bictegravir (GS-9883) / Gilead - LARVOL DELTA

Quality of life among older adults with HIV after switching to bictegravir-based three-drug or dolutegravir-based two-drug regimens. (PubMed, HIV Med) - "Among adults with HIV switching antiretroviral therapy, age ≥60 years was associated with differences in the distribution of reasons for treatment switch and with better perceived QoL, but not with differences in clinical outcomes."

HEOR • Journal • Cardiovascular • Diabetes • Dyslipidemia • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetic and clinical data supporting the lenacapavir (LEN) reloading strategy for bictegravir/lenacapavir (BIC/LEN) single-tablet regimen dosing in the ARTISTRY studies (IDWeek 2026) - No abstract available

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

Efficacy of dolutegravir or bictegravir-containing therapy in a real-life cohort of people with HIV-1 sub-subtype A6. (PubMed, AIDS) - "In PWH treated with DTG or BIC-containing first-line ART, LLV and virological failure with more than 1000 HIV RNA copies/ml were observed more frequently in PWH-1A6 than in PWH-1B. However, such events rarely resulted in INSTI resistance or discontinuation of INSTI-containing ART."

Journal • Human Immunodeficiency Virus • Infectious Disease

Evaluating the combination of bictegravir and lenacapavir as a single tablet option for HIV. (PubMed, Expert Opin Pharmacother) - "Future HIV therapy will evolve toward increasingly personalized treatment integrating daily oral, extended-interval oral, and long-acting injectables. Within this evolving paradigm, LEN/BIC will expand therapeutic options and advance patient-centered HIV care."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Clinical Resistance to Lenacapavir During Treatment of HIV Infection: A Review. (PubMed, Viruses) - "In contrast, no cases of viral rebound with resistance to LEN have been observed in virologically suppressed PWH switching to the once-daily single-tablet regimen (STR) combining LEN with the integrase strand-transfer inhibitor (INSTI) bictegravir after up to 48 weeks in two Phase 3 studies, and for >3 years in Phase 2. Similarly, no resistance to LEN has been observed after up to 96 weeks in the Phase 2 study of once-weekly regimen of the deoxyadenosine analog RT inhibitor islatravir + LEN...Overall, resistance to LEN in regimens using synchronous dosing (daily or weekly oral, or 6-monthly injectable) has been rare in clinical studies. As the use of LEN is predicted to increase in the near future with these potential new combinations, capabilities to test for capsid resistance are being developed through global commercial options as well as through regional health institutions."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Terminated | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Completed ➔ Terminated; The study was closed to accrual early based on Study Monitoring Committee review indicating that the study objectives had either been achieved or could not be met within a reasonable timeframe for the then-open arms.

Trial termination • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Week 96 resistance analysis in participants receiving bictegravir/lenacapavir in the phase 2 ARTISTRY-1 study. (PubMed, Antivir Ther) - "Two participants met criteria for resistance testing before resuppressing, with no treatment-emergent capsid or integrase RAMs. All 119 participants were suppressed at last observed visit.ConclusionsDurable viral suppression was maintained for up to 96 weeks in the Phase 2 extension, with all participants in the extension phase maintaining virologic suppression and no treatment-emergent resistance to study drugs, supporting long-term virologic durability of BIC/LEN STR in VS individuals on complex ART."

Clinical • Journal • P2 data • Human Immunodeficiency Virus • Infectious Disease

Doravirine/islatravir (Idvynso) for HIV. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Bottom-up particle engineering via solvent-mediated polymorphic transformation: a novel strategy for pharmaceutical processability enhancement. (PubMed, Int J Pharm) - "Bictegravir free acid exhibits one of the most complex polymorph landscapes reported for pharmaceutical compounds, presenting both a significant development challenge and a unique engineering opportunity...Raman spectroscopy was implemented to monitor transformation kinetics in real time, and multivariate analysis of the response surface (particle size) was used to identify the optimal operating range. This methodology is most applicable to compounds that possess accessible and isolable hydrates within a controllable water-activity window, and where a metastable-to-stable SMPT pathway exists that yields a more favorable crystal habit, offering a powerful and versatile means of particle engineering."

