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Real Life Egyptian Experience of Daclatasvir Plus Sofosbuvir with Ribavirin in Naïve Difficult to Treat HCV Patients

[ Vol. 20 , Issue. 1 ]

Author(s):

Engy A. Wahsh*, Amal K. Hussein, Ahmed A. Gomaa, Mohamed A. Baraka and Mohie Al-deen Abead   Pages 43 - 48 ( 6 )

Abstract:


Background: Chronic infection with Hepatitis C virus (HCV) is considered as a major cause for developing liver cirrhosis and hepatocellular carcinoma. A new era in HCV treatment is ongoing using Direct Acting Antiviral activity (DAA). The first approved DAA drug was Sofosbuvir which has a high tolerability and preferable pharmacokinetic profile. Another recently developed drug is Daclatasvir a first-in-class HCV NS5A replication complex inhibitor. Both drugs are administered orally once daily and have potent antiviral activity with wide genotypic coverage.

Methods: In the outpatient clinic, one hundred and fifty naïve difficult to treat chronic HCV patients were recruited from Tropical Medicine Department at Fayoum public hospital. A combination of Daclatasvir (60 mg) and Sofosbuvir (400 mg) (DCV/SOF) has been administered for those patients once daily with Ribavirin (1200 mg or 1000 mg based on patients’ weight on two divided doses) over a period of 12 weeks. All patients have been followed up for clinical, laboratory assessment and HCV PCR to detect the efficacy and safety of the therapy.

Results: Sustained Virologic Response rate (SVR12) was achieved in the vast majority of patients (90.67%). Cirrhotic patients showed lower SVR compared to non-cirrhotic patients (88.89% vs 90.91%, respectively). Around half of the patients (49.33%) developed adverse events (AEs) during treatment. The most common AEs were headache, fatigue and abdominal pain.

Conclusion: The available evidence seems to suggest that combination therapy of (DCV/SOF with RBV) in the treatment of chronic HCV genotype IV naïve difficult to treat patients either cirrhotic or non-cirrhotic is safe and effective. Monitoring for clinical and laboratory hepatic parameters was the basis for these findings.

Keywords:

Chronic hepatitis C, daclatasvir, sofosbuvir, ribavirin, difficult to treat, hepatocellular carcinoma, inhibitor.

Affiliation:

Department of Clinical Pharmacy, Faculty of Pharmacy, Nahda University, Beni Suef, Department of Pharmaceutical Technology, Faculty of Pharmacy, Minia University, Minia, Department of Tropical Medicine, Faculty of Medicine, Fayoum University, Fayoum, Department of Clinical Pharmacy, College of Pharmacy, Al Ain University, Al Ain, Department of Biochemistry, Egyptian Ministry of Interior, Cairo



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