Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare - LARVOL DELTA

Effects of combined antagonism of calcium channel/NMDAR overactivation and cART on mPFC neuron dysfunction induced by Coc self-administration and neuroHIV in rats (Neuroscience 2026) - "Rats will also receive daily repetitive s.c. injections of Triumeq and/or selective L-channel and NMDAR blockers (diltiazem and memantine, respectively) for 28 days (d). After 3-10d of withdrawal from the last SA, rats will be killed and prepared for defining the mechanism by which cortical neuron excitability is altered by Coc-SA, neuroHIV, cART, and/or blockade of L-channel/NMDAR overactivation. Our pilot study suggests that Coc-induced neuronal hyperactivity is worsened by chronic cART, and vice versa."

Preclinical • CNS Disorders • Cognitive Disorders

Tri-Combination Antiretroviral Therapy Induces Dose- and Time-Dependent Disruption of Intestinal Epithelial Barrier Function and Repair Responses in Human T84 Cells. (PubMed, J Xenobiot) - "However, this continuous oral dosing results in persistent exposure of the gastrointestinal tract (GIT), raising the need to investigate the effects of TC-ART (Tri-combinationL: Abacavir, Dolutegravir, Lamivudine-ART) on epithelial integrity, barrier recovery mechanisms, and surface barrier architecture...Together, these results support that TC-ART exposure alters epithelial responses in a way that may transition from early adaptation to signs of impaired recovery, leading to a gradual decline in mucosal barrier function. Such concentration- and time-dependent epithelial stress may contribute to gastrointestinal disturbances observed in treated HIV populations, emphasizing the need for incorporating intestinal epithelial health endpoints in drug safety evaluations."

Journal • Gastrointestinal Disorder • Human Immunodeficiency Virus • Infectious Disease • CTNNB1 • IL2 • IL6 • IL9 • MAPK1 • STAT3

CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: University College, London

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetics of abacavir and lamivudine in infants living with HIV with and without rifampicin co-treatment. (PubMed, J Antimicrob Chemother) - P2/3 | "Rifampicin co-treatment had minimal impact on abacavir and lamivudine pharmacokinetics in infants. Dose adjustment of abacavir/lamivudine is not required during rifampicin-containing tuberculosis treatment."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases • Tuberculosis

ARMED: an Australian cohort retrospective observational study to understand motivations for switching and clinical outcomes of individuals switching to dolutegravir/lamivudine. (PubMed, Sex Health) - "These real-world data support the use of DTG/3TC as a viable treatment strategy in this Australian population of individuals with HIV."

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

Bilateral Pathological Femoral Fractures Secondary to Long-Term Tenofovir Disoproxil Fumarate-Induced Osteomalacia in a Woman Living with HIV: A Case Report. (PubMed, Int Med Case Rep J) - "One year earlier, her regimen was switched to abacavir/lamivudine/dolutegravir due to emerging bone pain. Serum phosphate and alkaline phosphatase normalized, bone pain resolved, and no new fractures occurred, though full ambulation remained limited due to complications. This case demonstrates TDF as a reversible cause of severe osteomalacia and pathological fractures in long-term HIV treatment, emphasizing early recognition, regimen substitution to non-TDF agents, and proactive bone/mineral monitoring to prevent such outcomes in vulnerable populations."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Oncology • Orthopedics • Osteoporosis • Pain • Renal Disease

Cost–utility of bictegravir/emtricitabine/tenofovir alafenamide B/F/TAF as a switch therapy for adults living with HIV from the Chilean public health system perspective (AIDS 2026) - "Comparators reflected local practice: dolutegravir/abacavir/lamivudine (ABC/3TC/DTG), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and tenofovir disoproxil fumarate/emtricitabina plus darunavir/cobicistat (TDF/FTC + DRV/c). B/F/TAF is a cost-effective and dominant strategy compared to currently used TDF and ABC-based regimens in Chile. Despite the modeled economic performance of E/C/F/TAF, B/F/TAF represents the optimal switch option for long-term care, aligning with international standards for unboosted, high-genetic-barrier regimens."

