Tivicay (dolutegravir) / ViiV Healthcare 
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  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    The Treatment of Primary HIV (TopHIV) cohort: a prospective multicenter cohort in Germany (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_70;    
    We established a data- and biomaterial collection of a rare patient group, which allows expedited translational research. This cohort will be very valuable for future studies focussing on immune control and cure of HIV infection.
  • ||||||||||  lamivudine / Generic Mfg., Tivicay (dolutegravir) / ViiV Healthcare
    Comparing NRTI-sparing dual regimens using data from the Swiss HIV cohort study (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_66;    
    Estimates of relative effectiveness suggest that both dolutegravir regimens are not inferior to the alternative regimens used previously. Updated analyses show the stability of the earliest estimates with a slight gain in precision with each update.
  • ||||||||||  cabotegravir (GSK1265744) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
    PK/PD data, Journal:  Pharmacokinetics and Pharmacodynamics of Cabotegravir, a Long-Acting HIV Integrase Strand Transfer Inhibitor. (Pubmed Central) -  Nov 14, 2019   
    Indeed, preclinical and clinical studies have consistently shown that LAI cabotegravir is readily absorbed following intramuscular and subcutaneous administration, with an elimination half-life of approximately 40 days, permitting infrequent dosing, possibly once every 1 or 2 months (eventually combined with rilpivirine). Here, we reviewed the existing literature on the preclinical and clinical pharmacokinetics and pharmacodynamics of LAI cabotegravir, with emphasis on the actual pharmacokinetic challenges of this novel formulation, as well as its potential to act as a victim or perpetrator of drug-drug interactions.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  Safety and efficacy of dolutegravir in hemodialysis. (Pubmed Central) -  Nov 10, 2019   
    Eighty percent of the patients were virally suppressed at six months with 62.5% of those suppressed maintaining suppression and 37.5% achieving suppression over the course of the six months. In a retrospective review of ten patients receiving dolutegravir while on hemodialysis for at least six months, dolutegravir was generally safe and effective for use at standard dosages.
  • ||||||||||  Clinical, Observational data, Journal:  Virologic Outcomes Among ART-Naïve Individuals Initiating Dolutegravir, Elvitegravir, Raltegravir or Darunavir: An Observational Study. (Pubmed Central) -  Nov 9, 2019   
    In a retrospective review of ten patients receiving dolutegravir while on hemodialysis for at least six months, dolutegravir was generally safe and effective for use at standard dosages. In this large cohort representative of PLWH in care in the US, ART-naïve PLWH prescribed DTG had better virologic outcomes than RAL and DRV, but had virologic failure risks comparable to EVG, although RAL and DRV were preferentially prescribed to sicker individuals.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  Dolutegravir Resistance and Failure in a Kenyan Patient. (Pubmed Central) -  Nov 8, 2019   
    In this large cohort representative of PLWH in care in the US, ART-naïve PLWH prescribed DTG had better virologic outcomes than RAL and DRV, but had virologic failure risks comparable to EVG, although RAL and DRV were preferentially prescribed to sicker individuals. No abstract available
  • ||||||||||  Clinical, Journal:  Drug-Drug Interactions Studies between HCV Antivirals Sofosbuvir/Velpatasvir and Boosted and Unboosted HIV Antiretroviral Regimens in Healthy Volunteers. (Pubmed Central) -  Nov 6, 2019   
    SOF/VEL and ARV regimens were administered alone and in combination; ARVs (and pharmacokinetic enhancers) included atazanavir (ATV), cobicistat (COBI), darunavir (DRV), dolutegravir (DTG), efavirenz (EFV), elvitegravir (EVG), emtricitabine (FTC), lopinavir (LPV), raltegravir (RAL), rilpivirine (RPV), ritonavir (RTV), tenofovir alafenamide (TAF), and tenofovir disoproxil fumarate (TDF)...No clinically relevant differences in the pharmacokinetics (PK) of SOF, SOF metabolite GS-331007, or VEL were observed other than an approximate 50% decrease in VEL exposure when administered with EFV/FTC/TDF...SOF/VEL and ARV regimens including ATV, COBI, DRV, DTG, EVG, FTC, LPV, RAL, RPV, RTV, TAF, or TDF may be coadministered without dose adjustment. Use of SOF/VEL with EFV-containing regimens is not recommended due to ~50% reduction in VEL exposure.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, lopinavir/ritonavir / Generic Mfg.
