Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Abstract

Summary Background Health utilities measure patients' preferences for a health state. Aim To assess health utilities for sofosbuvir‐containing therapy for chronic hepatitis C. Methods The SF‐6D utility scores were derived from the SF‐36 instrument administered at baseline, during and post‐treatment to participants of the previously reported clinical trials of sofosbuvir. EQ‐5D utility scores were also approximated from the SF‐36 using a regression model. Results Nine hundred and ninety‐four patients were enrolled. Baseline SF‐6D and EQ‐5D scores were 0.66 ± 0.13 and 0.71 ± 0.22, respectively (the POSITRON trial), 0.71 ± 0.16 and 0.76 ± 0.23 (FISSION), 0.70 ± 0.14 and 0.75 ± 0.22 (FUSION), 0.72 ± 0.15 and 0.79 ± 0.22 (NEUTRINO). In all studies, SF‐6D and EQ‐5D scores were highly correlated with each other. (r = 0.83–0.87, P < 0.0001). After 12 weeks, patients receiving sofosbuvir + ribavirin (POSITRON) had similar utility scores to placebo (P > 0.05). Patients receiving 12 and 16 weeks of sofosbuvir + ribavirin (FUSION) had similar utility scores (P > 0.05). In FISSION, patients receiving sofosbuvir + ribavirin had significantly better utilities compared to patients receiving interferon + ribavirin (P < 0.001). Patients receiving sofosbuvir + ribavirin + interferon (NEUTRINO) had a decrease in utilities during treatment (SF‐6D: from 0.72 to 0.62, EQ‐5D: 0.79 to 0.65; P < 0.0001) similar to that observed in patients receiving pegylated interferon + ribavirin for 24 weeks in FISSION (0.72 to 0.62 and 0.77 to 0.65, respectively, P < 0.0001). After 12 weeks post‐treatment, patients with SVR (FUSION) had improvement in SF‐6D (+0.026 from baseline, P = 0.013) and EQ‐5D (+0.043, P = 0.013). In multivariate analyses, baseline depression, anxiety, fatigue, insomnia and treatment‐related anaemia were the most consistent predictors of utilities. Conclusions Patients' health utilities are minimally impacted by sofosbuvir + ribavirin treatment, as compared to interferon‐based, therapy regardless of treatment duration. Clinical trials' numbers: NCT01542788 (POSITRON), NCT01497366 (FISSION), NCT01604850 (FUSION), NCT01641640 (NEUTRINO).

Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir

“…Furthermore, improvements of HRQL, work productivity and health utilities during treatment or post-SVR regardless of the regimen were not associated with the stage of liver disease and were solely determined by the treatment regimen and the previously reported predictors of HRQL impairment such as history of prior anti-HCV treatment, psychiatric disorders and type 2 diabetes [32,[38][39][40][41][42].…”

“…On the other hand, an interferonfree RBV-containing regimen was also associated with moderate HRQL and work productivity impairment regardless of the stage of fibrosis (up to -5.4% for role physical of SF-36 in early fibrosis and up to -8.3% for role emotional of SF-36 in advanced fibrosis), but this impairment was again substantially lower when compared to the interferon-containing regimen. Furthermore, since no difference between the stages of fibrosis were observed in relation to HRQL changes during treatment, we believe that it is the side effects of ribavirin, rather than the stage of liver disease, that primarily determines on-treatment impact on quality of life in LDV/SOF-based treatment [32,[38][39][40][41][42].…”

The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection

“…All patients receiving HCV medications experienced a monthly QoL decrement related to adverse symptoms (14, 15). A proportion of patients experienced non–treatment-ending toxicity, including moderate anemia managed by ribavirin dose reduction and moderate neutropenia managed by pegylated interferon dose reduction and twice-weekly filgrastim (35).…”

Editorial: patients' preferences and health utility assessment in those with HCV treated with sofosbuvir - stating the obvious? Authors' reply

“…1,2 Indeed, investigating into the factors that influence patients' decision to start treatment is an important clinical problem. In fact, we have tried to investigate this issue in a recent study using National Health and Nutrition and Examination Survey (a sample of the U.S. general population), 3 where participants with HCV who chose not to undergo treatment were asked about their reasons.…”

“…1 There is a substantial literature indicating that gut permeability is increased in IBS, through mechanisms which include both infection, stress and mast cell activation. 2 Equally, the significant improvement in symptoms of nonconstipated IBS with tryptophan hydroxylase-1 (TpH1) inhibitors 3 or 5HT3 receptor antagonists (5-HT3RA) 4 is strong evidence that excess 5HT plays an important role in this subgroup. The current study asks the question whether there is a link between these two mechanisms of disease.…”