Tivicay (dolutegravir) / ViiV Healthcare 
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 26 Diseases   58 Trials   58 Trials   4692 News 


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  • ||||||||||  grazoprevir (MK-5172) / Merck (MSD), Sunvepra (asunaprevir) / BMS
    Review, Journal:  Computational drug discovery and repurposing for the treatment of COVID-19: A systematic review. (Pubmed Central) -  Jan 13, 2021   
    For the majority of these drugs, direct clinical evidence on their efficacy for the treatment of COVID-19 is lacking. Future clinical studies examining these drugs might come to conclude, which can be more useful to inhibit COVID-19 progression.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  Contribution of Dolutegravir to Obesity and Cardiovascular Disease (clinicaltrials.gov) -  Jan 13, 2021   
    P4,  N=30, Recruiting, 
    Future clinical studies examining these drugs might come to conclude, which can be more useful to inhibit COVID-19 progression. Not yet recruiting --> Recruiting | Trial completion date: Mar 2021 --> Jan 2022 | Initiation date: Jun 2020 --> Sep 2020 | Trial primary completion date: Jan 2021 --> Sep 2021
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Greater Weight Gain in Treatment Naïve Persons Starting Dolutegravir-Based Antiretroviral Therapy. (Pubmed Central) -  Jan 8, 2021   
    With INSTI-based first-line regimens in the US, Baseline Genotype offers minimal clinical benefit and is not cost-effective. Treatment-naïve PLWH starting dolutegravir-based regimens gained significantly more weight at 18 months than those starting NNRTI-based and elvitegravir-based regimens.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal, Adverse events:  Analysis of Pharmacovigilance Databases for Dolutegravir Safety in Pregnancy. (Pubmed Central) -  Jan 8, 2021   
    Given widespread use of new antiretroviral drugs worldwide and anticipated use of new drugs, prospective follow-up of pregnant women and birth surveillance studies such as Tsepamo are critically needed.Neural tube defects have been reported among infants born from women taking a wide range of antiretrovirals in 4 pharmacovigilance databases. Safety reports were inconsistent between databases and very hard to interpret.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  A new engineering process of biodegradable polymeric solid implants for ultra-long-acting drug delivery. (Pubmed Central) -  Jan 5, 2021   
    Herein the integrase inhibitor dolutegravir (DTG) was used to develop PSIs for HIV prevention...The physical/chemical properties of DTG were retained post-storage under accelerated storage conditions (40 °C/75% relative humidity) for 6 months. The versatility of this technology makes it an attractive drug delivery platform for HIV prevention applications.
  • ||||||||||  bictegravir (GS-9883) / Gilead
    Review, Journal, Adverse events:  Update on Adverse Effects of HIV Integrase Inhibitors. (Pubmed Central) -  Jan 3, 2021   
    This is worrying since patients from African descent are at higher risk of cardio-vascular events and increased body mass index (BMI) can cause further increase metabolic risk. There is possibly an additional effect of tenofovir alafenamide (TAF) on weight increase.Discrepancies between clinical trials - with low rates of adverse events - and reports from real-life settings might be due partly to under-representation of some groups of patients in clinical trials, and/or the short duration of follow-up, since some adverse effects may only occur after prolonged exposure.Preliminary data on safety of bictegravir (BIC), from clinical trials and non-trial settings, are very reassuring and seem to show lower rates of adverse events compared to DTG.Elvitegravir/cobicistat (EVG/cobi) need to be used with caution in patients with other co-morbidities given potential for polypharmacy, as it is the case for aging patients, because of the high potential of drug-drug interactions due to effects of the cobicistat booster.We are awaiting the release of cabotegravir (CAB), which could represent a good option for patients struggling with adherence, despite injection site reactions.Pharmacogenetics is a promising way to explore adverse effects occurrence in the INSTI class.
  • ||||||||||  bictegravir (GS-9883) / Gilead
    [VIRTUAL] Evaluation of the drug-drug interaction between metformin and bictegravir () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_3278;    
    No additional effect on HgbA1C was noted and appeared to be similar to an expected diabetes pharmacotherapy regimen response in PLWHIV. Prescribers should be aware of this potential interaction; however, no empiric MET TDD adjustment appears necessary when initiating MET-BIC concurrent therapy.
