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  • ||||||||||  Journal:  Direct-Acting Antivirals to Prevent Vertical Transmission of Viral Hepatitis C: When Is the Optimal Time to Treat? (Pubmed Central) -  Sep 26, 2019   
    The network model developed for drug effects in the in vitro cell cultures was applied successfully to link the in vivo tumor drug concentrations with tumor growth inhibition, incorporating more mechanistic features and accounting for disparate drug interaction outcomes in vitro and in vivo. Data to determine the best treatment point along the pregnancy-pediatric continuum are limited; however, given the lack of human data for use of DAAs during pregnancy, low rate of VT, high rate of spontaneous pediatric clearance, and recent approval of DAAs for pediatric patients, treatment of chronically infected children seems to be the optimal strategy currently.
  • ||||||||||  Clinical, PK/PD data, Journal, Combination therapy, Monotherapy:  Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir. (Pubmed Central) -  Sep 26, 2019   
    Internal evaluation confirmed that the population pharmacokinetic model developed was deemed appropriate to describe the time course of AL-335, ALS-022399, and ALS-022227 plasma concentrations and their associated variability in both healthy and HCV-infected subjects, as well as the interaction effect of simeprevir and/or odalasvir over AL-335 and its metabolites in healthy subjects. This model can be used as a starting point to evaluate drug-drug interaction processes in HCV-infected patients and support the development of a direct-acting antiviral (DAA) combination.
  • ||||||||||  remetinostat (SHP-141) / Medivir
    Trial completion date, Trial primary completion date:  Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer (clinicaltrials.gov) -  Sep 19, 2019   
    P2,  N=30, Recruiting, 
    We illustrate how the method could result in timely detection of photosensitivity reaction with simeprevir use...No abstract available Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), MIV-818 / Medivir
    MIV-818 stimulates an antitumor immune response in vitro and enhances the effects of pembrolizumab (Board 56: Level 2 - Hall D) -  Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_488;    
    These effects are further enhanced in combination with pembrolizumab and support future combination of MIV-818 with PD-(L)1 inhibitors in patients with HCC and other liver cancers. The effects of MIV-818 on tumor immune activation markers are being assessed the ongoing phase 1/2 clinical trial.
  • ||||||||||  birinapant (TL 32711) / Medivir, LMB-100 / National Cancer Institute, Roche
    Synergy between IAP inhibitors and a cytotoxic antibody-based chimeric protein in pancreatic cancer cells (Board 18: Level 2 - Hall D) -  Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_51;    
    The immunotoxin, LMB-100, targets surface mesothelin on pancreatic tumor cells but when tested on two pancreatic adenocarcinoma cell lines, AsPC1 and BxPc3, there was no detectable reduction in cell viability...BxPC3 cells remained resistant to the immunotoxin even in the presence of birinapant: the combination with the highest concentrations of both compounds reduced cell viability only to 50% after 72 hours... knowing the level of key proteins involved in the cell death pathway can explain the efficacy of drug combinations and could be used to predict responses.
  • ||||||||||  birinapant (TL 32711) / Medivir
    Biomarker, Journal:  Simulating and predicting cellular and in vivo responses of colon cancer to combined treatment with chemotherapy and IAP antagonist Birinapant/TL32711. (Pubmed Central) -  Sep 8, 2019   
    We therefore obtained insights into intracellular signal transduction kinetics and their population-based heterogeneities for chemotherapy/TL32711 combinations and provide proof-of-concept that mathematical modelling of apoptosis competency can simulate and predict responsiveness in vivo. Being able to predict response to IAP antagonist-based treatments on the background of cell-to-cell heterogeneities in the future might assist in improving treatment stratification approaches for these emerging apoptosis-targeting agents.
  • ||||||||||  tacrolimus / Generic Mfg., Daklinza (daclatasvir) / BMS
    SAFETY AND EFFICACY OF SOFOSBUVIR BASED REGIMENS IN HEPATITIS C VIRUS RECURRENCE POST LIVER TRANSPLANTATION (Poster Exhibition - Hall 7) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_3046;    
    All patients who received (SOF/SIM) were on Tacrolimus or rapamune based immunosuppression Mean age of the studied patients was 52.5±7.9 years (range 28-68), mostly males (99.7%)... Sofosbuvir based combinations are safe and effective in the treatment of recurrent HCV after LT, especially when combined with another directly acting antiviral.
