Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection
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...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-03-01
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| Series: | Infection and Drug Resistance |
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| Online Access: | https://www.dovepress.com/efficacy-and-safety-of-sofosbuvir-ledipasvir-for-treatment-of-a-cohort-peer-reviewed-article-IDR |
| _version_ | 1818062515496550400 |
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| author | Ahmed OA Kaisar HH Badawi R Hawash N Samir H Shabana SST Fouad MHA Rizk FH Khodeir SA Abd-Elsalam S |
| author_facet | Ahmed OA Kaisar HH Badawi R Hawash N Samir H Shabana SST Fouad MHA Rizk FH Khodeir SA Abd-Elsalam S |
| author_sort | Ahmed OA |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-10T14:05:26Z |
| format | Article |
| id | doaj.art-55a8e9862d08436bb0d5f1d9e6157edb |
| institution | Directory Open Access Journal |
| issn | 1178-6973 |
| language | English |
| last_indexed | 2024-12-10T14:05:26Z |
| publishDate | 2018-03-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Infection and Drug Resistance |
| spelling | doaj.art-55a8e9862d08436bb0d5f1d9e6157edb2022-12-22T01:45:40ZengDove Medical PressInfection and Drug Resistance1178-69732018-03-01Volume 1129529837010Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infectionAhmed OAKaisar HHBadawi RHawash NSamir HShabana SSTFouad MHARizk FHKhodeir SAAbd-Elsalam SOssama 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, Harvonihttps://www.dovepress.com/efficacy-and-safety-of-sofosbuvir-ledipasvir-for-treatment-of-a-cohort-peer-reviewed-article-IDRHCVtreatmentEgyptsofosbuvirledipasvirHarvoni. |
| spellingShingle | Ahmed OA Kaisar HH Badawi R Hawash N Samir H Shabana SST Fouad MHA Rizk FH Khodeir SA Abd-Elsalam S Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection Infection and Drug Resistance HCV treatment Egypt sofosbuvir ledipasvir Harvoni. |
| title | Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection |
| title_full | Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection |
| title_fullStr | Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection |
| title_full_unstemmed | Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection |
| title_short | Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection |
| title_sort | efficacy and safety of sofosbuvir ndash ledipasvir for treatment of a cohort of egyptian patients with chronic hepatitis c genotype 4 infection |
| topic | HCV treatment Egypt sofosbuvir ledipasvir Harvoni. |
| url | https://www.dovepress.com/efficacy-and-safety-of-sofosbuvir-ledipasvir-for-treatment-of-a-cohort-peer-reviewed-article-IDR |
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