Tivicay (dolutegravir) / ViiV Healthcare 
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  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Dolutegravir Resistance in African Programmatic Settings Among Patients With Failure of Dolutegravir-based ART. (Pubmed Central) -  Jul 1, 2024   
    Prospective research is needed to understand the scope of the problem, identify additional risk factors, and determine best management. In the short term, for most patients with dolutegravir resistance and prior non-nucleoside reverse transcriptase inhibitor exposure, the best option will be a timely switch to a regimen anchored by a boosted protease inhibitor, with a high genetic barrier to resistance.
  • ||||||||||  Opdivo (nivolumab) / BMS, Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Diarrhea as the Initial Presentation in a Patient With HIV Diagnosed With Hodgkin's Lymphoma. (Pubmed Central) -  Jul 1, 2024   
    In the short term, for most patients with dolutegravir resistance and prior non-nucleoside reverse transcriptase inhibitor exposure, the best option will be a timely switch to a regimen anchored by a boosted protease inhibitor, with a high genetic barrier to resistance. Here we discuss
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical data, Journal:  Predictors of Clinical Outcomes among People with HIV and Tuberculosis Symptoms after Rapid Treatment Initiation in Haiti. (Pubmed Central) -  Jul 1, 2024   
    After adjustment, less than secondary education (adjusted odds ratio [AOR] 0.21, 95% CI 0.10-0.46), dolutegravir initiation (AOR 2.57, 95% CI 1.22-5.43), age (AOR 1.42 per 10-year increase, 95% CI 1.01-1.99), and tuberculosis diagnosis (AOR 3.92, 95% CI 1.36-11.28) were significantly associated with retention...We identified sociodemographic, treatment-related, clinical, and laboratory-based predictors of clinical outcomes. These characteristics may serve as markers of sub- populations that could benefit from additional interventions to support treatment success after rapid treatment initiation.
  • ||||||||||  Sunlenca (lenacapavir) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    Preclinical, Journal:  Cell Culture Evaluation Hints Widely Available HIV Drugs Are Primed for Success if Repurposed for HTLV-1 Prevention. (Pubmed Central) -  Jun 27, 2024   
    Our results, if replicated in a clinical setting, could see transmission rates of HTLV-1 and future caseloads of HTLV-1-associated pathologies like ATLL dramatically cut via the simple repurposing of already widely available HIV pills in HTLV-1 endemic areas. Considering our findings with the old medical saying "it is better to prevent than cure", we highly recommend the inclusion of INSTIs and tenofovir prodrugs in upcoming HTLV-1 clinical trials as potential prophylactics.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Journal:  Long-term effectiveness, safety, and tolerability of doravirine in antiretroviral-experienced people with HIV in real life. (Pubmed Central) -  Jun 25, 2024   
    We evaluated the effectiveness of DOR plus two nucleos(t)ide reverse transcriptase inhibitors (NRTI), mainly abacavir/lamivudine, and dual therapies in people with HIV (PWH), mostly virologically suppressed...Participants were grouped as follows: A, received DOR plus two NRTI; B, dual therapy (DT) with DOR plus dolutegravir (DTG) or darunavir/cobicistat (DRVc); C, DOR plus ?two antiretroviral drugs...The combination of DOR plus ABV/3TC has shown even better safety and effectiveness than TFV/FTC. DOR plus two NRTI offers cost benefits compared to other regimens.
  • ||||||||||  Retrospective data, Journal:  Antiretroviral therapy among people with HIV with comorbidities in the United States: a retrospective cohort study. (Pubmed Central) -  Jun 24, 2024   
    The most commonly used anchor agents, 62.6%, were integrase strand transfer inhibitors (INSTIs): dolutegravir (30.4%), elvitegravir (24.2%), and raltegravir (7.3%)...From our analyses, ART prescribing did not appear to vary with the presence of comorbidities and potential medication contraindications. ART regimens may have comparable efficacy profiles; however, selection should be guided by each patient's comorbidities to prevent potential comedication drug toxicities.
