Sofosbuvir plus Daclatasvir with or without ribavirin for treatment of chronic HCV genotype 4 patients: real-life experience

  • G. Shiha
  • R. Soliman
  • M. ElBasiony
  • A. A. Hassan
  • N. N. H. Mikhail
Original Article
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Abstract

Introduction

New regimens involving direct-acting antiviral agents have recently been approved for the treatment of HCV. Our aim was to assess the efficacy and safety of 12 or 24 weeks of Sofosbuvir 400 mg plus Daclatasvir 60 mg, with or without ribavirin (800–1000 mg) in treating chronic hepatitis C genotype 4 patients.

Methods

This is an open-label observational study that describes the effect of 12 week or 24 weeks of daily oral Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60 mg with or without ribavirin (RBV) with dose adjustment if indicated. It included the first 1168 patients that fulfilled the inclusion and exclusion criteria and treated in the Egyptian Liver Research Institute and Hospital, Mansoura, Egypt.

Results

Sustained viral response after 12 weeks of end of treatment (SVR12) was achieved in 96.6% (95% CI 95.1–98.2%) of the patients receiving 12 weeks of DCV + SOF treatment, in 95.7% (95% CI 93.6–97.8%) of the patients receiving 12 weeks of DCV + SOF + RBV, in 93.3% (95% CI 90.0–96.6%) of those receiving 24 weeks of DCV + SOF, and in 92.2% (95% CI 85.4–98.9%) of patients receiving 24 weeks of DCV + SOF + RBV treatment. SVR12 rate was significantly higher in patients with no cirrhosis receiving DCV + SOF only for 12 weeks or 24 weeks (97.4 and 97.4%, respectively) than in patients with cirrhosis (91.7 and 88.9%, respectively). The most common adverse events were fatigue, headache, insomnia, and anemia. No treatment-related serious adverse events or death were reported in the studied groups.

Conclusion

Treatment with SOF (400 mg) plus DCV (60 mg), with or without RBV (800–1000 mg) for 12 or 24 weeks, was effective and well tolerated in chronic hepatitis C genotype 4 patients. SVR rates were higher for patients with no cirrhosis. Addition of RBV has benefit only in treatment-experienced group receiving 24 weeks.

Keywords

Chronic hepatitis C Treatment Daclatasvir Sofosbuvir Ribavirin Cirrhosis Genotype 4 DAAs 

Abbreviations

AE

Adverse events

BMI

Body mass index

CI

Confidence interval

CHC

Chronic hepatitis C

DAA

Direct-acting antivirals

DCV

Daclatasvir

ECG

Electrocardiography

ELRIAH

Egyptian Liver Research Institute and Hospital

HCV

Hepatitis C virus

HIV

Human immunodeficiency virus

IFN

Interferon

IQR

Inter-quartile range

kPa

Kilo Pascals

LLOQ

Lower limit of quantification

NS5A

Non-structural protein 5A

PegIFNα

Pegylated interferon alpha

RBV

Ribavirin

RNA

Ribonucleic acid

SD

Standard deviation

SOF

Sofosbuvir

SPSS

Statistical package for social sciences

SVR

Sustained virologic response

SVR12

Sustained virologic response after 12 weeks

ULN

Upper limit of normal

Notes

Acknowledgements

The authors thank the patients that allowed the use of their data in this report and the treating physicians for their time and contributions to this work.

Authors’ contribution

GS was involved in design, interpretation, and drafting of the manuscript. RS, ME, and AAH were involved in data acquisition and interpretation. NNHM was involved in data analysis and interpretation. All authors critically reviewed and revised the manuscript for content and approved the final draft for publication.

Compliance with Ethical Standards

Conflict of interest

The authors do not have any disclosures to report.

Financial Support

None to declare.

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Copyright information

© Asian Pacific Association for the Study of the Liver 2018

Authors and Affiliations

  • G. Shiha
    • 1
    • 2
  • R. Soliman
    • 1
    • 3
  • M. ElBasiony
    • 1
    • 2
  • A. A. Hassan
    • 1
  • N. N. H. Mikhail
    • 1
    • 4
  1. 1.Egyptian Liver Research Institute and Hospital (ELRIAH)MansouraEgypt
  2. 2.Hepatology and Gastroenterology Unit, Internal Medicine Department, Faculty of MedicineMansoura UniversityMansouraEgypt
  3. 3.Tropical Medicine Department, Faculty of MedicinePort Said UniversityPort SaidEgypt
  4. 4.Biostatistics and Cancer Epidemiology Department, South Egypt Cancer InstituteAssiut UniversityAssuitEgypt

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