title: Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes.
abstract: BACKGROUND
  Sofosbuvir-containing regimens have been approved for treatment of hepatitis C virus (HCV) infection in human immunodeficiency virus (HIV)-infected patients. We assessed the effect of treatment with sofosbuvir and ribavirin on patient-reported outcomes (PROs) in individuals with HIV/HCV coinfection.
  
  
  METHODS
  HIV/HCV-coinfected patients were treated for 12 or 24 weeks with sofosbuvir and ribavirin. Matched HCV-monoinfected controls were also evaluated. All subjects completed standard PRO questionnaires before, during, and after treatment.
  
  
  RESULTS
  Included were 497 participants from the PHOTON-1 and PHOTON-2 clinical trials. At baseline, more impairment in PRO scores was noted in HIV/HCV-coinfected patients, compared with HCV-monoinfected patients. During treatment, moderate decrements in PRO scores (change, up to -6.8% on a 0%-100% scale; P = .0053) were experienced regardless of treatment duration and were similar to those for HCV-monoinfected patients (all P > .05). In 413 HIV/HCV-coinfected patients with a virologic response sustained for 12 weeks after treatment cessation, most PRO scores improved (change, up to +7.6%; P < .0001), similar to findings for HCV-monoinfected patients. In multivariate analysis, in addition to clinico-demographic predictors, coinfection with HIV was associated with PRO impairment at baseline (beta, up to -7.6%; P < .002) but not with treatment-emergent changes in PRO scores (all P > .05).
  
  
  CONCLUSIONS
  Patients with HIV/HCV coinfection tolerate interferon-free sofosbuvir-based anti-HCV regimens well and, despite the presence of some baseline impairment, have treatment-emergent changes in PRO scores that are similar to those of patients with HCV monoinfection.
  
  
  BACKGROUND
  NCT01667731 (PHOTON-1), NCT01783678 (PHOTON-2), NCT01604850 (FUSION), and NCT01682720 (VALENCE).
authors.affiliation: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
authors.forename: Zobair M
authors.initials: ZM
authors.lastname: Younossi
authors.affiliation: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia Center for Outcomes Research in Liver Diseases, Washington, D.C.
authors.forename: Maria
authors.initials: M
authors.lastname: Stepanova
authors.affiliation: John Hopkins University, Baltimore, Maryland.
authors.forename: Mark
authors.initials: M
authors.lastname: Sulkowski
authors.affiliation: Duke Medical Center, Durham, North Carolina.
authors.forename: Susanna
authors.initials: S
authors.lastname: Naggie
authors.affiliation: Division of Infectious Diseases, AO Ospedale Niguarda Ca' Granda, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Puoti
authors.affiliation: Barts Health NHS Trust, London, United Kingdom.
authors.forename: Chloe
authors.initials: C
authors.lastname: Orkin
authors.affiliation: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hunt
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D060085:Coinfection / Q000821:virology*; D015658:HIV Infections / Q000503:physiopathology / Q000821:virology*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008103:Liver Cirrhosis / Q000503:physiopathology / Q000821:virology; D011788:Quality of Life; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D057566:Self Report; D000069474:Sofosbuvir; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: HCV/HIV coinfection; Hepatitis C treatment; cirrhosis; health-related quality of life; patient-reported outcomes; ribavirin; sofosbuvir