Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus

Z. M. Younossi, M. Stepanova, Mark Sulkowski, S. Naggie, L. Henry, S. Hunt

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalJournal of Viral Hepatitis
DOIs
StateAccepted/In press - 2016

Fingerprint

Hepatitis C
HIV
Ribavirin
Fatigue
Genotype
sofosbuvir drug combination ledipasvir
Patient Reported Outcome Measures
Withholding Treatment
Therapeutics
Multivariate Analysis
Quality of Life
Clinical Trials

Keywords

  • HIV
  • HRQL
  • HCV
  • LDV/SOF
  • Patient-reported outcomes
  • Work productivity

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology

Cite this

Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus. / Younossi, Z. M.; Stepanova, M.; Sulkowski, Mark; Naggie, S.; Henry, L.; Hunt, S.

In: Journal of Viral Hepatitis, 2016.

Research output: Contribution to journalArticle

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abstract = "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.",
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AU - Henry, L.

AU - Hunt, S.

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