Journal

Initial HIV Therapy for Adults and Treatment-Associated Weight Gain: The Opti-DOR Randomized Clinical Trial. (PubMed, JAMA) - P3 | "Antiretroviral therapy (ART), particularly regimens containing tenofovir alafenamide with dolutegravir or bictegravir, is associated with substantial weight gain, potentially exacerbating cardiometabolic risk in people with HIV. Among predominantly Black African adults initiating ART, a regimen with doravirine, lamivudine, and tenofovir disoproxil fumarate was noninferior to a regimen with dolutegravir, emtricitabine, and tenofovir alafenamide for 48-week viral suppression and was associated with less weight gain. ClinicalTrials.gov Identifier: NCT05924438."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

National cross-sectional survey on acquired HIV drug resistance in Haiti in 2023: warnings resistance to dolutegravir (AIDS 2026) - "3.77% of HIVs were resistant to dolutegravir and bictegravir, 4.4% to cabotegravir, 4.72% to raltegravir, and 5.03% to elvitegravir. Additionally, 15.19% of the viral strains were resistant to abacavir, 13.92% to lamivudine and emtricitabine, 6.65% to zidovudine, 8.23% to stavudine and didanosine, and 4.13% to tenofovir...Furthermore, some HIVs strains developed resistance against efavirenz (49.37%), nevirapine (50%), Rilpivirine (20.25%), Etravirine (12.66%), and doravirine (3.61%). Finally, HIV genome resistance was 0.63% against atazanavir/ritonavir and indinavir/ritonavir, 0.95% against lopinavir/ritonavir and 0.32% against darunavir/ritonavir. HIV acquired pharmacoresistance is moderate in Haiti and requires innovating adapted strategy for preventing its development, its transmission, and for protecting PLHIV health, while emphasizing on children and male individuals."

Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases

Sustained HIV-1 remission following CCR5 delta32/delta32 allogeneic hematopoietic stem cell transplantation: the Kansas City patient (AIDS 2026) - "The gray shaded area indicates time on ART (raltegravir, emtricitabine/tenofovir, darunavir/cobicistat; then bictegravir, emtricitabine, tenofovir)...AlloHSCT, which occurred in October 2020 following myeloablative conditioning (busulfan/cyclophosphamide), led to full donor chimerism and remission... We report HIV-1 remission sustained for 14 months following ATI in our patient post alloHSCT from a CCR5 delta32/delta32 donor. Ongoing monitoring will further determine HIV reservoir eradication."

Clinical • Late-breaking abstract • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Human Immunodeficiency Virus • Immunology • Infectious Disease • Leukemia • Transplantation • CCR5 • CD34

Metabolic Mechanisms of INSTI-Associated Weight Gain: A Multi-Omics Study in Male People with HIV. (PubMed, J Infect Dis) - "Our integrated multi-omics approach reveals that INSTI-based regimens induce universal metabolic changes. The change of thyroxine and the predictability of TTR in multi-omic studies show the critical role of thyroxine metabolism in INSTI-associated weight gain."

Journal • Human Immunodeficiency Virus • Infectious Disease

Early cardiometabolic safety of bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) among antiretroviral therapy–naïve people living with HIV in Chile (AIDS 2026) - "BIC/TAF/FTC achieved sustained viral suppression, immune recovery, modest weight gain without metabolic deterioration, and significant improvement in liver health, supporting its cardiometabolic and hepatic safety in routine HIV care."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Obesity • CD4

Renal outcomes of tenofovir alafenamide versus tenofovir-free regimens in antiretroviral-naïve people with HIV (AIDS 2026) - "We included adult antiretroviral-naïve PWH initiating TAF/emtricitabine-based regimens combined with bictegravir or dolutegravir, or DTG/3T. In antiretroviral-naïve PWH with preserved baseline renal function, TAF-based regimens were not associated with worse renal outcomes compared with DTG/3TC. These findings support the renal safety of TAF as comparable to tenofovir-free regimens in routine clinical practice."

Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • CD4

Advancing a multi-year subdermal antiretroviral delivery implant towards clinical assessment for HIV pre-exposure prophylaxis, treatment and multipurpose prevention (AIDS 2026) - "Leveraging previous NanoDDI data demonstrating 29 months of sustained islatravir (ISL) delivery and 100% preventive efficacy in non-human primates (NHPs), we expanded the platform to deliver MK-8527, lenacapavir (LEN), bictegravir (BIC), tenofovir alafenamide (TAF), and levonorgestrel (LNG) for clinical translation in PrEP, treatment, and multipurpose prevention. NanoDDI provides multi-year long ARV delivery, maintaining protective levels and showing efficacy against SHIV in NHPs. This technology is now being advanced for first-in-human studies."

Clinical • First-in-human • Human Immunodeficiency Virus • Infectious Disease • Inflammation • NLRP3

In-clinic evaluation of a rapid, point-of-care test to detect relevant concentrations of HIV intgrase inhibitors (AIDS 2026) - "BACKGROUND: A rapid, point-of-care lateral flow assay (LFA) was developed for the detection of HIV integrate strand transfer inhibitors (INSTI): bictegravir (BIC), cabotegravir (CAB), and dolutegravir (DTG) in whole blood and plasma at clinically relevant concentrations. The INSTI LFA demonstrated very good performance by clinical care providers. The LFA interpretations were confirmed by HPLC with a slight difference for only one time point. Three out of 5 persons receiving CAB-LA had consistently low trough levels, although the impact on prevention is unknown."

Human Immunodeficiency Virus • Infectious Disease

Baseline and week 48 resistance analyses in the phase 3 ARTISTRY-1 study evaluating the bictegravir/lenacapavir single-tablet regimen (AIDS 2026) - "Three of these 4 participants resuppressed HIV-1 RNA <50 copies/mL later in the study while remaining on the same regimen, while the 4th participant resuppressed after a switch from SBR to BIC/emtricitabine/tenofovir alafenamide + subcutaneous LEN. BIC/LEN STR maintained high levels of virologic suppression despite high frequency of baseline RAMs at enrollment. No resistance to BIC/LEN was detected in 2 participants with virologic rebound. These data underscore the potential for BIC/LEN STR as an option for treatment optimization in people with HIV who are virologically suppressed on complex regimens."

P3 data • Human Immunodeficiency Virus • Infectious Disease

Integrase inhibitor drug resistance among people with confirmed virologic failure on INSTI-based ART in Uruguay, 2024: an analysis using programmatic HIV drug resistance data (AIDS 2026) - "The objective of this analysis was to describe the number of DTG- or bictegravir (BIC)-associated resistance cases identified among PLWH with confirmed VF receiving DTG- or BIC-containing regimens in Uruguay’s national ART program for whom GRT was requested prior to regimen change...Of the eight sequences with DTG/BIC resistance, all had resistance to lamivudine/emtricitabine, two had resistance to tenofovir, and two to zidovudine (Table)... Among PLWH in Uruguay with confirmed VF while receiving DTG- or BIC-containing regimens and with a quality-assured GRT result available, we identified 8 cases with predicted DTG/BIC resistance, with preserved susceptibility to protease inhibitors. Although these findings arise from a selected subset (GRT requested and successful sequencing) and cannot be interpreted as population-level frequency, the detection of multiple resistance cases warrants attention as a programmatic signal of emerging integrase inhibitor resistance...."