  • ||||||||||  bictegravir (GS-9883) / Gilead
    [VIRTUAL] Impact of telehealth services in an HIV primary care clinic during COVID-19 () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_2775;    
    Viral load suppression rates and undetectable viral status were maintained in PLWH. Utilization of telehealth services is a useful approach which allows healthcare providers, nurses and clinical pharmacists the ability to provide remote services without jeopardizing patient outcomes.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] Dolutegravir/Doravirine: A dual-therapy, nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) sparing HIV antiretroviral regimen in a patient with declining renal function () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_2590;    
    The patient was prescribed a regimen of efavirenz/tenofovir DF/emtricitabine (Atripla) upon referral to the specialty clinic. On his first visit he was initiated on bictegravir/tenofovir alafenamide/emtricitabine (Biktarvy) but was switched to a regimen consisting of doravirine 100mg, dolutegravir 50mg, and lamivudine 50mg in January of 2019 because of his declining kidney function...The patient was on esomeprazole, a PPI, for management of severe GERD with esophageal damage (Schatzki’s ring), thus ruling out Juluca as an option...As of February 2020, his CD4 count was 707 and as of June 2020, the patient’s viral loads have remained consistently suppressed at 12 months on a two-drug combination of doravirine and dolutegravir.
  • ||||||||||  metformin / Generic mfg., amphetamine / Generic mfg.
    [VIRTUAL] The therapeutic use of vitamin supplements and probiotic therapy in a patient reinfected with COVID-19 who has comorbid HIV and schizoaffective disorder: a case report () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_1708;    
    The patient’s current medication regimen includes: acetaminophen, vitamin C, vitamin D3, zinc, a probiotic, loxapine, valproic acid, diphenhydramine, Epzicom, dolutegravir, metformin, and atorvastatin...Another underlying condition the patient had that could have lead to a poorer prognosis was the patient’s prior history of substance abuse because of the pulmonary effects of smoking and the cardiovascular effects of cocaine and amphetamine...Although more research is warranted for the administration of supplemental therapy of vitamin C, vitamin D, and zinc as well as the administration of probiotic therapy, this case report is an example of the therapy’s potential utility and the complications which can must be considered with it’s use. Update: Patient is currently doing well, free of COVID-19 but still on vitamin supplements as prophylaxis for a possible 2nd wave of the virus in the winter.
  • ||||||||||  Journal:  Antiretroviral therapy and liver disorders in the OPERA cohort. (Pubmed Central) -  Dec 22, 2020   
    There were no DILI diagnoses and discontinuation of treatment following liver disorders was rare across all groups. Overall, the incidence of liver disorders after starting a new HIV treatment regimen did not differ between four common antiretroviral drugs.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Journal:  Dolutegravir-Based Antiretroviral Regimens for HIV Liver Transplant Patients in Real-Life Settings. (Pubmed Central) -  Dec 17, 2020   
    The management of HIV-positive liver transplant recipients in clinical practice is a complex task, where possibility of simplifying antiretroviral regimens must be balanced with the need to guarantee optimal immunosuppression and the finest treatment tolerability. A multidisciplinary approach involving physicians and clinical pharmacologists/pharmacists could help achieve this goal.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  DoRIS: Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin (clinicaltrials.gov) -  Dec 17, 2020   
    P4,  N=36, Not yet recruiting, 
    A multidisciplinary approach involving physicians and clinical pharmacologists/pharmacists could help achieve this goal. Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Mar 2021 --> Mar 2022
  • ||||||||||  zidovudine / Generic mfg.
