Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection
Authors Ahmed OA, Kaisar HH, Badawi R, Hawash N, Samir H, Shabana SST, Fouad MHA, Rizk FH, Khodeir SA, Abd-Elsalam S
Received 2 October 2017
Accepted for publication 28 November 2017
Published 1 March 2018 Volume 2018:11 Pages 295—298
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Lucy Goodman
Peer reviewer comments 2
Editor who approved publication: Professor Suresh Antony
Ossama A Ahmed,1 Hany H Kaisar,1 Rehab Badawi,2 Nehad Hawash,2 Hossam Samir,1 Sherif ST Shabana,1 Mohamed Hassan A Fouad,1 Fatma H Rizk,3 Samy A Khodeir,4 Sherief Abd-Elsalam2
1Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 2Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt; 3Physiology Department, Faculty of Medicine, Tanta University, Tanta, Egypt; 4Department of Internal Medicine, Tanta University, Tanta, Egypt
Background and aims: Treatment of hepatitis C virus (HCV) infection has significantly changed during the last few years. The combination of ledipasvir and sofosbuvir has been shown to treat high proportions of patients with HCV genotype 1 with remarkable tolerability. The aim of the work was to assess the efficacy and safety of sofosbuvir plus ledipasvir in treating treatment-naïve Egyptian patients with genotype 4 HCV infection.
Patients and methods: In this open-label randomized study, 200 treatment-naive patients who were HCV antibody positive and HCV RNA positive by polymerase chain reaction, aged >18 years, were enrolled. The patients were classified into two groups: group I included 100 patients who received single therapy with sofosbuvir plus ledipasvir for 12 weeks and group II included 100 patients who received sofosbuvir plus oral weight-based ribavirin for 24 weeks. The primary end point was a sustained virological response at 12 weeks (SVR12) after the end of treatment, determined by quantitative polymerase chain reaction for HCV RNA.
Results: Group I patients showed statistically significant (p<0.05) higher SVR12 compared with group II patients (99% vs. 80%). There was no statistical difference (p>0.05%) between the studied groups regarding the frequencies of the side effects (26% vs. 29%). The most common adverse effects were headache, fatigue, myalgia, and cough.
Conclusion: Sofosbuvir and ledipasvir treatment for 12 weeks was well tolerated by patients with HCV genotype 4 and resulted in 99% SVR for all patients who received 12 weeks of the study drugs. ClinicalTrials.gov Identifier: NCT02992457.
Keywords: HCV, treatment, Egypt, sofosbuvir, ledipasvir, Harvoni
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