M P Curry1, E B Tapper2, B Bacon3, D Dieterich4, S L Flamm5, L Guest6, K V Kowdley7, Y Lee6, S Milligan6, N Tsai8, Z Younossi9, N H Afdhal1. 1. Division of Gastroenterology and Hepatology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. 2. Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA. 3. Division of Gastroenterology/ Hepatology, Saint Louis University School of Medicine, Saint Louis, MO, USA. 4. Division of Liver Diseases, Department of Medicine, Mount Sinai School of Medicine, New York, NY, USA. 5. Division of Hepatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 6. Trio Health Analytics, La Jolla, CA, USA. 7. Liver Care Network, Swedish Medical Center, Seattle, WA, USA. 8. The Liver Center, Queen's Medical Center, Honolulu, HI, USA. 9. Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA.
Abstract
BACKGROUND: Treatment of genotype 1 hepatitis C virus (HCV) infection with combination direct acting anti-virals is associated with very high rates of sustained virological response (SVR). Daily combination of ledipasvir and sofosbuvir for 12 weeks is approved for the treatment of genotype 1 HCV patients, though noncirrhotic patients who are naïve to treatment with a baseline HCV RNA <6 million IU/mL can be treated for 8 weeks. This guidance stemmed from a post hoc analysis of the ION 3 clinical trial, which demonstrated similar SVR for patients treated with ledipasvir and sofosbuvir with or without ribavirin for 8 or 12 weeks. AIM: To compare the SVR for 8 weeks vs 12 weeks of ledipasvir and sofosbuvir in HCV infected patients in a real-world setting. METHODS: We performed an observational real-world cohort study of treatment success following 8 or 12 weeks of ledipasvir and sofosbuvir for treatment-naïve genotype 1 HCV patients. RESULTS: A total of 826 patients were treated for either 8 (n=252) or 12 weeks (n=574) with ledipasvir and sofosbuvir and achieved SVR rate of 95.3% and there was no statistical difference in SVR rates in the two groups irrespective of any clinical or virological variables. CONCLUSIONS: In treatment-naïve HCV genotype 1 patients, SVR was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir. 8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen.
BACKGROUND: Treatment of genotype 1 hepatitis C virus (HCV) infection with combination direct acting anti-virals is associated with very high rates of sustained virological response (SVR). Daily combination of ledipasvir and sofosbuvir for 12 weeks is approved for the treatment of genotype 1 HCVpatients, though noncirrhotic patients who are naïve to treatment with a baseline HCV RNA <6 million IU/mL can be treated for 8 weeks. This guidance stemmed from a post hoc analysis of the ION 3 clinical trial, which demonstrated similar SVR for patients treated with ledipasvir and sofosbuvir with or without ribavirin for 8 or 12 weeks. AIM: To compare the SVR for 8 weeks vs 12 weeks of ledipasvir and sofosbuvir in HCV infectedpatients in a real-world setting. METHODS: We performed an observational real-world cohort study of treatment success following 8 or 12 weeks of ledipasvir and sofosbuvir for treatment-naïve genotype 1 HCVpatients. RESULTS: A total of 826 patients were treated for either 8 (n=252) or 12 weeks (n=574) with ledipasvir and sofosbuvir and achieved SVR rate of 95.3% and there was no statistical difference in SVR rates in the two groups irrespective of any clinical or virological variables. CONCLUSIONS: In treatment-naïve HCV genotype 1 patients, SVR was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir. 8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen.
Authors: Zhe Chen; Bryan D Cox; Ethel C Garnier-Amblard; Tamara R McBrayer; Steven J Coats; Raymond F Schinazi; Franck Amblard Journal: Bioorg Med Chem Lett Date: 2017-10-12 Impact factor: 2.823
Authors: Rachel A Stewart; Brooke R MacDonald; Tzu-Chun Chu; Jonathan D Moore; Esther O Fasanmi; Rohit P Ojha Journal: Dig Dis Sci Date: 2018-07-16 Impact factor: 3.199
Authors: Alexandra DeBose-Scarlett; Raymond Balise; Deukwoo Kwon; Susan Vadaparampil; Steven Xi Chen; Eugene R Schiff; Gladys Patricia Ayala; Emmanuel Thomas Journal: J Transl Med Date: 2018-06-28 Impact factor: 5.531