Published in:
01-04-2018 | Original Article—Liver, Pancreas, and Biliary Tract
Efficacy and safety of ledipasvir/sofosbuvir with ribavirin in chronic hepatitis C patients who failed daclatasvir/asunaprevir therapy: pilot study
Authors:
Yoshiiku Kawakami, Hidenori Ochi, Clair Nelson Hayes, Michio Imamura, Masataka Tsuge, Takashi Nakahara, Yoshio Katamura, Hiroshi Kohno, Hirotaka Kohno, Keiji Tsuji, Shintaro Takaki, Nami Mori, Yohji Honda, Keiko Arataki, Shoichi Takahashi, Shinsuke Kira, Toru Tamura, Kazunari Masuda, Toshio Nakamura, Masaya Kikkawa, Kazuaki Chayama
Published in:
Journal of Gastroenterology
|
Issue 4/2018
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Abstract
Background
In Japan, daclatasvir (DCV) and asunaprevir (ASV) therapy was the first IFN-free treatment to be approved, and thousands of patients have since been successfully treated, with an SVR rate of around 90%. The converse, however, is that around 10% of patients fail to achieve viral eradication and must be retreated using a different approach. This study is to evaluate treatment efficacy of ledipasvir/sofosbuvir and ribavirin in patients who failed to respond to DCV and ASV therapy.
Methods
Thirty patients were treated with 12 weeks of ledipasvir/sofosbuvir and ribavirin. We evaluated the rate of sustained virological response 12 weeks after the end of treatment (SVR12) and examined the incidence of adverse events during ledipasvir/sofosbuvir and ribavirin treatment. NS5A and NS5B resistance-associated variants (RAVs) in treatment failure cases were examined.
Results
The overall SVR12 rate was 86.7% (26/30). Large decreases in mean log10 HCV RNA levels were observed in patients without cirrhosis, and the SVR12 rate for these patients was 100% (12/12). In cases of cirrhosis, SVR12 rate was 72.2% (13/18). The common factors in treatment failure cases were the presence of liver cirrhosis and both NS5A L31M/I and Y93H RAVs. The frequency of RAVs did not change before and after treatment among patients who relapsed.
Conclusion
Ledipasvir/sofosbuvir with ribavirin is an effective retreatment option for patients with chronic hepatitis C who failed to respond to prior daclatasvir and asunaprevir therapy.