THE USE OF DACLATASVIR PLUS SOFOSBUVIR WITH OR WITHOUT RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 4 INFECTION

Elarabany, N.; Solyman, Hend M.; Besheer, Tarek A.; Abd-Allah, Gamal A.

doi:10.12816/0043191

THE USE OF DACLATASVIR PLUS SOFOSBUVIR WITH OR WITHOUT RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 4 INFECTION

Document Type : Original Research Papers

Authors

¹ Zoology department, Faculty of Science, Damietta University, New Damietta, Egypt

² Tropical Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt

³ Zoology Department, Faculty of Science, Damietta University, New Damietta, Egypt

10.12816/0043191

Abstract

Oral administration of dual or triple therapy is very effective in chronic hepatitis C virus infection. The current study was conducted to evaluate the effectiveness and safety of daclatasvir plus sofosbuvir with or without ribavirin in treatment-naïve patients with HCV genotype 4 infection. In this study, 90 naïve patients with HCV genotype 4 infection were divided into 3 groups (N=30 per each group) and randomly assigned to receive orally either daclatasvir (60 mg) plus sofosbuvir (400 mg) with or without ribavirin (800-1200 mg according to the patient’s weight) daily for 12 weeks, or sofosbuvir plus ribavirin orally and daily for 24 weeks. The primary endpoint was an HCV RNA level of < 25 IU per millilitre at week 12 (sustained virologic response at week 12, SVR₁₂). From the current study, the males received sofosbuvir plus daclatasvir had SVR₁₂ 50%, while the females within the same group achieved SVR₁₂57%. Males received sofosbuvir with ribavirin achieved SVR₁₂ 85% and SVR₂₄ 94.7%, while females in the same group achieved SVR₁₂90.9% and SVR₂₄ 98.9 %. The highest SVR₁₂ rates (100% in both males and females) were achieved in naive patients received the triple therapy of daclatasvir plus sofosbuvir with ribavirin. The most common adverse effects were fatigue, headache, and low haemoglobin content. Only, one female patient experienced elevated serum alanine aminotransferase (ALAT) activity after the end of the treatment. No deaths or serious adverse effects resulted in case of treatment discontinuation. In conclusion, for HCV genotype 4 infection, once-daily oral dose of the triple therapy of daclatasvir plus sofosbuvir with ribavirin for 12 weeks appears to be a very good treatment option with the lowest adverse effects and the highest SVR rates.

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