Sovaldi (sofosbuvir) / Gilead 
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 18 Diseases   22 Trials   22 Trials   2501 News 


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  • ||||||||||  paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS
    Clinical, Journal, Real-World Evidence:  Direct antiviral therapy for treatment of hepatitis C: A real-world study from Brazil. (Pubmed Central) -  Sep 30, 2020   
    SOF-based DAA regimens are effective and safe in the heterogeneous highly admixed Brazilian population and could remain an option for HCV treatment at least in low-income countries.
  • ||||||||||  Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
    Journal:  Sofosbuvir inhibits yellow fever virus in vitro and in patients with acute liver failure. (Pubmed Central) -  Sep 30, 2020   
    Sofosbuvir may be used as an option for treatment against YFV until other drugs are identified and approved for human use. These results offer insights into the role of nonstructural protein 5 (NS5) in YFV inhibition and suggest that nonstructural proteins may be explored as drug targets for YFV treatment.
  • ||||||||||  velpatasvir (GS-5816) / Gilead, Sovaldi (sofosbuvir) / Gilead
    Clinical, Journal:  Sofosbuvir as Repurposed Antiviral Drug Against COVID-19: Why Were We Convinced to Evaluate the Drug in a Registered/Approved Clinical Trial? (Pubmed Central) -  Sep 30, 2020   
    Sofosbuvir active metabolite, however, shows an extremely high intracellular stability So, it is hypothesized that SARS-CoV-2 infection could also be susceptible to sofosbuvir and we were convinced to design and run a clinical trial to evaluate the effect of sofosbuvir 400 mg (in combination with velpatasvir 100 mg, as add-on treatment, in addition to standard of care) on the COVID-19. However, we believe that this manuscript/correspondence should be made available to the international scientific community as soon as possible, with the help of this esteemed journal.
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
    Clinical, Retrospective data, Journal:  Incidence and predictors for abnormal liver function during direct-acting antiviral agents in chronic hepatitis C patients. (Pubmed Central) -  Sep 26, 2020   
    The presence of such events had no impact on sustained virological response 12 rates. Hepatitis B virus coinfection (aOR: 3.599, P < 0.001) and higher pretherapy ALT (1-5x, ≥5x upper limit of normal: aOR: 2.632, P = 0.024, aOR: 4.702, P = .011, respectively) were significant predictors for ALT elevation.On-treatment ALT elevation occurred in one-tenth CHC patients treated with preferred DAAs but had no impact on sustained virological response rate.
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Journal:  Direct Antiviral Treatments for Hepatitis C Virus Have Off-Target Effects of Oncologic Relevance in Hepatocellular Carcinoma. (Pubmed Central) -  Sep 25, 2020   
    Adverse events were mostly mild or moderate and comparable to those seen in the approval studies. Our findings suggested the possible occurrence of off-target effects ultimately modulating cell proliferation and/or migration and potentially justified previous findings showing some instances of particularly aggressive HCC recurrence as well as reduced incidence of recurrence of HCC following treatment with DAAs.
  • ||||||||||  Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead
    Journal:  Discovery of the pan-genotypic hepatitis C virus NS3/4A protease inhibitor voxilaprevir (GS-9857): A component of Vosevi. (Pubmed Central) -  Sep 24, 2020   
    Furthermore, hepatotoxicity was not observed in Phase 3 clinical trials with voxilaprevir, consistent with our design strategy. Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) is now an approved pan-genotypic treatment option for the most difficult-to-cure individuals who have previously failed direct acting antiviral therapy.
  • ||||||||||  Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, voxilaprevir (GS-9857) / Gilead, sofosbuvir/velpatasvir / Generic mfg.
    Journal:  Discovery of velpatasvir (GS-5816): A potent pan-genotypic HCV NS5A inhibitor in the single-tablet regimens Vosevi and Epclusa. (Pubmed Central) -  Sep 24, 2020   
    VEL combined with sofosbuvir (SOF) is Epclusa, an STR with 98% cure-rates for genotype 1-6 HCV infected patients. Addition of the pan-genotypic HCV NS3/4A protease inhibitor voxilaprevir to SOF/VEL is the STR Vosevi, which affords 97% cure-rates for genotype 1-6 HCV patients who have previously failed another treatment regimen.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead, ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal:  Wirelessly Observed Therapy to Optimize Adherence and Target Interventions for Oral Hepatitis C Treatment: Observational Pilot Study. (Pubmed Central) -  Sep 24, 2020   
    Our real-world cohort of Taiwan showed that a 12-week SOF/DCV-based treatment was well-tolerated and highly effective for genotype-2 CHC patients with or without liver cirrhosis. The findings of this study suggest that digital medicines can be used for wirelessly observed therapy to support adherence to antiviral HCV therapy, reduce unnecessary medication wastage and retreatment costs, and potentially optimize sustained virologic response rates, especially in populations at high risk for nonadherence.