  • ||||||||||  paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
    STUDY OF THE RESPONSE AND SAFETY OF DIRECT ACTING ANTIVIRAL COMBINATION THERAPY IN HEPATITIS C VIRUS-RELATED CHILD-B LIVER CIRRHOSIS (Poster Exhibition - Hall 7) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_3041;    
    In Child A patients, 260 had sofosbuvir (SOF)and daclatasvir (DAC) for 12 weeks,13 had SOF plus simeprevir (SIM) for 12 weeks and 2 had Ritonavir-Paritaprevir-Ombitasvir-Ribavirin for 12 weeks. Real-world results of generic DAAs combinations in Egyptian patients with chronic HCV-Child B were very safe and effective with SVR-12 (98.5%&86.7%) with very rare reported complications (0.01%,0.9%) in Child A&B, respectively.
  • ||||||||||  paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
    COMPARATIVE STUDY FOR RETREATING PATIENTS WHO FAILED TO PRIOR SOFOSBUVIR/ DACLATASVIR REGIMEN: AN OPEN LABELED RANDOMIZED TRIAL (Poster Exhibition - Hall 7) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_1303;    
    Eighty patients were randomly re-treated either by Sofosbuvir(400mg)/Daclatasvir(60mg)/ Simeprevir(150mg)/Ribavirin (SIM-group, n=40) versus Sofosbuvir(400mg) /Ombitasvir(25mg)/ Paritaprevir(150mg) /Ritonavir(100mg) /Ribavirin (OPr-group, n=40) for 12 weeks. Re-treating patients with previous NS5A failure is possible and safe with satisfactory results.
  • ||||||||||  Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer Internacional, Galen, Medivir
    Clinical, Journal:  Inhaled loxapine for agitation in patients with personality disorder: an initial approach. (Pubmed Central) -  Aug 7, 2019   
    The results showed that IL significantly decreased agitation within 10 minutes and its effect was greater at 20 minutes (Positive and Negative Syndrome Scale-excited component: from 22.78 ± 4.39 at baseline to 11.14 ± 4.17 at 20 minutes; p < 0.001; Agitation and Calmness Evaluation Scale: from 1.80 ± 0.49 at baseline to 4.53 ± 1.05 at 20 minutes; p < 0.01) without any severe adverse reactions registered. IL led to fast, safe and well-tolerated control of agitation in patients with PD.
  • ||||||||||  Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie
    Journal:  HCV compliance and treatment success rates are higher with DAAs in structured HCV clinics compared to general hepatology clinics. (Pubmed Central) -  Jul 23, 2019   
    Female patients (P = .02), older age (P < .0001), previous treatment (P = .03), treatment in SHC (OR 1.7, 95% CI 1.2, 2.3, P = .0008), and sofosbuvir/ledipasvir compared to sofosbuvir/velpatasvir, sofosbuvir, or elbasvir/grazoprevir had higher odds of treatment success. With 1:1 matching, the SHC group still had significantly higher odds than the GHC group of achieving treatment and compliance success.Our study shows that the effectiveness of HCV treatment could be improved by coordinating treatment in a structured HCV clinic.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Review, Journal, HEOR:  Cost-utility analysis of second-generation direct-acting antivirals for hepatitis C: a systematic review. (Pubmed Central) -  Jul 17, 2019   
    Expert commentary: Selected studies may be overestimating the true cost per QALY of second-generation DAAs in the treatment of HCV, mainly because of neglecting non-healthcare costs, using official list prices which are higher than actual transaction prices and not adopting the long run drug price in a dynamic approach. In addition, the impact of important price reductions of several DAAs in recent years on cost per QALY should be considered.
  • ||||||||||  Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer Internacional, Galen, Medivir, Geodon (ziprasidone) / RaQualia, Meiji Seika, Pfizer
    Clinical, Clinical data, Journal:  Clinical Outcomes in Patients Taking Inhaled Loxapine, Haloperidol, or Ziprasidone in the Emergency Department. (Pubmed Central) -  Jun 30, 2019   
    Furthermore, C-005 demonstrated robust antitumor efficacy and good tolerability in NCI-H1975, PC-9 and HCC827 xenograft mouse models, making it a potential candidate for human test in clinical. Treating patients with agitation due to psychotic episodes in an ED setting with inhaled loxapine versus haloperidol or ziprasidone was associated with significantly improved treatment outcomes, suggesting that inhaled loxapine may be a more effective and rapid treatment option.