    [VIRTUAL] PREVALENCE OF ANEMIA IN PEOPLE LIVING WITH HIV IN THE CENTRAL-WEST REGION OF MINAS GERAIS () -  Nov 26, 2020 - Abstract #HEMO2020HEMO_733;    
    The low prevalence of anemia in the studied patients is relevant information since this disorder has been associated with a worsening of the clinical condition and is related to the increased risk of death in HIV-infected patients. In view of the relevance of anemia in this context, further studies should investigate this association to prevent and treat anemia in people living with HIV.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] EPOCH-RR IN A PATIENT WITH SIMULTANEOUS DIAGNOSIS OF BURKITT AND HIV LYMPHOMA: CASE REPORT () -  Nov 26, 2020 - Abstract #HEMO2020HEMO_366;    
    The EPOCH-RR protocol was chosen, with cycles every 21 days, consisting of the following drugs: Rituximab 375 mg / m2 / EV in D1 and 5, Doxorubicin 10 mg / m2 + Vincristine 0.7 mg / m2 + Etoposide 50 mg / m2 / EV in 24-hour continuous infusion of D1 at 4, Cyclophosphamide 750 mg / m2 / EV at D5 and Prednisone 60 mg / m2 / VO at D1 at 5...Concomitantly, antiretroviral treatment - ART with Tenofovir + Lamivudine and Dolutegravir was started...At the end of 6 cycles, the patient repeated the PET SCAN, which demonstrated Complete Remission. Although it is the report of only one case, the data presented here suggest that chemotherapy treatment according to the EPOCH-RR protocol constitutes a viable alternative for the treatment of patients with Burkitt's Lymphoma associated with HIV infection, especially when there is impairment of the general condition.
  • ||||||||||  Trial completion date, Trial primary completion date:  BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) (clinicaltrials.gov) -  Nov 25, 2020   
    P1/2,  N=77, Recruiting, 
    Although it is the report of only one case, the data presented here suggest that chemotherapy treatment according to the EPOCH-RR protocol constitutes a viable alternative for the treatment of patients with Burkitt's Lymphoma associated with HIV infection, especially when there is impairment of the general condition. Trial completion date: Nov 2020 --> Sep 2021 | Trial primary completion date: Oct 2020 --> Aug 2021
  • ||||||||||  Prezcobix (darunavir/cobicistat) / Gilead, J&J, Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    [VIRTUAL] WHEN CD8 ENTERS THE CSF: A RARE PRESENTATION OF CNS IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME () -  Nov 21, 2020 - Abstract #ACAAI2020ACAAI_690;    
    Brain biopsy and steroids were deferred given clinical and radiographic improvement with ART modification to include Dolutegravir after finding an M184V mutation.Discussion The patient’s symptomatology was ultimately attributed to CD8E given triad of diffuse encephalitis, CD8+ T-cell predominance in CSF, and diffuse leukoencephalopathy with perivascular enhancement. Given the potential reversibility of CD8E with modification of ART or steroids, it is useful for clinicians to recognize this syndrome early in order to facilitate prompt treatment.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  Dolutegravir in Reservoirs (clinicaltrials.gov) -  Nov 20, 2020   
    P=N/A,  N=40, Suspended, 
    Given the potential reversibility of CD8E with modification of ART or steroids, it is useful for clinicians to recognize this syndrome early in order to facilitate prompt treatment. Trial completion date: Oct 2020 --> May 2021 | Trial primary completion date: Oct 2020 --> May 2021
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    PK/PD data, Journal:  ABCG2 Deficiency Does Not Alter Dolutegravir Metabolism and Pharmacokinetics. (Pubmed Central) -  Nov 14, 2020   
    In summary, this study demonstrated that deficiency of ABCG2 does not alter DTG metabolism and pharmacokinetics, suggesting that dose adjustment of DTG is not needed for individuals with ABCG2 deficiency. SIGNIFICANCE STATEMENT: The current work demonstrated that deficiency of ABCG2 does not alter DTG metabolism and pharmacokinetics, suggesting that dose adjustment of DTG is not needed for individuals with ABCG2 deficiency.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment change, Trial withdrawal:  i2-D (clinicaltrials.gov) -  Nov 9, 2020   
    P4,  N=0, Withdrawn, 
    SIGNIFICANCE STATEMENT: The current work demonstrated that deficiency of ABCG2 does not alter DTG metabolism and pharmacokinetics, suggesting that dose adjustment of DTG is not needed for individuals with ABCG2 deficiency. N=200 --> 0 | Not yet recruiting --> Withdrawn