ledipasvir/sofosbuvir / Generic mfg. 
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 54 Diseases   8 Trials   8 Trials   2662 News 


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  • ||||||||||  Daklinza (daclatasvir) / BMS
    [VIRTUAL] HIV coinfection and risk of morbidity and mortality in HCV patients treated with DAAs (Channel 5) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-135;    
    Participants were predominantly treated by Sofosbuvir and Ledipasvir (48.8% and 34.5%, respectively) or Sofosbuvir and Daclatasvir (32.6% and 31.2%, respectively) and SVR was observed in 92.9% and 94.6% overall, respectively. After DAA treatment, the risk of liver-related events and liver-related mortality were similar between HIV/HCV co-infected and HCV mono-infected but HIV co-infection tended to increase the risk of non-liver-related mortality.
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie, velpatasvir (GS-5816) / Gilead
    [VIRTUAL] Using HCV Infected Organs and the Challenge of Third-Party Payers (Virtual) -  May 29, 2020 - Abstract #ATC2020ATC_1668;    
    However, exploitation of such a resource requires commitment of third-party payers to deliver the appropriate post-transplant DAA therapy. So far, insurance appeal rates remain high and a safety net for drug coverage outside patients’ insurance remains necessary
  • ||||||||||  Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta, sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    [VIRTUAL] The Clinical Impact of HCV D+/r- Kidney Transplantation (Virtual) -  May 29, 2020 - Abstract #ATC2020ATC_1665;    
    No negative effects of transplantation with HCV+ kidneys were identified in this cohort to date. 2.
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
    Clinical, Review, Journal:  Hepatitis C virus infection in children and adolescents. (Pubmed Central) -  May 27, 2020   
    Key actions to address the current policy gaps and achieve treatment scale-up that is comparable to that in adults include: establishment of a campaign on access to testing and treatment that is targeted at children and adolescents; fast-track evaluation of pan-genotypic regimens; and accelerated approval of paediatric formulations. Research gaps that need to be addressed include: age-specific prevalence studies of HCV viraemia in priority countries; further validation of non-invasive tests for staging of liver disease in children; and establishment of paediatric treatment registries and international consortia to promote collaborative research agendas.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Clinical, Retrospective data, Journal, Real-World Evidence:  Sofosbuvir-based regimens in the treatment of patients with chronic hepatitis C virus infection: Real-world efficacy in Thailand. (Pubmed Central) -  May 19, 2020   
    Trial completion date: Sep 2027 --> Nov 2024 | Trial primary completion date: Sep 2027 --> Nov 2024 Sofosbuvir-based regimens in the treatment of patients with chronic HCV infection were highly efficacious with excellent safety and tolerability profiles in a real-world setting; however, further research is required to establish whether or not such a regimen is an adequate treatment for all genotype 6 patients.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Enrollment closed:  BArT: Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection (clinicaltrials.gov) -  May 18, 2020   
    P2,  N=40, Active, not recruiting, 
    Sofosbuvir-based regimens in the treatment of patients with chronic HCV infection were highly efficacious with excellent safety and tolerability profiles in a real-world setting; however, further research is required to establish whether or not such a regimen is an adequate treatment for all genotype 6 patients. Recruiting --> Active, not recruiting
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Journal:  Treatment of chronic hepatitis C virus infection in Rwanda with ledipasvir-sofosbuvir (SHARED): a single-arm trial. (Pubmed Central) -  May 7, 2020   
    P4
    The high adherence and treatment success without intensive support measures or highly specialised clinical providers, and lack of treatment discontinuations due to adverse events support the feasibility of HCV treatment decentralisation and scale-up in sub-Saharan Africa. Genotype 4r is uniquely expressed in this region and associated with high rates of treatment failure, suggesting a need for rigorous test-of-cure in clinical practice and consideration of the use of newer pangenotypic direct-acting antiviral regimens in this region.
