Tivicay (dolutegravir) / ViiV Healthcare - LARVOL DELTA

DOLPHIN Moms: Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV (clinicaltrials.gov) - P1/2 | N=252 | Active, not recruiting | Sponsor: The Aurum Institute NPC | Trial primary completion date: Dec 2024 ➔ Oct 2025 | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Dec 2025

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

Exploring the impact of baseline and on-treatment variables on durability of responses to fostemsavir through weeks 96 and 192 in the phase 3 BRIGHTE study. (PubMed, HIV Med) - "Multivariable analysis (MVA) identified several factors predictive of virologic response. No baseline factors were highly predictive of virologic failure at Weeks 96 or 192. Findings support the use of fostemsavir in diverse populations with MDR HIV-1."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • CD4

Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS) (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: The Aurum Institute NPC | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2024 ➔ Jul 2025

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

PSD04 Recurrent and persistent genital ulcers in an immunocompromised man: an uncommon presentation of herpes zoster. (PubMed, Br J Dermatol) - "He is currently on an oral daily dose of tenofovir 300 mg, lamivudine 300 mg, dolutegravir 50 mg, atazanavir 300 mg and ritonavir 100 mg...Complete resolution was obtained with a higher dose of aciclovir appropriate for VZV infection...This case was interesting because VZV as an aetiological agent for persistent genital ulcers has not previously been reported to the best of our knowledge. Clinical consideration of such a unique presentation of VZV is important for timely diagnosis and appropriate management, especially in immunocompromised individuals, to avoid possible complication of repeated treatment for HSV infection."

Journal • Cytomegalovirus Infection • Herpes Simplex • Herpes Zoster • Human Immunodeficiency Virus • Infectious Disease • Pain • Varicella Zoster • CD4

A model-based comparison of dose reduction strategies for fixed-dose dolutegravir-containing regimens. (PubMed, J Antimicrob Chemother) - "Safety and effectiveness of TLD dose reduction strategies can only be established in clinical studies and cannot be extrapolated from models. However, these models can inform regimen design to limit the window of opportunity for emergence of resistance, i.e. where viral replication occurs in the presence of appreciable drug concentrations."

Journal

HIV-1 genotyping and drug resistance mutations in Morocco (2009-2024): a systematic review addressing critical gaps in molecular surveillance. (PubMed, AIDS Rev) - "These findings underline the critical need to re-establish molecular surveillance in Morocco to capture post-2019 resistance dynamics under dolutegravir-based therapy. Strengthening genotypic monitoring and integrating resistance testing into clinical care will be pivotal to preserving long-term ART efficacy and achieving the UNAIDS 95-95-95 and HIV elimination targets by 2030."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Low burden of clinically relevant anaemia and thrombocytopenia among adolescents living with HIV receiving tenofovir/lamivudine plus dolutegravir: the CIPHER-ADOLA study in Cameroon. (PubMed, AIDS Res Ther) - "In the TLD era, anaemia remains common but generally mild, and thrombocytopenia is uncommon. Cytopenias were associated with unsuppressed viral load, with a stronger association for anaemia in females. These findings support programmatic targeted haemovigilance prioritising adolescents with unsuppressed viral load, particularly females, in settings where access to FBC testing is limited."

Journal • Anemia • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Thrombocytopenia • CD4

Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

Efficacy and safety of the HIV-1 maturation inhibitor GSK3640254 plus dolutegravir as a two-drug regimen in adults naive to antiretroviral therapy (DYNAMIC): 24-week results from a randomised phase 2b study. (PubMed, EClinicalMedicine) - P2 | "Participants were centrally randomised to receive once-daily oral GSK'254 100 (N = 22), 150 (N = 20), or 200 mg (N = 22) or lamivudine (3TC) 300 mg (double-blinded dose) (N = 21), all with open-label DTG 50 mg. GSK'254 plus DTG demonstrated generally comparable efficacy and safety to DTG plus 3TC, supporting potential further evaluation of maturation inhibitors for HIV-1 treatment. ViiV Healthcare."

