- |||||||||| 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
- |||||||||| 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
- |||||||||| 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
- |||||||||| 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
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