Tivicay (dolutegravir) / ViiV Healthcare - LARVOL DELTA

A real-time urine tenofovir assay improves drug adherence among people with HIV with prior virologic failure in a randomized controlled trial. (PubMed, Clin Infect Dis) - "UTRA-enhanced adherence support did not result in a significantly higher VS rate, but was associated with increased TFV-DP in DBS, in turn associated with lower CRP levels, suggesting that UTRA-enhanced adherence support improves long-term drug exposure and could also reduce HIV-associated inflammation."

Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CRP

Evaluation of antiretroviral regimen switching options in adults with HIV with sustained viral load non-suppression on dolutegravir, lamivudine, and tenofovir in eastern, central, southern, and western Africa: a modelling study. (PubMed, Lancet HIV) - "Introduction of HIV drug resistance testing for people with sustained viral load non-suppression on dolutegravir-based antiretroviral therapy is likely to be cost-effective. We suggest that exploratory planning for increased access and scale-up of high-quality, low-cost drug resistance testing for the region is undertaken."

Journal • Human Immunodeficiency Virus • Infectious Disease

A randomised trial to compare dolutegravir plus boosted darunavir versus recommended standard of care antiretroviral regimens in people with HIV-1, whose first-line non-nucleoside reverse transcriptase inhibitor therapy has failed: Final 96-week results of the D2EFT study. (PubMed, Clin Infect Dis) - "After 96 weeks of follow-up, DTG+DRV/r and DTG+TDF/XTC demonstrated virological superiority over DRV/r+2NRTIs after first-line NNRTI-failure. However, emerging dolutegravir resistance, which was observed only in individuals taking DTG+TDF/XTC, requires ongoing global surveillance."

Journal • Human Immunodeficiency Virus • Infectious Disease

The effect of dolutegravir on obstetrical outcomes among women living with HIV: A retrospective cohort study. (PubMed, J Obstet Gynaecol Res) - "DTG therapy is not associated with the risk of gestational hypertension nor preterm birth, and antenatal ART switching to DTG decreases the risk of growth restriction."

Journal • Retrospective data • Cardiovascular • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Obstetrics • Small for Gestational Age

Simplification with Boosted Protease Inhibitor-Based ART Versus Maintenance of Conventional ART: Results from a Five-Year Controlled Cohort. (PubMed, Viruses) - "Dolutegravir-based antiretroviral therapy (ART) simplification is increasingly common, although some patients cannot take this drug due to intolerance or drug resistance...No difference was observed in metabolic parameters. Based on our findings, ART simplification without INSTI has shown efficacy and safety comparable to maintenance of triple therapy even in the long term, and could be an option in these situations, which might be even more important in settings with limited options."

Journal • Human Immunodeficiency Virus • Infectious Disease

Dolutegravir in Pregnancy and Metabolic Health. (PubMed, MCN Am J Matern Child Nurs) - No abstract available

Journal

Bictegravir decreases expression of system L-amino acid transporters and inhibits leucine uptake activity in a human placental cell line. (PubMed, Biomed Pharmacother) - "Syncytialized BeWo cells were treated with atazanavir, darunavir, efavirenz, dolutegravir, raltegravir, bictegravir or cabotegravir for 24 h at Cmax and half Cmax therapeutic concentrations. Bictegravir, which has been recently added to perinatal treatment guidelines, was associated with downregulation of system L expression and function in BeWo cells. Further in vivo studies are warranted to confirm our findings."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

High prevalence of undisclosed antiretroviral drug use among individuals initiating HIV treatment in Gaborone, Botswana. (PubMed, Front Public Health) - "The ARV drug screening panel used detects 4 ARV drugs: Integrase Strand Transfer Inhibitor [INSTI]-dolutegravir (DTG), two non-nucleoside reverse transcriptase inhibitors [NNRTIs]-Efavirenz (EFV), Nevirapine (NVP), and a protease inhibitor [PI]-Lopinavir. We report a relatively high proportion of individuals with undisclosed drug use in their baseline plasma. Our results suggest the need to implement pre-drug screening for routine HIV incidence surveillance, including pre-treatment drug resistance evaluations before ART initiation."

Journal • Human Immunodeficiency Virus • Infectious Disease

Prevalence and factors associated with hyperuricemia among people living with HIV in Uganda: a cross-sectional study at a tertiary hospital in Uganda. (PubMed, Ther Adv Infect Dis) - "A total of 360 (92.3%) were on dolutegravir-based ART regimens, and 94.7% (306/323) were virally suppressed (viral load < 1000 copies/mL)...Alcohol use was identified as a potential modifiable risk factor for hyperuricemia. While alcohol cessation programs are needed to mitigate the risk of hyperuricemia, studies should explore the effect of hyperuricemia on lung function among PLWH."

