Friday, April 27, 2018

Harvoni effective for HCV genotype 4, including cirrhotic cases

In The Journal
Original article 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
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

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Significance of this study
What is already known about this subject?
► In Egypt, which has one of the highest prevalences of hepatitis C virus (HCV) infection in the world (6.3%), >90% of patients are infected with HCV genotype 4.
► At the time of study design, sofosbuvir was the only direct-acting antiviral (DAA) drug available in Egypt. As such, the only DAA treatment options were sofosbuvir plus ribavirin plus pegylated interferon for 12 weeks, or sofosbuvir plus ribavirin for 24 weeks; there were no treatment options for patients who had failed direct-acting antiviral agent therapy.
► We sought to find the optimal regimen for ledipasvir–sofosbuvir in Egypt. Shorter treatment durations and/or the removal of ribavirin and pegylated interferon and their associated toxicities would be of benefit to patients. What are the new findings?
► Treatment-naive patients without cirrhosis were effectively and safely treated with the fixeddose combination of ledipasvir/sofosbuvir for 8 weeks.
► Rates of sustained virological response 12 weeks post-treatment (SVR12) of ≥94% were observed with 12 weeks of ledipasvir/ sofosbuvir±ribavirin treatment in interferonexperienced patients with or without cirrhosis. All sofosbuvir or ledipasvir–sofosbuvirexperienced patients in this study achieved SVR12 with 12 weeks of ledipasvir–sofosbuvir plus ribavirin for 12 weeks.
► Overall, the addition of ribavirin did not appear to increase rates of SVR observed with ledipasvir–sofosbuvir, but it was associated with an increase in the incidence of adverse  events.
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Commentary @ Healio
Harvoni effective for HCV genotype 4, including cirrhotic cases
April 27, 2018 
Patients with hepatitis C genotype 4 had high sustained virologic response rates with Harvoni over 8 weeks in treatment-naive cases without cirrhosis and over 12 weeks with ribavirin regardless of cirrhosis or treatment experience, according to recently published data from a phase 3 study in Egypt.

“Given the high prevalence of HCV in Egypt and the heterogeneity of the HCV-infected population with respect to age, comorbidities and prior HCV therapy, there is a need in Egypt for a highly efficacious, well-tolerated, single-tablet regimen with simple monitoring,” Gamal Shiha, MD, PhD, from the Liver Research Institute and Hospital in Egypt, and colleagues wrote. “With the widespread use of sofosbuvir, an efficacious treatment for those who have failed treatment with a sofosbuvir-based regimen would also be highly desirable.”

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