Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes
Journal of Infect Dis August 1, 2015 V.212 N.3 P.367-377
Zobair M. Younossi, Maria Stepanova, Mark Sulkowski, Susanna Naggie, Massimo Puoti, Chloe Orkin, and Sharon L. Hunt
1Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital
2Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia
3Center for Outcomes Research in Liver Diseases, Washington, D.C.
4John Hopkins University, Baltimore, Maryland
5Duke Medical Center, Durham, North Carolina
6Division of Infectious Diseases, AO Ospedale Niguarda Ca’ Granda, Milan, Italy
7Barts Health NHS Trust, London, United Kingdom
Correspondence: Zobair M. Younossi, MD, MPH, Betty and Guy Beatty Center for Integrated Research, Claude Moore Health Education and Research Bldg, 3300 Gallows Rd, Falls Church, VA 22042 (firstname.lastname@example.org).
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.
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.
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).
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).