Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients

Promising Effect on Liver Fibrosis

Asmaa M. Abdel-Aziz, Mohamed A. Ibrahim, Azza A. El-Sheikh, Maha Y. Kamel, Nagwa M. Zenhom, Salam Abdel-Raheim, Hisham Abdelhaleem

Research output: Contribution to journalArticleResearchpeer-review

7 Citations (Scopus)

Abstract

Background/purpose: The effect of sofosbuvir and daclatasvir in treatment of genotype 4 Hepatitis C Virus (HCV) is not well documented. This study investigated the safety and efficacy of sofosbuvir plus daclatasvir with or without ribavirin in treatment of HCV genotype 4 patients. The impact of therapy on liver fibrosis as well as the role of IL18 polymorphism in therapeutic outcome was assessed. Methods: One hundred HCV genotype 4 patients were categorized into 2 groups. The group 1 comprised treatment naïve patients, with total serum bilirubin ≤ 1.2 mg/10−1 L, serum albumin ≥ 3.5 g/10−1 L, INR ≤ 1.2, and platelet count ≥ 150 × 109/L. This group was treated with sofosbuvir plus daclatasvir for 12 weeks. The group 2 included Peg-IFN-α-or sofosbuvir treatment experienced, or patients with at least 2 of the following findings: total serum bilirubin > 1.2 mg/10−1 L, serum albumin < 3.5 g/10−1 L, INR > 1.2, and platelet count < 150 × 109L−1. Group 2 was treated with sofosbuvir–daclatasvir + ribavirin for 12 weeks, with the exception of sofosbuvir treatment experienced patients, who were treated with sofosbuvir/daclatasvir + ribavirin for 24 weeks. Results: Sustained Virological Response (SVR12) (undetectable viremia12 weeks post-treatment), was 93.3% in group 1 and 87.5% in group 2 (total = 91%). Such high efficacy was accompanied with tolerable adverse effects as well as with significant improvement in liver fibrosis. No significant association was observed between IL18 polymorphism (rs1946518) at position −607 and achievement of SVR12 in HCV patients after treatment. Conclusion: Sofosbuvir plus daclatasvir, with or without ribavirin achieved high efficacy and safety in HCV genotype 4 patients. Their effects were accompanied with attenuation of liver fibrosis. Further wider-scale studies are needed to evaluate the actual role of IL18 polymorphisms in treatment response with sofosbuvir/daclatasvir.

Original languageEnglish
Pages (from-to)15-22
Number of pages8
JournalJournal of Clinical and Experimental Hepatology
Volume8
Issue number1
DOIs
Publication statusPublished - 1 Mar 2018

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Hepacivirus
Liver Cirrhosis
Genotype
Ribavirin
Interleukin-18
Therapeutics
Platelet Count
Bilirubin
Serum Albumin
Sofosbuvir
BMS-790052
Safety
International Normalized Ratio
Serum

Keywords

  • daclatasvir
  • HCV
  • IL-18 polymorphism
  • sofosbuvir

Cite this

Abdel-Aziz, Asmaa M. ; Ibrahim, Mohamed A. ; El-Sheikh, Azza A. ; Kamel, Maha Y. ; Zenhom, Nagwa M. ; Abdel-Raheim, Salam ; Abdelhaleem, Hisham. / Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients : Promising Effect on Liver Fibrosis. In: Journal of Clinical and Experimental Hepatology. 2018 ; Vol. 8, No. 1. pp. 15-22.
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title = "Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients: Promising Effect on Liver Fibrosis",
abstract = "Background/purpose: The effect of sofosbuvir and daclatasvir in treatment of genotype 4 Hepatitis C Virus (HCV) is not well documented. This study investigated the safety and efficacy of sofosbuvir plus daclatasvir with or without ribavirin in treatment of HCV genotype 4 patients. The impact of therapy on liver fibrosis as well as the role of IL18 polymorphism in therapeutic outcome was assessed. Methods: One hundred HCV genotype 4 patients were categorized into 2 groups. The group 1 comprised treatment na{\"i}ve patients, with total serum bilirubin ≤ 1.2 mg/10−1 L, serum albumin ≥ 3.5 g/10−1 L, INR ≤ 1.2, and platelet count ≥ 150 × 109/L. This group was treated with sofosbuvir plus daclatasvir for 12 weeks. The group 2 included Peg-IFN-α-or sofosbuvir treatment experienced, or patients with at least 2 of the following findings: total serum bilirubin > 1.2 mg/10−1 L, serum albumin < 3.5 g/10−1 L, INR > 1.2, and platelet count < 150 × 109L−1. Group 2 was treated with sofosbuvir–daclatasvir + ribavirin for 12 weeks, with the exception of sofosbuvir treatment experienced patients, who were treated with sofosbuvir/daclatasvir + ribavirin for 24 weeks. Results: Sustained Virological Response (SVR12) (undetectable viremia12 weeks post-treatment), was 93.3{\%} in group 1 and 87.5{\%} in group 2 (total = 91{\%}). Such high efficacy was accompanied with tolerable adverse effects as well as with significant improvement in liver fibrosis. No significant association was observed between IL18 polymorphism (rs1946518) at position −607 and achievement of SVR12 in HCV patients after treatment. Conclusion: Sofosbuvir plus daclatasvir, with or without ribavirin achieved high efficacy and safety in HCV genotype 4 patients. Their effects were accompanied with attenuation of liver fibrosis. Further wider-scale studies are needed to evaluate the actual role of IL18 polymorphisms in treatment response with sofosbuvir/daclatasvir.",
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Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients : Promising Effect on Liver Fibrosis. / Abdel-Aziz, Asmaa M.; Ibrahim, Mohamed A.; El-Sheikh, Azza A.; Kamel, Maha Y.; Zenhom, Nagwa M.; Abdel-Raheim, Salam; Abdelhaleem, Hisham.

