Title |
Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection
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Published in |
Infection and Drug Resistance, March 2018
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DOI | 10.2147/idr.s153060 |
Pubmed ID | |
Authors |
Ossama A Ahmed, Hany H Kaisar, Rehab Badawi, Nehad Hawash, Hossam Samir, Sherif ST Shabana, Mohamed Hassan A Fouad, Fatma H Rizk, Samy A Khodeir, Sherief Abd-Elsalam |
Abstract |
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. 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. 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. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Egypt | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 39 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 7 | 18% |
Lecturer | 4 | 10% |
Other | 3 | 8% |
Student > Ph. D. Student | 3 | 8% |
Student > Bachelor | 3 | 8% |
Other | 4 | 10% |
Unknown | 15 | 38% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 10 | 26% |
Social Sciences | 3 | 8% |
Biochemistry, Genetics and Molecular Biology | 2 | 5% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 5% |
Agricultural and Biological Sciences | 1 | 3% |
Other | 3 | 8% |
Unknown | 18 | 46% |