TY - JOUR
T1 - Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected with Hepatitis C Virus and HIV
T2 - The Impact on Patient-Reported Outcomes
AU - Younossi, Zobair M.
AU - Stepanova, Maria
AU - Sulkowski, Mark
AU - Naggie, Susanna
AU - Puoti, Massimo
AU - Orkin, Chloe
AU - Hunt, Sharon L.
N1 - Publisher Copyright:
© 2015 The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - 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. Clinical Trials Registration. NCT01667731 (PHOTON-1), NCT01783678 (PHOTON-2), NCT01604850 (FUSION), and NCT01682720 (VALENCE).
AB - 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. Clinical Trials Registration. NCT01667731 (PHOTON-1), NCT01783678 (PHOTON-2), NCT01604850 (FUSION), and NCT01682720 (VALENCE).
KW - HCV/HIV coinfection
KW - Hepatitis C treatment
KW - cirrhosis
KW - health-related quality of life
KW - patient-reported outcomes
KW - ribavirin
KW - sofosbuvir
UR - http://www.scopus.com/inward/record.url?scp=84936846257&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84936846257&partnerID=8YFLogxK
U2 - 10.1093/infdis/jiv005
DO - 10.1093/infdis/jiv005
M3 - Article
C2 - 25583164
AN - SCOPUS:84936846257
SN - 0022-1899
VL - 212
SP - 367
EP - 377
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 3
ER -