Dovato (dolutegravir/lamivudine) / ViiV Healthcare - LARVOL DELTA

No biomarker evidence of CNS injury after switching to dual therapy with Dolutegravir/Lamivudine in HIV (ESCMID Global 2026) - No abstract available

Biomarker • Human Immunodeficiency Virus • Infectious Disease

Lipid changes after switching from bictegravir/emtricitabine/tenofovir alafenamide to dolutegravir/lamivudine among people living with HIV: a multi-centre retrospective cohort study (ESCMID Global 2026) - No abstract available

Retrospective data • Human Immunodeficiency Virus • Infectious Disease

Changes in sleep quality following a switch of antiretroviral regimen from three to two drugs: a comparative study between dolutegravir/lamivudine (DTG+3TC) and dolutegravir/rilpivirine (DTG+RPV) (ESCMID Global 2026) - No abstract available

Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

The evolution of antiretroviral-associated drug-resistance mutations in an individual receiving dolutegravir/lamivudine. (PubMed, AIDS) - No abstract available

Journal

The Role of Prior HBV Infection on the Efficacy of 3TC/DTG as a Maintenance Therapy. (PubMed, Viruses) - "Lamivudine/dolutegravir (3TC/DTG) is an effective and well-tolerated antiretroviral regimen for most people with HIV (PWH) who are virologically suppressed; however, specific clinical characteristics, such as prior hepatitis B virus (HBV) exposure or archived resistance-associated mutations (RAMs), may influence the risk of virological failure (VF)...Given the limited number of virological events, these findings should be interpreted with caution. Nevertheless, they suggest that prior HBV exposure, particularly in the context of tenofovir discontinuation, may represent a clinically relevant factor when considering simplification to 3TC/DTG."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Pharmacokinetics of Dolutegravir, nucleoside analogues, and intracellular metabolites using plasma separation cards: A comparative analysis with traditional sampling methods in healthy volunteers. (PubMed, PLoS One) - P1 | "This study provides important insights into the elimination kinetics of NRTI, their intracellular metabolites and DTG. Plasma separation cards are a promising alternative for adherence monitoring, enabling simultaneous quantification of parent and intracellular moieties from a single sample. Differences in TFV-DP levels between TDF and TAF regimens, and DBS sampling method, underscore the need for matrix and regimen-specific interpretation to validate adherence benchmarks."

Clinical • Journal • PK/PD data

Efficacy of dolutegravir plus lamivudine in treatment-naïve people with HIV with baseline transmitted drug-resistance mutations. (PubMed, AIDS) - "DTG/3TC showed high efficacy in participants with tRAMs not affecting this regimen. The detection of such tRAMs did not compromise treatment outcomes in treatment-naïve individuals in this setting."

Journal • Human Immunodeficiency Virus • Infectious Disease

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

Trial design and enrolment characteristics of LATA (long-acting treatment in adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12... (PubMed, Contemp Clin Trials) - P3 | "LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing."

Head-to-Head • HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Effectiveness and safety of two-drug regimens containing an integrase inhibitor and reverse transcriptase inhibitor in a cohort of virologically suppressed people with HIV: Data from the COMBINE-2 study. (PubMed, HIV Med) - "Among suppressed people living with HIV in a real-world setting, INSTI+RTI two-drug regimens were highly effective and well tolerated over 96 weeks of follow-up."

Journal • Human Immunodeficiency Virus • Infectious Disease

Effectiveness and tolerability of dolutegravir/lamivudine in virologically suppressed people with HIV at 96 weeks in a multicentre cohort. (PubMed, HIV Med) - "Switching from 2NRTIs + PI or 2NRTIs + INSTI increased risk of VF compared with NRTIs+NNRTI DTG/3TC showed high effectiveness and tolerability at 96 weeks, with consistent outcomes across most subgroups. Previous VF reduced the likelihood of sustained VS."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Antiretroviral resistance in at least second-line HIV-1 treatment virologic failure with common InSTI-based regimens. (PubMed, AIDS) - "The overall prevalence of VF was low for all regimens. B/F/TAF was associated with a numerically lower prevalence of RAMs at VF compared with DTG/3TC and CAB + RPV. These observational findings highlight the importance of monitoring resistance patterns to optimize HIV treatment outcomes."

Journal • Human Immunodeficiency Virus • Infectious Disease

VOLITION: A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (clinicaltrials.gov) - P3 | N=171 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Sep 2026 ➔ Apr 2026

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (clinicaltrials.gov) - P2 | N=550 | Not yet recruiting | Sponsor: ViiV Healthcare | Trial completion date: Mar 2029 ➔ Nov 2028

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Dolutegravir/lamivudine versus bictegravir/ emtricitabine/tenofovir alafenamide fumarate: Real-world Assessment of effectiveness and weight Gain in naïve people living with HIV of Asian OrigiN (DRAGON). (PubMed, Int J Infect Dis) - "In this large real-world Asian cohort, BIC/FTC/TAF and DTG/3TC demonstrated comparable virological efficacy. However, TAF-containing regimen-particularly among individuals with lower CD4 counts and BMI-were associated with greater weight gain and attenuated increases in HDL cholesterol, highlighting the need for careful metabolic monitoring."

