Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt
| Autor: | Benedetta Massetto, Imam Waked, Mohamed Elbasiony, Sophia Lu, Mohamed Hassany, Kathryn Kersey, Radi Hammad, Diana M. Brainard, Aisha Elsharkawy, John G. McHutchison, Wahid Doss, Gamal Esmat, Gamal Shiha, Anu Osinusi, Talaat Zakareya, Reham Soliman, Wael Abdel-Razek, Rabab Fouad |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Liver Cirrhosis Male Cirrhosis Sofosbuvir Hepacivirus medicine.disease_cause Gastroenterology chemistry.chemical_compound 0302 clinical medicine Genotype Clinical endpoint virus diseases Middle Aged Treatment Outcome 030211 gastroenterology & hepatology Drug Therapy Combination Egypt Female chronic hepatitis Uridine Monophosphate medicine.drug Ledipasvir Adult medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Hepatitis C virus Antiviral Agents 03 medical and health sciences Internal medicine Ribavirin medicine Humans Adverse effect Aged Fluorenes Hepatology business.industry cirrhosis Hepatitis C Chronic medicine.disease digestive system diseases 030104 developmental biology chemistry Benzimidazoles business |
| Zdroj: | Gut |
| ISSN: | 1468-3288 0017-5749 |
| Popis: | ObjectiveWe evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens.DesignIn this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Randomisation was stratified by cirrhosis status. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12).ResultsWe enrolled 255 patients from four centres in Egypt. Among treatment-naive patients, SVR12 rates were 95% and 90% for those receiving 8 weeks of ledipasvir/sofosbuvir alone and with ribavirin, respectively, and 98% for those receiving 12 weeks of ledipasvir/sofosbuvir both alone and with ribavirin. Among interferon-experienced patients, SVR rates were 94% for those receiving 12 weeks of ledipasvir/sofosbuvir and 100% for those receiving 12 weeks of ledipasvir/sofosbuvir plus ribavirin. All patients previously treated with sofosbuvir regimens who received ledipasvir/sofosbuvir plus ribavirin achieved SVR12. The most common adverse events, headache and fatigue, were more common among patients receiving ribavirin.ConclusionAmong non-cirrhotic treatment-naive patients with HCV genotype 4, 8 weeks of ledipasvir/sofosbuvir±ribavirin was highly effective. Twelve weeks of ledipasvir/sofosbuvir±ribavirin was highly effective regardless of presence of cirrhosis or prior treatment experience, including previous treatment with sofosbuvir or ledipasvir/sofosbuvir.Trial registration numberNCT02487030. |
| Databáze: | OpenAIRE |
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