bictegravir (GS-9883) / Gilead 
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  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    Review, Journal:  Weight Gain in HIV Adults Receiving Antiretroviral Treatment: Current Knowledge and Future Perspectives. (Pubmed Central) -  Nov 27, 2024   
    In this manuscript, we review weight changes among PLWH receiving HAART and the relevant underlying pathogenic mechanisms described in recent literature. We try to provide a more critical appraisal of the available data and to underline the challenges in assessing the role of HAART in weight changes in both ART initiation and setting switching.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Vemlidy (tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Preclinical, Journal:  A dual-purpose humanized mouse model for testing antiviral strategies against both SIV and HIV. (Pubmed Central) -  Nov 19, 2024   
    Infected mice showing chronic viremia were treated with a combination anti-retroviral treatment (cART) regimen consisting of emtricitabine/elvitegravir/tenofovir disoproxil fumarate (FTC/EVG/TDF)...Next, a cART regimen consisting of emtricitabine/bictegravir/tenofovir alafenamide fumarate (FTC/BIC/TAF) was similarly evaluated...These findings highlight the utility of humanized mice for in vivo screening of new combinations of ARV compounds against various SIVs prior to employing them in NHPs. In addition to identifying new effective cART regimens against SIVs, this model would also be amenable to evaluating immunotherapeutic strategies using broadly neutralizing antibodies, LRAs and novel therapeutics in comparative cure studies of SIV and HIV.
  • ||||||||||  Preclinical, Journal:  Bictegravir alters glucose tolerance in vivo and causes hepatic mitochondrial dysfunction. (Pubmed Central) -  Nov 13, 2024   
    This study evaluated the impact of lamivudine, dolutegravir (DTG), bictegravir (BIC), tenofovir disoproxil fumarate, and TAF on metabolic alterations, and explored glucose homeostasis and mitochondrial stress as potential mechanisms...BIC promoted mitochondrial dysfunction, modified carbohydrate metabolism and glucose consumption in hepatocytes, and altered glucose tolerance and gluconeogenesis regulation in mice. These findings suggest that BIC contributes to insulin resistance and diabetes in people living with HIV, warranting clinical studies to clarify its association with carbohydrate metabolism disorders.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Economic estimation of the management of neuropsychiatric events in people with HIV in real life (Virtual) -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_413;    
    Real-world discontinuation rates due to NPAEs with BIC are lower than with DTG, leading to savings in cost and resource use for their management. Findings from this study could help treatment decision-making in PHIV.
  • ||||||||||  Women living with HIV: how far to fulfil the gap? () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_307;    
    Moreover, they were characterized by higher burden of comorbidities, in particular obesity and diabetes. That led to multiple vicious circles, enhanced by different cultural, social and economic determinants: treatment choice of 3DR versus dual regimen, difficulties in screening and management of comorbidities, lower rate of cancer screening.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Pifeltro (doravirine) / Merck (MSD), Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Safety and efficacy of doravirine plus tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC) in heavily pre?treated patients () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_277;    
    Prior ARV was INSTI based in 12 cases (52%), PI based in one (4%), and both INSTI and PI in 10 (43%), with additional maraviroc in three cases (13%)...Among the four subjects with persistent low-grade viraemia, two changed to long-acting cabotegravir/rilpivirine with virological success, and two maintained the combination with last available HIV RNA of 1.82 and 1.90 logs, respectively. The use of DOR plus TAF/FTC/BIC in heavily pre-treated patients was safe
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Central nervous system safety of long?acting cabotegravir/rilpivirine in patients with previous oral INSTI?related CNS toxicity () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_203;    
    Prior to C/R, 45% (N = 13) were on NNRTI-based therapies: TAF/FTC/RPV in 11 and TAF/FTC plus doravirine in two... In this cohort of heavily pretreated patients, the rate of CNS-related toxicity withdrawal was very low (1.5%), but the incidence of CNS toxicity and CNS-related withdrawals were significantly higher in patients with prior oral INSTI-related CNS adverse events.
  • ||||||||||  Antiretroviral therapy in pregnancy in England in 2019?2022: common regimens and treatment modifications () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_130;    
    Among pregnancies conceived on ART, most common (reported in >5%) first regimens were efavirenz (EFV) + tenofovir disoproxil fumarate (TDF) + emtricitabine (FTC) (13.5% [267/1974]), rilpivirine (RPV) +TDF+FTC (11.6% [228/1974]), darunavir/ritonavir (DRV/r) +TDF+FTC (8.0% [158/1974]), dolutegravir (DTG) + lamivudine (3TC) + abacavir (ABC) (7.7% [152/1974]), and raltegravir (RAL) +TDF+FTC (6.4% [127/1974]). Where ART was initiated during pregnancy (55.7% [234/420] diagnosed antenatally), median gestational age at start was 15 weeks (IQR 12
  • ||||||||||  bictegravir (GS-9883) / Gilead, Isentress (raltegravir) / Merck (MSD)
    PK/PD data, Journal:  Ideal Time to Conduct a Pharmacokinetic Investigation After Delivery to Fully Capture the Effect of Pregnancy on Drug Exposure. (Pubmed Central) -  Oct 23, 2024   
    Pharmacokinetic investigations on hepatically cleared drugs should not be conducted before the fifth week after delivery to fully characterize the effect of pregnancy on drug exposure. Because physiological changes remain after delivery, early measurements can underestimate the pregnancy effect on pharmacokinetics, leading to suboptimal dosing recommendations during pregnancy.
  • ||||||||||  bictegravir (GS-9883) / Gilead
    Journal:  Birth outcomes following bictegravir exposure during pregnancy. (Pubmed Central) -  Oct 16, 2024   
    These findings provide preliminary data without significant safety concerns for fetal bictegravir exposure in this United States cohort. Comparative data and continued surveillance of outcomes among infants exposed to bictegravir during gestation are warranted.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    Journal:  Antiretrovirals and Weight Change: Weighing the Evidence. (Pubmed Central) -  Oct 15, 2024   
    We review weight changes in major randomized trials of pre-exposure prophylaxis (PrEP) and initial and switch HIV therapy, highlighting the challenges to assessing the role of ART in weight change. This examination forms the basis for a model that questions assumptions regarding an association between INSTI and TAF and excessive weight gain and calls for more careful consideration of these data when making HIV treatment decisions.
  • ||||||||||  Sunlenca (lenacapavir) / Gilead, bictegravir (GS-9883) / Gilead
    Enrollment open:  Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 (clinicaltrials.gov) -  Sep 20, 2024   
    P2/3,  N=75, Recruiting, 
    Tenofovir alafenamide use in people living with HIV is associated with significant alterations in lipid profile. Not yet recruiting --> Recruiting
  • ||||||||||  Skyrizi (risankizumab-rzaa) / AbbVie, Boehringer Ingelheim
    Successful management of psoriasis in a patient with HIV using risankizumab (Poster Area) -  Aug 5, 2024 - Abstract #EADV2024EADV_4939;    
    At the time of presentation, he was receiving a combination of emcitrabine, tenofovir and bictegravir. Although there is limited data on the use of biologics in HIV patients, this case suggests that IL-23 inhibitors may be a valuable therapeutic option for this patient group.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Preclinical, Journal:  Antiretroviral drug dolutegravir induces inflammation at the mouse brain barriers. (Pubmed Central) -  Jul 10, 2024   
    NPAEs seem to improve after switching to a DRV/c- or DOR-based regimen after the first 4 and 12 weeks. To address this question, we evaluated the effect of two INSTIs, DTG and bictegravir (BTG), on folate transporters and receptor expression at the mouse BCSFB and the BBB in