Tivicay (dolutegravir) / ViiV Healthcare 
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  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Observational data, Journal:  Metabolic syndrome in Zambian adults with human immunodeficiency virus on antiretroviral therapy: Prevalence and associated factors. (Pubmed Central) -  Apr 21, 2021   
    Age (adjusted odds ratio [OR] 1.07; 95% CI 1.04-1.11), female sex (OR 3.02; 95% CI 1.55-5.91), VF (OR 1.98; 95% CI 1.01-3.87), dolutegravir (DTG)-based regimen (OR 2.10; 95% CI 1.05-4.20), hip-circumference (OR 1.03; 95% CI 1.01-1.05), T-lymphocyte count (OR 2.23; 95% CI 1.44-3.43), high-sensitivity C-reactive protein (hsCRP) (OR 1.14; 95% CI 1.01-1.29), and fasting insulin (OR 1.02; 95% CI 1.01-1.04) were significantly associated with MetS.Metabolic syndrome was highly prevalent among HIV+ adults receiving ART in Zambia and associated with demographic, clinical, anthropometric, and inflammatory characteristics. The association between MetS and dolutegravir requires further investigation, as does elucidation of the impact of MetS on ART outcomes in sub-Saharan African PWH.
  • ||||||||||  bictegravir (GS-9883) / Gilead
    Clinical, Journal:  Susceptibility to HIV-1 integrase strand transfer inhibitors (INSTIs) in highly treatment-experienced patients failing an INSTI-based regimen. (Pubmed Central) -  Apr 20, 2021   
    The aim of this study was to characterize the genotypic and phenotypic resistance profile to the integrase strand transfer inhibitor (INSTI) bictegravir (BIC) and other INSTIs in patients who previously failed twice-daily raltegravir (RAL)-based or twice-daily dolutegravir (DTG)-based regimens...Of these 14 samples, all showed high levels of resistance to elvitegravir (EVG) and RAL...Overall, for the 14 INSTI-resistant isolates, the median (range) fold-change in phenotypic susceptibility was: BIC 3.2 (0.6, 66), DTG 6.3 (0.8, >186), EVG >164 (2.6, >164), and RAL >188 (2.7, >197). In conclusion, our findings supported the in vitro activity of BIC and DTG against most isolates derived from highly treatment-experienced patients failing INSTI regimens.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] Real-World DATA Analysis of Antiretroviral Treatment for HIV-Infected Adult Patients in Ukraine () -  Apr 12, 2021 - Abstract #ISPOR2021ISPOR_708;    
    CONCLUSIONS. ABC/VEN analysis of the real-world data showed that medicines for the antiretroviral treatment for adult HIV-infected patients in Ukraine correspond to the international treatment guidelines and regulatory lists which provides reliable additional evidence for the health technology assessment.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD), Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Clinical, Journal:  Risk of birth defects and perinatal outcomes in HIV-infected women exposed to integrase strand inhibitors during pregnancy. (Pubmed Central) -  Apr 7, 2021   
    An extended 5-day and 6-day artemether-lumefantrine regimen is predicted to overcome these drug-drug interactions with efavirenz and rifampicin respectively. We found a non-significant trend for an association between exposure to raltegravir at conception and birth defects which needs to be evaluated by larger prospective surveillance data, as these drugs are increasingly prescribed in women living with HIV.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment closed:  Second-line Switch to Dolutegravir Study (clinicaltrials.gov) -  Mar 26, 2021   
    P4,  N=795, Active, not recruiting, 
    Blips and virologic failure were uncommon using either regimen, with no treatment-emergent resistance. Recruiting --> Active, not recruiting
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Weight gain and integrase inhibitors. (Pubmed Central) -  Mar 24, 2021   
    Although INSTI-based regimens are highly efficacious for viral suppression, they appear to cause more weight gain and treatment emergent obesity than non-INSTI-based regimens and may increase the risk of weight-related comorbidities. More studies are needed to understand the pathogenesis of weight gain with INSTIs in PLWH, in order to prevent this serious complication.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Two drugs regimens for HIV. (Pubmed Central) -  Mar 24, 2021   
    More studies are needed to understand the pathogenesis of weight gain with INSTIs in PLWH, in order to prevent this serious complication. 2DR will increasingly form part of the choice we are able to offer people with HIV but we must consider some of the limitations to ensure these regimens are used in the most clinically appropriate manner.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] COVERAGE OF VIRAL LOAD MONITORING DURING PREGNANCY IN SOUTH AFRICA, NATIONAL SURVEY () -  Mar 18, 2021 - Abstract #CROI2021CROI_953;    
    The low viral suppression among pregnant women initiating ART during pregnancy highlights the importance of enhanced adherence counselling and the need to fast-track the roll-out of Dolutegravir to enable achievement of more rapid viral suppression. The coverage of viral load testing could be improved further by implementing quality improvement initiatives.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] CHANGES IN ACCESS TO CARE FOR WOMEN LIVING WITH HIV DURING THE COVID-19 PANDEMIC () -  Mar 18, 2021 - Abstract #CROI2021CROI_939;    
    Addressing medication stock-outs and transportation challenges may help HIV programs in resource-constrained settings ensure that access to HIV and FP services is not disrupted during the COVID-19 pandemic. As the pandemic continues, FP access and use should continue to be monitored to avoid unintended pregnancies.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] DOLUTEGRAVIR AND VIRAL LOAD SUPPRESSION AMONG PEDIATRIC PATIENTS IN CARE IN ZAMBIA () -  Mar 18, 2021 - Abstract #CROI2021CROI_810;    
    DTG-associated regimens were associated with superior viral suppression among children living with HIV in Zambia, supporting their inclusion in the national guidelines for all eligible pediatric clients.The lack of an objective ART adherence tool is a limitation of this study. Improved fidelity of DTG-containing pediatric ART regimens are likely to attain sustained viral suppression and improved health outcomes.
  • ||||||||||  dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan, Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] PREDICTED LONG-TERM ADVERSE BIRTH AND CHILD HEALTH OUTCOMES IN THE ADVANCE TRIAL () -  Mar 18, 2021 - Abstract #CROI2021CROI_782;    
    There are consistent associations between pre-pregnancy clinical obesity and higher risks of adverse maternal, infant and child health outcomes. For every 100 women becoming pregnant after three years of TAF/FTC+DTG treatment, this analysis predicted 18 additional adverse outcomes.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    [VIRTUAL] MATERNAL WEIGHT AND ADVERSE PREGNANCY OUTCOMES AMONG WOMEN ON ART AT CONCEPTION () -  Mar 18, 2021 - Abstract #CROI2021CROI_781;    
    ART regimens associated with weight gain may reduce the percentage of low weight women at risk for certain severe adverse pregnancy outcomes but increase the number at risk of maternal hypertension. Further research is needed to determine whether weight-based ART treatment strategies could improve maternal and child health.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] HYPERGLYCEMIA AND DIABETES MELLITUS IN PERSONS LIVING WITH AND WITHOUT HIV IN AFRICOS () -  Mar 18, 2021 - Abstract #CROI2021CROI_729;    
    In this African cohort, hyperglycemia and diabetes were more commonly seen in PLWH than persons without HIV especially those over 50. There was a higher incidence of hyperglycemia in the PLWH 50 did not pose a significant risk for incident diabetes although this is likely limited by the sample size.