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Effectiveness of 8 or 12 Week Treatment Duration of Ledipasvir/Sofosbuvir for Hepatitis C: Evidence from a Large Academic Medical Center

Abstract Background U.S. FDA labeling restricts 8-week treatment courses of ledipasvir/sofosbuvir (LDV/SOF) to treatment-naïve, HCV-genotype 1, non-cirrhotic patients with baseline viral load (VL) < 6 million IU/mL. A large proportion of patients who meet this criteria continue to undergo longer treatment durations. The primary objective of this analysis was to compare sustained virologic response rates at 12 weeks after treatment (SVR12) among patients receiving 8 vs. 12 weeks of therapy in a real-world clinical setting. Our secondary objective was to quantify uptake of the 8-week regimen in eligible patients. Methods This was a single-center, retrospective study of HCV-infected patients prescribed LDV/SOF at ambulatory clinics associated with the University of Maryland Medical Center (UMMC) from May 2015 to May 2016. Data were obtained from the UMMC electronic medical record and outpatient pharmacy claims database. Comparison between groups were made using Chi-squared or Fisher’s exact test for categorical variables and Student’s t-test or Wilcoxon rank-sum for continuous variables. Results A total of 288 patients were included. Median age was 58 years; 62.8% were male; 81.9% were black. Patients who received 12 weeks of therapy were significantly more likely to have a cirrhosis diagnosis, higher mean fibrosis score, and HCV/HIV-coinfection at baseline. SVR12 was achieved in 67 (95.7%) patients in the 8-week group vs. 138 (93.9%) in the 12 week group (P = 0.755). Amongst black patients, 168 (93.9%) achieved SVR12 compared with 36 (97.3%) non-black patients, (P = 0.944). Amongst HCV/HIV-coinfected patients, 89 (93.1%) achieved SVR12 compared with 67 (94.7%) without HCV/HIV-coinfection (P = 0.748). Overall, 40.6% (n = 117) met criteria for an 8-week treatment duration and 44% (n = 52) of those eligible patients received 8 weeks of therapy. The uptake rate of the 8-week treatment course was 44.4%. Conclusion Eight-week treatment duration of LDV/SOF was effective for treatment-naïve, non-cirrhotic, HCV-genotype 1 patients in this real-world setting. Race and HCV/HIV-coinfection did not significantly impact patients’ ability to achieve SVR12. Increased uptake of the 8-week regimen will decrease costs of therapy for patients and payers without compromising outcomes. Disclosures All authors: No reported disclosures.