  • ||||||||||  Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
    Enrollment change:  REVOLUTIOn: Antiviral Agents Against COVID-19 Infection (clinicaltrials.gov) -  Sep 19, 2020   
    P2/3,  N=1134, Not yet recruiting, 
    It seems possible that other potent, but impermeable, phosphate-containing inhibitors might likewise benefit from this approach. N=189 --> 1134
  • ||||||||||  tacrolimus / Generic mfg.
    [VIRTUAL] Hidden Immune Complexes: A Rare Case of Renal Failure Secondary to Hepatitis C Following Sustained Virologic Response () -  Sep 15, 2020 - Abstract #ACG2020ACG_2721;    
    She had been treated with sofosbuvir and ribavirin in 2013 with sustained virologic response (SVR) and was listed for liver transplant...She underwent liver transplantation a week later and received mycophenolate and tacrolimus with marked improvement in renal function...This suggests that despite resolution of HCV and absence of ongoing viral replication, the accompanying immunologic phenomena may persist. Therefore, treated HCV should not be dismissed as potential cause of MPGN.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Enrollment change, Trial completion date, Trial primary completion date:  Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients (clinicaltrials.gov) -  Sep 14, 2020   
    P2/3,  N=100, Recruiting, 
    Therefore, treated HCV should not be dismissed as potential cause of MPGN. N=200 --> 100 | Trial completion date: Dec 2030 --> Oct 2020 | Trial primary completion date: Dec 2030 --> Oct 2020
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Sovaldi (sofosbuvir) / Gilead
    Review, Journal:  Hepatitis E Virus Drug Development. (Pubmed Central) -  Sep 11, 2020   
    The current therapy options are limited to the unspecific antivirals Ribavirin (RBV) and pegylated Interferon-α (pegIFN-α)...We provide an overview of the current status of HEV antiviral research. Furthermore, we discuss strategies for drug development and the limitations of the approaches with respect to HEV.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Journal:  Sofosbuvir for COVID-19 infection: A potential candidate. (Pubmed Central) -  Sep 10, 2020   
    Furthermore, we discuss strategies for drug development and the limitations of the approaches with respect to HEV. No abstract available
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Journal:  Hepatitis C virus treatment in people who inject drugs (PWID) in Bangladesh. (Pubmed Central) -  Sep 5, 2020   
    Not yet recruiting --> Completed Our findings strongly suggest that HCV treatment using sofosbuvir+daclatasvir for PWID enrolled in existing harm reduction programs in Bangladesh is feasible but may require additional interventions such as Opioid Substitution Therapy, intense follow up by outreach workers, and services and counselling provided by full time clinicians.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Journal:  Confronting the Multidimensional Challenges of Research in the Context of Emerging Infectious Diseases in Brazil: The Example of Yellow Fever. (Pubmed Central) -  Sep 2, 2020   
    In the most recent Brazilian yellow fever (YF) outbreak, a group of clinicians and researchers initiated in mid-January 2018 a considerable effort to develop a multicenter randomized controlled clinical trial to evaluate the effect of sofosbuvir on YF viremia and clinical outcomes (Brazilian Clinical Trials Registry: RBR-93dp9n)...Had enrollment been initiated 3 weeks earlier, an additional 31 patients could have been enrolled, reaching the prespecified sample size for the interim analysis. This recent experience highlights the urgent need to improve local preparedness for research in the setting of explosive outbreaks, as has been seen in the last few years in different countries.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Journal:  Characterization of Usutu virus NS5 protein. Polymerase activity, protein-protein interaction and cellular localization. (Pubmed Central) -  Sep 1, 2020   
    To further examine the characteristics of USUV polymerase in a more biological context, we have expressed NS5 and the RdRpD in eukaryotic cells and analyzed its subcellular location. NS5 is predominantly found in the cytoplasm, a significant proportion is directed to the nucleus and this translocation involves nuclear location signals (NLS) located, at least, between the MTase and RdRpD domains.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, sofosbuvir/velpatasvir / Generic mfg., Sovaldi (sofosbuvir) / Gilead
    [VIRTUAL] Innovative procedures for micro-elimination of HCV infection in a high-risk population of undocumented migrants and low-income refugees (Poster Area) -  Aug 31, 2020 - Abstract #EASLILCI2020EASL-ILC-I-2290;    
    HCV-RNA positive patients were treated with sofosbuvir plus velpatasvir+ribavirin for 12 weeks and followed up untreated for 12 weeks after treatment withdrawal Of the 3,401 migrants observed in the study period, 3,286 (96.6%) accepted to be screened. This innovative procedures for micro-elimination of HCV infection seems to be effective in undocumented migrants and low-income refugees with rates of diagnosis, linkage to care and cure in line with the WHO goals
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., Sovaldi (sofosbuvir) / Gilead
    Clinical, Journal:  Prevention of viral transmission during lung transplantation with hepatitis C-viraemic donors: an open-label, single-centre, pilot trial. (Pubmed Central) -  Aug 27, 2020   
    P1
    Early and intermediate clinical outcomes were not significantly different between patients receiving viraemic HCV donor lungs and HCV-negative donor lungs. Donor organ treatment with UVC perfusate irradiation during EVLP significantly decreased HCV viral loads within the first 7 days after transplantation and shows the proof-of-concept for a novel approach of minimising viral load ex vivo before transplantation, with intent of preventing donor-recipient transmission.
