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Ledipasvir/Sofosbuvir with Or Without Ribavirin for 8 Or 12 Weeks For Hepatology ORIGINAL ARTICLE Ledipasvir/sofosbuvir with or without ribavirin for Gut: first published as 10.1136/gutjnl-2017-315906 on 17 April 2018. Downloaded from 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt Gamal Shiha,1,2 Gamal Esmat,3 Mohamed Hassany,4 Reham Soliman,2,5 Mohamed Elbasiony,1,2 Rabab Fouad,3 Aisha Elsharkawy,3 Radi Hammad,4 Wael Abdel-Razek,6 Talaat Zakareya,6 Kathryn Kersey,7 Benedetta Massetto,7 Anu Osinusi,7 Sophia Lu,7 Diana M Brainard,7 John G McHutchison,7 Imam Waked,6 Wahid Doss4 ► Additional material is ABSTRact published online only. To view Objective We evaluated the efficacy and safety of Significance of this study please visit the journal online ledipasvir/sofosbuvir alone and with ribavirin for 8 (http:// dx. doi. org/ 10. 1136/ What is already known about this subject? gutjnl- 2017- 315906). and 12 weeks in Egyptian patients with and without In Egypt, which has one of the highest 1 cirrhosis, who were infected with hepatitis C virus ► Internal Medicine Department, prevalences of hepatitis C virus (HCV) infection Mansoura University, Mansoura, (HCV) genotype 4, including those who had failed Egypt previous treatment with sofosbuvir regimens. in the world (6.3%), >90% of patients are 2Egyptian Liver Research Design In this open-label, multicentre, phase III study, infected with HCV genotype 4. Institute and Hospital (ELRIAH), treatment-naive patients were randomised to receive ► At the time of study design, sofosbuvir was the Mansoura, Egypt 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. only direct-acting antiviral (DAA) drug available 3Cairo University, Giza, Egypt 4 in Egypt. As such, the only DAA treatment National Hepatology and Interferon treatment-experienced patients were Tropical Medicine Research randomised to receive 12 weeks of ledipasvir/ options were sofosbuvir plus ribavirin plus Institute, Cairo, Egypt sofosbuvir±ribavirin, while sofosbuvir-experienced pegylated interferon for 12 weeks, or sofosbuvir 5 Tropical Medicine, Port Said or ledipasvir/sofosbuvir-experienced patients plus ribavirin for 24 weeks; there were no University, Port Said, Egypt treatment options for patients who had failed http://gut.bmj.com/ 6National Liver Institute– received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Menoufia University, Shebeen El Randomisation was stratified by cirrhosis status.T he direct-acting antiviral agent therapy. Kom, Egypt primary endpoint was sustained virological response ► We sought to find the optimal regimen 7Gilead Sciences, Foster City, 12 weeks post-treatment (SVR12). for ledipasvir–sofosbuvir in Egypt. Shorter California, USA Results We enrolled 255 patients from four centres treatment durations and/or the removal of in Egypt. Among treatment-naive patients, SVR12 ribavirin and pegylated interferon and their Correspondence to associated toxicities would be of benefit to Professor Gamal Shiha, Egyptian rates were 95% and 90% for those receiving 8 weeks on October 2, 2021 by guest. Protected copyright. Liver Research Institute and of ledipasvir/sofosbuvir alone and with ribavirin, patients. Hospital (ELRIAH), Mansoura, respectively, and 98% for those receiving 12 weeks What are the new findings? Dakahlia 35516, Egypt; g_ of ledipasvir/sofosbuvir both alone and with ribavirin. Treatment-naive patients without cirrhosis were shiha@ hotmail. com Among interferon-experienced patients, SVR rates ► effectively and safely treated with the fixed- were 94% for those receiving 12 weeks of ledipasvir/ Received 20 December 2017 dose combination of ledipasvir/sofosbuvir for 8 sofosbuvir and 100% for those receiving 12 weeks Revised 7 March 2018 weeks. Accepted 29 March 2018 of ledipasvir/sofosbuvir plus ribavirin. All patients Rates of sustained virological response 12 previously treated with sofosbuvir regimens who ► weeks post-treatment (SVR12) of ≥94% received ledipasvir/sofosbuvir plus ribavirin achieved were observed with 12 weeks of ledipasvir/ SVR12. The most common adverse events, headache sofosbuvir±ribavirin treatment in interferon- and fatigue, were more common among patients experienced patients with or without cirrhosis. receiving ribavirin. All sofosbuvir or ledipasvir–sofosbuvir- Conclusion Among non-cirrhotic treatment-naive experienced patients in this study achieved patients with HCV genotype 4, 8 weeks of ledipasvir/ SVR12 with 12 weeks of ledipasvir–sofosbuvir sofosbuvir±ribavirin was highly effective. Twelve plus ribavirin for 12 weeks. weeks of ledipasvir/sofosbuvir±ribavirin was highly Overall, the addition of ribavirin did not effective regardless of presence of cirrhosis or prior ► appear to increase rates of SVR observed with treatment experience, including previous