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Journal articles on the topic 'Daclatasvir'

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Author: Grafiati

Published: 9 March 2023

Last updated: 10 March 2023

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1

Sacramento, Carolina Q., Natalia Fintelman-Rodrigues, Jairo R. Temerozo, Aline de Paula Dias Da Silva, Suelen da Silva Gomes Dias, Carine dos Santos da Silva, André C. Ferreira, et al. "In vitro antiviral activity of the anti-HCV drugs daclatasvir and sofosbuvir against SARS-CoV-2, the aetiological agent of COVID-19." Journal of Antimicrobial Chemotherapy 76, no. 7 (April 21, 2021): 1874–85. http://dx.doi.org/10.1093/jac/dkab072.

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Abstract Background Current approaches of drug repurposing against COVID-19 have not proven overwhelmingly successful and the SARS-CoV-2 pandemic continues to cause major global mortality. SARS-CoV-2 nsp12, its RNA polymerase, shares homology in the nucleotide uptake channel with the HCV orthologue enzyme NS5B. Besides, HCV enzyme NS5A has pleiotropic activities, such as RNA binding, that are shared with various SARS-CoV-2 proteins. Thus, anti-HCV NS5B and NS5A inhibitors, like sofosbuvir and daclatasvir, respectively, could be endowed with anti-SARS-CoV-2 activity. Methods SARS-CoV-2-infected Vero cells, HuH-7 cells, Calu-3 cells, neural stem cells and monocytes were used to investigate the effects of daclatasvir and sofosbuvir. In silico and cell-free based assays were performed with SARS-CoV-2 RNA and nsp12 to better comprehend the mechanism of inhibition of the investigated compounds. A physiologically based pharmacokinetic model was generated to estimate daclatasvir’s dose and schedule to maximize the probability of success for COVID-19. Results Daclatasvir inhibited SARS-CoV-2 replication in Vero, HuH-7 and Calu-3 cells, with potencies of 0.8, 0.6 and 1.1 μM, respectively. Although less potent than daclatasvir, sofosbuvir alone and combined with daclatasvir inhibited replication in Calu-3 cells. Sofosbuvir and daclatasvir prevented virus-induced neuronal apoptosis and release of cytokine storm-related inflammatory mediators, respectively. Sofosbuvir inhibited RNA synthesis by chain termination and daclatasvir targeted the folding of secondary RNA structures in the SARS-CoV-2 genome. Concentrations required for partial daclatasvir in vitro activity are achieved in plasma at Cmax after administration of the approved dose to humans. Conclusions Daclatasvir, alone or in combination with sofosbuvir, at higher doses than used against HCV, may be further fostered as an anti-COVID-19 therapy.

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2

Smith, Michael A., Randolph E. Regal, and Rima A. Mohammad. "Daclatasvir." Annals of Pharmacotherapy 50, no. 1 (October 20, 2015): 39–46. http://dx.doi.org/10.1177/1060028015610342.

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3

Reviriego, C. "Daclatasvir dihydrochloride." Drugs of the Future 36, no. 10 (2011): 735. http://dx.doi.org/10.1358/dof.2011.036.10.1703570.

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4

SHULPEKOVA, Y. O., N. V. SHULPEKOVA, M. C. SEMENISTAYA, A. A. USANOVA, and C. S. PAVLOV. "TREATMENT OF HCV INFECTION BY A COMBINATION OF SOFOSBUVIR AND DACLATASVIR." Medical Council, no. 4 (May 26, 2017): 36–41. http://dx.doi.org/10.21518/2079-701x-2017-4-36-41.

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The purpose of the review is to evaluate the efficacy and safety of using pangenotypic combination «of Sofosbuvir/Daclatasvir» — the direct action antiviral drugs in the treatment of chronic HCV infection at different stages of liver damage.Main provisions: Sofosbuvir is the antisense nucleotide, inhibiting RNA-dependent RNA-polymerase NS5B, this drug has earned a reputation as one of the strongest anti-replication drugs, including when there is interferon resistance. Daclatasvir is a powerful non-nucleotide inhibitor of NS5А protein, catalyzing formation of replicative complexes. Both components are proven to be effect against HCV genotypes 1-6. Their combination provides pangenotypic activity, and the mutual strengthening effect diminishes the risk of development of drug resistance. Indications for the administration of a combination «Sofosbuvir/Daclatasvi» are: treatment of HCV infection at the stage of acute hepatitis (for genotypes 1–6 of the virus), treatment for HCV infection at the stage of chronic hepatitis (for genotypes 1–6 of the virus), treatment of HCV infection in co-infection with HIV, treatment of HCV infection at the stage of liver cirrhosis, treatment of recurrent HCV infection after liver transplantation, treatment of HCV infection with immune manifestations.Conclusion: the combination «Sofosbuvir/Daclatasvir» is shown to be highly effective in the treatment of HCV infection of genotypes 1-6 with a frequency of SVR 93—97% at the stage of the hepatitis and 88—95% — at the stage of cirrhosis. Good tolerance and high efficiency has led to active use of this combination фе the stage of cirrhosis. This combination has been successfully used for the treatment of recurrence of HCV infection in the liver graft, including co-infection with HIV.

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5

Chakravarthy, V. Ashok, Sailaja Bbv, and Praveen Kumar A. "METHOD DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-VISIBLE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF HEPATITIS-C DRUGS - DACLATASVIR AND SOFOSBUVIR IN ACTIVE PHARMACEUTICAL INGREDIENT FORM." Asian Journal of Pharmaceutical and Clinical Research 9, no. 9 (December 1, 2016): 61. http://dx.doi.org/10.22159/ajpcr.2016.v9s3.14616.

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ABSTRACTObjective: The objective of the present work is to develop a simple, efficient, and reproducible spectrophotometric method for the quantitativeestimation of hepatitis-C drugs - Daclatasvir and Sofosbuvir in its active pharmaceutical ingredient (API) form.Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of hepatitis-C drugs - Daclatasvir and Sofosbuvir isbased on measurement of absorption at a wavelength maximum (λmax) of 317 and 261 nm using methanol as solvent.Results: The method was validated in terms of specificity, precision, linearity, accuracy, and robustness as per the ICH guidelines. The method wasfound to be linear in the range of 50-150% for Daclatasvir and in the range of 43-143% for Sofosbuvir. The percentage recovery values were in therange of 99.4-100.6% for Daclatasvir and in the range of 99.7-100.6% for Sofosbuvir at different concentration levels. Relative standard deviation forprecision and intermediate precision results were found to be <2%. The correlation coefficient value observed for Daclatasvir and Sofosbuvir drugsubstances was not <0.99, 0.99, respectively. Results obtained from the validation experiments prove that the developed method is quantified for theestimation of Daclatasvir and Sofosbuvir drug substances.Conclusion: The developed method can be successfully applied for routine analysis, quality control analysis, and also suitable for stability analysis ofDaclatasvir and Sofosbuvir in API form as per the regulatory requirements.Keywords: Daclatasvir, Sofosbuvir, Method development, Validation, Ultraviolet-visible spectrophotometry.

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6

C. Damle, Mrinalini, and Nivedita B. Pawar. "STABILITY INDICATING HPLC METHOD FOR SOFOSBUVIR AND DACLATASVIR IN COMBINATION." Indian Drugs 59, no. 10 (November 14, 2022): 74–79. http://dx.doi.org/10.53879/id.59.10.12506.

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Direct acting fixed dose combination of sofosbuvir and daclatasvir to treat the viral hepatitis C disease is available in the market. So, a precise and robust stability indicating HPLC method for sofosbuvir and daclatasvir was developed. The SunQ C18 column (250 x 4.6 mm) was used for chromatographic separation with mobile phase consisting of 0.03 mM potassium dihydrogen phosphate buffer (pH 7): ACN (50: 50V/V). Optimised method satisfies the system suitability parameters with good resolution with 4.9 min Rt of sofosbuvir and 7.6 min Rt of daclatasvir. The method was validated as per ICH guidelines. Linearity was observed over range of 10-50 (µg mL-1) and 2.25-11.25 (µg mL-1) for sofosbuvir and daclatasvir, respectively. Both drugs were subjected to various stress conditions and high recovery values were found for daclatasvir on photolytic stress. The degradation was more on oxidative and hydrolytic stress for sofosbuvir. This optimised method offers new insight towards stability studies of both drugs.

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7

Hessel, Marleen H. M., Adam F. Cohen, and Robert Rissmann. "Sofosbuvir and daclatasvir." British Journal of Clinical Pharmacology 82, no. 3 (June 12, 2016): 878–79. http://dx.doi.org/10.1111/bcp.13011.

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8

Red. "Zulassungserweiterung für Daclatasvir." MMW - Fortschritte der Medizin 158, no. 8 (April 2016): 87. http://dx.doi.org/10.1007/s15006-016-8160-x.

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9

Godela, Ramreddy, and Sowjanya G. "Concurrent Determination of Daclatasvir and Sofosbuvir in Pure Binary Mixture and Their Combined Film Coated Tablets by a Simple Stability Indicating RP-HPLC Method." Research Journal of Pharmacy and Technology, November 30, 2021, 5913–18. http://dx.doi.org/10.52711/0974-360x.2021.01028.

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A trouble-free, simple, specific and highly sensitive stability indicating phase HPLC method was developed for concurrent assessment of Daclatasvir and Sofosbuvir in pure and in their combined tablet formulation. An effectual separation was accomplished by using XDB Phenyl (250 x 4.6mm, 5µ,100 A0) column, mobile phase composition of Acetonitrile: buffer(0.1%v/v Trifluoroaceticacid in water) (50:50 v/v) and isocratic elution at a flow rate of 1ml/min and detection wavelength of 275nm. The extreme stress conditions like hydrolysis with acid and base, peroxide oxidation, thermal decomposition were used as per ICH specifications to assess the stability of the analytes in bulk and dosage forms. The retention times of Daclatasvir and Sofosbuvir were found at 2.8 and 3.7min respectively. The proposed method has linear response in the concentration ranges from 12 to 36µg/ml and 80 to 240 µg/ml for Daclatasvir and Sofosbuvir respectively. The detection and quantification limits calculated as 2.5μg/ml and 7.8μg/ml for DCL, 5.2μg/ml and 15.8μg/ml SOF respectively. All the method validation parameters were met the acceptance limits of Q2 specifications of ICH procedures. The degradation products produced by forced degradation studies were have good resolution from Daclatasir and Sofosbuvir peaks, which represents the methods stability. The proposed RP-HPLC method was highly sensitive, precise, stability indicating and economical. That’s why the method has the capacity to employ in the pharmaceutical manufacturing of Daclatasvir and Sofosbuvir and routine analysis in quality control department.

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10

"Daclatasvir." Reactions Weekly 1641, no. 1 (March 2017): 102. http://dx.doi.org/10.1007/s40278-017-27016-7.

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11

"Daclatasvir." Reactions Weekly 1587, no. 1 (February 2016): 111. http://dx.doi.org/10.1007/s40278-016-14430-2.

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12

"Daclatasvir." Reactions Weekly 1802, no. 1 (May 2020): 113. http://dx.doi.org/10.1007/s40278-020-78031-y.

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13

Elbadawy, Heba A., Sara A. Wahdan, and Ebtehal El-Demerdash. "Effect of atorvastatin on single oral pharmacokinetics and safety of daclatasvir in rats: Emphasis on P-glycoprotein and cytochrome P450." Current Drug Metabolism 23 (April 4, 2022). http://dx.doi.org/10.2174/1389200223666220404134524.

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Objective: This study was aimed to investigate the effect of atorvastatin on daclatasvir oral pharmacokinetics and safety and assess the possible underlining mechanisms through targeting P-glycoprotein (P-gp) and cytochrome P450 (CYP3A4). Methods: The transport of daclatasvir, as well as the standard rhodamine 123 by P-gp across the rat intestine, was studied in vitro using the non-everted sac method. To assess the pharmacokinetic profile of daclatasvir in vivo, rats were divided into three groups receiving either saline, a standard P-gp inhibitor verapamil (25 mg/kg), or atorvastatin (10 mg/kg), 2hrs prior to a single dose of daclatasvir (7 mg/kg). In addition, the markers of liver and kidney functions and muscle rhabdomyolysis were assessed. Further, histopathological examination of liver and kidney tissue and assessment of CYP3A4 level were done. Results: The inhibitory effect of atorvastatin on Pgp activity and expression was manifested by increased serosal transport of the standard rhodamine 123, as well as daclatasvir. In vivo, Cmax (peak plasma concentration) and Area under the curve (AUC (0‐t)) of daclatasvir after atorvastatin treatment increased compared to vehicle group but not in a significant manner. On the other hand, atorvastatin caused a significant increase in the clearance of daclatasvir. Concomitant administration of atorvastatin with daclatasvir significantly decreased CYP3A4 content compared to the control group. The combination also showed increased liver enzymes and some pathological alterations in the liver. Conclusion: Atorvastatin has a significant effect on P-gp mediated intestinal transport of daclatasvir, however, it did not affect the systemic bioavailability of a single oral dose of daclatasvir.

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14

"Daclatasvir/sofosbuvir." Reactions Weekly 1837, no. 1 (January 2021): 195. http://dx.doi.org/10.1007/s40278-021-88794-8.

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15

"Asunaprevir/daclatasvir." Reactions Weekly 1928, no. 1 (October 15, 2022): 76. http://dx.doi.org/10.1007/s40278-022-25341-x.

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16

"Asunaprevir/daclatasvir." Reactions Weekly 1922, no. 1 (September 3, 2022): 102. http://dx.doi.org/10.1007/s40278-022-22387-2.

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17

"Daclatasvir/sofosbuvir." Reactions Weekly 1879, no. 1 (October 2021): 119. http://dx.doi.org/10.1007/s40278-021-04603-y.

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18

"Asunaprevir/daclatasvir." Reactions Weekly 1583, no. 1 (January 2016): 155. http://dx.doi.org/10.1007/s40278-016-12718-4.

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19

"Asunaprevir/daclatasvir." Reactions Weekly 1586, no. 1 (January 2016): 51. http://dx.doi.org/10.1007/s40278-016-14077-6.

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20

"Asunaprevir/daclatasvir." Reactions Weekly 1687, no. 1 (February 2018): 44. http://dx.doi.org/10.1007/s40278-018-41465-z.

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"Asunaprevir/daclatasvir." Reactions Weekly 1688, no. 1 (February 2018): 34. http://dx.doi.org/10.1007/s40278-018-41669-8.

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22

"Daclatasvir/sofosbuvir." Reactions Weekly 1689, no. 1 (February 2018): 72. http://dx.doi.org/10.1007/s40278-018-41941-4.

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"Asunaprevir/daclatasvir." Reactions Weekly 1690, no. 1 (February 2018): 39. http://dx.doi.org/10.1007/s40278-018-42105-8.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1692, no. 1 (March 2018): 125. http://dx.doi.org/10.1007/s40278-018-42653-6.

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"Asunaprevir/daclatasvir." Reactions Weekly 1693, no. 1 (March 2018): 70. http://dx.doi.org/10.1007/s40278-018-42960-z.

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"Asunaprevir/daclatasvir." Reactions Weekly 1696, no. 1 (April 2018): 49. http://dx.doi.org/10.1007/s40278-018-44237-x.

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"Asunaprevir/daclatasvir." Reactions Weekly 1706, no. 1 (June 2018): 64. http://dx.doi.org/10.1007/s40278-018-47393-6.

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"Asunaprevir/daclatasvir." Reactions Weekly 1707, no. 1 (June 2018): 55. http://dx.doi.org/10.1007/s40278-018-47871-y.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1713, no. 1 (August 2018): 120. http://dx.doi.org/10.1007/s40278-018-49954-5.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1713, no. 1 (August 2018): 121. http://dx.doi.org/10.1007/s40278-018-49955-5.

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"Asunaprevir/daclatasvir." Reactions Weekly 1714, no. 1 (August 2018): 61. http://dx.doi.org/10.1007/s40278-018-50241-4.

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"Asunaprevir/daclatasvir." Reactions Weekly 1717, no. 1 (September 2018): 52. http://dx.doi.org/10.1007/s40278-018-51122-5.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1722, no. 1 (October 2018): 123. http://dx.doi.org/10.1007/s40278-018-52452-6.

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"Daclatasvir/simeprevir." Reactions Weekly 1629, no. 1 (November 2016): 96. http://dx.doi.org/10.1007/s40278-016-23368-0.

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"Asunaprevir/daclatasvir." Reactions Weekly 1631, no. 1 (December 2016): 32. http://dx.doi.org/10.1007/s40278-016-23810-8.

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"Asunaprevir/daclatasvir." Reactions Weekly 1633, no. 1 (January 2017): 91. http://dx.doi.org/10.1007/s40278-017-24362-5.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1633, no. 1 (January 2017): 251. http://dx.doi.org/10.1007/s40278-017-24520-5.

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"Asunaprevir/daclatasvir." Reactions Weekly 1636, no. 1 (January 2017): 47. http://dx.doi.org/10.1007/s40278-017-25607-2.

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"Asunaprevir/daclatasvir." Reactions Weekly 1636, no. 1 (January 2017): 48. http://dx.doi.org/10.1007/s40278-017-25608-2.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1640, no. 1 (February 2017): 119. http://dx.doi.org/10.1007/s40278-017-26672-5.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1640, no. 1 (February 2017): 120. http://dx.doi.org/10.1007/s40278-017-26673-5.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1641, no. 1 (March 2017): 103. http://dx.doi.org/10.1007/s40278-017-27017-7.

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"Asunaprevir/daclatasvir." Reactions Weekly 1643, no. 1 (March 2017): 46. http://dx.doi.org/10.1007/s40278-017-27519-x.

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"Asunaprevir/daclatasvir." Reactions Weekly 1643, no. 1 (March 2017): 47. http://dx.doi.org/10.1007/s40278-017-27520-9.

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"Asunaprevir/daclatasvir." Reactions Weekly 1646, no. 1 (April 2017): 56. http://dx.doi.org/10.1007/s40278-017-28420-8.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1647, no. 1 (April 2017): 106. http://dx.doi.org/10.1007/s40278-017-28798-8.

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"Asunaprevir/daclatasvir." Reactions Weekly 1648, no. 1 (April 2017): 55. http://dx.doi.org/10.1007/s40278-017-29034-z.

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"Asunaprevir/daclatasvir." Reactions Weekly 1680, no. 1 (December 2017): 60. http://dx.doi.org/10.1007/s40278-017-38991-0.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1681, no. 1 (December 2017): 126. http://dx.doi.org/10.1007/s40278-017-39402-3.

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"Daclatasvir/sofosbuvir." Reactions Weekly 1683, no. 1 (January 2018): 240. http://dx.doi.org/10.1007/s40278-018-40177-7.

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