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

Treatment failure and associated factors among people living with HIV on second-line antiretroviral therapy in Zambia. (PubMed, Int Health) - "This study found that treatment failure among people living with HIV on second-line ART in Zambia remains a significant concern. To improve treatment outcomes and reduce HIV-associated morbidity and mortality in Zambia, strengthening routine viral load monitoring and adherence support initiatives is essential."

Journal • Human Immunodeficiency Virus • Infectious Disease

Efficacy of Dolutegravir Plus Lamivudine in People With TB/HIV Co-Infection Using a Rifampicin or Rifabutin-Based Regimen: A Retrospective Observational Case Series. (PubMed, Immun Inflamm Dis) - "This case series preliminarily validated the efficacy of DTG + 3TC when combined with rifabutin-based anti-TB regimens in patients with TB and HIV."

Journal • Observational data • Retrospective data • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8

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

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

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

Bone Health in People Living with HIV: From Pathophysiology to Practical Management. (PubMed, Infect Chemother) - "Tenofovir alafenamide is associated with improved renal and bone safety profiles. Recent data on integrase inhibitor-based or tenofovir-sparing regimens such as dolutegravir/lamivudine and long-acting cabotegravir plus rilpivirine suggest favorable effects on bon health...Optimizing ART selection to minimize bone toxicity is also an important consideration. As PLWH age, bone health must be integrated into comprehensive HIV care."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Renal Disease • Rheumatology

A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: ViiV Healthcare | N=550 ➔ 150 | Trial primary completion date: May 2027 ➔ Sep 2027 | Not yet recruiting ➔ Recruiting

Enrollment change • Enrollment open • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Inflammatory Biomarkers Decay After First-Line Antiretroviral Therapy Initiation With Dolutegravir/Lamivudine or Bictegravir/Emtricitabine/Tenofovir Alafenamide in Persons With HIV: A Substudy of a Randomized Clinical Trial. (PubMed, Health Sci Rep) - No abstract available

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

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=386 | Active, not recruiting | Sponsor: PENTA Foundation | Trial completion date: Sep 2025 ➔ Sep 2026

Head-to-Head • Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Changes in cardiovascular and metabolic risk scores after switching to DOR/3TC/TDF, DTG/3TC or BIC/FTC/TAF: results from a multicenter Italian cohort. (PubMed, AIDS) - "We found that switching to DOR/3TC/TDF was associated with more favorable changes in SCORE-2 and METS-IR compared to DTG/3TC and BIC/FTC/TAF."

Journal • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease

Real-world experience of Dolutegravir/Lamivudine for rapid initiation of antiretroviral therapy among treatment-naïve HIV-1-infected adults in China: a multicenter retrospective study. (PubMed, Front Med (Lausanne)) - "Throughout the 48-week follow-up period, changes in liver function, renal function, and lipid levels from baseline did not differ significantly between the two groups. Our study provides clinical evidence supporting the effectiveness and safety of DTG/3TC for rapid ART in treatment-naïve PLWH, with outcomes comparable to those of non-rapid initiation."

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

Comparative effectiveness of dolutegravir + lamivudine versus three-drug regimens in Swedish clinical practice: a nationwide study. (PubMed, J Int AIDS Soc) - "In this long-term, real-world, national cohort, switching to DTG+3TC was associated with low rates of VF and antiretroviral therapy resistance, indicating that eligible individuals can be switched to DTG+3TC without increased risk of VF."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Is Two Drug Therapy with Dolutegravir and Lamivudine an Appropriate Option for People with HIV and Historic Lamivudine Resistance? (PubMed, Clin Infect Dis) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Impact of Proviral-DNA M184V/I on 96-Week Outcomes of DTG/3TC Maintenance Therapy: Results from the VOLVER Clinical Trial. (PubMed, Clin Infect Dis) - P2 | "Proviral-DNA M184V/I detection was not associated with virological outcomes in participants receiving DTG/3TC supporting its limited clinical value in this specific setting."

Journal • 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