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

Effectiveness and safety of dual therapy with co-packaged dolutegravir and lamivudine compared to triple therapy as switching strategy in clinical practice. (PubMed, Rev Esp Quimioter) - "Co-packaged DTG/3TC demonstrated high persistence and virologic suppression rates with a favorable safety profile in clinical practice. Its effectiveness and safety were comparable to DTG-based triple therapy, supporting its use as a cost-effective alternative for treatment-experienced PLWH in resource-limited settings."

Journal • Human Immunodeficiency Virus • Infectious Disease

Metabolic Health Consequences of Switching to the Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir Plus Lamivudine Regimens in Virologically Suppressed People Living with HIV Aged > 40 Years: A Retrospective Real-World Study. (PubMed, Infect Drug Resist) - "This study aimed to evaluate the safety and metabolic health consequences of two switched regimens in a real-world setting among virologically suppressed PLWH previously treated with EFV/TDF/3TC. In this study, the B/F/TAF or DTG/3TC regimens are safe for virologically suppressed PLWH aged > 40 years. The transition to B/F/TAF demonstrated dual clinical benefits, significantly reducing hyperglycemia incidence while preserving renal function."

Journal • Real-world evidence • Retrospective data • Diabetes • Human Immunodeficiency Virus • Infectious Disease

VOGUE: A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy (clinicaltrials.gov) - P3 | N=481 | Active, not recruiting | Sponsor: ViiV Healthcare | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2026 ➔ Feb 2027 | Trial primary completion date: Nov 2025 ➔ Mar 2026

Enrollment closed • Head-to-Head • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • B2M • CST3

Health Economics Evaluation of Bictegravir/Emtricitabine/Tenofovir for a First-Line Treatment of HIV-1 Infection in China. (PubMed, Clinicoecon Outcomes Res) - "We developed a monthly-cycle Markov model to evaluate the economics of B/F/TAF versus dolutegravir/lamivudine (DTG/3TC) as a first-line ART for adult HIV-1 patients over a lifelong time. After adopting the B/F/TAF regimen in China, the cost-benefit and cost-effectiveness of HIV prevention and treatment have significantly improved. We should advocate for B/F/TAF as the first-line treatment to enhance HIV management."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

MODULO: Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully (clinicaltrials.gov) - P2 | N=408 | Recruiting | Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

A Stable Switch From Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) to Dolutegravir/Lamivudine (DTG/3TC) in the Absence of Historical Resistance Records: Results From the Switch to Dovato in Patients Suppressed on Biktarvy (SOUND) Cohort. (PubMed, Cureus) - " Results from SOUND support the efficacy and safety of switching to DTG/3TC for people living with HIV-1 who are virologically suppressed on B/FTC/TAF with unknown resistance history and may confer a weight advantage."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Viral kinetics among persons living with HIV (PLWH) on Dolutegravir-based antiretroviral Regimen: A retrospective and prospective analysis from selected HIV clinics in Ghana. (PubMed, PLoS One) - "The presence of virologic failures was of concern despite the high rates of viral suppression that DTG-based ART demonstrated. Undetectable viral suppression was higher than detectable viral suppression. Regular monitoring of viral kinetics, adherence, and comorbidities is essential to meeting the United Nations program on HIV/AIDS (UNAIDS) 95-95-95 targets and providing efficient therapeutic approaches for PLWH."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

TRANS-SWITCH: The Purpose of This Study is to Evaluate the Safety and Efficacy of a DTG + 3TC Based Dual Therapy as Switch Strategy Among ART-experienced TGW With HIV Receiving Suppresive Antiretroviral Therapy (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: UBATEC

New P4 trial • Human Immunodeficiency Virus • Infectious Disease

Efficacy of dolutegravir plus lamivudine in treatment-naïve people with HIV with baseline transmitted drug-resistance mutations: a subanalysis of the D2ARLING study (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Human Immunodeficiency Virus • Infectious Disease

The Impact of Immune Reconstitution Inflammatory Syndrome (IRIS) in HIV-Positive People with CD4 <200 Cells/mm³ Initiating Dolutegravir/Lamivudine Dual Therapy: DOLCE Study Findings (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Human Immunodeficiency Virus • Infectious Disease • CD4

Patient-Reported Outcomes among virally suppressed people living with HIV switching to dolutegravir/lamivudine vs. continuing bictegravir/emtricitabine/tenofovir alafenamide from the randomized DYAD study (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease

Week 96 Results from Dolutegravir/lamivudine versus bictegravir/ emtricitabine/tenofovir alafenamide fumarate: Real-world Assessment of weight Gain in people with HIV of Asian OrigiN (DRAGON) (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

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

The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in newly diagnosed people living with HIV (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Human Immunodeficiency Virus • Infectious Disease