  • ||||||||||  NN1213 / Novo Nordisk
    Trial completion, Enrollment change:  STOP-CO: Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant (clinicaltrials.gov) -  May 5, 2020   
    P4,  N=68, Completed, 
    Genotype 4r is uniquely expressed in this region and associated with high rates of treatment failure, suggesting a need for rigorous test-of-cure in clinical practice and consideration of the use of newer pangenotypic direct-acting antiviral regimens in this region. Active, not recruiting --> Completed | N=50 --> 68
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
    LONGITUDINAL HCV CARE OF PREGNANT PATIENTS IN AN “OBSTETRIC HEPATOLOGY” CLINIC () -  May 4, 2020 - Abstract #DDW2020DDW_5525;    
    This low rate of treatment may have been related to limitations on insurance coverage as women transitioned into postpartum healthcare. Nonetheless, this clinic provides an opportunity for HCV infected women to gain education about hepatitis C and access to HCV treatment at an early stage of life, thus helping to prevent progression to advanced HCV-related liver disease
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
    First Reported Treatment Failure in a Recipient of a Hepatitis C Viremic Heart Transplant () -  Apr 26, 2020 - Abstract #ISHLT2020ISHLT_93;    
    After approval for and treatment with ledipasvir/sofosbuvir (L/S) for 8 weeks, the patient's viral load was initially undetectable...He was subsequently initiated on sofosbuvir/velpatasvir/voxilaprevir (S/V/V) with persistent undetectable viral loads to date at 4 months.SummaryThis is the first documented case of DAA treatment failure in a recipient of HCV+/NAT+ transplanted heart treated with L/S...In the new era of HCV transplantation, selection of DAA and duration of treatment are critical. Awareness of the resistance development data is needed when selecting HCV treatment regimens.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Enrollment closed:  Harvoni Treatment Porphyria Cutanea Tarda (clinicaltrials.gov) -  Apr 21, 2020   
    P2,  N=49, Active, not recruiting, 
    The patient tolerated gemcitabine, dexamethasone, cisplatin, and rituximab and achieved sustained virologic response after treatment with ledipasvir/sofosbuvir. Recruiting --> Active, not recruiting
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Journal:  Effects of Age on Treatment of Chronic Hepatitis C with Direct Acting Antivirals. (Pubmed Central) -  Apr 14, 2020   
    The results suggest that CPS could be effectively utilized in drug therapy management of HCV-infected patients treated with DAAs. The high efficacy and tolerance of interferon-free regimens is confirmed in elderly patients in real-life conditions.
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD), Sovaldi (sofosbuvir) / Gilead, Cimivir-L (ledipasvir/sofosbuvir) / Gilead, Tehran University of Medical Sciences
    Journal:  Rescue Therapy for Genotype-3 DAA Non-responders, Almost all Done. (Pubmed Central) -  Apr 14, 2020   
    All the cases achieved sustained virologic response (SVR) at week +12 without adverse effects. In our experience, this combo may represent an effective and safe option for these patients.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial primary completion date:  APOSTLE: Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (clinicaltrials.gov) -  Apr 9, 2020   
    P2,  N=25, Recruiting, 
    The generic SOF/LED fixed-dose combination is safe and effective in children, 9-12 years, and adolescents with vRVR rate of 96%, 100% EOT response and SVR12. Trial completion date: Feb 2020 --> Feb 2021 | Trial primary completion date: Nov 2019 --> Aug 2020
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD), Pifeltro (doravirine) / Merck (MSD), Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    PK/PD data, Journal:  Investigation of Pharmacokinetic Interactions Between Doravirine and Elbasvir/Grazoprevir and Ledipasvir/Sofosbuvir. (Pubmed Central) -  Mar 31, 2020   
    Co-administration of doravirine with elbasvir + grazoprevir or ledipasvir/sofosbuvir was generally well tolerated. Clinically relevant DDIs are not expected to occur between doravirine and elbasvir/grazoprevir or ledipasvir/sofosbuvir at the therapeutic doses.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Retrospective data, Journal:  Effectiveness of 8 weeks of ledipasvir/sofosbuvir for hepatitis C in HCV-HIV-coinfected patients. (Pubmed Central) -  Mar 24, 2020   
    Eight weeks of LDV/SOF was effective for treatment-naïve, non-cirrhotic, HCV-genotype 1 patients in this real-world setting, regardless of HIV status. Increased uptake of the 8-week regimen can decrease costs for patients and payers without compromising outcomes.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) (clinicaltrials.gov) -  Mar 19, 2020   
    P4,  N=10, Completed, 
    The community pharmacists could be accountable to provide such services-if they get the education, training, and remuneration. Recruiting --> Completed | N=15 --> 10 | Trial completion date: Sep 2020 --> Oct 2019 | Trial primary completion date: Aug 2020 --> Jul 2019
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Association of Ledipasvir-Sofosbuvir Treatment With Uveitis in Patients Treated for Hepatitis C. (Pubmed Central) -  Mar 10, 2020   
    In these patients, it appears that treatment with ledipasvir-sofosbuvir for hepatitis C was associated with a mild posterior uveitis different than interferon retinopathy. Given the large number of patients treated with ledipasvir-sofosbuvir, these findings cannot be considered causative, and an association cannot be quantified at this time.