Journal • Observational data • Addiction (Opioid and Alcohol) • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease

Dolutegravir Inhibits Autophagy In Vitro in a Mouse Blood-Brain Barrier Model. (PubMed, FASEB J) - "We demonstrated that DTG exposure at therapeutically relevant concentrations significantly increased Sqstm/p62, LC3B-I and LC3B-II protein expression, and downregulated autophagy-related genes Ulk1 and Atg14, suggesting an autophagy inhibition as a result of DTG treatment. This study provides new insights into the toxicological mechanisms of DTG and pathogenesis of DTG-associated brain complications."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

Prevalence and determinants of metabolic syndrome among adults living with HIV on first-line antiretroviral treatment in southern Ethiopia: a cross-sectional study. (PubMed, Ther Adv Chronic Dis) - "However, dolutegravir-based first-line regimens were not significantly associated with MetS (p=0.482 for DTG initiation, and p=0.34 for switching to DTG)...Therefore, routine screening of PLWH for components of MetS is essential to reduce the health risks associated with metabolic disorders. As most of the identified risk factors are modifiable, implementing lifestyle interventions is also imperative."

Journal • Observational data • Cardiovascular • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders

Predictors of treatment-emergent resistance to dolutegravir. (PubMed, Lancet HIV) - "HIV drug resistance does not emerge if selective drug pressure is not present, so some exposure to the ART regimen with virological failure is associated with higher rates of resistance than complete non-adherence. Detectable objective metrics of adherence (eg, ART drug concentrations in urine, plasma, dried blood spots, and hair) have been associated with high levels of viral resistance and can be used to triage who needs resistance testing the most."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Long-term efficacy and safety of fixed-dose dolutegravir-lamivudine in people with HIV: A retrospective study from India. (PubMed, Int J STD AIDS) - "Minor statistically significant variations in cholesterol, triglycerides, and creatinine levels were observed. Nine patients discontinued DTG/3TC due to AEs, primarily weight gain and gastrointestinal issues.ConclusionThe study demonstrates that the DTG/3TC FDC is an effective, safe, and well-tolerated regimen for maintaining virological suppression in real-world settings, supporting its viable use as a switching strategy in reducing drug exposure and managing long-term toxicity."

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

Virological treatment failure and associated factors among adults on first-line antiretroviral therapy in West Hararghe, Ethiopia. (PubMed, Front Public Health) - "Baseline undernutrition (AOR = 3.717: 1.051, 13.139), non-disclosure of serostatus (AOR = 4.453: 1.340, 14.793), early (≤ 30 days) ART initiation (AOR = 0.235: 0.064, 0.859), a history of missed daily ART doses (AOR = 3.156: 1.007, 9.891), and the use of a dolutegravir (DTG)-based regimen (AOR = 0.275: 0...Factors such as undernutrition, non-disclosure of serostatus, interruption of ART doses, and the use of DTG-based regimens were identified as significant predictors of virological treatment failure. Healthcare providers should focus on the accelerated initiation of ART (preferably with a DTG-based regimen) and supplemental nutritional therapy for patients with undernutrition."

Journal • Human Immunodeficiency Virus • Infectious Disease

Obstetric and newborn outcomes of mothers with and without HIV infection in Anaka general hospital in Northern Uganda. (PubMed, PLoS One) - "HIV infection was significantly associated with an increased risk of congenital anomalies, while other obstetric and neonatal outcomes were similar between HIV-positive and HIV-negative women. We recommend enhanced prenatal monitoring and early fetal screening among HIV-positive pregnant women on dolutegravir-based ART. Additionally, prospective studies are needed to better understand the contribution of dolutegravir and maternal factors to congenital anomalies in HIV-exposed pregnancies."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Obstetrics

HIV-associated nephropathy in a patient with undetectable viral load: a case report (ERA 2025) - "He was on a regimen of Bictegravir/Emtricitabine/Tenofovir Alafenamide and had additional comorbidities, including chronic lung disease and active smoking...He was diagnosed with influenza A pneumonia and was hospitalized due to hypoxemia, initiating oseltamivir treatment...Two days after admission, the patient developed bacterial pneumonia, and Piperacillin-tazobactam was initiated...ART was subsequently changed to Ritonavir/Darunavir and Dolutegravir... Nephropathy in HIV patients presents a multifactorial challenge. This case highlights the complexity of diagnosing HIVAN, emphasizing the importance of maintaining a high index of suspicion even in patients with undetectable or low HIV RNA levels, particularly in the presence of a history of nonadherence to ART and CD4+ T-cell counts below 200 cells/µL. We may hypothesize if the respiratory infection was the trigger for developing the disease, although the patient had prior de novo proteinuria."

