sofosbuvir/velpatasvir / Generic mfg. 
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  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Trial initiation date:  Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir (clinicaltrials.gov) -  Sep 3, 2020   
    P1,  N=10, Not yet recruiting, 
    Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Dec 2020 --> Dec 2021 Initiation date: Jul 2020 --> Oct 2020
  • ||||||||||  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.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Trial primary completion date:  Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection (clinicaltrials.gov) -  Aug 14, 2020   
    P4,  N=75, Recruiting, 
    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. Trial primary completion date: Jul 2020 --> Jul 2021
  • ||||||||||  ribavirin / Generic mfg.
    Trial primary completion date:  MINMON: Monitoring SOF/VEL in Treatment Na (clinicaltrials.gov) -  Aug 11, 2020   
    P4,  N=400, Active, not recruiting, 
    Trial primary completion date: Jul 2020 --> Jul 2021 Trial primary completion date: Jan 2021 --> Jul 2020
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD)
    Enrollment open:  SHELTER: Transplanting Hepatitis C Lungs Into Negative Lung Recipients (clinicaltrials.gov) -  Aug 8, 2020   
    P1/2,  N=10, Recruiting, 
    Trial primary completion date: Jan 2021 --> Jul 2020 Active, not recruiting --> Recruiting
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    [VIRTUAL] TREATMENT OF A PATIENT WITH GENOTYPE 7 HEPATITIS C VIRUS INFECTION (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_5632;    
    At 12 weeks after the end of treatment the HCV RNA was undetectable confirming sustained virological response. This is a case of successful treatment with sofosbuvir and velpatasvir of a patient with a rare HCV genotype only reported in individuals from Democratic Republic of the Congo.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    [VIRTUAL] TREATMENT OF A PATIENT WITH GENOTYPE 7 HEPATITIS C VIRUS INFECTION (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_3656;    
    At 12 weeks after the end of treatment the HCV RNA was undetectable confirming sustained virological response. This is a case of successful treatment with sofosbuvir and velpatasvir of a patient with a rare HCV genotype only reported in individuals from Democratic Republic of the Congo.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    [VIRTUAL] TREATMENT OF A PATIENT WITH GENOTYPE 7 HEPATITIS C VIRUS INFECTION (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_1672;    
    At 12 weeks after the end of treatment the HCV RNA was undetectable confirming sustained virological response. This is a case of successful treatment with sofosbuvir and velpatasvir of a patient with a rare HCV genotype only reported in individuals from Democratic Republic of the Congo.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Trial completion date, Trial primary completion date:  A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic (clinicaltrials.gov) -  Jul 14, 2020   
    P4,  N=20, Active, not recruiting, 
    Sofosbuvir-velpatasvir for 12 weeks was effective and well-tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4, or 6 infection, including those with compensated cirrhosis. Trial completion date: May 2020 --> Sep 2020 | Trial primary completion date: Apr 2020 --> Sep 2019
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Enrollment closed:  Micro-elimination of Hepatitis C Virus Infection in Uremics (clinicaltrials.gov) -  Jul 10, 2020   
    P3,  N=135, Active, not recruiting, 
    For genotypes 1, 2, and 3, patients with prior SOF/VEL-experience had lower SVR rates. Recruiting --> Active, not recruiting
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Trial completion date, Trial initiation date, Trial primary completion date:  THINKER-NEXT: A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients (clinicaltrials.gov) -  Jul 9, 2020   
    P2,  N=500, Not yet recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Dec 2023 --> Dec 2024 | Initiation date: Mar 2020 --> Dec 2020 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead, elbasvir (MK-8742) / Merck (MSD)
    Journal, Combination therapy:  Optimization of a sensitive and robust strategy for micellar electrokinetic chromatographic analysis of sofosbuvir in combination with its co-formulated hepatitis C antiviral drugs. (Pubmed Central) -  Jun 19, 2020   
    Based on our previous work with "pseudostationary-ion exchanger sweeping", we use this strategy to develop a sensitive, reliable and robust method for the analysis of the newly-FDA approved hepatitis C antiviral drugs namely; sofosbuvir (SOV), daclatasvir (DAC), ledipasvir (LED) and velpatasvir (VEP) in their pure forms and co-formulated pharmaceutical dosage forms using micellar electrokinetic chromatography (MEKC) as a separation method...The selectivity of the developed method for determination of the studied compounds in their pharmaceutical dosage forms or in the presence of ribavirin (RIB) or elbasvir (ELB), which are other prescribed medications in the treatment regimen of patients with hepatitis C virus infection, is demonstrated. It is shown that with acidic sample matrix and basic BGE, an efficient and precise approach was designed in which analyte adsorption on the capillary wall was minimized while keeping repeatable peak height, peak area and migration time together with the highest possible enrichment efficiency.
