Tivicay (dolutegravir) / ViiV Healthcare - LARVOL DELTA

Unlocking the catalytic potential of transaminase: A two-decade evolution toward green and scalable biocatalysis. (PubMed, Bioorg Chem) - "Although these enzymes are now regularly used in industry for the synthesis of Sitagliptin, Mexiletine, Dolutegravir, etc., there is still scope for improvement involving challenges such as equilibrium thermodynamics, co-product removal, limited substrate tolerance, and scope. This review focuses on the detailed use of these enzymes in the pharmaceutical industry over the past 20 years and comprehensive approaches encompassing protein and equilibrium engineering, immobilization, continuous-flow biocatalysis, smart donors, and multi-enzymatic cascades, which have been and are being used for their evolution into the pharmaceutical industry."

Journal • Review

A cross-sectional study of viral load suppression among youth living with HIV in Namibia. (PubMed, South Afr J HIV Med) - "The VLS of 84.8% remains below the Joint United Nations Programme on HIV/AIDS target of 95%. There is a need for improvements in antiretroviral treatment programmes, particularly in scaling up dolutegravir-based regimens, enhancing adherence and peer support to end AIDS by 2030."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Comparative Analysis of Effectiveness of Dolutegravir-Based Regimen (TLD) vs. Efavirenz-Based Regimen (TLE) to Prevent Mother-to-Child Transmission of HIV. (PubMed, Cureus) - "The TLD regimen was associated with a trend towards lower MTCT of HIV compared to the TLE regimen. Thus, continued use of dolutegravir-based therapy is recommended to support national and global goals of eliminating new HIV infections among exposed infants."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial. (PubMed, BMJ Open) - P3 | "Participants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms. NCT06203132; EU-CT, 2023-508626-10-00."

Clinical protocol • Head-to-Head • Journal • P3 data • Cardiovascular • Diabetes • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders

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

Cooperation between HIV-1 integrase natural polymorphism K156N and 3'PPT mutations in dolutegravir monotherapy failure. (PubMed, J Antimicrob Chemother) - "These findings establish a direct functional relationship between natural variation in HIV-1 integrase and the emergence of 3'PPT mutations. People harbouring a virus with the K156N natural polymorphism may be predisposed to developing 3'PPT mutations upon failure with DTG. However, the clinical relevance of this association remains to be established."

Clinical • Journal • Monotherapy • Human Immunodeficiency Virus • Infectious Disease

Model-informed Dolutegravir Dose Selection in Pediatrics With First-generation INSTI Resistance. (PubMed, Pediatr Infect Dis J) - "Twice-daily dosing of Dolutegravir is approved for adults with HIV and integrase strand transfer inhibitor resistance, but not for children. Population pharmacokinetic modeling and simulations identified a weight-tiered twice-daily dose for children, predicted to yield dolutegravir exposures within the therapeutic window and provide similar efficacy and safety as seen in adults with HIV-1 and first-generation integrase strand transfer inhibitor resistance."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Effect of 1HP on dolutegravir concentrations (ESCMID Global 2026) - No abstract available

Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Limited emergence of dolutegravir-associated resistance mutations in HIV-1 across Africa (ESCMID Global 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV (clinicaltrials.gov) - P1/2 | N=144 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Initiation date: Dec 2025 ➔ May 2026

Trial initiation date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Association Between High Serum Alanine Aminotransferase to High Density Lipoprotein Cholesterol Ratio and Metabolic Syndrome among People Living with HIV on Dolutegravir-Based ART in South-Western Uganda. (PubMed, J Int Assoc Provid AIDS Care) - "ALT-to-HDL-C ratio at an optimal cutoff of 0.33 had a significant ability (AUC=0.820, 95%CI: 0.782 - 0.861) to differentiate between participants with MetS from those without MetS at a sensitivity of 92% and specificity of 54%.ConclusionHigher ALT-to-HDL-C ratio is potentially associated with MetS. Since both ALT and HDL-C are routine measurements in HIV Care, this warrants further studies on the potential of ALT-to-HDL-C ratio as a biomarker for MetS."

Journal • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Effect of weight reduction intervention vs standard of care among people living with HIV experiencing significant weight gain from dolutegravir-based regimens: a randomised controlled trial (WISH-DTG trial) (ESCMID Global 2026) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease

Letter to the editor: Mitochondrial DNA patterns among individuals living with HIV-1 on dolutegravir with hyperglycemia. (PubMed, J Acquir Immune Defic Syndr) - No abstract available

Journal • Diabetes • Human Immunodeficiency Virus • Infectious Disease

Human bioequivalence study of Dolutegravir Sodium Tablets (ChiCTR) - P=N/A | N=48 | Not yet recruiting | Sponsor: Deyang City People's Hospital; Deyang City People's Hospital

New trial • Human Immunodeficiency Virus • Infectious Disease

Clinical and Epidemiological Profile of Dolutegravir Use and Antiretroviral Resistance in Honduras. (PubMed, Health Educ Behav) - "High viral loads were observed in PLHIV receiving ART, regardless of the population type. Monitoring of antiretroviral resistance through phenotypic and genotypic testing is crucial for optimizing HIV treatment in Honduras."