  • ||||||||||  PLWHA Ukrainian war refugees in Slovakia: a retrospective, observational study () -  Jun 18, 2024 - Abstract #AIDS2024AIDS_4029;    
    The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
  • ||||||||||  Vocabria (cabotegravir oral) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
    Increased incidence of emergent integrase drug resistance with cabotegravir versus dolutegravir in randomised switching trials () -  Jun 18, 2024 - Abstract #AIDS2024AIDS_3983;    
    The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Patterns of dolutegravir resistance in sub-Saharan Africa 2022-2024: the DTG RESIST study of IeDEA () -  Jun 18, 2024 - Abstract #AIDS2024AIDS_3982;    
    The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Retrospective data, Journal:  Comorbidity and concomitant medication use in an integrase strand transfer inhibitor na (Pubmed Central) -  Jun 17, 2024   
    Metformin use led to increased blood glucose levels (p=0.009); participants on rifampicin (n=8) received an additional daily dose of dolutegravir. Virological outcomes in participants on sodium valproate (n=2) and St John
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Review, Journal:  A review of dolutegravir-associated weight gain and secondary metabolic comorbidities. (Pubmed Central) -  Jun 17, 2024   
    Some clinical investigators speculate that dolutegravir could interfere with central nervous system appetite regulation (melanocortin-4 receptor) and insulin signaling, or may have better penetration of adipose tissue where they could exert a direct impact on adipose tissue adipogenesis, fibrosis, and insulin resistance. This review summarizes our current understanding of weight gain and fat changes associated with dolutegravir and its possible secondary metabolic comorbidities.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion, Trial completion date:  IMPAACT P1093: Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents (clinicaltrials.gov) -  Jun 12, 2024   
    P1/2,  N=181, Completed, 
    This review summarizes our current understanding of weight gain and fat changes associated with dolutegravir and its possible secondary metabolic comorbidities. Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> Oct 2023
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Dolutegravir induces FOLR1 expression during brain organoid development. (Pubmed Central) -  Jun 3, 2024   
    The Brillouin frequency shift observed at the surface of DTG-exposed brain organoids indicates an increase in superficial tissue stiffness. In contrast, reverberant OCE measurements indicate decreased organoid volumes and internal stiffness.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    New P4 trial:  LIROH - Liraglutide for Obesity in HIV (clinicaltrials.gov) -  May 31, 2024   
    P4,  N=40, Recruiting, 
  • ||||||||||  dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Viatris, Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Prophylaxis and treatment of HIV infection in pregnancy, Swedish guidelines 2024. (Pubmed Central) -  May 28, 2024   
    In May 2024, the Swedish Reference Group on Antiviral Therapy updated the guidelines on management of HIV infection in pregnancy. The most important recommendations and revisions were: (i) ART during pregnancy should be started as early as possible and continue after delivery; (ii) Suppressive ART should normally not be modified; (iii) The treatment target of HIV RNA <20 copies/ml remains; (iv) Dolutegravir/emtricitabine/tenofovir DF is the first-line drug combination also in pregnant women and women planning pregnancy; (v) There is no evidence of an increased risk of neural tube defects associated with dolutegravir; (vi) Mode of delivery for women with effective ART and HIV RNA <200 copies/ml should follow standard obstetric procedures; (vii) Caesarean section is recommended if HIV RNA ?200 copies/ml; (viii) Scalp electrode, foetal blood sampling and/or vacuum delivery should be used on strict indications, but does not necessitate intensified infant prophylaxis; (ix) Management and mode of delivery in case of premature or full-term rupture of membranes should follow standard obstetric procedures; (x) Recommended infant antiretroviral prophylaxis has been updated; (xi) The duration of infant antiretroviral prophylaxis (gestational age ?35?weeks and mother on effective ART and HIV RNA <200 copies/ml) has been changed from 4 to 2?weeks; (xii) Infants born to women with HIV RNA ?200 copies/ml should receive 4?weeks of combination prophylaxis; (xiii) Fertility evaluation and assisted reproduction should be offered to women on suppressive ART according to the same principles as for other women; (xiv) Women living with HIV should still be advised against breastfeeding; (xv) Women who nevertheless opt to breastfeed should be offered intensified support and follow-up.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  The cyclical cascade of HIV care: Temporal care engagement trends within a population-wide cohort. (Pubmed Central) -  May 24, 2024   