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

A model-based comparison of dose reduction strategies for fixed-dose dolutegravir-containing regimens. (PubMed, J Antimicrob Chemother) - "Safety and effectiveness of TLD dose reduction strategies can only be established in clinical studies and cannot be extrapolated from models. However, these models can inform regimen design to limit the window of opportunity for emergence of resistance, i.e. where viral replication occurs in the presence of appreciable drug concentrations."

Journal

Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents (clinicaltrials.gov) - P3 | N=32 | Completed | Sponsor: ViiV Healthcare | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ May 2025

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

Clarifying INSTINCT: Switching from DTG/3TC to BIC/FTC/TAF Shows Comparable Inflammatory and Weight Outcomes. (PubMed, Clin Infect Dis) - No abstract available

Journal

Toxoplasmic encephalitis unmasked during treatment for miliary tuberculosis in a patient with human immunodeficiency virus infection: a case report and literature review. (PubMed, Trop Med Health) - "TE can emerge during immune recovery at CD4 counts > 100 cells/µL when corticosteroid administration coincides with early ART. In patients receiving tuberculosis treatment who develop new brain lesions soon after ART, T. gondii polymerase chain reaction and prompt antiparasitic therapy should be pursued. Rifabutin permits concomitant use of dolutegravir, and TMP-SMX desensitization allows effective treatment and prophylaxis."

Journal • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Pain • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

Enhanced immune recovery with B/F/TAF compared with DTG/3TC in HIV patients: A prospective observational study. (PubMed, J Infect Public Health) - "These findings underscore the clinical advantages of the B/F/TAF regimen in promoting immune reconstitution among HIV patients. Future studies should investigate whether the observed differences in immune recovery translate into reduced morbidity and mortality rates over time."

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

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

Prevalence and risk factors of adverse drug events with dolutegravir-based regimens among Thai people living with HIV: a retrospective cohort study. (PubMed, AIDS Res Ther) - "Over half (53.86%) of patients on long-term DTG-based therapy experienced at least one ADE. Risk was significantly elevated in older adults, those with psychiatric illness, previous cryptococcosis, underweight status, or lower baseline eGFR. Healthcare providers should implement proactive monitoring and tailored management strategies for these high-risk patients to optimize ART safety and efficacy outcomes."

Adverse events • Journal • Retrospective data • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Mental Retardation • Psychiatry

Comparative Safety of B/F/TAF vs. Other Antiretroviral Therapy Regimens for Treatment-Experienced People With HIV-1: A Systematic Literature Review and Indirect Comparisons Using Multilevel Network Meta-Regression (ISPOR-EU 2025) - "Compared to B/F/TAF, ML-NMR results showed significantly greater decline in eGFR from baseline with dolutegravir/lamivudine (DTG/3TC) (mean difference [95% CrI]: -4.40 [-5.30, -3.51]) and DTG/abacavir/3TC (-3.60 [-5.74, -1.50]); change in eGFR was similar to DTG+F/TAF (-1.19 [-3.35, 1.06]). B/F/TAF demonstrated a more favorable renal safety profile compared to tenofovir-sparing DTG-based regimens, with similar all-cause discontinuation rates compared to other recommended ARTs, including DTG/3TC, and the investigational NRTI-sparing doravirine/islatravir. These findings support B/F/TAF as a renally safe and well-tolerated treatment option for TE PWH."

Clinical • Review • Human Immunodeficiency Virus • Infectious Disease

Two or Three? Clinical and Proteomic Perspectives on Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial HIV Treatment. (PubMed, Open Forum Infect Dis) - "Despite being used in patients with more advanced profiles, BIC/F/TAF effectively reduced systemic inflammation over 2 years. Both regimens attenuated inflammatory activity, though with distinct trajectories that may carry implications for immune recovery and long-term outcomes."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Management of HIV-related Progressive Multifocal Leukoencephalopathy: insights from metagenomic next-generation diagnosis and pembrolizumab-lenalidomide therapy, a case report (EACS 2025) - "The individual received intensified cART (dolutegravir, lamivudine, zidovudine, albuvirtide), a 21-day course of lenalidomide (25 mg/day), and four pembrolizumab infusions (100 mg/dose). This case emphasizes the diagnostic value of brain tissue mNGS for PML when CSF testing is inconclusive. The pembrolizumab-lenalidomide regimen showed tolerability and potential efficacy in restoring anti-JCV immunity, supported by improved clinical outcomes and immune markers. However, long-term benefits and mechanisms require validation in larger cohorts."

Case report • Clinical • IO biomarker • Human Immunodeficiency Virus • Infectious Disease • CD4 • CXCL8 • IL6