ledipasvir/sofosbuvir / Generic mfg. 
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  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  Ledipasvir/Sofosbuvir: A Review in Chronic Hepatitis C. (Pubmed Central) -  Apr 5, 2019   
    In other trials, ledipasvir/sofosbuvir (± ribavirin) was associated with high SVR12 rates in various CHC populations, including patients with HCV GT2, 3, 4, 5 or 6 infection, cirrhosis, pre and/or post liver or renal transplantation, inherited blood disorders or failure after prior DAA and/or interferon therapy. Thus, ledipasvir/sofosbuvir (± ribavirin) is a valuable effective and generally well tolerated option for adolescent and adult patients with HCV GT1, 4, 5 or 6 infection, including those with HIV co-infection or cirrhosis, with evidence also supporting its use in patients with chronic HCV GT2 or 3 infection.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Biomarker, Journal:  Evolution of glomerular filtration rates and neutrophil gelatinase-associated lipocalin during treatment with direct acting antivirals. (Pubmed Central) -  Apr 5, 2019   
    ...Subgroup analysis on serum NGAL was conducted in those receiving sofosbuvir/ledipasvir, with complete follow-up until week 12 after the end of treatment (FU-12)...In conclusion, compared to a negligible eGFR decline observed in the entire cohort analyzed, a significant NGAL increase was observed after HCV treatment with DAA in a small subgroup. This could reflect tubular damage during DAA treatment rather than glomerular injury.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Clinical, PK/PD data, Journal:  Clinical Pharmacokinetics and Drug Interactions of Doravirine. (Pubmed Central) -  Mar 30, 2019   
    No clinically significant interactions were noted between doravirine and an antacid (aluminum-magnesium), pantoprazole, ledipasvir/sofosbuvir, or elbasvir/grazoprevir. Further study is needed to better understand doravirine's efficacy and safety profile when co-administered with other agents known to be CYP inducers or inhibitors.
  • ||||||||||  Strimvelis (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) / Orchard Therap, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  Successful treatment with Harvoni in an ADA-SCID infant with HCV infection allowed gene therapy with Strimvelis. (Pubmed Central) -  Mar 25, 2019   
    In case of HCV positivity, patients might be excluded from life-saving treatments. As HCV antibodies could be negative in young infant immunodeficient patients due to their immature/impaired immune system, or positive due to maternal-fetal antibody transmission, the risk is usually also evaluated on the basis of the HCV-RNA.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Safety and Efficacy of Ledipasvir-Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6-11. (Pubmed Central) -  Mar 25, 2019   
    As HCV antibodies could be negative in young infant immunodeficient patients due to their immature/impaired immune system, or positive due to maternal-fetal antibody transmission, the risk is usually also evaluated on the basis of the HCV-RNA. Ledipasvir-sofosbuvir was well tolerated and highly effective in children 6 to <12 years old with chronic HCV.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial primary completion date, Adherence:  Evaluation of HepCure Toolkit to Improve Harvoni Adherence (clinicaltrials.gov) -  Mar 11, 2019   
    P=N/A,  N=99, Recruiting, 
    In this SOF-experienced NS5A inhibitor-naïve population, which included participants with cirrhosis or HCV/HIV co-infection, high SVR12 rates were achieved. Trial completion date: Dec 2018 --> Mar 2019 | Trial primary completion date: Dec 2018 --> Mar 2019
  • ||||||||||  NN1213 / Novo Nordisk, Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma, Exviera (dasabuvir) / AbbVie
    Trial completion date, Trial primary completion date:  DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (clinicaltrials.gov) -  Mar 5, 2019   
    P2/3,  N=32, Recruiting, 
    Trial completion date: Dec 2018 --> Mar 2019 | Trial primary completion date: Dec 2018 --> Mar 2019 Trial completion date: Dec 2018 --> Dec 2020 | Trial primary completion date: Dec 2018 --> Oct 2020
  • ||||||||||  Trial completion date, Trial primary completion date:  SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) -  Feb 28, 2019   
    P2,  N=160, Recruiting, 
    Trial completion date: Dec 2018 --> Dec 2020 | Trial primary completion date: Dec 2018 --> Oct 2020 Trial completion date: Mar 2019 --> Dec 2020 | Trial primary completion date: Dec 2018 --> Oct 2020
  • ||||||||||  Trial primary completion date:  PRIORITIZE: Study of Oral Treatments for Hepatitis C (clinicaltrials.gov) -  Jan 29, 2019   
    P4,  N=1676, Active, not recruiting, 
    Active, not recruiting --> Completed Trial primary completion date: Jan 2019 --> Apr 2019
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial primary completion date, Metastases:  Hepatitis C Virus(HCV) Heart and Lung Study (clinicaltrials.gov) -  Dec 21, 2018   
    P4,  N=50, Recruiting, 
    Trial completion date: Dec 2018 --> Jun 2019 Trial completion date: Dec 2018 --> Apr 2019 | Trial primary completion date: Dec 2018 --> Apr 2019
