- |||||||||| Journal: Features of resistance-associated substitutions after failure of multiple direct-acting antiviral regimens for hepatitis C. (Pubmed Central) - Aug 22, 2020
R30H and L31-RAS in NS5A were frequently detected after failure of regimens including daclatasvir...S282T RAS in NS5B was detected in 3.9% of ledipasvir/sofosbuvir failures...We investigated RASs after failure of various treatments for chronic hepatitis C, and found that more complicated RASs accumulated in the viral genome with successive failed treatments. The highly resistant P32del RAS at NS5A region was uniquely found in patients for whom DAA treatments had failed, and was linked to the presence and absence of specific RASs.
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Forced Oxidative Degradation Pathways of the Imidazole Moiety of Daclatasvir. (Pubmed Central) - Aug 20, 2020 Degradants 2-8 were observed in a solution of DCV exposed to high intensity light/UV light; the formation of degradants 2 and 5-8 were postulated through four degradation pathways. The degradants 3 and 4 were deemed to be secondary degradants of 7 and 5, respectively.
- |||||||||| Preclinical, Journal: Anti-HIV and anti-HCV drugs inhibit p-glycoprotein efflux activity in Caco-2 cells and precision-cut rat and human intestinal slices. (Pubmed Central) - Aug 20, 2020
Lopinavir, ritonavir, saquinavir, atazanavir, maraviroc, ledipasvir, and daclatasvir inhibited the efflux of a model ABCB1 substrate, rhodamine 123 (RHD123), in Caco-2 cells and rat-derived PCIS...Abacavir, zidovudine, tenofovir disoproxil fumarate, etravirine, and rilpivirine did not inhibit intestinal ABCB1...Our data help clarify the molecular mechanisms responsible for reported increases in the bioavailability of ABCB1 substrates including antivirals and drugs prescribed to treat co-morbidity. These results could help guide the selection of combination pharmacotherapies and/or suitable dosing schemes for patients infected with HIV and/or HCV.
- |||||||||| 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
- |||||||||| simvastatin / Generic mfg., Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Clinical effects of simvastatin in chronic hepatitis C patients receiving sofosbuvir/daclatasvir combination. A randomized, placebo-controlled, double-blinded study. (Pubmed Central) - Aug 1, 2020 Logistic regression analysis showed that high baseline CRP, low baseline hemoglobin level and non-statin usage had an independent effect on increasing the probability of SVR failure in both groups; p = 0.03, p = 0.0028, p = 0.02, respectively. Statins could have an irreplaceable role in successful treatment of CHC patients receiving sofosbuvir/daclatasvir.
- |||||||||| Daklinza (daclatasvir) / BMS
Clinical, Journal: Management of HCV in Children in the Era of DAA's. (Pubmed Central) - Jul 29, 2020 Efforts from worldwide health organizations, the pharmaceutical industry, and clinical and research institutions have resulted in very effective interferon-free therapy with direct-acting antiviral agents (DAA's) for HCV-infected children. In this manuscript, we will briefly review the epidemiology of HCV in children, historic treatment, current published data on DAA's in children and conclude with suggestions for management of the child with HCV in the era of DAA's.
- |||||||||| Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
Journal: Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program. (Pubmed Central) - Jul 25, 2020 DCV-based antiviral therapy was well tolerated and resulted in a high SVR when combined with SOF either in pre-transplant and in OLT patients and in "difficult to treat" HCV genotypes. Regimens containing DCV in combination with NS3 protease inhibitors obtained suboptimal results.
- |||||||||| Daklinza (daclatasvir) / BMS
[VIRTUAL] SUCCESSFUL TREATMENT OF HEPATITIS C IN AN EGYPTIAN PATIENT WITH POLYCYTHEMIA RUBRA VERA WITH DIRECT-ACTING ANTIVIRALS (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_5631; The diagnosis of PRV was confirmed and she was kept on hydroxyurea 500mg twice daily, in addition to pentoxifylline, and aspirin 100mg once daily for fear of thrombotic complications...According to national protocols, she received Sofosbuvir 400mg, Daclatasvir 60mg and Ribavirin (RBV) 800mg once daily for 12 weeks, with monthly follow-up...At week 12, since hemoglobin level became stable (14.6 g/dl) and PLT was 575x103/mm3, the dose of hydroxyurea was increased to thrice daily, anagrelide was reduced to twice daily, and pentoxifylline was stopped. The patient achieved sustained virological response by HCV PCR done 12 weeks after end of treatment, and her labs (including liver functions and blood picture) remained stable.