Clinical • HEOR • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Orthopedics • CD4

Clinical, immunological, and virological outcomes following HIV acquisition through solid organ transplantation (SOT) in Rio de Janeiro, Brazil: a 12-month follow-up study (AIDS 2026) - "Sociodemographic characteristics K-A1 Age at the time of SOT: 61y Gender: cis woman Race/color: black K-A2 Age at the time of SOT: 62y Gender: cis woman Race/color: mixed (pardo) L-B Age at the time of SOT: 75y Gender: cis man Race/color: white K-B1 Age at the time of SOT: 49y Gender: cis woman Race/color: mixed (pardo) K-B2 Age at the time of SOT: 43y Gender: cis woman Race/color: mixed (pardo) Etiology of end-stage organ disease Arterial Hypertension (probable) Polycystic kidney disease Hepatitis B with hepatocellular carcinoma Systemic lupus erythematosus Type 1 diabetes mellitus Current immunosuppressive regimen Tacrolimus, sirolimus, prednisone Tacrolimus, sirolimus, prednisone Sirolimus Tacrolimus, sirolimus, prednisone Tacrolimus, sirolimus, prednisone Time from transplant to ART initiation (days) 264 264 138 138 141 ART scheme Lamivudine, dolutegravir; and Tenofovir alafenamide, lamivudine, dolutegravir Tenofovir alafenamide, lamivudine, dolutegravir Tenofovir..."

Clinical • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Focal Segmental Glomerulosclerosis • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Hepatitis B • Hepatocellular Cancer • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Metabolic Disorders • Nephrology • Polycystic Kidney Disease • Pulmonary Arterial Hypertension • Respiratory Diseases • Solid Organ Transplantation • Solid Tumor • Systemic Lupus Erythematosus • Transplantation • Tuberculosis • Type 1 Diabetes Mellitus • CD4 • CD8

Economic evaluation of first-line bictegravir/tenofovir alafenamide/emtricitabine (B/F/TAF) in people living with HIV (PLWHIV) with high risk of osteoporosis and renal dysfunction in Chile (AIDS 2026) - "Comparators reflected local practice: abacavir/lamivudine/dolutegravir (ABC/3TC/DTG), dolutegravir/tenofovir disoproxil fumarate/lamivudine (TDF/3TC/DTG), and elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). Positioning B/F/TAF as a first-line regimen for this population represents a cost-effective and, in some comparisons, dominant strategy. The economic evidence supports reevaluating the current prioritization of higher-toxicity regimens and the restriction of B/F/TAF to second-line use in order to optimize resource allocation and clinical outcomes."

Clinical • HEOR • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Osteoporosis • Renal Disease • Rheumatology

Moso: POC HIV Testing and Early DTG Use for Infants (clinicaltrials.gov) - P4 | N=900 | Active, not recruiting | Sponsor: Harvard School of Public Health (HSPH) | Trial completion date: Aug 2026 ➔ Dec 2026

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

Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-experienced people with HIV-1: a systematic literature review and network meta-analysis. (PubMed, J Comp Eff Res) - "Triglycerides changes favored B/F/TAF versus DTG/ABC/3TC (-15.01 [-29.18, -1.06]) and protease inhibitor (+ or /) b + 2 NRTIs (-24.48 [-41.60, -7.47]). Switching to or remaining on B/F/TAF in TE PWH was generally well tolerated and did not worsen lipid, renal or safety outcomes versus most other contemporary ART. Improvements in select lipid parameters and stable renal function, with low rates of adverse events and discontinuation, support B/F/TAF as a safe option for long-term management in TE PWH."

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

Evaluation of triumeq treatment on a TDP-43 mouse model of amyotrophic Lateral sclerosis. (PubMed, Sci Rep) - "This study investigates the effects of the antiretroviral treatment Triumeq on ALS disease that occurs through TDP-43 pathology by utilising the doxycycline (Dox)-suppressible rNLS8 TDP-43 expression mouse model. Triumeq treatment transiently and modestly improved motor function and influenced TDP-43 associated inflammatory gene expression in an ALS mouse model. These findings support the potential use of Triumeq in treating TDP-43-associated ALS and supports further investigation to better understand if the beneficial actions of Triumeq are via disruption of TDP-43-driven inflammation in ALS."