  • ||||||||||  GDC0152 / Roche, birinapant (TL 32711) / Medivir
    Journal:  SMAC Mimetics Induce Autophagy-Dependent Apoptosis of HIV-1-Infected Resting Memory CD4+ T Cells. (Pubmed Central) -  Jun 23, 2019   
    Genetic or pharmacological inhibition of autophagy induction, but not autophagy-mediated degradation, abrogated this interaction and subsequent cell death. Our findings identify a mechanism whereby DIABLO/SMAC mimetics exploit autophagy and apoptotic machinery to selectively induce killing of HIV-T without viral reactivation while sparing uninfected cells.
  • ||||||||||  remetinostat (SHP-141) / Medivir
    Trial completion date, Trial initiation date, Trial primary completion date:  Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC) (clinicaltrials.gov) -  Jun 23, 2019   
    P2,  N=30, Not yet recruiting, 
    Our findings identify a mechanism whereby DIABLO/SMAC mimetics exploit autophagy and apoptotic machinery to selectively induce killing of HIV-T without viral reactivation while sparing uninfected cells. Trial completion date: Nov 2022 --> Oct 2021 | Initiation date: May 2019 --> Oct 2019 | Trial primary completion date: May 2022 --> Apr 2021
  • ||||||||||  glibenclamide / generics
    Journal:  Functional characterization for polymorphic organic anion transporting polypeptides (OATP/SLCO1B1, 1B3, 2B1) of monkeys recombinantly expressed with various OATP probes. (Pubmed Central) -  Jun 17, 2019   
    ...In this study, hepatic uptake by recombinantly expressed monkey OATP1B1, OATP1B3 and OATP2B1 was investigated using three human OATP1B1 and OATP1B3 substrates (pitavastatin, pravastatin and rosuvastatin) and one OATP1B3 substrate (telmisartan), as the governmental drug interaction guidelines recommend, and seven reported clinical drugs...In contrast, atorvastatin, bosentan, etoposide, fexofenadine, fluvastatin, glibenclamide and simeprevir were broadly transported by recombinant monkey OATP1B1, OATP1B3 and OATP2B1...Despite that the sequences of monkey recombinant OATPs are not totally reflexive of those of human OATPs, our results collectively suggested that OATP1B1, OATP1B3 or OATP2B1 in monkeys could mediate roughly similar hepatic uptake of various OATP probes. Recombinant monkey OATPs would be good experimental tools for in vitro hepatic uptake in cell systems.
  • ||||||||||  birinapant (TL 32711) / Medivir
    Journal:  Anti-hepatoma effects of Smac analogue Birinapant and its related molecular mechanism (Pubmed Central) -  May 4, 2019   
    Direct-acting antiviral treatment is highly effective and well-tolerated in liver transplant recipients with recurrent GT1 HCV infection. Birinapant can inhibit the expression of cIAP-1, cIAP-2 and the proteins of Ras-Raf-MEK-ERK signal pathways, so as to activate the mitochondria mediated endogenous apoptosis pathway.Birinapant shows a certain inhibitory effect on liver cancer.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Multicenter Experience using Ledipasvir/Sofosbuvir ± RBV to Treat HCV GT 1 Relapsers after Simeprevir and Sofosbuvir Treatment. (Pubmed Central) -  Apr 24, 2019   
    Birinapant can inhibit the expression of cIAP-1, cIAP-2 and the proteins of Ras-Raf-MEK-ERK signal pathways, so as to activate the mitochondria mediated endogenous apoptosis pathway.Birinapant shows a certain inhibitory effect on liver cancer. Treatment with LDV/SOF with/without RBV for 12-24 weeks was very well tolerated and resulted in high SVR 12 rates (96%) in HCV GT1 relapsers to SMV + SOF treatment.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Clinical, Journal:  Interferon-based Simeprevir Therapy for Pediatric Patients with Chronic Hepatitis C Viral Infection. (Pubmed Central) -  Apr 24, 2019   
    Interferon-based simeprevir therapy showed high efficacy and tolerability in children with genotype 1 hepatitis C virus infection. While direct-acting antivirals (DAAs) therapy are undergoing study in children, this regimen is considered an available therapeutic option for selected patients in countries where DAAs have not yet been approved.
  • ||||||||||  Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie, paritaprevir/ritonavir (ABT-450/r) / AbbVie
    Journal:  Insulin resistance does not impair response of chronic hepatitis C virus to direct-acting antivirals, and improves with the treatment. (Pubmed Central) -  Apr 11, 2019   
    In line with the findings of the OPTIMIST-2 trial for Q80K and the EASL-guidelines 2016 for NS5A-RASs, baseline RASs appeared to have an impact on treatment outcome albeit a statistical significance was not observed in this low-prevalence population. IR does not impair the response of patients with HCV treated with DAAs, and improves significantly in patients who achieve an SVR.