dolutegravir

Overview

Dolutegravir is an antiretroviral drug in the integrase strand transfer inhibitor class and is used in the treatment of HIV infection. By inhibiting HIV integrase, it blocks a key step in the viral life cycle: the insertion of viral DNA into the host genome. This mechanism makes dolutegravir a central component of modern antiretroviral therapy, including first-line regimens and switch strategies for people living with HIV.

Clinically, dolutegravir is used both as a standalone agent within combination therapy and in fixed-dose combinations such as dolutegravir/lamivudine and dolutegravir/abacavir/lamivudine. Recent research has continued to evaluate its effectiveness, tolerability, metabolic effects, and broader virologic or immunologic impacts in diverse populations, including treatment-naive adults, treatment-experienced patients, children and adolescents, and people receiving long-term post-marketing care.

Focus of Latest Publications

Recent publications on dolutegravir have focused on its role in antiretroviral therapy across multiple clinical settings, with particular attention to treatment switching, first-line regimen comparisons, pediatric dosing, and post-marketing safety. In treatment-experienced people with HIV-1, one real-world study examined switching from an INSTI-based triple-drug regimen to dolutegravir/lamivudine, reflecting ongoing interest in simplified maintenance therapy. Another Chinese cohort compared bictegravir/emtricitabine/tenofovir alafenamide with dolutegravir plus lamivudine as first-line regimens in ART-naive patients, reporting comparable virologic suppression over 24 months, similar weight changes, and similar cumulative metabolic abnormalities between groups. Although crude EGFR decline appeared more frequent with dolutegravir plus lamivudine, adjusted analyses did not show an independent association with renal decline.

Additional publications have addressed longer-term safety and effectiveness in routine practice and special populations. A 10-year post-marketing surveillance study in Japanese people living with HIV evaluated single-agent dolutegravir and the fixed-dose combination dolutegravir/abacavir/lamivudine, aiming to provide country-specific evidence on safety and effectiveness. In children with HIV, pharmacokinetic and safety data were assessed for dolutegravir dosing according to World Health Organization guidelines, including in those with tuberculosis coinfection. Related pediatric work also used population pharmacokinetic modeling to support a weight-tiered twice-daily dolutegravir dose for children with first-generation integrase strand transfer inhibitor resistance, predicting exposures within the therapeutic window and suggesting efficacy and safety comparable to adult experience.

Beyond HIV treatment, dolutegravir has also been studied in other viral and neurologic contexts. A phase 2 controlled trial evaluated dolutegravir in adults with human T-cell lymphotropic virus type 1 infection, assessing effects on proviral load and clinical neurological outcomes. In children and adolescents with HIV in Lesotho, investigators examined tolerability after programmatic transition from lopinavir/ritonavir-based therapy to dolutegravir-based ART, focusing on treatment satisfaction and potential side effects. Together, these studies highlight continued interest in dolutegravir as a versatile therapy with expanding evidence across adult, pediatric, and real-world settings.

Key Publications

May Efficacy and metabolic outcomes of switching from an INSTI-based triple-drug regimen to dolutegravir/lamivudine in treatment-experienced HIV-1-infected patients: a 48-week real-world study. (Annals of medicine, 2026, PMID 42124360): "Real-world data on switching from INSTI-based triple therapy to DTG/3TC in the Chinese population are lacking."
May Comparative safety and efficacy of BIC/FTC/TAF versus DTG+3TC in antiretroviral treatment-naive patients with HIV as first-line regimens: A real-world cohort study. (Bioscience trends, 2026, PMID 42036350): "While bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir plus lamivudine (DTG+3TC) are first-line regimens for treatment-naive people with HIV (PWH), long-term real-world head-to-head comparisons of their metabolic and renal outcomes remain limited."
Jun Safety and Effectiveness Analysis of Dolutegravir and Dolutegravir/Abacavir/Lamivudine in Japanese People Living with HIV: 10 years of Post-Marketing Surveillance. (Advances in therapy, 2026, PMID 41910934): "Dolutegravir (DTG), an integrase strand transfer inhibitor, is recommended as a first-line antiretroviral therapy (ART) for HIV/AIDS in international guidelines."
Jul Pharmacokinetics of Dolutegravir in Children With HIV With and Without Tuberculosis Coinfection Treated According to World Health Organization Dosing Guidelines. (Journal of acquired immune deficiency syndromes (1999), 2026, PMID 41855524): "The pharmacokinetics (PK) and safety of dolutegravir (DTG) in children with HIV (CWH) weighing at least 20 kg with and without tuberculosis (TB) treated according to World Health Organization dosing guidelines was examined."
May Dolutegravir Reduces Human T-Cell Lymphotropic Virus Type 1 Proviral Load and Improves Neurological Outcomes in a Phase 2 Controlled Trial. (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026, PMID 41834485): "We tested the effect of dolutegravir (DTG) on clinical outcomes and on HTLV-1 proviral load (PVL) in adults with HTLV-1 infection."
Feb Model-informed Dolutegravir Dose Selection in Pediatrics With First-generation INSTI Resistance. (The Pediatric infectious disease journal, 2026, PMID 41634915): "Twice-daily dosing of Dolutegravir is approved for adults with HIV and integrase strand transfer inhibitor resistance, but not for children."
May Tolerability of lopinavir versus dolutegravir in children and adolescents with HIV. (AIDS (London, England), 2026, PMID 41467721): "Children and adolescents with HIV previously taking ritonavir-boosted lopinavir (LPV/r)-based antiretroviral therapy (ART) were recently programmatically transitioned to dolutegravir (DTG)-based ART in Lesotho, southern Africa."