    Biomarker, Clinical, Journal:  Metabolic effects of initiating lopinavir/ritonavir-based regimens among young children: 7-year follow-up of the IMPAACT P1060 trial. (Pubmed Central) -  Oct 31, 2019   
    P2
    Given the virologic superiority of LPV/r-based regimens in young children and open questions regarding the roll-out of dolutegravir in resource-limited settings, children are currently being maintained on LPV/r-based regimens. Our results suggest continual assessment of total cholesterol among young children initiating a LPV/r-based regimen to monitor cardiometabolic health.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  Two cases of dolutegravir failure with R263K mutation. (Pubmed Central) -  Oct 31, 2019   
    Our results suggest continual assessment of total cholesterol among young children initiating a LPV/r-based regimen to monitor cardiometabolic health. No abstract available
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    Journal:  The transition to dolutegravir and other new antiretrovirals in low- and middle-income countries - what are the issues? (Pubmed Central) -  Oct 29, 2019   
    Most of these patients are using the combination of tenofovir (TDF), lamivudine (3TC) and efavirenz (EFV)...The prodrug of TDF, tenofovir alafenamide (TAF) is cheaper to manufacture than TDF...However, the clinical development programmes for DTG and TAF did not include extensive analysis of several key populations: pregnant women, people with HIV-tuberculosis (TB) coinfection taking rifampicin-based treatment, and treatment-naive or pretreated patients with NRTI drug resistance...Clinical trials of new antiretrovirals in key populations should be conducted earlier in their development. This will ensure that new treatments can be introduced into LMICs soon after their launch in high-income countries.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Journal:  Durable suppression of HIV-1 with resistance mutations to integrase inhibitors by dolutegravir following drug washout. (Pubmed Central) -  Oct 29, 2019   
    There is need for drug resistance monitoring and clinical vigilance to ensure effectiveness of HIV treatment programmes even in the era of DTG based ART. DTG antiretroviral activity in tissue culture is more durable than that of either RAL or EVG after drug washout and this is true for both WT and drug-resistant viruses.
  • ||||||||||  Truvada (emtricitabine/tenofovir disoproxil fumarate) / Gilead, Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Journal:  Emergence of Integrase Resistance Mutations During Initial Therapy Containing Dolutegravir. (Pubmed Central) -  Oct 27, 2019   
    Dolutegravir (DTG) is a preferred drug for initial treatment of human immunodeficiency virus type 1 infection. We present next-generation sequencing analysis of integrase genotypes during a period of virologic failure in a treatment-naive man who initiated tenofovir disoproxil fumarate/emtricitabine plus DTG.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Review, Journal:  Antiretroviral treatment for HIV: is it time for 2 drug regimens? (Pubmed Central) -  Oct 27, 2019   
    We present next-generation sequencing analysis of integrase genotypes during a period of virologic failure in a treatment-naive man who initiated tenofovir disoproxil fumarate/emtricitabine plus DTG. No abstract available
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Clinical, Journal:  Prevalence of drug resistance in children recently diagnosed with HIV-1 infection in France (2006-17): impact on susceptibility to first-line strategies. (Pubmed Central) -  Oct 10, 2019   
    The prevalence of PI-, NRTI-, efavirenz/nevirapine-, etravirine/rilpivirine- and doravirine-associated RAMs was 0%, 3.6%, 6.0%, 11.9% and 2.4%, respectively...Additionally, 3/60 (5%) strains had integrase inhibitor (INI)-related RAMs (an isolated E157Q mutation, which could mostly affect the susceptibility to raltegravir/elvitegravir rather than that to dolutegravir)...The proportion of NRTI- and NNRTI-related TDR in children is lower in France than in low- and middle-income countries. However, we suggest favouring PI- or dolutegravir- over NNRTI-based combinations to treat newly diagnosed HIV-infected children, even in the absence of previous exposure to antiretroviral prophylaxis of MTCT.