Journal • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • ATF4 • CXCL10 • IRF1 • TARDBP

ITACO_2780_OPBG_2022: The Italian Cohort (ITACO) and the Analytical Antiretroviral Treatment Interruption Italian Cohort (ITACO-ATI) study guided by molecular HIV-1 reservoir profiling (clinicaltrialsregister.eu) - P2/3 | N=61 | Completed | Sponsor: Ospedale Pediatrico Bambino Gesu | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Antiretroviral therapy persistence among treatment-experienced people with HIV and mental health disorders and/or substance use disorders in the USA (2017-2024): a retrospective cohort study. (PubMed, J Comp Eff Res) - "Materials & In this retrospective cohort study of claims from the Optum Research Database, nonpersistence (i.e., discontinuation, switch, add-on or death) was assessed in treatment-experienced PWH who switched to or restarted an antiretroviral therapy regimen of interest (i.e., bictegravir [B]/emtricitabine [F]/tenofovir alafenamide [TAF], dolutegravir [DTG]/lamivudine [3TC], DTG/abacavir [ABC]/3TC, DTG + F/TAF, DTG + F/tenofovir disoproxil fumarate [TDF] or cabotegravir + rilpivirine) from 1 July 2017 to 30 November 2023. Compared with B/F/TAF, nonpersistence risk was greater with DTG/3TC, DTG/ABC/3TC, DTG + F/TAF and DTG + F/TDF in the MHD/SUD (all p < 0.05) and PDC < 85% (all p < 0.05 except DTG/3TC) groups. These results indicate that B/F/TAF may offer greater likelihood of persistence and emphasize the importance of regimen selection to optimize outcomes in..."

Journal • Retrospective data • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Psychiatry

Safety and Effectiveness Analysis of Dolutegravir and Dolutegravir/Abacavir/Lamivudine in Japanese People Living with HIV: 10 years of Post-Marketing Surveillance. (PubMed, Adv Ther) - "This 10-year post-marketing surveillance confirms the long-term safety and effectiveness of single-agent DTG and DTG/ABC/3TC in Japanese PLHIV. No new safety concerns emerged over the 10-year surveillance period, further supporting their established safety profiles and reinforcing their continued role as key therapeutic options in routine clinical practice."

Journal • P4 data • Human Immunodeficiency Virus • Infectious Disease • CD4

Exposure to Frontline Antiretroviral Dolutegravir Disrupts Oligodendrocyte Development Across Differentiation Stages. (PubMed, ASN Neuro) - "Previous studies have shown that antiretrovirals impair oligodendrocyte (OL) differentiation leading us to hypothesize that OL maturation might be inhibited by exposure to a frontline ART drug cocktail (Triumeq®) prescribed during pregnancy containing dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC). Although we found that DTG robustly activated the integrated stress response (ISR), attempted rescue experiments showed that DTG primarily inhibits OL maturation independently of the ISR. Collectively, our novel data on DTG underscore the necessity of investigating how ART drugs that are administered during pregnancy and cross the placental barrier can affect fetal CNS development."

Journal • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Solid Tumor

Gestational and lactational exposure to HIV tri-combination therapy induces sex- and dose-dependent changes in inflammatory cytokine profiles, intestinal permeability, and villi morphology in adult rat offspring. (PubMed, Front Immunol) - "Our previous work has demonstrated dose-dependent changes in the fecal and mucosa-associated microbiome of adult rat offspring perinatally exposed to TC-ART (tri-combination ART: dolutegravir, abacavir, and lamivudine). In females, while some intestinal permeability genes were downregulated, the upregulation of other permeability genes suggests a compensatory mechanism to maintain the intestinal barrier function, indicating an overall milder response to TC-ART. These findings suggest that perinatal exposure to TC-ART may have differential impacts on intestinal health, with females exhibiting a more adaptive response compared to males, highlighting the need for sex-specific considerations in evaluating long-term effects of ART."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease • CSF1 • IL12A • IL17A • IL5 • IL7

Baseline resistance mutations and virological response to dolutegravir in treatment-naïve patients: a multicentre NGS study. (PubMed, J Antimicrob Chemother) - "Our findings indicate that pre-existing IN and RT DRM, including low-abundance and secondary/polymorphic variants, did not compromise the virological efficacy of dolutegravir-based triple therapy in ART-naïve individuals, supporting the high resistance barrier of dolutegravir and the lack of need for baseline resistance testing."