- |||||||||| Daklinza (daclatasvir) / BMS
[VIRTUAL] SUCCESSFUL TREATMENT OF HEPATITIS C IN AN EGYPTIAN PATIENT WITH POLYCYTHEMIA RUBRA VERA WITH DIRECT-ACTING ANTIVIRALS (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_3655; The diagnosis of PRV was confirmed and she was kept on hydroxyurea 500mg twice daily, in addition to pentoxifylline, and aspirin 100mg once daily for fear of thrombotic complications...According to national protocols, she received Sofosbuvir 400mg, Daclatasvir 60mg and Ribavirin (RBV) 800mg once daily for 12 weeks, with monthly follow-up...At week 12, since hemoglobin level became stable (14.6 g/dl) and PLT was 575x103/mm3, the dose of hydroxyurea was increased to thrice daily, anagrelide was reduced to twice daily, and pentoxifylline was stopped. The patient achieved sustained virological response by HCV PCR done 12 weeks after end of treatment, and her labs (including liver functions and blood picture) remained stable.
- |||||||||| Daklinza (daclatasvir) / BMS
[VIRTUAL] SUCCESSFUL TREATMENT OF HEPATITIS C IN AN EGYPTIAN PATIENT WITH POLYCYTHEMIA RUBRA VERA WITH DIRECT-ACTING ANTIVIRALS (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_1671; The diagnosis of PRV was confirmed and she was kept on hydroxyurea 500mg twice daily, in addition to pentoxifylline, and aspirin 100mg once daily for fear of thrombotic complications...According to national protocols, she received Sofosbuvir 400mg, Daclatasvir 60mg and Ribavirin (RBV) 800mg once daily for 12 weeks, with monthly follow-up...At week 12, since hemoglobin level became stable (14.6 g/dl) and PLT was 575x103/mm3, the dose of hydroxyurea was increased to thrice daily, anagrelide was reduced to twice daily, and pentoxifylline was stopped. The patient achieved sustained virological response by HCV PCR done 12 weeks after end of treatment, and her labs (including liver functions and blood picture) remained stable.
- |||||||||| Copegus (ribavirin) / Bausch Health, Daklinza (daclatasvir) / BMS
Clinical, Journal: Retreatment of Egyptian Chronic Hepatitis C Patients Not Responding to Pegylated Interferon and Ribavirin Dual Therapy. (Pubmed Central) - Jul 16, 2020 In the current study, we aimed to assess the efficacy of different Sofosbuvir (SOF)-based antiviral regimens available in Egypt in the treatment of Pegylated interferon/Ribavirin (PEG-INF/RBV)-experienced chronic hepatitis C virus (HCV) patients...The patients received one of the following 3 regimens for 12 weeks; PEG-INF/SOF, Simeprevir/SOF (SIM/SOF), and Daclatasvir/SOF (DCV/SOF)...A SIM/SOF regimen provokes the highest SVR12 in PEG-INF/RBV-experienced chronic HCV patients. Retreatment with PEG-INF/SOF in PEG-INF/RBV-experienced chronic HCV patients has a high probability of treatment failure.
- |||||||||| Clinical, Journal: Successful treatment of HBV, HCV, & HEV, with 12-week long use of tenofovir, sofosbuvir, daclatasvir, and ribavirin: A case report. (Pubmed Central) - Jul 4, 2020
Here, we suggest well-tolerated sofsobuvir-based treatment regimen in patient infected with HBV, HCV, and HEV. Twelve weeks long treatment with sofsobuvir, daclatasvir, ribavirin, and tenofovir resulted in sustained virological response (SVR) and cleared HBV, HCV, and HEV in diabetic and asthmatic patient.
- |||||||||| velpatasvir (GS-5816) / Gilead, Daklinza (daclatasvir) / BMS
Clinical, Journal: Effect of the baseline Y93H resistance-associated substitution in HCV genotype 3 for direct-acting antiviral treatment: real-life experience from a multicenter study in Sweden and Norway. (Pubmed Central) - Jul 4, 2020 This RAS may impair HCV DAA treatment response, since it possesses a high fold in vitro resistance to daclatasvir (DCV) and velpatasvir (VEL) in GT 3...Detection of baseline Y93H above 20% prompted a prolonged treatment duration of NS5A-inhibitor and sofosbuvir (SOF) and/or addition of ribavirin (RBV)...In the control group, 2/4 patients with Y93H at baseline treated with ledipasvir/SOF/RBV or DCV/SOF without RBV, failed treatment. The results from this real-life study are in accordance with the findings of the randomised controlled trials in 2015 and the EASL-guidelines of 2016, thus, baseline Y93H impacts on DCV and VEL treatment outcome.
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Direct-Acting Antiviral Drugs and Occurrence of Hepatocellular Carcinoma: Unjust or Oppressed. (Pubmed Central) - Jul 3, 2020 No significant changes in MELD score. Treatment of HCV-related LC patients with sofosbuvir and daclatasvir with or without ribavirin for 3 or 6 months showed high SVR and significant improvement in CP score, but still at risk of HCC even if treated and should be followed up regularly according to screening programs with special meticulous attention to those with non-SVR.
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