging PWH are warranted."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4 • GDF15

Potential treatment options following virological failure with long-acting injectable cabotegravir and rilpivirine: an analysis based on reported cases (EACS 2025) - "Purpose : Virological failure (VF) with long-acting injectable cabotegravir and rilpivirine (LAI-CAB/RPV) is rare but may lead to selection of resistance-associated mutations (RAMs) that limit future treatment options. Resistance to CAB/RPV was common, being more prevalent among people with A compared to non-A subtypes. Reduced susceptibility to alternative treatment options was more pronounced for INI (dolutegravir/bictegravir) than for NNRTI (doravirine/etravirine)."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Mapping patterns of resistance to 2nd generation INSTI in clinical practice: results from the ROSETTA-registry (EACS 2025) - "181 PWH received dolutegravir (DTG), 26 bictegravir (BIC), and 13 cabotegravir (CAB), 14.5% (32/220) were on two drugs,75.5% (166/220) on three drugs and 10% (22/220) on other combinations. Resistance was also observed below 1000 cp/mL and more frequent in those with previous ART exposure. Specific patterns of resistance were observed according to reported previous ART-exposure and viral-subtype."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Paradoxical Immune Reconstitution Inflammatory Syndrome associated with Pneumocystis jirovecii pneumonia in a person living with HIV: a case report (EACS 2025) - "He was treated with trimethoprim-sulfamethoxazole and a short 5-day course of prednisolone, followed by ART (bictegravir/emtricitabine/tenofovir) five days later. This case highlights paradoxical IRIS associated with P. jirovecii pneumonia, likely triggered by ART initiation and steroid withdrawal. Major risk factors include low CD4+ count and high viral load upon diagnosis. Although IRIS is rare in the context of P. jirovecii pneumonia, it should not be overlooked."

Case report • Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Bictegravir in aging adults living with HIV: sustained virologic control and age-appropriate safety profile (EACS 2025) - "BIC achieved durable virologic efficacy in older adults living with HIV, supporting immunological recovery while managing metabolic shifts typical of aging. The regimen’s tolerability—evidenced by low discontinuation and stable organ markers—underscores its suitability for aging populations, balancing virologic control with age-related health dynamics."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Effect of SARS-CoV-2 vaccination on HIV viral load in patients under BIC/TAF/FTC therapy: a retrospective observational study (EACS 2025) - "Purpose : The purpose of our study is to evaluate the impact of SARS-CoV-2 vaccination on HIV viremia in patients treated with bictegravir-based regimen. 2) estimated a risk of blip among non-vaccinated group in OR 3.78 (95% CI, 1.46-9.78). Conclusions : Our data suggest that SARS-CoV-2 vaccination may stimulate an immune response that enhances CD4+ and CD8+ cell function, contributing to a reduction in number of blips and maintaining a good viro-immunological control in patients with HIV, supporting the importance of vaccination in this population"

Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8