Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and treated patients with chronic hepatitis C genotype-4

Esmat, Gamal; Elbaz, Tamer; Raziky, Maissa El; Gomaa, Asmaa; Abouelkhair, Mahmoud; Deen, Hadeel Gamal El; Sabry, Ahmed; Ashour, Mohamed; Allam, Naglaa; Abdel‐Hamid, Mohamed; Nada, Ola; Helmy, Sherine; Abdel-Maguid, Hanaa; Colonno, Richard J.; Brown, Nathaniel; Ruby, Eric; Waked, Imam

doi:10.1016/j.jhep.2017.09.006

Cited by 19 publications

(19 citation statements)

References 36 publications

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“…The MoH strongly supported local producers of generic DAAs by providing “fast track registration” of generic DAAs including SOF and DCV provided they reduced their prices. Several publications compared the efficacy of brand and generic drugs produced in Egypt or used generic SOF with new DAA molecules, such as ravidasvir, that proved safe and effective . Although DAA therapy was found cost‐effective at a cost of US$ 40 000 per patient treated in the United States, the initial cost of the generic products used in this report was US$ 240 for a 12‐week supply of SOF+DCV.…”

Section: Discussionmentioning

confidence: 99%

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt

Omar

El-Akel

Elbaz

et al. 2017

Aliment Pharmacol Ther

101

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Section: Discussionmentioning

confidence: 99%

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt

Omar

El-Akel

Elbaz

et al. 2017

Aliment Pharmacol Ther

101

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“…Carried out in Egypt, it concluded that treatment with ravidasvir plus sofosbuvir, with or without RBV, was well-tolerated and associated with high SVR rate for patients infected with HCV GT4, with and without cirrhosis, regardless of previous interferon-based treatments. 71 Confirmatory studies are needed.…”

Section: Ravidasvirmentioning

confidence: 99%

Eliminating hepatitis C within low-income countries – The need to cure genotypes 4, 5, 6

Asselah

Hassanein

Waked³

et al. 2018

Journal of Hepatology

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Around 70 to 100 million people are chronically infected with HCV worldwide. HCV antiviral drug development has revolutionised the treatment of HCV, with several direct-acting antiviral agents offering patients the chance of cure after only 8-12 weeks of treatment. Drug development was initially focussed on HCV genotype 1 (GT1) infection, since this was the most prevalent worldwide, although clinical trials included all genotypes prevalent in the US and Europe. Because the earliest in vitro assays utilised the GT1b and 2 replicons, the initial classes of direct-acting antivirals (protease inhibitors, non-nucleotide polymerase inhibitors) were GT1-specific, albeit they had an effect on other less prevalent genotypes. Epidemiological data has shown the regional importance of other HCV genotypes. More than 50% of all HCV infections around the globe are not with GT1. The prevalence of HCV genotype 4 (GT4), 5 (GT5), and 6 (GT6) is increasing in North America and Europe due to migration from the Middle East, Africa and South-East Asia. With the successful development of the multi and pan-genotypic non-structural protein 5A inhibitors, second generation protease inhibitors and nucleotide non-structural protein 5B inhibitors comes a unique opportunity to achieve global HCV elimination. The goal of this review is to summarise the available information pertaining to GT4, GT5 and GT6, with a specific focus on direct-acting antiviral agents.

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“…3,4 Ravidasvir ( Figure 1) is chemically described as methyl N- [1-[2-[5-[6-[2- [1-[2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidin-2-yl]-3H-benzimidazol-5-yl]naphthalen-2-yl]-1H-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl] carbamate dihydrochloride and is an investigation NS5A inhibitor that are presently experiencing clinical preliminaries for chronic HCV-4. 5 NS5A inhibition has been associated with a significant reduction in HCV RNA levels in cell culture-based models, thereby placing this agent among the most potent antiviral molecule developed to date. 5 As of late, the World Health Organization (WHO) has included ravidasvir as a future pan-genotypic direct-acting antiviral to the list of suggested treatments in their rules for the consideration and treatment of individual detected to have HCV.…”

Section: Introductionmentioning

confidence: 99%

“…5 NS5A inhibition has been associated with a significant reduction in HCV RNA levels in cell culture-based models, thereby placing this agent among the most potent antiviral molecule developed to date. 5 As of late, the World Health Organization (WHO) has included ravidasvir as a future pan-genotypic direct-acting antiviral to the list of suggested treatments in their rules for the consideration and treatment of individual detected to have HCV. 6 Furthermore, the Chinese Food and Drug Administration included hepatitis C NS5A inhibitor ravidasvir together with the list that was proposed as preference report to quicken its new medication application procedure.…”

Section: Introductionmentioning

confidence: 99%

<p>Validated Microwell-Based Spectrofluorimetric Method for Quantification of Ravidasvir (New Anti-Chronic Hepatitis C Virus-GT4) in Rat Plasma and Its Application to Pharmacokinetic Study</p>

Hefnawy

Al‐Shehri

Al-Rashood

et al. 2020

DDDT

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Background: Ravidasvir (RAV) has been regarded as a potent new NS5A inhibitor with a magnificent safety and tolerability in the management of genotype 4 hepatitis C virus (HCV) patients. Suitable analytical techniques are needed for the measurement of RAV in different biological matrices. Methods: We have developed a fast, sensitive and economical 96-microwell-based spectrofluorimetric technique combined with one-step protein precipitation extraction strategy for the measurement of RAV in rat plasma. Results: Under the optimum conditions, the direct relationship in rat plasma was accomplished between the RAV concentrations and the fluorescence (FL) intensity in a scope of 2.5-200 ng/mL with 0.9998 and 0.9999 for the quantification and correlation coefficients, respectively. The lower limit of detection (LLOD) was 0.840 ng/mL and this demonstrates the high sensitivity of the proposed assay. The accuracy (RE%) ranged from 95.34% to 102.29%, and the precision (RSD%) was less than 3.59%. The recovery was ranged from 93.12% to 96.26%. The stability of RAV in rat plasma was carried out and established its good stability in the range of room conventional temperature and at long-term stability (−80° C, 30 days). The developed technique was validated as stated by the United States Food and Drug Administration (US-FDA) guidelines for bioanalytical technique verification. Conclusion: The approved technique was effectively applied for a pharmacokinetic (PK) study after single oral gavage administration of RAV at a dose of 35 mg/kg and it could be presumed that the proposed assay can be applied to clinical trials.

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Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and treated patients with chronic hepatitis C genotype-4

Cited by 19 publications

References 36 publications

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt

Eliminating hepatitis C within low-income countries – The need to cure genotypes 4, 5, 6

<p>Validated Microwell-Based Spectrofluorimetric Method for Quantification of Ravidasvir (New Anti-Chronic Hepatitis C Virus-GT4) in Rat Plasma and Its Application to Pharmacokinetic Study</p>

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