Real-World Treatment Results with Ledipasvir-Sofosbuvir in Patients Coinfected with HIV and Hepatitis C

MAY 25, 2016
Katherine Hasal
“In ION-4, ledipasvir/sofosbuvir (LDV/SOF) yielded a sustained virologic response (SVR12) rate of 96% in genotype 1, treatment-naïve hepatitis C virus (HCV) patients co-infected with HIV-1 in ION-4. Given the remarkable efficacy achieved in clinical trials, we aimed to understand real-world outcomes across a heterogeneous co-infected population,” said Douglas Dieterich, MD, of the Icahn School of Medicine in Chicago, 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).
The purpose of this study was to evaluate the efficacy of LDV/SOF with or without ribavirin (RBV) for 8, 12, or 24 weeks in the treatment of a real-world population of post-transplant genotype 1 HCV patients who were co-infected with HIV. Data were collected from providers and specialty pharmacies included in Trio Health’s Innervation Platform, a cloud-based disease management program. Data providers included AcariaHealth, Allcare Plus, Aureus Health, BioCure, Encompass Rx, Islandcare, Pharmacare Hawaii, Premier, SkyeMed, and other pharmacies. All post-transplant genotype 1 HCV patients who initiated treatment with LDV/SOF with or without RBV were included in the analysis.
Data from 140 patients were collected. Overall, 59% were treated in a community site and 41% were treated in an academic setting. Sixty-nine percent were male, 88% were under the age of 65 years, 29% were African American, 80% had genotype 1a HCV, 54% were HCV treatment-naive, 35% had cirrhosis, 85% had platelet counts in access of 100K, 82% had creatinine clearance of 60 mL/minute or higher, and 43% had a baseline viral RNA of 2MM IU/mL or greater.

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