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
    Clinical, Journal, HEOR:  Comparative effectiveness of pan-genotypic therapies for the treatment of patients with hepatitis C virus infection in Bulgaria. (Pubmed Central) -  Jun 18, 2020   
    It is shown that with acidic sample matrix and basic BGE, an efficient and precise approach was designed in which analyte adsorption on the capillary wall was minimized while keeping repeatable peak height, peak area and migration time together with the highest possible enrichment efficiency. Sofosbuvir/velpatasvir/voxilaprevir is a noninferior therapy offering a simple and short-term treatment regimen with high efficacy, favorable safety profile and good tolerability.
  • ||||||||||  Clinical, Journal:  Changing demographics among populations prescribed HCV treatment, 2013-2017. (Pubmed Central) -  Jun 12, 2020   
    Policymakers should consider the role of 340B discounts when evaluating policies to reduce drug spending. In the United States, since the introduction of interferon-free HCV regimens, the patient population prescribed treatment has changed, becoming predominantly treatment-naïve, without cirrhosis, and treated in nonacademic centers.
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie, elbasvir (MK-8742) / Merck (MSD)
    [VIRTUAL] HCV DAA treatment failure is associated to hepatocellular carcinioma presence (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-833;    
    Background and Aims: Sustained Virological Responses (SVR) are nowaday obtained in real life settings, in almost 98-99% of HCV-infected patients using 8 or 12W schedules and 2nd generation DAAs (glecaprevir/pibrentasvir, sofosbuvir/velpatasvir and elbasvir/gazoprevir). The presence of HCC and cirrhosis independently increase the risk of HCV treatment failure with DAAs
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    [VIRTUAL] Management of hepatitis C in primary healthcare in the country of Georgia (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-832;    
    Our study reported the feasibility and effectiveness of integrating a simplified HCV diagnostic and treatment model in PHCs. Countrywide expansion of this model is warranted to bridge the gaps in the HCV care continuum and ensure high rates of treatment uptake towards achieving elimination targets.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., Sovaldi (sofosbuvir) / Gilead
    [VIRTUAL] Final challenges: real-world experience with sofosbuvir, velpatasvir and voxilaprevir in patients with advanced cirrhosis (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-831;    
    This is the first Australian study to assess the real-world efficacy and safety of SOF/VEL/VOX amongst patients with advanced liver disease. SVR12 rates were good, but data suggests there remain a small number of very hard to cure patients, particularly those with GT3 and advanced disease, suggesting a need to explore strategies to optimise SVR in these groups.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    [VIRTUAL] Efficacy of sofosbuvir/velpatasvir (s/v): impact of treatment adherence (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-830;    
    Suboptimal adherence was rare and not associated with treatment failure nor with any specific demographic profile. These data endorse the relative robustness of the S/V regimen in clinical practice and is reassuring as the use of S/V is expanded into populations facing multiple obstacles to treatment adherence.
  • ||||||||||  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 (Channel 5) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-811;    
    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 lowincome refugees with rates of diagnosis, linkage to care and cure in line with the WHO goals
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
    [VIRTUAL] Virological patterns of HCV-patients with failure to second generation direct-acting antivirals (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-809;    
    Pts can fail also with second-line therapeutic regimens. These pts frequently show mutations above all in the NS5A region, in particular in pts experienced Sofosbuvir/Velpatasvir and in Grazoprevir/Elbasvir regimen than in pts experienced Glecaprevir/Pibrentasvir failure probably due to short lasting of the last cited therapy.