Adherence to Interferon (IFN) and Ribavirin (RBV)-Free Regimens for Treatment of Chronic Hepatitis C (CH-C): Are There Any Associations With Clinical and Patient-Reported Outcomes (PROs)?

Abstract

Introduction: Patients' experience (PROs) may affect treatment adherence. Our aim was to assess the impact of clinical and PRO factors on adherence to IFN- and RBV-free regimens of sofosbuvir and ledipasvir (LDV/SOF). Methods: PRO data (SF-36, CLDQ-HCV, FACIT-F, WPAI:SHP) from multinational clinical trials of a fixed-dose combination (FDC) of LDV/SOF were available. Treatment non-adherence was defined as < 80% of FDC doses. Results: 1,158 CH-C patients with HCV genotype 1 (74.4% treatment-naïve, 16.4% cirrhotic) were included. Of these patients, 1,117 (96.5%) were adherent to the treatment regimen, and 41 (3.5%) were non-adherent. Prior to treatment, the only clinical variable that was more common in non-adherent patients was that they were less likely to be employed (43.6% vs. 63.1%, p=0.01). At baseline, all PROs were similar between those who would be adherent and non-adherent to FDC (all p>0.05). By week 4 of treatment, non-adherent patients had more impairment in bodily pain (BP) (69.12±24.69 vs. 75.45±24.76, p=0.04), Mental Health (MH) (69.40±21.49 vs. 76.09± 19.13, p=0.03), and Physical wellbeing (PWB) (22.78±4.44 vs. 23.68±5.04, p=0.02). By the end of treatment, non-adherent patients had more impairment in Role Emotion (RE) (76.53±26.48 vs. 83.76±23.57, p=0.02). After 12 and 24 weeks of follow-up, PROs in adherent and non-adherent patients were no longer different (p>0.05). In multivariate logistic regression analysis, adherence to LDV/SOF was not associated with any of the PRO or clinical factors. Conclusion: The IFN- and RBV-free regimen with LDV/SOF (FDC) is associated with very high rates of adherence. Non-adherence to FDC could not be predicted by clinical and PRO variables.