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

2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial (clinicaltrials.gov) - P4 | N=134 | Completed | Sponsor: University Hospital, Ghent | Recruiting ➔ Completed | Trial completion date: Apr 2027 ➔ Mar 2026 | Trial primary completion date: Jun 2026 ➔ Mar 2026

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

Virologic outcomes among people living with HIV on dolutegravir-based antiretroviral therapy in Kenya, 2018-2024: a comparison retrospective longitudinal analysis. (PubMed, Lancet Reg Health Afr) - "Long-term virologic outcome data of tenofovir fumarate disoproxil-lamivudine-dolutegravir (TLD) versus tenofovir fumarate disoproxil-lamivudine-efavirenz (TLE) from resource-constrained settings remain limited...No specific funding was received for the analysis. HIV program support was provided by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the CDC."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

PREDUAL: Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women (clinicaltrials.gov) - P4 | N=210 | Recruiting | Sponsor: Fundación Huésped | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jul 2028 ➔ Oct 2028

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

Dolutegravir + Lamivudine in People with HIV-1 Who Are Naive to Antiretroviral Therapy with Baseline Viral Load ≥500,000 c/mL: Systematic Literature Review and Meta-Analysis of Real-World Evidence (IDWeek 2026) - No abstract available

HEOR • Real-world • Real-world evidence • Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease

Virologic Outcomes by ART Initiation Timing: Subanalysis of the REVIVE Study (DTG/3TC and BIC/F/TAF) (IDWeek 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Virologic Outcomes of Individuals Prescribed Dolutegravir/Lamivudine After an Oral Antiretroviral Therapy Treatment Interruption: Findings from the OPERA Cohort (IDWeek 2026) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease

Narrative Review of Two-Drug Regimens in Modern HIV Care: Driving Innovation, Flexibility, and Quality of Life. (PubMed, Infect Dis Ther) - "Dolutegravir/lamivudine, dolutegravir/rilpivirine and long-acting cabotegravir/rilpivirine are the regimens studied the most, supported by randomised trials and real-world evidence. Long-acting injectable strategies may be particularly valuable for individuals who face challenges with daily oral adherence or treatment-related stigma. This narrative review summarizes current evidence on the role of oral and injectable 2DRs in key domains including innovation, flexibility, tolerability, adherence and quality of life, while discussing current limitations and future perspectives."

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

Antiretroviral therapy regimens initiated during pregnancy and risks of adverse perinatal outcomes. (PubMed, AIDS) - "Our observational study findings for the composite outcome were comparable to the IMPAACT 2010/VESTED trial in a real-world programmatic setting and enabled evaluation of additional regimen and broader set of outcomes. In settings where randomized trial data are limited, well designed observational emulations of trials using nonrandomized data can provide informative evidence. As Botswana expands use of TAF in pregnancy, these results provide reassuring evidence supporting its safety."

Adverse events • Journal • Human Immunodeficiency Virus • Infectious Disease • Small for Gestational Age

A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: ViiV Healthcare

New P2 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

VOLVER: Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine (clinicaltrials.gov) - P2 | N=167 | Completed | Sponsor: Fundacion SEIMC-GESIDA | N=121 ➔ 167

Enrollment change • Human Immunodeficiency Virus • Infectious Disease • CD4

Evaluation of Real-World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir/Lamivudine Fixed-Dose Combination in Treatment-Naive and Pretreated People Living With HIV Who are Virologically Suppressed, in Routine Clinical Care in France: Results From the CARAVEL Study. (PubMed, Open Forum Infect Dis) - "The average change in body weight over the follow-up was +2.0 (±6.0) (P = .13) kg in TN-PLWH and -0.2 (±6.5) (P = .78) kg in PT-PLWH, among participants with available data (N = 156). These real-world data demonstrated high virological success and good safety after up to 3 years on DTG/3TC in both TN-PLWH and PT-PLWH populations."