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Enrollment closed, Trial completion date, Trial primary completion date:  Study of Hepatitis C Treatment During Pregnancy (clinicaltrials.gov) -  Dec 6, 2018   
    P1,  N=15, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Sep 2019 --> Feb 2020 | Trial primary completion date: Sep 2019 --> Feb 2020
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial primary completion date:  BArT: Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection (clinicaltrials.gov) -  Nov 20, 2018   
    P2,  N=44, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Sep 2019 --> Feb 2020 | Trial primary completion date: Sep 2019 --> Feb 2020 Trial completion date: Oct 2020 --> May 2022 | Trial primary completion date: Oct 2018 --> May 2019
  • ||||||||||  ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Phase classification:  Efficacy and Safety of Sofosbuvir/Ledipasvir  (clinicaltrials.gov) -  Nov 16, 2018   
    P3b,  N=341, Completed, 
    Trial completion date: Oct 2020 --> May 2022 | Trial primary completion date: Oct 2018 --> May 2019 Phase classification: P3 --> P3b
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date, HEOR:  Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection (clinicaltrials.gov) -  Oct 25, 2018   
    P3,  N=14, Completed, 
    Phase classification: P3 --> P3b Enrolling by invitation --> Completed | N=30 --> 14 | Trial completion date: Feb 2019 --> Jun 2018 | Trial primary completion date: Dec 2018 --> Jun 2018
  • ||||||||||  NN1213 / Novo Nordisk
    Trial completion date, Trial primary completion date:  STOP-CO: Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant (clinicaltrials.gov) -  Sep 24, 2018   
    P4,  N=50, Recruiting, 
    Recruiting --> Completed | N=10 --> 7 | Trial completion date: Sep 2017 --> Aug 2018 | Trial primary completion date: Aug 2017 --> Aug 2018 Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial primary completion date:  APOSTLE: Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (clinicaltrials.gov) -  Sep 10, 2018   
    P2,  N=10, Recruiting, 
    Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Trial completion date: Nov 2018 --> Nov 2019 | Trial primary completion date: Aug 2018 --> May 2019
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date:  Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients. (clinicaltrials.gov) -  Aug 31, 2018   
    P4,  N=0, Withdrawn, 
    Active, not recruiting --> Completed N=20 --> 0 | Trial completion date: Aug 2021 --> Apr 2018 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2018 --> Feb 2018
  • ||||||||||  Trial completion, Enrollment change:  Impact of Antiviral Therapy on Gastroesophageal Varices. (clinicaltrials.gov) -  May 30, 2018   
    P=N/A,  N=237, Completed, 
    Trial completion date: Nov 2024 --> Aug 2023 | Trial primary completion date: May 2024 --> Aug 2023 Active, not recruiting --> Completed | N=374 --> 237
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD), Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma, Exviera (dasabuvir) / AbbVie
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  PRIORITIZE: Study of Oral Treatments for Hepatitis C (clinicaltrials.gov) -  Mar 22, 2018   
    P4,  N=1670, Active, not recruiting, 
    In post kidney transplant patients with HCV infection with or without co-infection with HIV, a combination of LDV/SOF was well tolerated and effective. Recruiting --> Active, not recruiting | N=2670 --> 1670 | Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Aug 2020 --> Jan 2019
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Trial completion, Trial completion date:  Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients (clinicaltrials.gov) -  Mar 19, 2018   
    P4,  N=112, Completed, 
    Recruiting --> Active, not recruiting | N=2670 --> 1670 | Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Aug 2020 --> Jan 2019 Recruiting --> Completed | Trial completion date: Dec 2017 --> Mar 2018
  • ||||||||||  Pegasys (pegylated interferon ? -2a) / Roche, Sunvepra (asunaprevir) / BMS, Olysio (simeprevir) / J&J, Medivir
    Trial completion date, Trial primary completion date:  SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) -  Mar 19, 2018   
    P2,  N=160, Recruiting, 
    Recruiting --> Completed | Trial completion date: Dec 2017 --> Mar 2018 Trial completion date: Dec 2017 --> Mar 2019 | Trial primary completion date: Dec 2017 --> Dec 2018
  • ||||||||||  Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma, Exviera (dasabuvir) / AbbVie
    Trial completion date, Trial primary completion date:  DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (clinicaltrials.gov) -  Mar 19, 2018   
    P2/3,  N=32, Recruiting, 
    Trial completion date: Dec 2017 --> Mar 2019 | Trial primary completion date: Dec 2017 --> Dec 2018 Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Dec 2018
  • ||||||||||  daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Trial completion, Trial completion date, Trial primary completion date:  Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients (clinicaltrials.gov) -  Mar 19, 2018   
    P3,  N=48, Completed, 
    Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Dec 2018 Recruiting --> Completed | Trial completion date: Dec 2017 --> Mar 2018 | Trial primary completion date: Sep 2017 --> Dec 2017