Rapid virologic suppression with DTG/3TC facilitates early switch to CAB+RPV LA for treatment-naive people living with HIV: Suppression Phase outcomes from the Phase 3b VOLITION study (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

P3 data • Human Immunodeficiency Virus • Infectious Disease

Two-drug regimen with dolutegravir plus lamivudine for HIV treatment in children: a narrative review. (PubMed, New Microbiol) - "The review highlights the need for further research to support the use of 2DR in children and adolescents, particularly regarding long-term safety and efficacy. With increasing focus on quality of life and affordability, the integration of 2DR into pediatric HIV care may represent a critical advance in improving treatment outcomes for this vulnerable population and warrants continued clinical investigation and careful implementation into practice."

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

Immunosenescence markers in T- and NK-cells according to the CD4/CD8 ratio in successfully treated people living with HIV. (PubMed, Front Med (Lausanne)) - "We prospectively included PLWH on successful and stable ART (antiretroviral therapy) > 60 years old and receiving either BIC/FTC/TAF or DTG/3TC, in Nice, France. A CD4/CD8 cut-off value below 0.4 showed the strongest association with immune dysfunction, including NK+ cells. Such results could be useful for identifying patients requiring closer follow-up and screening for complications."

Journal • Cardiovascular • Human Immunodeficiency Virus • Hypertension • Infectious Disease • B3GAT1 • CD4 • CD8 • KLRG1

Efficacy and Safety of DTG/3TC in Treatment-naïve HIV-1 Infected Patients (clinicaltrials.gov) - P=N/A | N=200 | Enrolling by invitation | Sponsor: Chungnam National University Hospital

New trial • Human Immunodeficiency Virus • Infectious Disease

REVIVE: Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States (clinicaltrials.gov) - P=N/A | N=800 | Completed | Sponsor: Midway Specialty Care Center | Recruiting ➔ Completed | Trial primary completion date: Dec 2024 ➔ Apr 2025

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

COMPARATIVE CARDIOVASCULAR RISK IN HIV: A RETROSPECTIVE ANALYSIS OF DUAL VS TRIPLE THERAPY OUTCOMES - Joshua Chang (ACC 2025) - "Dolutegravir/Lamivudine (DTG/3TC) is the only dual ART approved for treatment-naive patients while Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) is a commonly used single-tablet, triple ART. We conducted a retrospective cohort study utilizing data from the TriNetX database, which covers 60 healthcare organizations providing real-world electronic health records. Our study contradicts Greenberg et al. (2021), which found no difference in cardiovascular events between dual vs triple therapy, and support Pulido et al. (2017) and Hung et al."

Retrospective data • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Human Immunodeficiency Virus • Infectious Disease • Ischemic stroke • Myocardial Infarction

Dolutegravir plus lamivudine downregulates cellular stress responses versus three-drug HIV Regimens. (PubMed, AIDS) - "Reducing NRTIs in DTG-based 2DR, particularly by omitting ABC or TAF/TDF, suggests decreased activation of stress response and immune-related pathways. Importantly, the functional capacity of circulating immune cells remains largely unchanged between 2DR and 3DR."

Journal • Human Immunodeficiency Virus • Infectious Disease • CXCL8 • IL17A • PMM2

D3 (Penta21): DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old (clinicaltrials.gov) - P2/3 | N=370 | Active, not recruiting | Sponsor: PENTA Foundation | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Metabolic Complications After Initiating BIC/FTC/TAF Versus DTG + 3TC in ART-naive Adults With Human Immunodeficiency Virus (HIV): A Multicenter Prospective Cohort Study. (PubMed, Clin Infect Dis) - "In this nationwide cohort of ART-naive individuals, initiation of BIC/FTC/TAF or DTG + 3TC resulted in similar modest increases in weight and lipid levels after 96 weeks, with no significant differences in metabolic outcomes or clinical events. These findings suggest that the metabolic profile of TAF should not be a deciding factor when choosing between 2- and 3-drug ART regimens."

Journal • Cardiovascular • Diabetes • Dyslipidemia • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders

Efficacy and Safety Outcomes in Adults Initiating Dolutegravir/Lamivudine With High Viral Load in the GEMINI-1/-2 and STAT Trials. (PubMed, Open Forum Infect Dis) - P3, P3b | "Clinical Trials Registration. NCT02831673/NCT02831764; NCT03945981."

Clinical • Journal

PASO-DOBLE: DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: (clinicaltrials.gov) - P4 | N=554 | Completed | Sponsor: Fundacion SEIMC-GESIDA | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

IDOLTIB: Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs (clinicaltrials.gov) - P3 | N=36 | Completed | Sponsor: University of Liege | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4