Human Immunodeficiency Virus • Infectious Disease

Body weight gain associated with tenofovir alafenamide and second-generation integrase strand transfer inhibitors: a meta-analysis of randomized controlled trials (AIDS 2026) - "Studies including efavirenz or zidovudine were excluded. Across RCTs, TAF was associated with modest but statistically significant weight gain compared with regimens with or without TDF. In contrast, no significant association was found with dolutegravir or bictegravir. The clinical relevance and long-term persistence of this effect remain uncertain."

Retrospective data • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Resistance profile of the HIV integrase strand transfer inhibitor GS-3242, a potent novel long-acting injectable INSTI in clinical development (AIDS 2026) - "BACKGROUND: The development of novel integrase strand transfer inhibitors (INSTIs) compatible with long-acting injectable lenacapavir dosing would provide an attractive treatment option for people with HIV-1 (PWH) who have challenges taking daily pills... GS-3242 retained potent activity, defined as an EC50 fold-change (FC) <2.5, against 71% of INSTI-resistant isolates tested, as compared to 82%, 62%, 53%, and 7% for bictegravir, dolutegravir, cabotegravir, and elvitegravir, respectively... GS-3242 exhibits a high resistance barrier and minimal cross-resistance within the INSTI class, a profile comparable to bictegravir. These observations support ongoing clinical evaluation of GS-3242 as a key component of a long-acting injectable treatment regimen for PWH."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Efficacy and safety of BIC/LEN single-tablet regimen in virologically suppressed people with HIV aged ≥65 years: week 48 analysis of participants in the Phase 3 portion of ARTISTRY-1 (AIDS 2026) - P2/3 | "It evaluated the efficacy and safety of switching to a single-tablet regimen (STR) combining bictegravir (BIC) and lenacapavir (LEN) among people with HIV (PWH) with virologic suppression (HIV-1 RNA <50 copies/mL) on complex ART. Over 48 weeks, BIC/LEN maintained high rates of virologic suppression in participants aged =65 years and was well tolerated, with low rates of discontinuation due to adverse events. These data support BIC/LEN as a treatment option for older PWH on complex regimens, with a higher burden of comorbidities and concomitant medications."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease • CD4

The impact of antiretroviral regimen on macrosomia: a retrospective analytic study on the use of dolutegravir and bictegravir in pregnancy (AIDS 2026) - "Preliminary findings suggest DTG exposure in pregnancy may increase odds of macrosomia. An independent association of first-trimester ART initiation with macrosomia is also noted. These observational results require confirmation in larger prospective studies before altering clinical guidance."

Retrospective data • Human Immunodeficiency Virus • Infectious Disease

Increased treatment satisfaction and maintained health-related quality of life among people with HIV switching to a bictegravir/lencapavir single-tablet regimen from complex regimens: results from the phase 3 ARTISTRY-1 trial (AIDS 2026) - P2/3 | "Treatment satisfaction increased from W4 and remained high through W48, while HRQoL remained stable in PWH who switched to BIC/LEN STR from CRs. These findings support BIC/LEN STR as a person-centered option for treatment optimization in PWH on CRs."

Clinical • HEOR • P3 data • Cardiovascular • Chronic Kidney Disease • Diabetes • Dyslipidemia • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease

Metabolic changes at 48 weeks in people with HIV and virologic suppression switching to single-tablet bictegravir/lenacapavir from complex antiretroviral regimens: results from the Phase 3 ARTISTRY-1 trial (AIDS 2026) - P2/3 | "Fasting lipid parameters, including LDL cholesterol, total cholesterol, and triglycerides, improved at W48 after switching from CRs to BIC/LEN, particularly in participants switching from PI-containing regimens. These results further support the use of BIC/LEN STR as a new option for treatment optimization for PWH with VS on a CR, including for those with multiple comorbidities including dyslipidemia."

P3 data • Cardiovascular • Chronic Kidney Disease • Diabetes • Dyslipidemia • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease