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Articles de revues sur le sujet « Daclatasvir »

Auteur : Grafiati

Publié le 9 mars 2023

Mis à jour le 22 juin 2025

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1

Sacramento, Carolina Q., Natalia Fintelman-Rodrigues, Jairo R. Temerozo, 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 (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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Smith, Michael A., Randolph E. Regal, and Rima A. Mohammad. "Daclatasvir." Annals of Pharmacotherapy 50, no. 1 (2015): 39–46. http://dx.doi.org/10.1177/1060028015610342.

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CH., V. S. Gautam* N. Harika V. Balaji V. Srinivas Prasad. "METHOD DEVELOPMENT AND VALIDATION OF DACLATASVIR IN BULK & PHARMACEUTICAL DOSAGE FORM BY UV-VISIBLE SPECTROPHOTOMETRY." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 03 (2018): 1980–85. https://doi.org/10.5281/zenodo.1213232.

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Objective: The objective of the present work is to develop a simple, efficient, and reproducible spectrophotometric method for the quantitative estimation of hepatitis-C drug - Daclatasvir in active pharmaceutical ingredient(API) form and in pharmaceutical dosage form Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of hepatitis-C drugs - Daclatasvir based on measurement of absorption at a wavelength maximum (λmax) of 317 nm using methanol as solvent. Results: The method was validated in terms of, precision, linearity, accuracy, and robustness, LOD, LOQ as per the ICH guidelines. The method was found to be linear in the range of 50-150% for Daclatasvir. The percentage recovery values were in the range of 99.9-100.9% for Daclatasvir at different concentration levels. Relative standard deviation for precision and intermediate precision results were found to be <2%. The correlation coefficient value observed for Daclatasvir drug substances was not <0.99, 0.99, respectively. Results obtained from the validation experiments prove that the developed method is quantified for the estimation of Daclatasvir drug substances. Conclusion: The developed method can be successfully applied for routine analysis, quality control analysis, and also suitable for stability analysis of Daclatasvir in API & its pharmaceutical dosage form as per the regulatory requirements. Keywords: Daclatasvir, Method development, Validation, Ultraviolet-visible spectrophotometry.

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Ravindra S Morey, Ganesh G Tapadiya, and Manisha V Doud. "Development and validation of stability indicating HPTLC method for estimation of Daclatasvir Dihydrochloride in pharmaceutical dosage form." World Journal of Advanced Research and Reviews 23, no. 2 (2024): 2470–78. http://dx.doi.org/10.30574/wjarr.2024.23.2.2569.

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A high-performance thin-layer chromatographic method was developed and validated for estimation of Daclatasvir Dihydrochloride in pharmaceutical dosage form. The proposed method was applied successfully to the pharmaceutical analysis of the recently approved dosage form of Daclatasvir Dihydrochloride which is available in market as a brand name of ‘NALDAC 60’ tablets. The drugs were satisfactorily show peak with RF 0.38 for Daclatasvir Dihydrochloride. Method was validated according to the ICH guidelines. The calibration plot was linear between 50-300 ng per band for Daclatasvir Dihydrochloride. The LOD and LOQ for Daclatasvir Dihydrochloride were found to be 0.171 μg per band and 0.521 μg per band, respectively. Accuracy and precision of the proposed method was evaluated by recovery studies (% recovery for Daclatasvir Dihydrochloride was 99.88%) and intra-day and inter-day precision studies (standard deviation value for precision studies was found to be 0.453). In stability testing, Daclatasvir Dihydrochloride was found susceptible to acid hydrolysis and alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it can be used as a stability indicating method. The proposed validated stability indicating assay for the sensitive determination of the mentioned drugs is suitable for Quality control laboratories as a simple fast economic method. Degradation product of Daclatasvir Dihydrochloride in alkaline condition was carried out.

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Ravindra, S. Morey, G. Tapadiya Ganesh, and V. Doud Manisha. "Development and validation of stability indicating HPTLC method for estimation of Daclatasvir Dihydrochloride in pharmaceutical dosage form." World Journal of Advanced Research and Reviews 23, no. 2 (2024): 2470–78. https://doi.org/10.5281/zenodo.14891592.

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A high-performance thin-layer chromatographic method was developed and validated for estimation of Daclatasvir Dihydrochloride in pharmaceutical dosage form. The proposed method was applied successfully to the pharmaceutical analysis of the recently approved dosage form of Daclatasvir Dihydrochloride which is available in market as a brand name of ‘NALDAC 60’ tablets. The drugs were satisfactorily show peak with RF 0.38 for Daclatasvir Dihydrochloride. Method was validated according to the ICH guidelines. The calibration plot was linear between 50-300 ng per band for Daclatasvir Dihydrochloride. The LOD and LOQ for Daclatasvir Dihydrochloride were found to be 0.171 μg per band and 0.521 μg per band, respectively. Accuracy and precision of the proposed method was evaluated by recovery studies (% recovery for Daclatasvir Dihydrochloride was 99.88%) and intra-day and inter-day precision studies (standard deviation value for precision studies was found to be 0.453). In stability testing, Daclatasvir Dihydrochloride was found susceptible to acid hydrolysis and alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it can be used as a stability indicating method. The proposed validated stability indicating assay for the sensitive determination of the mentioned drugs is suitable for Quality control laboratories as a simple fast economic method. Degradation product of Daclatasvir Dihydrochloride in alkaline condition was carried out.

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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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Reviriego, C. "Daclatasvir dihydrochloride." Drugs of the Future 36, no. 10 (2011): 735. http://dx.doi.org/10.1358/dof.2011.36.10.1703570.

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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 (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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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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Ahmad Ather, Ch Adnan, Mariyam Nawaz, Sohail Bashir Sulehria, Saadia Chaudary, Zara Mehmood, and Maria Rehman. ""TREATMENT SUCCESS OF SOFOSBUVIR AND DACLATSVIR WITH OR WITHOUT RIBAVIRIN IN PATIENTS OFHEPATITIS C VIRUS"." Journal of Akhtar Saeed Medical & Dental College 05, no. 02 (2023): 90–96. https://doi.org/10.51127/jamdcv5i2oa05.

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Background:To compare the frequency of responders achieving SVR12 after taking sofosbuvir and daclatasvir with vs without ribavirin.Material and Methods:Total 180 patients meeting inclusion criteria were enrolled in the studyfromDepartment of Medicine, Government Teaching Hospital Shahdara, Lahore.This randomized controlled trial was conducted fromMarch 25, 2021,to September 24, 2021.Treatment naive cases were given tablet sofosbuvir & daclatasvir for 12 weeks. Treatment-experienced and naive with cirrhosis were given ribavirin based on their body weight along with sofosbuvir and daclatasvir for 12 weeks. After 3 months of treatment, patients were called for follow up at 12thweek post-treatment for HCV RNA PCR to see if patient has achieved SVR12 or not. Statistical analysis was performed using SPSS v25.0. Frequency of responders was compared using the Chi-square test. P-value less than or equal to 0.05 was considered statistically significant. Results: In group-A, 54(60.0%) patients were males and 36(40%) patients were females. In group-B, 52(57.8%) patients were males and 38(42.2%) were females. The mean age in patients of group-A was 45.69±12.481 years while that was 44.99±14.590 years in group-B. In group-A (Sofosbuvir and daclatasvir with ribavirin), 81(90.0%) patients had a response rate and in groupB (Sofosbuvir and daclatasvir), 65(72.2%) patients had a response rate with p-value (p=0.002). Conclusion:It was concluded that sofosbuvir & daclatasvir with ribavirin was found more efficacious than sofosbuvir & daclatasvir alone in achieving SVR 12 in patients of chronic hepatitis C infection, so it will help in delaying disease process and improving quality of life,especially in the developing world.KeyWords:Sofosbuvir, Daclatasvir, Ribavirin, Hepatitis C

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C. Damle, Mrinalini, and Nivedita B. Pawar. "STABILITY INDICATING HPLC METHOD FOR SOFOSBUVIR AND DACLATASVIR IN COMBINATION." Indian Drugs 59, no. 10 (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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Ahmed, Hussien, Abdelrahman Ibrahim Abushouk, Mohamed Gadelkarim, Arwa Mohamed, Mohamed Gabr, and Ahmed Negida. "Efficacy of daclatasvir plus peginterferon alfa and ribavirin for patients with chronic hepatitis C genotype 4 infection." Bangladesh Journal of Pharmacology 12, no. 1 (2017): 12. http://dx.doi.org/10.3329/bjp.v12i1.29940.

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<p class="Abstract">Clinical trials evaluating the safety and efficacy of daclatasvir for chronic hepatitis C virus (HCV) genotype 4 infection are scarce and yet with small sample sizes. Therefore, we conducted this systematic review to investigate the efficacy of daclatasvir in HCV genotype 4 treatment. A computer literature search of PubMed, Scopus, Embase, Ovid, Web of knowledge, and Cochrane central was conducted. We selected studies comparing daclatasvir plus peginterferon-alfa/ribavirin versus placebo plus peginterferon-alfa/ribavirin in patients with HCV genotype 4 infection. Pooling data from two randomized controlled trials (n = 154 patients) showed that daclatasvir/peg-interferon/ribavirin treatment achieved a moderate sustained virologic response rate of 76% after 12 weeks and of 79% after 24 weeks. The daclatasvir containing regimen was superior to the placebo containing regimen in terms of virologic response rates after 12 weeks (RR=1.9% CI 1.3 to 2.6) and 24 weeks (RR=1.8% CI 1.3 to 2.5). More effective regimens are needed for HCV genotype 4.</p>

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Hanaa, Saleh Gamal H. Ragab Mohammed A. Othman. "STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF DACLATASVIR IN PURE AND TABLETS DOSAGE FORMS." iajps,csk publications 03, no. 12 (2017): 1565–72. https://doi.org/10.5281/zenodo.236131.

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A sensitive, simple, selective and accurate HPLC method was developed and validated for analysis of antiviral drug Daclatasvir (BMS-790052, DCV) in pure form and in tablet dosage form in the presence of its degradation products. The chromatographic separation achieved by isocratic elution on Hypersil BDS C18, 4.6×150 mm, 5µm column at 25˚c. The mobile phase was a mixture of 0.05M Potassium dihydrogen phosphate (pH-4.5) and acetonitrile in ratio of 50:50 (v/v). The injection volume was 10µl. The flow rate was 1ml/ minute. The detection wavelength was 320 nm. The developed method was validated as per ICH guidelines; it was precise, accurate and robust. The calibration curve of Daclatasvir was linear in range 0.5- 100µg/ml with a correlation coefficient ≥ 0.999. Also the validated method was helpful for rapid routine analysis as the run time was less than 3 minute; the retention time for Daclatasvir was about 2.33 minute. The method was successfully applied to analysis of Daclatasvir in tablet form and the recovery was from 99.71% to 100.86%. Keywords: HPLC, stability indicating, Daclatasvir, tablets.

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Mobarak, Sara, Mehdi Salasi, Ahmad Hormati, et al. "Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)." Journal of Antimicrobial Chemotherapy 77, no. 3 (2021): 758–66. http://dx.doi.org/10.1093/jac/dkab433.

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Abstract Background The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. Methods This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation &lt;95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. Results Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95–1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77–1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. Conclusions We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.

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Eslami, Gholamali, Sajedeh Mousaviasl, Esmat Radmanesh, et al. "The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19." Journal of Antimicrobial Chemotherapy 75, no. 11 (2020): 3366–72. http://dx.doi.org/10.1093/jac/dkaa331.

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Abstract Objectives Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combination with daclatasvir in treating patients with COVID-19. Methods Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT–PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included. Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir/daclatasvir. All participants also received the recommended national standard treatment which, at that time, was lopinavir/ritonavir and single-dose hydroxychloroquine. The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality. Results Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm. The median duration of stay was 5 days for the sofosbuvir/daclatasvir group and 9 days for the ribavirin group. The mortality in the sofosbuvir/daclatasvir group was 2/35 (6%) and 9/27 (33%) for the ribavirin group. The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04–0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1–12.1, P &lt; 0.01). Conclusions Given these encouraging initial results, and the current lack of treatments proven to decrease mortality in COVID-19, further investigation in larger-scale trials seems warranted.

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Barrail-Tran, Aurélie, Corine Vincent, Valérie Furlan, et al. "Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir." Antimicrobial Agents and Chemotherapy 59, no. 12 (2015): 7903–5. http://dx.doi.org/10.1128/aac.01603-15.

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ABSTRACTRaltegravir pharmacokinetics was studied in 20 patients included in the ANRS HC30 QUADRIH Study before and after addition of anti-hepatitis C virus (anti-HCV) quadritherapy, including pegylated-interferon–ribavirin and asunaprevir plus daclatasvir. Raltegravir pharmacokinetic parameters remained unchanged whether administered on or off anti-HCV therapy. In addition, concentrations of raltegravir, asunaprevir, and daclatasvir were not affected by liver cirrhosis. These data suggest that in human immunodeficiency virus (HIV)-HCV-coinfected patients, whether cirrhotic or not, asunaprevir and daclatasvir could be administered safely with raltegravir.

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Garimella, T., R. Wang, W. L. Luo, et al. "Assessment of Drug-Drug Interactions between Daclatasvir and Methadone or Buprenorphine-Naloxone." Antimicrobial Agents and Chemotherapy 59, no. 9 (2015): 5503–10. http://dx.doi.org/10.1128/aac.00478-15.

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ABSTRACTHepatitis C virus (HCV) infection is common among people who inject drugs, including those managed with maintenance opioids. Pharmacokinetic interactions between opioids and emerging oral HCV antivirals merit evaluation. Daclatasvir is a potent pangenotypic inhibitor of the HCV NS5A replication complex recently approved for HCV treatment in Europe and Japan in combination with other antivirals. The effect of steady-state daclatasvir (60 mg daily) on stable plasma exposure to oral opioids was assessed in non-HCV-infected subjects receiving methadone (40 to 120 mg;n= 14) or buprenorphine plus naloxone (8 to 24 mg plus 2 to 6 mg;n= 11). No relevant interaction was inferred if the 90% confidence interval (CI) of the geometric mean ratio (GMR) of opioid area under the plasma concentration-time curve over the dosing interval (AUCτ) or maximum concentration in plasma (Cmax) with versus without daclatasvir was within literature-derived ranges of 0.7 to 1.43 (R- andS-methadone) or 0.5 to 2.0 (buprenorphine and norbuprenorphine). Dose-normalized AUCτ forR-methadone (GMR, 1.08; 90% CI, 0.94 to 1.24),S-methadone (1.13; 0.99 to 1.30), and buprenorphine (GMR, 1.37; 90% CI, 1.24 to 1.52) were within the no-effect range. The norbuprenorphine AUCτ was slightly elevated in the primary analysis (GMR, 1.62; 90% CI, 1.30 to 2.02) but within the no-effect range in a supplementary analysis of all evaluable subjects. Dose-normalizedCmaxfor both methadone enantiomers, buprenorphine and norbuprenorphine, were within the no-effect range. Standardized assessments of opioid pharmacodynamics were unchanged throughout daclatasvir administration with methadone or buprenorphine. Daclatasvir pharmacokinetics were similar to historical data. Coadministration of daclatasvir and opioids was generally well tolerated. In conclusion, these data suggest that daclatasvir can be administered with buprenorphine or methadone without dose adjustments.

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

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

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

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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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Sayed, Rania A., Ahmed R. Mohamed, Wafaa S. Hassan, and Manal S. Elmasry. "Comparative study of four innovative earth-friendly platforms for rapid analysis of daclatasvir dihydrochloride: Application on different matrices." BMC Chemistry 17, no. 1 (2023). http://dx.doi.org/10.1186/s13065-023-00923-4.

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Abstract Background Daclatasvir dihydrochloride has important roles not only in the management of COVID-19 pandemic symptoms but also in the treatment of chronic hepatitis C infection. Objective The current research presents four novel and simple platforms including silver-nanoparticles spectrophotometric technique and three electrochemical conductometric ones for daclatasvir analysis in its tablet, biological fluids, and dissolution media. Methods The spectrophotometric platform involved the synthesis of silvernanoparticles through a redox reaction between the reducing agent (daclatasvir) and the oxidizing agent (silver nitrate) in presence of polyvinylpyrrolidone as a stabilizing agent. The produced silver-nanoparticles have an intense surface plasmon resonance peak at 421 nm where the measured absorbance values were utilized for quantitative spectrophotometric determination of daclatasvir. While the electrochemical conductometric platforms involved the reaction of daclatasvir with three different precipitating reagents (silver nitrate, phosphomolybdic acid, and ammonium reineckate) to form ion associates between these reagents and daclatasvir in the aqueous system. Results All proposed platforms were validated in line with recommendations of the international conference on harmonization producing satisfactory outcomes within the agreed boundaries. Conclusion The proposed platforms are green alternatives for routine rapid assay of daclatasvir at the cheapest cost because their results were observed to be nearly similar to those of the reported platform. Moreover, the suggested spectrophotometric platform’s sensitivity can be employed for investigating daclatasvir bioequivalence.

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Yamana, Anil Vikas, and Chandra Sekhar Kothapalli Bonnoth. "Validated Method development for estimation of Sofosbuvir and Daclatasvir in bulk and their dosage form by using RP-HPLC." Research Journal of Pharmacy and Technology, June 28, 2022, 2447–50. http://dx.doi.org/10.52711/0974-360x.2022.00408.

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A simple, Accurate, precise method was developed for the simultaneous estimation of the Sofosbuvir and Daclatasvir in Tablet dosage form. Chromatogram was run through Standard Ascentis C18 150 x 4.6mm, 5m. Mobile phase containing Acetonitrile: Water taken in the ratio 60:40 was pumped through column at a flow rate of 0.7ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 279nm. Retention time of Sofosbuvir and Daclatasvir were found to be 2.198 min and 2.765 min. %RSD of the Sofosbuvir and Daclatasvir were and found to be 0.4 and 0.3 respectively. %Recovery was obtained as 99.88% and 99.80% for Sofosbuvir and Daclatasvir respectively. LOD, LOQ values obtained from regression equations of Sofosbuvir and Daclatasvir were 1.73, 5.23 and 0.12, 0.36 respectively. Regression equation of Sofosbuvir is y = 9010x+ 21702, and y = 10136x+1757 of Daclatasvir Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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