부산대학교 도서관

A fixed-dose combination of ledipasvir and sofosbuvir ( LDV/ SOF) has been approved for treatment of HCV patients. We assessed the effect of LDV/ SOF on patient-reported outcomes ( PROs) in HIV- HCV-co-infected patients. Patient-reported outcomes data from HIV- HCV-co-infected patients who were treated with LDV/ SOF for 12 weeks were collected as a part of a clinical trial ( ION-4). Historical controls were HIV- HCV-co-infected patients treated with SOF and ribavirin ( RBV) in PHOTON-1. We included 335 HIV- HCV-co-infected patients ( SVR-12 in HCV genotype 1 was 96%) who received LDV/ SOF, while 223 patients ( SVR-12 in HCV genotype 1 was 76.3%) received SOF/ RBV. During treatment, patients receiving LDV/ SOF showed improvement in all of their PRO scores (+6.0% in activity/energy of CLDQ- HCV, +5.0% in fatigue score of FACIT-F, +6.8% in physical component of SF-36; all P < 0.0001) while those receiving SOF+ RBV showed moderate decline in some of their PRO scores (−4.8% in physical functioning of SF-36, −4.4% in fatigue score of FACIT-F, both P < 0.001). Patients who achieved sustained virologic response with LDV/ SOF also showed improvement of PROs (average +5.1%) while those treated with SOF/ RBV showed less or no improvement (average +1.4%). In a multivariate analysis, in addition to depression and fatigue, receiving SOF+ RBV ( vs LDV/ SOF) was independently associated with more PRO impairment during treatment (beta −6.1 to −12.1%, P < 0.001). Hence, HIV- HCV patients treated with LDV/ SOF show significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation. [ABSTRACT FROM AUTHOR]