Journal • Human Immunodeficiency Virus • Infectious Disease

Price as a challenge to the sustainability of the universal access policy to antiretrovirals in SUS: the case of dolutegravir. (PubMed, Cien Saude Colet) - "A major difference was found between national and international prices, even with the entry of generics into the Brazilian market; in 2023, the price of international generics was almost 12 times lower than that of the national procurement. The DTG case highlights the importance of monitoring prices, patent barriers, and local production, and of becoming familiar with the structure of production costs in order to negotiate fair prices and ensure the sustainability of the national pharmaceutical assistance policy."

Journal

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

First characterization of insertions in the HIV-1 integrase-coding region from people with HIV. (PubMed, J Antimicrob Chemother) - "Our study has revealed that the mutations observed in people living with HIV-1 do not confer resistance to anti-integrase compounds but are detrimental to viral replication."

Journal • Human Immunodeficiency Virus • Infectious Disease

HIV-1 3΄ polypurine tract mutations and integrase inhibitor resistance. (PubMed, AIDS) - "The WHO recommends the use of the integrase strand transfer inhibitor (INSTI) dolutegravir for first-line antiretroviral therapy (ART) in all adults living with HIV infection...We also discuss technical complications that arise as a result of uDNA expression in culture-based drug susceptibility assays, and critically evaluate the supporting evidence for current models of 3΄PPT mutant replication. We conclude by proposing additional studies to determine the role of the 3΄PPT in clinical HIV-1 drug resistance."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Pharmacoeconomic perspectives on HIV: integrating data for long-term treatment and prevention. (PubMed, Front Med (Lausanne)) - "Economic evaluations consistently show that high-impact interventions such as dolutegravir-based ART, targeted PrEP delivery, and voluntary medical male circumcision often fall within favorable cost-effectiveness thresholds, with typical incremental cost-effectiveness ratios (ICERs) ranging from as low as US $245 per DALY averted for PrEP in serodiscordant couples to US $174-2,800 per infection averted for VMMC. This review synthesizes the pharmacoeconomic evidence across treatment and prevention, highlights the value of integrating real-world costs and equity considerations, and underscores the need for robust, context-specific economic models to support sustainable HIV responses. Achieving long-term epidemic control will depend on addressing persistent indirect costs, improving access for marginalized populations, and aligning investments with interventions that demonstrate both clinical effectiveness and compelling economic value."

HEOR • Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Reversible Effects of Integrase Inhibitors on Newly Differentiated Adipocytes. (PubMed, Viruses) - "Thus, we examined the effects of the INSTI, Dolutegravir (DTG), on human adipose cells in vitro and the reversibility of these effects by switching to a protease inhibitor, Darunavir (DRV). Exposure to DTG during differentiation lowered triglyceride accumulation and adiponectin secretion without altering the expression of adipogenic markers. Thus, DTG exposure resulted in changes in adipocyte function consistent with the progression of metabolically adverse phenotypes, and these effects were reversible."

Journal • Human Immunodeficiency Virus • Infectious Disease • LEP

HIV persistence in tissues on dolutegravir-based therapy is not associated with resistance mutations to dolutegravir. (PubMed, Commun Med (Lond)) - "Despite ongoing transcriptional activity, persistence of HIV-1 in deep tissues is not associated with the selection of DRMs to dolutegravir on intact proviruses. Our results suggest that the detectable transcriptional activity stems predominantly from defective proviral DNA."

Journal • Human Immunodeficiency Virus • Infectious Disease

Repurposing of FDA-Approved Drugs to Identify Potential NS2B/NS3 Protease Inhibitors against Dengue Virus: In Silico and In Vitro Evaluation. (PubMed, Acta Trop) - "The three hits, Simeprevir, Saquinavir, and Dolutegravir of were subsequently evaluated for their cytotoxicity and antiviral activity in Vero cells, using MTT and infectivity-based assays, respectively. This study reflects on the potential of Dolutegravir as a dengue protease inhibitor and also indicates the efficacy of drug repurposing as a drug discovery strategy in the paradigm of antiviral discovery. Dolutegravir was identified as a potential candidate against DENV-2, and additional research is needed with molecular dynamics, mechanistic inquiry, and in vivo support investigation."

FDA event • Journal • Preclinical • Dengue Fever • Infectious Disease

Weight gain, body composition, and metabolic parameters of dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: an ancillary analysis of the ODYSSEY trial. (PubMed, Lancet Child Adolesc Health) - P2/3 | "Over approximately 5 years, indices defining excessive weight gain and central adiposity were similar with dolutegravir and other anchor drugs, and lipid and glycaemia profiles with dolutegravir were reassuring, providing supporting evidence for dolutegravir-based ART as the preferred treatment in children and adolescents."

Journal • Human Immunodeficiency Virus • Infectious Disease • Obesity