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Clinical, Retrospective data, Journal:  Effectiveness of direct-acting antivirals for hepatitis C virus infection in hepatitis C/HIV coinfected individuals: A multicenter study. (Pubmed Central) -  Aug 27, 2020   
    In a hepatitis C virus (HCV)/HIV-positive Brazilian cohort, evaluate the safety and efficacy of HCV DAAs, the frequency of resistance substitutions in the HCV NS5A and NS5B genes and identify predictors of treatment failure.Retrospective multicenter study of HCV/HIV patients treated with sofosbuvir (SOF)-based regimens at 10 reference centers in Brazil.Clinical and virological data were collected...An SOF/daclatasvir (DCV) regimen was used in most patients (98%)...By multivariate analysis, therapeutic failure was associated, in the m-ITT analysis, with concomitant use of anticonvulsant drugs (P = .001), age (P = .04), and female gender (P = .04).SOF/DCV regimens were associated with a high SVR rate in an HCV/HIV population. The use of concurrent anticonvulsant drugs and DAAs decreases the chances of achieving an SVR.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Journal:  Development of a long-acting direct-acting antiviral system for hepatitis C virus treatment in swine. (Pubmed Central) -  Aug 18, 2020   
    Tunable release kinetics of DAAs was enabled for 1 mo with drug-polymer pills in vitro, and the LA-DAAS safely and successfully provided at least month-long release of sofosbuvir in vivo...The LA-DAAS was cost-effective compared to DAA therapy alone in all groups considered (base case incremental cost-effectiveness ratio $39,800). We believe that the LA-DAA system can provide a cost-effective and patient-centric method for HCV treatment, including in high-risk populations who are currently undertreated.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Enrollment open:  Sofosbuvir in Treatment of COVID 19 (clinicaltrials.gov) -  Aug 7, 2020   
    P2/3,  N=60, Recruiting, 
    Cellular graft rejection following the successful treatment of HCV needs further investigation. Not yet recruiting --> Recruiting
  • ||||||||||  Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
    Enrollment change, Trial completion date, Trial primary completion date:  REVOLUTIOn: Antiviral Agents Against COVID-19 Infection (clinicaltrials.gov) -  Aug 7, 2020   
    P2/3,  N=189, Not yet recruiting, 
    Not yet recruiting --> Recruiting N=125 --> 189 | Trial completion date: Oct 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Dec 2021
  • ||||||||||  Vistide (cidofovir) / Gilead, abacavir / Generic mfg., Vemlidy (tenofovir alafenamide) / Gilead
    Journal:  A library of nucleotide analogues terminate RNA synthesis catalyzed by polymerases of coronaviruses that cause SARS and COVID-19. (Pubmed Central) -  Aug 6, 2020   
    Prodrugs of five of these nucleotide analogues (Cidofovir, Abacavir, Valganciclovir/Ganciclovir, Stavudine and Entecavir) are FDA-approved medications for treatment of other viral infections, and their safety profiles are well established. After demonstrating potency in inhibiting viral replication in cell culture, candidate molecules can be rapidly evaluated as potential therapies for COVID-19.
  • ||||||||||  doxorubicin hydrochloride / Generic mfg., cyclophosphamide intravenous / Generic mfg., Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Journal:  Direct-Acting Antivirals in Hepatitis C Virus-Associated Diffuse Large B-cell Lymphomas. (Pubmed Central) -  Aug 2, 2020   
    The favorable reported results on long-term outcome seem to support the eradication of HCV with DAAs in all patients with HCV-positive DLBCL. Moreover, the results from the concurrent approach were effective and safe and displayed an advantage in preventing hepatic toxicity during I-CT.