Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus.
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.
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA. zobair.younossi@inova.org.|Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA. zobair.younossi@inova.org.
Z M
ZM
Younossi
Center for Outcomes Research, Washington, DC, USA.
M
M
Stepanova
John Hopkins University, Baltimore, MD, USA.
M
M
Sulkowski
Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA.
S
S
Naggie
Center for Outcomes Research, Washington, DC, USA.
L
L
Henry
Center for Outcomes Research, Washington, DC, USA.
S
S
Hunt
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D004526:Efficiency; D005221:Fatigue / Q000453:epidemiology; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use*; D015658:HIV Infections / Q000150:complications*; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D000069474:Sofosbuvir / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir

HCV
; 
HIV
; 
HRQL
; LDV/SOF; patient-reported outcomes; work productivity