Tivicay (dolutegravir) / ViiV Healthcare 
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  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Lung Transplant in HIV-Infected Patients. Single Centre Experience () -  Apr 26, 2020 - Abstract #ISHLT2020ISHLT_240;    
    At the end of the study the other four patients have been discharged and are improving the pulmonary function tests (Table 2). Conclusion The experience of the first five VIH LT patients in Spain shows that LT is feasible without increasing the risk of infectious or immunological complications.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Structural basis of second-generation HIV integrase inhibitor action and viral resistance. (Pubmed Central) -  Apr 26, 2020   
    The expanded chemical scaffolds of second-generation compounds mediate interactions with the protein backbone, which are critical for antagonizing Q148H/G140S mutant virus. Our results reveal that binding to magnesium ions underpins a fundamental weakness of the INSTI pharmacophore that is exploited by the virus to engender resistance and provide a structural framework for the development of this important class of anti-HIV/AIDS therapeutics.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  IMPAACT P1093: Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents (clinicaltrials.gov) -  Apr 24, 2020   
    P1/2,  N=300, Active, not recruiting, 
    Our results reveal that binding to magnesium ions underpins a fundamental weakness of the INSTI pharmacophore that is exploited by the virus to engender resistance and provide a structural framework for the development of this important class of anti-HIV/AIDS therapeutics. Trial completion date: Jun 2023 --> Oct 2023 | Trial primary completion date: Jun 2020 --> Jan 2021
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial initiation date:  i2-D (clinicaltrials.gov) -  Apr 23, 2020   
    P4,  N=200, Not yet recruiting, 
    This simplification strategy reduced pill burden and preserved viral suppression in treatment-experienced patients with no major mutations to rilpivirine at historical genotyping. Initiation date: Mar 2020 --> Aug 2020
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  Clinical Extrapolation of the Effects of Dolutegravir and Other HIV Integrase Inhibitors on Folate Transport Pathways. (Pubmed Central) -  Apr 22, 2020   
    Elvitegravir and raltegravir inhibited PCFT, but only raltegravir inhibition of intestinal PCFT was flagged as potentially clinically relevant at the highest 1.2-g dose (not the 400-mg dose)...The present studies showed that dolutegravir is not a clinical inhibitor of folate transport pathways, and it is not predicted to elicit clinical decreases in maternal and fetal folate levels. Furthermore, clinically-relevant HIV integrase inhibitor drug class effect on folate transport pathways was not observed.
  • ||||||||||  Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD)
    Trial completion date, Trial primary completion date:  POPARV: Population Pharmacokinetics of Antiretroviral in Children (clinicaltrials.gov) -  Apr 21, 2020   
    P=N/A,  N=700, Recruiting, 
    Furthermore, clinically-relevant HIV integrase inhibitor drug class effect on folate transport pathways was not observed. Trial completion date: Jun 2019 --> Jun 2022 | Trial primary completion date: Jun 2019 --> Jun 2022
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  Dolutegravir-induced extrapyramidal syndrome in a young woman. (Pubmed Central) -  Apr 16, 2020   
    Until further information is available, raltegravir or other first-line agents are recommended for women with HIV planning to become pregnant. No abstract available
  • ||||||||||  Prezcobix (darunavir/cobicistat) / Gilead, J&J, emtricitabine/tenofovir disoproxil fumarate / Generic mfg., Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] Chorea and pancerebellar syndrome caused by cerebrospinal fluid HIV escape (Room Vienna) -  Apr 9, 2020 - Abstract #EAN2020EAN_2269;    
    We described a rare case of chorea and cerebellar syndrome secondary to HIV escape in CSF. Here we can see two causes that contributed to the escape phenomena: non-adherence to therapy and resistance to ART.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment open:  Second-line Switch to Dolutegravir Study (clinicaltrials.gov) -  Mar 26, 2020   
    P4,  N=766, Recruiting, 
    Countries with low- or moderate HIV prevalence should be included in studies reviewing pregnancy outcomes and in any surveillance system to ensure the accuracy of drug safety revision. Not yet recruiting --> Recruiting
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Mutations in the HIV-1 envelope glycoprotein can broadly rescue blocks at multiple steps in the virus replication cycle. (Pubmed Central) -  Mar 26, 2020   
    Remarkably, the Env compensatory mutants can also rescue a replication-delayed integrase (IN) mutant, and exhibit reduced sensitivity to the IN inhibitor Dolutegravir (DTG), demonstrating that they confer a global replication advantage...We attribute this phenotype to the ability of the Env mutants to mediate highly efficient cell-to-cell transmission, resulting in an increase in the multiplicity of infection. These findings have broad implications for our understanding of Env function and the evolution of HIV-1 drug resistance.
  • ||||||||||  lamivudine / Generic mfg., Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  A comparison between two dolutegravir-based two-drug regimens as switch strategies in a multicentre cohort of HIV-1-infected patients. (Pubmed Central) -  Mar 24, 2020   
    Drug-resistance mutations selected at failure of these regimens were those expectable in case of failure of any regimen including DTG, 3TC or RPV, but the impact of resistance to nucleoside reverse transcriptase inhibitors on efficacy of DTG+3TC seems lower than expected. DTG+RPV and DTG+3TC were compared in populations with different characteristics in clinical practice: both regimens showed good effectiveness and improved lipid profile.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  Increased dose of dolutegravir as a potential rescue therapy in multi-experienced patients. (Pubmed Central) -  Mar 24, 2020   
    For the first time 100 mg BID of DTG were administered to five multi-experienced patients harboring the mutation complex G140-Q148. Although a small number of patients were tested, the results show a potential for an high-dose regimens of DTG as a rescue therapy in patients harboring INSTI resistant viruses.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    When First-Line Fails: Salvage Therapy for Severe Pneuomcystis Pneumonia in Acquired Immunodeficiency Syndrome (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area B) -  Mar 15, 2020 - Abstract #ATS2020ATS_7286;    
    She was started on antiretroviral therapy with tenofovir alafenamide–emtricitabine and dolutegravir and clinically improved. Antibiotics were de-escalated to azithromycin 1200 mg every week for Mycobacterium avium prophylaxis and clindamycin-primaquine with prednisone for 21 days.This case serves to alert providers to appropriate salvage therapy in severe pneumocystis pneumonia when TMP-SMX is contraindicated and can contribute to the dearth of positive data for clindamycin-primaquine in severe pneumocystis pneumonia.
  • ||||||||||  ceftriaxone / Generic mfg., Tivicay (dolutegravir) / ViiV Healthcare
    Double Whammy, an Uncommon Endocarditis with an Uncommon Pathogen (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area A) -  Mar 15, 2020 - Abstract #ATS2020ATS_6507;    
    While rare, endocarditis has been associated with Salmonella bacteremia. PVE is rare and can be managed conservatively with antibiotics in the absence of hemodynamic insufficiency.