In: Journal of Clinical and Experimental Hepatology, Vol. 8, No. 1, 01.03.2018, p. 15-22.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients

T2 - Promising Effect on Liver Fibrosis

AU - Abdel-Aziz, Asmaa M.

AU - Ibrahim, Mohamed A.

AU - El-Sheikh, Azza A.

AU - Kamel, Maha Y.

AU - Zenhom, Nagwa M.

AU - Abdel-Raheim, Salam

AU - Abdelhaleem, Hisham

PY - 2018/3/1

Y1 - 2018/3/1

N2 - Background/purpose: The effect of sofosbuvir and daclatasvir in treatment of genotype 4 Hepatitis C Virus (HCV) is not well documented. This study investigated the safety and efficacy of sofosbuvir plus daclatasvir with or without ribavirin in treatment of HCV genotype 4 patients. The impact of therapy on liver fibrosis as well as the role of IL18 polymorphism in therapeutic outcome was assessed. Methods: One hundred HCV genotype 4 patients were categorized into 2 groups. The group 1 comprised treatment naïve patients, with total serum bilirubin ≤ 1.2 mg/10−1 L, serum albumin ≥ 3.5 g/10−1 L, INR ≤ 1.2, and platelet count ≥ 150 × 109/L. This group was treated with sofosbuvir plus daclatasvir for 12 weeks. The group 2 included Peg-IFN-α-or sofosbuvir treatment experienced, or patients with at least 2 of the following findings: total serum bilirubin > 1.2 mg/10−1 L, serum albumin < 3.5 g/10−1 L, INR > 1.2, and platelet count < 150 × 109L−1. Group 2 was treated with sofosbuvir–daclatasvir + ribavirin for 12 weeks, with the exception of sofosbuvir treatment experienced patients, who were treated with sofosbuvir/daclatasvir + ribavirin for 24 weeks. Results: Sustained Virological Response (SVR12) (undetectable viremia12 weeks post-treatment), was 93.3% in group 1 and 87.5% in group 2 (total = 91%). Such high efficacy was accompanied with tolerable adverse effects as well as with significant improvement in liver fibrosis. No significant association was observed between IL18 polymorphism (rs1946518) at position −607 and achievement of SVR12 in HCV patients after treatment. Conclusion: Sofosbuvir plus daclatasvir, with or without ribavirin achieved high efficacy and safety in HCV genotype 4 patients. Their effects were accompanied with attenuation of liver fibrosis. Further wider-scale studies are needed to evaluate the actual role of IL18 polymorphisms in treatment response with sofosbuvir/daclatasvir.

AB - Background/purpose: The effect of sofosbuvir and daclatasvir in treatment of genotype 4 Hepatitis C Virus (HCV) is not well documented. This study investigated the safety and efficacy of sofosbuvir plus daclatasvir with or without ribavirin in treatment of HCV genotype 4 patients. The impact of therapy on liver fibrosis as well as the role of IL18 polymorphism in therapeutic outcome was assessed. Methods: One hundred HCV genotype 4 patients were categorized into 2 groups. The group 1 comprised treatment naïve patients, with total serum bilirubin ≤ 1.2 mg/10−1 L, serum albumin ≥ 3.5 g/10−1 L, INR ≤ 1.2, and platelet count ≥ 150 × 109/L. This group was treated with sofosbuvir plus daclatasvir for 12 weeks. The group 2 included Peg-IFN-α-or sofosbuvir treatment experienced, or patients with at least 2 of the following findings: total serum bilirubin > 1.2 mg/10−1 L, serum albumin < 3.5 g/10−1 L, INR > 1.2, and platelet count < 150 × 109L−1. Group 2 was treated with sofosbuvir–daclatasvir + ribavirin for 12 weeks, with the exception of sofosbuvir treatment experienced patients, who were treated with sofosbuvir/daclatasvir + ribavirin for 24 weeks. Results: Sustained Virological Response (SVR12) (undetectable viremia12 weeks post-treatment), was 93.3% in group 1 and 87.5% in group 2 (total = 91%). Such high efficacy was accompanied with tolerable adverse effects as well as with significant improvement in liver fibrosis. No significant association was observed between IL18 polymorphism (rs1946518) at position −607 and achievement of SVR12 in HCV patients after treatment. Conclusion: Sofosbuvir plus daclatasvir, with or without ribavirin achieved high efficacy and safety in HCV genotype 4 patients. Their effects were accompanied with attenuation of liver fibrosis. Further wider-scale studies are needed to evaluate the actual role of IL18 polymorphisms in treatment response with sofosbuvir/daclatasvir.

KW - daclatasvir

KW - HCV

KW - IL-18 polymorphism

KW - sofosbuvir

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DO - 10.1016/j.jceh.2017.06.006

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VL - 8

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EP - 22

JO - Journal of Clinical and Experimental Hepatology

JF - Journal of Clinical and Experimental Hepatology

SN - 0973-6883

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