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EVALUATION OF THE SAFETY AND RESISTANCE ASSOCIATED VARIANTS OF SOFOSBUVIR/DACLATASVIR AMONG EGYPTIAN PATIENTS WITH HEPATITIS C VIRUS: A PROSPECTIVE STUDY

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Last updated: 25 Dec 2024

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Abstract

Background: Hepatitis C virus (HCV) is a major health problem. Current treatment by direct-acting antivirals achieved high sustained virological response (SVR). However, drug intolerance or relapse may occur. We aimed to demonstrate the safety of sofosbuvir (SOF) plus daclatasvir (DCV) regimen in Egyptian patients with hepatitis C infection and the assessment of resistance associated variants (RAVs) in non-responders. Methods: In this prospective study, 850 HCV patients eligible to SOF + DCV ± ribavirin (RBV) were recruited. They were divided into two groups; patients with chronic hepatitis C (CHC) and patients with liver cirrhosis. Baseline data included clinical history, examination, routine laboratory tests and HCV viral load. Safety evaluation was assessed during treatment up to 12 weeks after the end of treatment. RAVs assessment was considered at baseline and in cases of relapse.  Results:  CHC group included 548 patients while 302 had liver cirrhosis. The most frequent adverse events were headache 20%, fatigue 14%, myalgia 5.2%. Diarrhea occurred in 4.6% with significantly higher frequency among liver cirrhosis group; 7.3% vs. 3.1% (P= 0.04). No patients had to stop treatment because of adverse events. SVR was achieved in 91.2% while 75 (8.8%) had relapse. At baseline, RAVs were found in 10%. After therapy, RAVs (E237D) were detected in 1 non-responder. Conclusion:  Treatment with SOF/DCV was effective and well tolerated in patients with HCV. RAVs testing is not routinely recommended before treatment as resistant variants could occur naturally in HCV.
 

DOI

10.21608/bfsa.2022.271826

Keywords

HCV, DAAs, Sofosbuvir, Daclatasvir, RAVs

Authors

First Name

Haidi

Last Name

-Allah Ramadan

MiddleName

Karam

Affiliation

Department of Tropical Medicine & Gastroenterology, Faculty of Medicine, Assiut University, Assiut, Egypt

Email

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City

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Orcid

-

First Name

, Soha

Last Name

Abdel-Monem

MiddleName

Saoud

Affiliation

Department of Microbiology & Immunology, Faculty of pharmacy, Minia University,Egypt

Email

-

City

-

Orcid

-

First Name

Ahlam

Last Name

Ahmed

MiddleName

Mohamed

Affiliation

Department of Tropical Medicine & Gastroenterology, Faculty of Medicine, Assiut University, Assiut, Egypt

Email

ahlam.farghaly@med.aun.edu.eg

City

-

Orcid

-

First Name

Rasha

Last Name

Omar

MiddleName

Maree

Affiliation

Department of Tropical Medicine & Gastroenterology, Faculty of Medicine, Assiut University, Assiut, Egypt

Email

rasha.maree77@aun.edu.eg

City

-

Orcid

-

First Name

Hala

Last Name

Ahmed

MiddleName

Rady

Affiliation

Department of Microbiology & Immunology, Faculty of pharmacy, Minia University,Egypt.

Email

halaradyahmed@yahoo.com

City

-

Orcid

-

First Name

Helal

Last Name

Hetta

MiddleName

F.

Affiliation

Department of Microbiology & Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt

Email

-

City

-

Orcid

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Volume

45

Article Issue

2

Related Issue

37882

Issue Date

2022-12-01

Receive Date

2022-04-28

Publish Date

2022-12-01

Page Start

1,143

Page End

1,153

Print ISSN

1110-0052

Online ISSN

3009-7703

Article File

BFSA_Volume 45_Issue 2_Pages 1143-1153.pdf

PDF . 1.1MB

Link

https://bpsa.journals.ekb.eg/article_271826.html

Detail API

https://bpsa.journals.ekb.eg/service?article_code=271826

Order

271,826

Type

Original Article

Type Code

1,096

Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

https://bpsa.journals.ekb.eg/

MainTitle

EVALUATION OF THE SAFETY AND RESISTANCE ASSOCIATED VARIANTS OF SOFOSBUVIR/DACLATASVIR AMONG EGYPTIAN PATIENTS WITH HEPATITIS C VIRUS: A PROSPECTIVE STUDY

Details

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Article

Created At

22 Jan 2023