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

Effectiveness of dolutegravir/lamivudine versus bictegravir/emtricitabine/tenofovir alafenamide in people with HIV with very high viral load (≥500 000 copies/mL). (PubMed, J Antimicrob Chemother) - "In ART-naive PWH with HIV-RNA ≥500 000 cp/mL and CD4+ ≥200/mm3, including those with PHI, DTG/3TC and BIC/FTC/TAF showed similar effectiveness and comparable safety profiles at Week 48."

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

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

VOGUE: Noninferior Efficacy of Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-1 Naive to Treatment. (PubMed, Open Forum Infect Dis) - P3 | "These findings establish DTG/3TC as an effective and simplified initial ART regimen across a broad clinical spectrum. Clinical trial registration:  ClinicalTrials.gov identification number, NCT05979311; URL, https://clinicaltrials.gov/study/NCT05979311."

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

Efficacy and Safety of Albuvirtide Plus Dolutegravir or Dolutegravir/Lamivudine in Hospitalized People with Advanced AIDS: A Retrospective Real-World Study. (PubMed, AIDS Res Hum Retroviruses) - "No significant differences in efficacy or safety were found between the ABT + DTG and ABT + DTG/3TC regimens. In a real-world setting, ABT-based regimens containing DTG (with or without 3TC) demonstrated high efficacy and excellent safety in hospitalized people with advanced AIDS, supporting its use in this difficult-to-treat population."

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

Challenges in Porphyria diagnosis and management: When variegate Porphyria meets HIV. (PubMed, Mol Genet Metab) - "We present the case of a 32-year-old woman with HIV receiving antiretroviral therapy (dolutegravir, lamivudine, and ritonavir) who had generalized seizures, psychosis, and polyneuropathy, initially interpreted as secondary to infection...Despite treatment with methylprednisolone and intravenous immunoglobulins, her health worsened, requiring intensive care and extended mechanical ventilation...This case shows the complex interactions between genetic predisposition, environmental factors, and comorbidities in VP, emphasizing the importance of genetic and biochemical testing for accurate diagnosis, hemin administration during acute attacks, and careful medication review. Clinicians should remain vigilant about interactions between antiretroviral therapy and porphyria when treating HIV-positive patients with suspected or confirmed Acute Hepatic Porphyria."

Journal • CNS Disorders • Critical care • Epilepsy • Genetic Disorders • Hematological Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Metabolic Disorders • Pain • Psychiatry • PPOX

Access to quality affordable WHO-recommended non-TLD first-line HIV treatment – TAF-based, dual oral, and long-acting – regimens in LMICs: mapping the landscape of MPP-licensed products (AIDS 2026) - " Generic TAF-based products (TAF/FTC/DTG 25/200/50 mg and TAF/3TC/DTG 25/300/50 mg tablets), dual DTG-based regimen DTG/3TC (50/300 mg), and CAB-LA (200 mg/mL) + RPV-LA (300 mg/mL) are all potentially accessible in a large number of LMICs (Figure 1-A,B,C). This data shows that, despite limited progress to date, TAF-based and dual oral regimens could be implemented in many more LMICs – covering most of Africa and many countries in Asia, Eastern Europe, Latin America, and the Caribbean – at generic-induced affordable prices, which should further reduce as demand increases. Once developed, CAB-LA+RPV-LA could also be widely accessible."

Clinical • Human Immunodeficiency Virus • Infectious Disease

In VOGUE: DTG/3TC Demonstrates Non-Inferior Efficacy to BIC/FTC/TAF as First-Line Treatment (AIDS 2026) - P3 | "In individuals naive to treatment, DTG/3TC is non-inferior to BIC/FTC/TAF through Week 48, with no treatment-emergent resistance. In a study population that includes high VLs and low CD4+ cell counts at baseline, these findings demonstrate DTG/3TC as an effective and simplified initial ART regimen."

Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • CD4

The impact of archived HIV-1 drug resistance on maintenance of virologic suppression through week 48 in children aged 2 to <15 years receiving DTG/3TC: PENTA-21 intensive pharmacokinetic sub-study (AIDS 2026) - "In the PENTA-21 nested PK sub-study, high VS rates were maintained through W48 regardless of archived major RAMs. Pre-existing M184V/I appeared to have limited impact on VS after switching to DTG/3TC, although large sample sizes and longer follow-up are needed. Consistent with TANGO and SALSA studies in adults, these data support the potency and high genetic barrier of DTG/3TC as maintenance therapy in pediatric populations with treatment experience and VS, including in resource-limited settings."

Clinical • Late-breaking abstract • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Real-life experience with dolutegravir and lamivudine as treatment switch in a older population living with HIV (AIDS 2026) - "Although DTG/3TC as dual therapy showed sustained long-term virological efficacy and immunological stability in older PLWH, LLV/virological failures were associated with lower pre-switch CD4/CD8 ratios. This parameter may represent a clinically relevant predictor of virological risk and should be considered in future discussions on ART simplification."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Trends in hepatitis B serological profiles among older people living with HIV in the era of dual antiretroviral therapy (AIDS 2026) - "Changes in all HBV serological profiles are illustrated in Figure 2.Three participants were identified as anti-HBs-/anti-HBc+/HBsAg+; two were receiving DTG/3TC plus entecavir with sustained HBV suppression, and one experienced HBV reactivation after the switch. The high proportion of participants susceptible or with undocumented HBV serological profiles reveals a critical gap. Verifying HBV serology before antiretroviral regimen simplification is critical for patient safety. These results support making this assessment a routine requirement and point to the need for continued medical education and strengthened HBV monitoring/vaccination in older PLWH."

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

Renal outcomes of tenofovir alafenamide versus tenofovir-free regimens in antiretroviral-naïve people with HIV (AIDS 2026) - "We included adult antiretroviral-naïve PWH initiating TAF/emtricitabine-based regimens combined with bictegravir or dolutegravir, or DTG/3T. In antiretroviral-naïve PWH with preserved baseline renal function, TAF-based regimens were not associated with worse renal outcomes compared with DTG/3TC. These findings support the renal safety of TAF as comparable to tenofovir-free regimens in routine clinical practice."

Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • CD4

No reactivation of hepatitis B in African patients on a tenofovir free regimen for the treatment of HIV: results from the switch to DTG/3TC (Sungura) study (AIDS 2026) - P3 | " The Sungura study (NCT06444620) is a phase 3 single arm clinical trial at multiple sites in Kenya enrolling participants aged =60 years, with VL <50 copies/ml on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). The absence of HBV reactivation is reassuring for the use of tenofovir sparing, two drug regimens in PLWH with prior hepatitis B exposure. Efforts to provide HBV vaccination should continue."

Clinical • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Real-world outcomes of long-acting cabotegravir plus rilpivirine in virally suppressed people with HIV in south China (AIDS 2026) - "Prior regimens mainly included BIC/TAF/FTC (57.6%) and DTG/3TC (28.8%). In this multicenter real-world cohort from South China, CAB+RPV LA demonstrated excellent short-term effectiveness, safety, and high patient acceptance, providing important Asian real-world evidence supporting direct-to-injection long-acting ART."

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

Four-year survival outcomes on dolutegravir-based antiretroviral therapy from a large-scale programmatic implementation and observational cohort study, India, 2021 to 2025 (AIDS 2026) - "At DTG transition, 82% of treatment-experienced PWH were virally suppressed, and 97.7% received tenofovir disoproxil fumerate + lamivudine + dolutegravir. In this large programmatic cohort, DTG-based ART was associated with high four-year survival compared to the non DTG containing regimens. Unsuppressed viral load IS key predictor of poorer survival, underscoring the importance of clinical monitoring and sustained viral suppression."

Observational data • Human Immunodeficiency Virus • Infectious Disease • CD4