Shorter Course of Ledipasvir-Sofosbuvir Therapy Effective in Patients with Genotype 1 Hepatitis C

MAY 24, 2016
Katherine Hasal
“This comparative analysis was conducted to determine whether it is feasible to shorten the duration of treatment of previously untreated patients with HCV genotype 1 infection with ledipasvir-sofosbuvir from 12 weeks to 8 weeks in the real-world clinical setting,” said Kris Kowdley, MD, of the Swedish Medical Center in Seattle, Washington, at a presentation at Digestive Disease Week 2016, a joint meeting of the American Academy for the Study of Liver Diseases (AASLD), American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
In the real-world clinical setting, it can be useful to shorten therapy. The decision to shorten therapy is usually based on the patient’s treatment history, cirrhosis status, and baseline viral load.
The phase 3 ION-3 trial was a multicenter, randomized, open-label trial consisting of three treatment arms: ledipasvir-sofosbuvir for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary efficacy end point, sustained virologic response, was defined as an HCV-RNA level of less than 25 IU per milliliter at 12 weeks, after the end of therapy. In the ION-3 trial, patients received a fixed-dose combination tablet containing 90 mg of ledipasvir and 400 mg of sofosbuvir, administered orally once daily. Weight-based ribavirin was administered orally twice daily.
In this comparative analysis, data from the ION-3 trial were compared with real-word effectiveness data from six diverse and heterogeneous real-world and post-marketing population cohorts.
While the optimal duration of therapy depends on many factors, post-hoc analyses of the ION-3 clinical trial data with a fixed-dose combination of ledipasvir and sofosbuvir, two direct-acting antiviral agents with distinct viral targets and mechanisms of action, showed that the rapidity and durability of viral suppression achieved with this regimen allows a shorter treatment course of 8 weeks. In this study, the best predictor of sustained virologic response (SVR) was a viral load less than 6 million.

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