Journal • P2b data • Human Immunodeficiency Virus • Infectious Disease • CD4

Efficacy and safety of the HIV-1 maturation inhibitor GSK3640254 plus two NRTIs in adults naive to antiretroviral therapy (DOMINO): 24-week results from a randomised phase 2b study. (PubMed, EClinicalMedicine) - P2 | "Participants were centrally randomised to receive once-daily oral GSK'254 100, 150, or 200 mg (double-blinded dose) or open-label dolutegravir (DTG) 50 mg, each with open-label NRTIs. GSK'254 plus two NRTIs demonstrated efficacy and safety with no treatment-emergent resistance, consistent with DTG plus two NRTIs, supporting potential further evaluation of maturation inhibitors. ViiV Healthcare."

Journal • P2b data • Human Immunodeficiency Virus • Infectious Disease • CD4

Machine learning guided virtual screening of FDA approved drugs targeting GSK-3β in Alzheimer's disease. (PubMed, Sci Rep) - "A HOMO-LUMO gap of 3.07 eV was found by density functional theory (DFT) analysis, indicating robust electron transport characteristics and balanced reactivity that are favorable for protein-ligand interaction. Together, these findings show that dolutegravir is a potential repurposable option against AD and how integrative ML, docking, MD, ADMET, and quantum chemistry techniques may speed up the identification of new drugs."

FDA event • Journal • Alzheimer's Disease • CNS Disorders • GSK3B

Proportion of depression and associated factors among HIV-positive youth attending antiretroviral therapy clinics at public hospitals in Gamo and Ari zones, South Ethiopia: A facility-based cross-sectional study. (PubMed, PLoS One) - "Depression is found to be a significant public health problem in the study settings. Poor psychosocial support, death of parents, substance use, advanced WHO clinical staging, and initiation on a non-DTG-based regimen were significant predictors of depression. Special attention should be given to those with poor psychosocial support, substance use, orphaned, and poor baseline clinical characteristics. Moreover, early identification and treatment of youths with depression during routine HIV care is essential to avert depression."

Journal • Observational data • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

Maternal and health worker preferences for paediatric antiretroviral formulations in neonates exposed to HIV. (PubMed, AIDS Care) - P1/2 | "Oral liquid formulations of zidovudine (ZDV) and nevirapine (NVP) are the main antiretrovirals (ARVs) for neonates born to mothers living with HIV, but they have limitations including poor palatability, short shelf-life, frequent dosing and supply challenges...Within the PETITE-DTG trial in South Africa (NCT05590325), evaluating the pharmacokinetics, safety and acceptability of novel dolutegravir (DTG) formulations in neonates, we explored ARV preferences among mothers (n = 28) and health workers (n = 6)...Transdermal patches were least favoured, with concerns regarding the comfort of neonates, impact of water exposure and effectiveness. These findings underscore strong support for innovative ARV options, emphasizing usability, ease of administration and reduced dosing frequency for the treatment of neonates."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Prevalence and Correlates of Metabolic Syndrome among People living with HIV receiving Dolutegravir-based ART in Northwest Ethiopia: A cross-sectional study. (PubMed, Int J Infect Dis) - "Overall, our study showed that MetS (27.7%) was relatively common among PLWH receiving DTG-based ART. Alcohol use, inadequate physical activity, BMI ≥25 kg/m2, and CD4 T-cell count ≥500 cell/mm3 were significantly associated with MetS. Routine clinical monitoring and assessment of all MetS components are recommended for PLWH receiving DTG-based ART, with particular attention to those who consume alcohol, have inadequate physical activity, elevated BMI, or higher CD4+ T-cell count."

Journal • Observational data • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4

Fixed-dose combination bictegravir-emtricitabine-tenofovir alafenamide twice-daily for treatment of HIV during rifampicin-based tuberculosis treatment (INSIGHT Study): a phase 2b, open-label, randomised non-comparative trial. (PubMed, Lancet HIV) - P2 | "The INSIGHT trial provides evidence to support the use of twice-daily bictegravir-emtricitabine-tenofovir alafenamide in people with HIV taking rifampicin-based tuberculosis treatment."

Journal • P2b data • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

Virological failure in a pediatric cohort on a dolutegravir based regimen: a retrospective study in northwest Ethiopia, 2017-2023. (PubMed, Front Pediatr) - "Despite potent DTG-based ARTs being introduced, virologic failure remains a concern in the study area. Special consideration should be directed towards children under the age of 10 years who are in the care of a guardian or neighbors, have lost both parents, are infected with opportunistic infections, have a poor adherence status, are experiencing adverse drug reactions, and anemic."

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

Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Brigham and Women's Hospital | Trial completion date: Mar 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Dec 2026

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

Dolutegravir-based therapy, diet, physical activity and weight gain: a 48-week prospective cohort in South Africa. (PubMed, J Acquir Immune Defic Syndr) - "Weight gain in people transitioning to TLD was not strongly linked to lifestyle. Interventions targeting diet and exercise may be unlikely to mitigate weight gain in this population."

Journal • Human Immunodeficiency Virus • Infectious Disease

Canadian guideline on HIV pre- and postexposure prophylaxis: 2025 update. (PubMed, CMAJ) - "Multiple safe, effective PrEP and PEP regimens are now available in Canada, making it increasingly possible to find suitable options for all who could benefit. Implementation of this guideline should expand access to biomedical HIV prevention interventions for those at risk and decrease the incidence of HIV in Canada."

Clinical guideline • Journal • Human Immunodeficiency Virus • Infectious Disease

Profile of HIV resistance to antiretrovirals in children born to HIV-positive mothers on dolutegravir in Togo from 2021 to 2023. (PubMed, Infect Dis Now) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

HIV drug resistance during antiretroviral therapy scale-up in Uganda, 2012-19: a population-based, longitudinal study. (PubMed, Lancet Microbe) - "Despite rising NNRTI resistance among pretreatment people with HIV, overall population prevalence of pretreatment HIV drug-resistant viraemia decreased due to increasing ART uptake and viral suppression. This finding underscores the crucial role of achieving and maintaining high ART coverage in reducing transmission of drug-resistant HIV. The high prevalence of mutations conferring resistance to components of first-line ART regimens among viraemic people with HIV is potentially concerning."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Differential adipose tissue remodeling and metabolic effects of dolutegravir and bictegravir: implications for HIV therapy. (PubMed, Biomed Pharmacother) - "Collectively, these findings demonstrate that DTG and BIC exert distinct yet overlapping influences on adipogenesis and WAT biology that might contribute to metabolic alterations in PWH. Understanding these mechanisms is essential for optimizing long-term HIV treatment strategies and mitigating the cardiometabolic risk associated with modern antiretroviral regimens."

Journal • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Virological outcomes and treatment retention in North Vietnam amidst transition to social insurance-based HIV services and dolutegravir-based regimens. (PubMed, Sci Rep) - "In conclusion, successful maintenance of virologic outcomes of ART and high treatment retention were observed amid various social and clinical changes in Vietnam. These real-world data support the national rollout of DTG."

Journal • Reimbursement • US reimbursement • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease

Virological and drug-resistance outcomes for people living with HIV initiating or switching to tenofovir, lamivudine, and dolutegravir in six PEPFAR-supported countries: a prospective cohort study. (PubMed, Lancet HIV) - "High rates of viral suppression in response to tenofovir-lamivudine-dolutegravir therapy in individuals who had suppression before switching support international treatment guidelines for this population. Findings on resistance mutations and tenofovir diphosphate concentrations suggest that incomplete adherence was a key factor in the suboptimal outcomes of people with virological failure at the time of switching treatment."

Journal • Human Immunodeficiency Virus • Infectious Disease

Weight Gain Among Children and Adolescents on Dolutegravir in Spain. (PubMed, J Pediatric Infect Dis Soc) - "DTG-based regimens increased BMI Z-scores without clear clinical relevance. Continuous monitoring of weight trajectories is essential to protect long-term cardiovascular health in this population."

Journal • Cardiovascular • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity