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Sofosbuvir and ledipasvir improve patient‐reported outcomes in patients co‐infected with hepatitis C and human immunodeficiency virus
Author(s) -
Younossi Z. M.,
Stepanova M.,
Sulkowski M.,
Naggie S.,
Henry L.,
Hunt S.
Publication year - 2016
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12554
Subject(s) - ledipasvir , sofosbuvir , medicine , ribavirin , hepatitis c virus , hepatitis c , gastroenterology , immunology , virus
Summary 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 ( PRO s) 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 PRO s (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.