Journal • Next-generation sequencing • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

FLAIR: Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (clinicaltrials.gov) - P3 | N=631 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2025 ➔ Dec 2029

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Alternative Administration of Antiretroviral Therapy in People with HIV Unable to Swallow: A Scoping Review. (PubMed, HIV AIDS (Auckl)) - "Key findings included: (1) Bictegravir/emtricitabine/tenofovir alafenamide was associated with viral suppression when dissolved and administered enterally; (2) Dolutegravir/abacavir/lamivudine crushed via nasogastric tube was associated with viral suppression within 10 months; (3) Dolutegravir requires separation from enteral feeds containing polyvalent cations to avoid chelation and reduced absorption. Alternative administration ART, namely INSTI-based regimens and NRTIs, may help maintain viral suppression in these settings, provided that drug-specific pharmacokinetic considerations and enteral feeding interactions are addressed. Further prospective studies with therapeutic drug monitoring are needed to establish standardized protocols."

Journal • Review • Gastrointestinal Disorder • Human Immunodeficiency Virus • Infectious Disease

Real-world use of second-generation integrase strand transfer inhibitors (INSTI) as switch therapy in the prospective ANRS-CO3-AquiVIH-NA cohort. (PubMed, HIV Med) - "In this real-world cohort, treatment persistence 18 months after therapy switch was similar for B/F/TAF, DTG/RPV and DTG/3TC, but significantly lower for DTG/3TC/ABC. All regimens maintained high levels of viral suppression. Furthermore, the cohort illustrates the disease burden experienced by middle-aged and elderly people living with HIV and highlights the importance of adapting ART to the specific needs of this population."

Journal • Real-world evidence • Cardiovascular • Chronic Kidney Disease • Diabetes • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease

Antiretroviral Treatment Switch Among Treatment-Experienced People with HIV. (PubMed, J Health Econ Outcomes Res) - "PWH who switched to an ART regimen of interest (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF], dolutegravir/lamivudine, dolutegravir/abacavir/lamivudine, dolutegravir + emtricitabine/tenofovir alafenamide, dolutegravir + emtricitabine/tenofovir disoproxil fumarate, and cabotegravir + rilpivirine) between July 1, 2017, and November 30, 2023, were included. This analysis showed that PWH taking B/F/TAF, both in the overall population and the Medicare Advantage subset, maintained their initial treatment regimen longer and had a reduced risk of treatment switch/add-on compared with the other regimens of interest. These findings suggest that B/F/TAF has a lower likelihood of treatment switch/add-on for treatment-experienced PWH than other current ART regimens."

Journal • Human Immunodeficiency Virus • Infectious Disease

Antiretroviral therapy switch among Medicare beneficiaries with HIV. (PubMed, J Manag Care Spec Pharm) - "ART regimens included bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), dolutegravir/lamivudine (DTG/3TC), dolutegravir/abacavir/lamivudine (DTG/ABC/3TC), or multitablet regimens (MTRs; dolutegravir + emtricitabine/tenofovir alafenamide [DTG + F/TAF] or dolutegravir + emtricitabine/tenofovir disoproxil fumarate [DTG + F/TDF]). Medicare-insured PWH indexed on B/F/TAF had lower risk of treatment switch compared with other ART regimens, both overall and in the subgroup with mental health and/or substance use disorders. These findings may inform targeted strategies for optimal treatment selection for PWH."

Journal • Medicare • Reimbursement • US reimbursement • Human Immunodeficiency Virus • Infectious Disease

Longitudinal changes in circulating biomarkers from baseline to week 48 in treatment-Naïve people living with HIV initiating integrase inhibitor-based antiretroviral therapy. (PubMed, PLoS One) - "All INSTI-based regimens led to immune restoration, but modest differences in biomarker trajectories suggest distinct immunomodulatory effects. The clinical relevance of these differences remains unclear and warrants further study to assess their role in long-term comorbidity risk."

Biomarker • IO biomarker • Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD163 • CD40 • ICAM1 • IL10 • LEP

Real-World Persistence After Starting Bictegravir- or Dolutegravir-Based Regimens Among Adults Aged ≥50 Years with HIV in the United States. (PubMed, Drugs Aging) - "B/F/TAF was associated with higher persistence than other ART regimens among older PWH. Findings underscore the importance of tailored ART selection to address the unique challenges faced by older PWH."

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