    Disengagement is common and occurs at various points along the cascade, making it challenging to identify high-impact intervention opportunities. While historical HIV cascades remain valuable for target setting and service monitoring, they can be complemented with insights from more detailed cyclical cascades.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis (clinicaltrials.gov) -  May 19, 2024   
    P2,  N=30, Recruiting, 
    Thus, DTG-based first-line ART regimens supplementation should be sustained to achieve global and national targets for zero new infections in HIV-exposed infants. Trial completion date: May 2025 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Feb 2025
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Management of the Drug-Drug Interactions Between Valproic Acid and Dolutegravir-A Case Study. (Pubmed Central) -  May 17, 2024   
    We are confident that our findings can contribute to a better understanding of the clinical problems that infectious disease physicians encounter in their daily management of people with HIV and how therapeutic drug monitoring may add value in this context. This case also highlights the importance of multidisciplinary services for the optimal management of polypharmacy in people with HIV.
  • ||||||||||  dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods, Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Pharmaco-virological outcomes and genotypic resistance profiles among children and adolescents receiving a DTG-based regimen in Togo. (Pubmed Central) -  May 15, 2024   
    In this representative sample of patients with suppressed HIV, antiretroviral therapy was the primary factor driving costs, which may be reduced by using generic drugs to mitigate the high cost of lifelong HIV treatment. These first findings in such a large series of adolescents in a low-income country, showed a good virological response of 80% and the presence of an integrase DRM in 9.4% of the virological failures, supporting the need to monitor DTG drug resistance to reduce the risk of resistance acquisition.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Dolutegravir and Folic Acid Interaction during Neural System Development in Zebrafish Embryos. (Pubmed Central) -  May 11, 2024   
    Of note, we observed the disruption of ngn1 expression in the dopaminergic regions of the developing forebrain, spinal cord neurons and spinal motor neuron projections, with the depletion of the tyrosine hydroxylase (TH)+ dopaminergic neurons of the dorsal diencephalon and the strong reduction in larvae locomotion. Our study further supports previous evidence that DTG can interfere with FA pathways in the developing brain but also provides new insights regarding the mechanisms involved in the increased risk of DTG-associated fetal neurodevelopmental defects and adverse neurologic outcomes in in utero exposed children, suggesting the impairment of dopaminergic pathways.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Biomarker, Trial completion, Trial completion date, Trial primary completion date:  Gut Microbiota, PGx and INSTIs Response (clinicaltrials.gov) -  May 10, 2024   
    P=N/A,  N=180, Completed, 
    Our study further supports previous evidence that DTG can interfere with FA pathways in the developing brain but also provides new insights regarding the mechanisms involved in the increased risk of DTG-associated fetal neurodevelopmental defects and adverse neurologic outcomes in in utero exposed children, suggesting the impairment of dopaminergic pathways. Recruiting --> Completed | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Associations between antiretroviral regimen and changes in blood pressure: results from the D2EFT study. (Pubmed Central) -  May 9, 2024   
    In this randomised, controlled study in 14 low- and middle-income countries, individuals taking dolutegravir with darunavir/ritonavir for 48 weeks had a greater increase in systolic and diastolic blood pressure than individuals taking two nucleoside reverse transcriptase with darunavir/ritonavir. The difference remained significant after controlling for confounding factors including weight gain.
  • ||||||||||  NN1213 / Novo Nordisk, Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  DGVTAF: Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection (clinicaltrials.gov) -  May 8, 2024   
    P4,  N=74, Active, not recruiting, 
    The difference remained significant after controlling for confounding factors including weight gain. Trial completion date: Apr 2025 --> May 2028 | Trial primary completion date: Apr 2024 --> May 2027