treatment To cite: Shiha G, Esmat G, ledipasvir–sofosbuvir, but it was associated Hassany M, et al. Gut Epub with sofosbuvir or ledipasvir/sofosbuvir. with an increase in the incidence of adverse ahead of print: [please Trial registration number NCT02487030. include Day Month Year]. events. doi:10.1136/ gutjnl-2017-315906 Shiha G, et al. Gut 2018;0:1–8. doi:10.1136/gutjnl-2017-315906 1 Hepatology (LLOQ), or 15 IU/mL. Patients with or without compensated Significance of this study cirrhosis were eligible. Patients with hepatic decompensation, co-infection with hepatitis B virus or HIV, or contraindications Gut: first published as 10.1136/gutjnl-2017-315906 on 17 April 2018. Downloaded from How might it impact on clinical practice in the foreseeable to ribavirin therapy were excluded. Detailed inclusion/exclusion future? criteria are presented in the online supplementary appendix. ► Ledipasvir/sofosbuvir for 8 or 12 weeks is an effective and Patients were enrolled in three cohorts. Treatment-naive well-tolerated treatment for HCV genotype 4 infection, patients (cohort 1) were randomly assigned in a 1:1:1:1 ratio to without any of the safety concerns associated with ribavirin one of four treatment groups: ledipasvir–sofosbuvir for 8 weeks, therapy. In addition, a shorter treatment duration of 8 weeks ledipasvir–sofosbuvir+ribavirin for 8 weeks, ledipasvir–sofos- represents a treatment option for treatment-naive patients buvir for 12 weeks or ledipasvir–sofosbuvir+ribavirin for 12 without cirrhosis. weeks. In cohort 2, patients who had received sofosbuvir plus ► Shorter treatment durations and the benefit of once-daily, ribavirin for 12 or 24 weeks as part of a prior study (Clinical - single-tablet regimens should improve patient adherence Trials. gov, NCT01838590) but had failed to achieve SVR1215 or and help reduce the considerable burden of HCV on Egypt’s patients who had participated in cohort 1 of the current study healthcare system. and failed to achieve SVR12 with 8 weeks of ledipasvir–sofosbu- vir±ribavirin were enrolled to receive ledipasvir–sofosbuvir+rib- avirin for 12 weeks. Cohort 3 included interferon-experienced INTRODUCTION patients with no prior exposure to a direct-acting antiviral In 2014, WHO issued its first viral hepatitis guidelines calling targeting HCV NS5A or NS5B polymerase. These patients were for the elimination of hepatitis C virus (HCV) infection by randomised in a 1:1 ratio to ledipasvir–sofosbuvir or ledipasvir– 2030. In line with this goal, the estimated seroprevalence of sofosbuvir+ribavirin for 12 weeks. Patients in cohorts 1 and 3 HCV in Egypt has declined from 12.5% in 2008 to 6.3% in were stratified according to cirrhosis status. 2015.1 2 Although the prevalence of HCV may be decreasing overall, Egypt has among the highest incidences of HCV infec- Treatment tion worldwide with an estimated 168 600 new cases in 2013.1–4 Ledipasvir–sofosbuvir was administered orally as a fixed-dose More than 90% of Egyptian patients with HCV infections are combination tablet (90 mg ledipasvir and 400 mg sofosbuvir), infected by the genotype 4 strain of the virus.5 6 once daily. Ribavirin was administered twice daily, with food, At the time this study was designed, the only direct-acting at a total daily oral dose of 1000 or 1200 mg for patients antiviral drug approved in Egypt was sofosbuvir. As such, the weighing <75 kg or ≥75 kg, respectively. Dose reductions and only treatment options were sofosbuvir plus ribavirin plus discontinuation of ribavirin were allowed in accordance with the pegylated interferon for 12 weeks or sofosbuvir plus ribavirin product label. for 24 weeks.7 Retreatment options for patients who had failed prior direct-acting antiviral treatment were unavailable at the time. Ribavirin-free treatment options are especially crucial in Endpoints The primary efficacy endpoint was SVR12 (the proportion of patient populations for whom treatment with ribavirin is not http://gut.bmj.com/ advisable, such as older patients with underlying comorbidities. patients with HCV RNA <LLOQ 12 weeks post-treatment). Ribavirin-free regimens are also desirable to avoid the signifi- The primary safety endpoint was any adverse event leading to cant side effects associated with its use, including anaemia and permanent discontinuation of study drug(s). fatigue, as well as genotoxicity and teratogenicity.8 9 The fixed-dose combination of ledipasvir, an NS5A inhib- Study assessments itor, and sofosbuvir (ledipasvir–sofosbuvir) for 8 or 12 weeks HCV RNA levels were determined using the Ampliprep/TaqMan has proven to be highly effective and well tolerated in patients HCV Test, V.2.0 (Roche Molecular Systems, Branchburg, on October 2, 2021 by guest. Protected copyright. with HCV genotype 1 in phase III studies, with
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