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.

Clinical trials registration: NCT01667731 (PHOTON-1), NCT01783678 (PHOTON-2), NCT01604850 (FUSION), and NCT01682720 (VALENCE).

Keywords: HCV/HIV coinfection; Hepatitis C treatment; cirrhosis; health-related quality of life; patient-reported outcomes; ribavirin; sofosbuvir.

Figure 1.

Changes in patient-reported outcomes at the end of treatment (A) and after sustaining a virologic response for 12 weeks after treatment cessation (B) in patients coinfected with human immunodeficiency virus and hepatitis C virus (HCV). Values above the upper and below the lower red lines denote statistically significant changes. Abbreviations: BP, bodily pain scale; CLDQ-HCV, Chronic Liver Disease Questionnaire–Hepatitis C Virus; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire; MCS, mental component summary score; MH, mental health scale; PCS, physical component summary score; PF, physical functioning scale; RE, role emotional scale; RP, role physical scale; SF, social functioning scale; SF-36, Short-Form 36 questionnaire; VT, vitality scale; WPAI:SHP, Work Productivity and Activity–Specific Health Problem questionnaire.

Figure 2.

Patient-reported outcomes throughout treatment with sofosbuvir/ribavirin in patients coinfected with human immunodeficiency virus and hepatitis C virus (HCV) and matched controls with HCV monoinfection. The physical component summary (PCS) score is significantly lower in HIV/HCV-coinfected patients, compared with HCV-monoinfected patients (P < .05) at baseline, 12 weeks after treatment cessation in those who achieved sustained virologic response (SVR12); mental component summary at posttreatment week 4; fatigue scale at SVR12; total Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire baseline, SVR12; Chronic Liver Disease Questionnaire–Hepatitis C Virus (CLDQ-HCV) instrument at SVR12; work productivity and activity impairment of Work Productivity and Activity–Specific Health Problem (WPAI:SHP) questionnaire are similar between HIV/HCV-coinfected patients and HCV-monoinfected subjects at all time points (all P > .05). Abbreviations: AI, activity impairment; FS, fatigue scale; WI, work productivity impairment.

Figure 3.

Normalized changes in patient-reported outcomes at the end of treatment (A) and after sustaining a virologic response for 12 weeks after treatment cessation (B) in patients coinfected with human immunodeficiency virus and hepatitis C virus who did (n = 76) or did not (n = 421) have cirrhosis. All P values were > .05 for comparisons between cirrhosis and noncirrhosis cohorts. Abbreviations: CLDQ-HCV, Chronic Liver Disease Questionnaire–Hepatitis C Virus instrument; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire; MCS, mental component summary score; PCS, physical component summary score; SF-36, Short-Form 36 questionnaire.