PT  - JOURNAL ARTICLE
AU  - Gamal Shiha
AU  - Gamal Esmat
AU  - Mohamed Hassany
AU  - Reham Soliman
AU  - Mohamed Elbasiony
AU  - Rabab Fouad
AU  - Aisha Elsharkawy
AU  - Radi Hammad
AU  - Wael Abdel-Razek
AU  - Talaat Zakareya
AU  - Kathryn Kersey
AU  - Benedetta Massetto
AU  - Anu Osinusi
AU  - Sophia Lu
AU  - Diana M Brainard
AU  - John G McHutchison
AU  - Imam Waked
AU  - Wahid Doss
TI  - 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
AID  - 10.1136/gutjnl-2017-315906
DP  - 2019 Apr 01
TA  - Gut
PG  - 721--728
VI  - 68
IP  - 4
4099  - http://gut.bmj.com/content/68/4/721.short
4100  - http://gut.bmj.com/content/68/4/721.full
SO  - Gut2019 Apr 01; 68
AB  - Objective We 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.Design In 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).Results We 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.Conclusion Among 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 number NCT02487030.