Delving into the Latest Updates on Daclatasvir/Sofosbuvir with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Sovodak, 达拉他韦/索磷布韦

Target

NS5A x NS5B polymerase

Mechanism

NS5A inhibitors(Nonstructural protein 5A inhibitors), NS5B polymerase inhibitors(Hepatitis C virus NS5B RNA-dependent RNA polymerase inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis C, Chronic

Inactive Indication-

Originator Organization

RojanPharma Pharmaceutical Company

Active Organization

RojanPharma Pharmaceutical Company

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

Structure

Molecular FormulaC40H50N8O6

InChIKeyFKRSSPOQAMALKA-CUPIEXAXSA-N

CAS Registry1009119-64-5

View All Structures (2)

In this study, the simultaneous spectrophotometric estimation of Sofosbuvir (SOF) and Daclatasvir (DAC) in synthetic mixtures and tablet formulation in the presence of overlapping spectra was performed based on continuous wavelet transform (CWT) and derivative spectrophotometry (DS) methods without any separation process. The Coiflet (Coif2) and Daubechies (Db3) wavelet families with wavelength of 256 nm and 218 nm were obtained as the best families for the simultaneous determination of SOF and DAC, respectively. Also, the first derivative absorption spectra revealed the best results corresponding to the analysis of SOF and DAC at 237 nm and 291 nm, respectively. The ranges of limit of detection (LOD) and limit of quantitation (LOQ) related to the CWT and DS methods were 2.45 × 10^-3 to 0.5054 and 6.91 × 10^-3 to 0.6027, respectively. Mean recovery values of SOF and DAC in synthetic mixtures for CWT approach were 98.55%, 98.09% and in DS method were 98.78% and 95.83%, respectively. Real samples, including Sovodak tablet and urine was used for accurate simultaneous determination of the mentioned components. Analyzing Sovodak tablet was implemented using high-performance liquid chromatography (HPLC) as a reference method that the results were near to the CWT and DS methods. In order to investigate the existence of significant differences between the methods, analysis of variance (ANOVA) test at the 95% confidence level was performed but no significant differences were observed. In addition, the amounts of SOF and DAC in the complex matrix of biological sample were well predicted by the proposed methods.

Advanced Pharmaceutical Bulletin

Efficacy of Sovodak in the Management of Patients Co-infected with HIV/HCV

Article

Author: Sedghi, Roya ; Sepehri, Bita ; Somi, Mohammad Hossein ; Nikniaz, Zeinab

Purpose: Sofosbuvir (SOF) and daclatasvir (DOC) are suggested for the treatment of hepatitis C virus (HCV) in patients with concomitant HCV and human immunodeficiency virus (HIV). In 2016, Sovodak tablet a combination of SOF and DOC was introduced. In the present study we assessed the effectiveness of SOF in the treatment of HCV in patients co-infected with HIV. Methods: A total of 26 HCV patients co-infected with HIV received SOF for 3 months. One patient did not adhere to the drug protocol and was removed from the final analysis. The blood sample for qualitative polymerase chain reaction (PCR) was obtained after treatment and sustained virological response (SVR) was calculated. Results: Twenty five patients finished the study. The mean patients’ age was 44.16±6.21 years. About 72% of participants had HCV genotype 1a, 8% genotype 1b, and 20% genotype 3a. After 3 months of intervention with Sovodak, the SVR12 was about 96%. None of the patients reported any adverse events. Conclusion: For the first time, the results of the present study showed that Sovodak had high SVR12 in HCV patients co-infected with HIV. However, for a precise conclusion, there is a need for larger studies and an equal number of patients with different virus genotypes.

100 Deals associated with Daclatasvir/Sofosbuvir

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C, Chronic	IR	RojanPharma Pharmaceutical Company	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASL2023	Not Applicable	Hepatitis C First line	90	Sofosbuvir/SimeprevirSofosbuvir/Simeprevir	(irbwgsxmtd) = ounrebupcb jmsrvwmmrp (htqaijgect )	-	21 Jun 2023
				Sofosbuvir/Daclastavir	(irbwgsxmtd) = xchbqlmtrb jmsrvwmmrp (htqaijgect )
ASN2019	Not Applicable	Chronic hepatitis C genotype 3 Maintenance	-	Sofosbuvir 400 mg daily/Daclatasvir 60 mg daily	(johqjgkxzw) = uupjvpotyz utqraeimcb (cywqkbjiar )	Positive	05 Nov 2019
				Sofosbuvir 400 mg thrice a week/Daclatasvir 60 mg daily	(johqjgkxzw) = afskmumlye utqraeimcb (cywqkbjiar )
EASL2019	Not Applicable	Hepatitis C, Chronic	40	Ledipasvir/sofosbuvir (LDV/SOF)	trpmapgktw(vzbfhhpmnp) = A significant decrease in ALT was observed llbbeujyxe (ramcahzmrw ) View more	-	11 Apr 2019
				Daclatasvir/sofosbuvir (DCV/SOF)
IAS2015	Not Applicable	Coinfection	562	Daclatasvir plus sofosbuvir	(ehtkuhrazj) = libhosecmp wbquqovokz (uoxxvmkmtp ) View more	-	01 Jan 2015
				Daclatasvir plus sofosbuvir plus ribavirin	(ehtkuhrazj) = axtwzvaewo wbquqovokz (uoxxvmkmtp ) View more