  • ||||||||||  Prezista (darunavir) / J&J, Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Preclinical, Journal:  Differential Effects of Antiretroviral Drugs on Neurons In Vitro: Roles for Oxidative Stress and Integrated Stress Response. (Pubmed Central) -  Oct 9, 2019   
    Further, we expanded our assessment to include three integrase strand transfer inhibitors, raltegravir, dolutegravir, and elvitegravir...Future in vivo studies will be critical to confirm the neurotoxicity profiles of these drugs for incorporation of these findings into patient management. The EAR and ISR pathways are potential access points for the development of adjunctive therapies to complement antiretroviral therapies and limit their contribution to HAND persistence.
  • ||||||||||  PK/PD data, Journal:  Pharmacokinetics of Tenofovir Alafenamide When Co-administered With Other HIV Antiretrovirals. (Pubmed Central) -  Oct 9, 2019   
    The EAR and ISR pathways are potential access points for the development of adjunctive therapies to complement antiretroviral therapies and limit their contribution to HAND persistence. Evaluation of the drug interaction between TAF and other commonly prescribed boosted and unboosted ARVs provides characterization of the susceptibility of TAF and/or TFV PK to inhibitors or inducers of Pgp/BCRP transporters.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Journal:  Genital HIV-1 Shedding with Dolutegravir (DTG) plus Lamivudine (3TC) Dual Therapy. (Pubmed Central) -  Oct 8, 2019   
    Evaluation of the drug interaction between TAF and other commonly prescribed boosted and unboosted ARVs provides characterization of the susceptibility of TAF and/or TFV PK to inhibitors or inducers of Pgp/BCRP transporters. No abstract available
  • ||||||||||  Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  Effect on HIV Medications on EPC Cells (clinicaltrials.gov) -  Oct 8, 2019   
    P=N/A,  N=30, Recruiting, 
    No abstract available Trial completion date: Sep 2019 --> Sep 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Journal:  HIV-1 integrase inhibitors that are broadly effective against drug-resistant mutants. (Pubmed Central) -  Sep 28, 2019   
    Of the three FDA-approved INSTIs, dolutegravir (DTG) is the least apt to select for resistance...Two of the new compounds, 4c and 4d, had superior antiviral profiles against the mutants we tested compared to DTGThe susceptibility profiles of 4c and 4d suggest that these compounds are candidates for development as INSTIs. Modeling the binding of 4d to HIV-1 IN reinforced the significance of mimicking the DNA substrate in developing compounds that broadly effective in their ability to inhibit HIV-1 INs with mutations in the active site.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Clinical, Journal:  Integrase strand-transfer inhibitors for treatment of early HIV infection: A case series. (Pubmed Central) -  Sep 27, 2019   
    Furthermore, subgroup sensitivity analyses failed to detect significant correlations based on definite or probable diagnoses, treatment using elvitegravir or dolutegravir, or the time from HIV diagnosis to ART initiation.This series of EHI cases indicate that using ART with ISTI-based regimens is efficacious and well-tolerated. However, earlier initiation of treatment was not significantly correlated with common parameters of immunological recovery.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare, Sovaldi (sofosbuvir) / Gilead
    RESOLUTION OF HEPATOPULMONARY SYNDROME WITH SUCCESSFUL TREATMENT OF CHRONIC HEPATITIS C INFECTION (Ernest N. Morial Convention Center - Exhibit Hall - Poster Area 2) -  Sep 25, 2019 - Abstract #CHEST2019CHEST_2754;    
    For her HCV, the patient was later started on a 12-week course of sofosbuvir, velpatasvir and ribavarin, which was confirmed to have eliminated her HCV infection at 24 weeks post-treatment...In conclusion this case report describes the successful reversal of HPS following the treatment of chronic HCV infection. These findings suggests that further research may discover a role for the use of DAAs in treatment of HPS.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion:  Dolutegravir Pediatric Liquid Formulation Study (clinicaltrials.gov) -  Sep 22, 2019   
    P1,  N=22, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed