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

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Younossi, ZM; Stepanova, M; Sulkowski, M; Naggie, S; Henry, L; Hunt, S
Published in: J Viral Hepat
November 2016

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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Published In

J Viral Hepat

DOI

EISSN

1365-2893

Publication Date

November 2016

Volume

23

Issue

11

Start / End Page

857 / 865

Location

England

Related Subject Headings

  • Treatment Outcome
  • Sofosbuvir
  • Patient Satisfaction
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
  • HIV Infections
  • Gastroenterology & Hepatology
  • Fluorenes
 

Citation

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Younossi, Z. M., Stepanova, M., Sulkowski, M., Naggie, S., Henry, L., & Hunt, S. (2016). Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus. In J Viral Hepat (Vol. 23, pp. 857–865). England. https://doi.org/10.1111/jvh.12554
Younossi, Z. M., M. Stepanova, M. Sulkowski, S. Naggie, L. Henry, and S. Hunt. “Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus.” In J Viral Hepat, 23:857–65, 2016. https://doi.org/10.1111/jvh.12554.
Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Henry L, Hunt S. Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus. In: J Viral Hepat. 2016. p. 857–65.
Younossi, Z. M., et al. “Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus.J Viral Hepat, vol. 23, no. 11, 2016, pp. 857–65. Pubmed, doi:10.1111/jvh.12554.
Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Henry L, Hunt S. Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus. J Viral Hepat. 2016. p. 857–865.
Journal cover image

Published In

J Viral Hepat

DOI

EISSN

1365-2893

Publication Date

November 2016

Volume

23

Issue

11

Start / End Page

857 / 865

Location

England

Related Subject Headings

  • Treatment Outcome
  • Sofosbuvir
  • Patient Satisfaction
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
  • HIV Infections
  • Gastroenterology & Hepatology
  • Fluorenes