Case report • Clinical • Chronic Kidney Disease • Fibrosis • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Influenza • Metabolic Disorders • Monoclonal Gammopathy • Nephrology • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • CD4

HIV drug resistance, early treatment outcomes and impact of guidelines compliance after protease inhibitor-based second-line failure in a dedicated resistance clinic in western Kenya: a retrospective cohort study. (PubMed, J Int AIDS Soc) - "We found high levels of drug resistance and early VF following PI-based second-line failure in Kenya. Treatment guidelines compliance and switches to third-line, even within guidelines recommendations, improved early viral outcomes. Findings highlight the vulnerability of PLWH with advanced ART experience and resistance profiles, and the importance of following guidelines and improving access to third-line and drug resistance testing, particularly in the new ART era."

Compliance • Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

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

Comparison of Efavirenz and Dolutegravir on Gut Microbiome and Gut Barrier Functions. (PubMed, ACS Omega) - "Furthermore, we identified a significant reduction in Lactobacillus in EFV-treated mice. Our results suggest that EFV and DTG may directly lead to gut dysbiosis and compromised gut barrier integrity, which could be targeted to prevent the side effects associated with EFV and DTG."

Journal • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Mental Retardation • Psychiatry • CD14 • TJP1

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Apr 2025 ➔ Jul 2025 | Completed ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Nail the diagnosis: Lamivudine-induced periungual pyogenic granulomas in PLHIV. (PubMed, IDCases) - "A 30-year-old male living with HIV presented with painful, progressively enlarging ulcero-proliferative lesions on the fingertips and toes, occurring 12 months after initiating highly active antiretroviral therapy (HAART) comprising Tenofovir disoproxil (300 mg), Lamivudine (300 mg), and Dolutegravir (50 mg)...Among ART agents, lamivudine and indinavir have been most frequently associated with periungual PGs...Periungual pyogenic granulomas can lead to significant discomfort and functional impairment. This case highlights the potential role of lamivudine as a causative agent and underscores the importance of ART modification in the effective management of drug-induced PG."

Journal • Angiosarcoma • Human Immunodeficiency Virus • Infectious Disease • Kaposi Sarcoma • Non-melanoma Skin Cancer • Oncology • Pain • Sarcoma • Solid Tumor

Sex differences in discontinuations due to side effects of second-generation integrase strand transfer inhibitors: a systematic review and meta-analysis. (PubMed, EClinicalMedicine) - "Further research is needed to determine whether these trends extend to other second-generation integrase strand transfer inhibitors, such as bictegravir and cabotegravir, and to better understand the specific side effects contributing to dolutegravir discontinuation in women. Additionally, the lack of sex-disaggregated reporting during our literature search identifies a need to prioritize sex/gender-based analyses in future research on antiretrovirals. None."

Adverse events • Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • Psychiatry

A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Kidney impairment in HIV: an insight into the burden and associated factors among adults on antiretroviral therapy in Zambia. A retrospective cross-sectional study. (PubMed, Ther Adv Infect Dis) - "After accounting for duration on ART, sex and blood pressure (systolic and diastolic), older age and being on a Dolutegravir (DTG) and tenofovir disoproxil fumarate/lamivudine (TDF/3TC) based regimen was positively associated with kidney impairment (adjusted odds ratio (aOR) 1.09; 95% CI: 1.05, 1.14, p < 0.001) and (aOR 2.44; 95% CI: 1.02, 5.79, p = 0.043), respectively. The prevalence of kidney impairment was common among adult PLWH and was significantly associated with older age and the use of a DTG and TDF/3TC-based regimen. There is a need to regularly monitor kidney function among people with HIV, especially older people who are on a DTG and TDF/3TC-based regimen."

Journal • Observational data • Retrospective data • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease

Lighthouse III: RolloverTreatment With Triumeq for People With ALS Following the Lighthouse II Trial (clinicaltrials.gov) - P3 | N=12 | Terminated | Sponsor: Macquarie University, Australia | N=70 ➔ 12 | Trial completion date: Dec 2026 ➔ Jun 2025 | Enrolling by invitation ➔ Terminated | Trial primary completion date: Dec 2026 ➔ Jun 2025; This is a rollover study following the Lighthouse II trial; it was scheduled to stop when the LH II trial was stopped/completed. The LH II trial has been prematurely terminated so, likewise, this study has also now been stopped.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Amyotrophic Lateral Sclerosis • CNS Disorders