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Sofosbuvir/ribavirin showed minimal effect on health utility scores

Therapy with sofosbuvir and ribavirin did not dramatically affect health utility scores in patients with hepatitis C virus, according to study results.

Patients (n=994) from four phase 3 trials (POSITRON, FISSION, FUSION and NEUTRINO) studying sofosbuvir plus ribavirin, with or without pegylated interferon, were included in the cohort. Previous data were used to evaluate and determine any impact treatments involving sofosbuvir had on patients’ utility scores. All scores were measured using the SF-6D metric from the SF-36v2 questionnaire patients received at baseline in each study.

At baseline, SF-6D and EQ-5D scores were 0.66 ± 0.13 and 0.71 ± 0.22, respectively, in the POSITRON trial; 0.71 ± 0.16 and 0.76 ± 0.23 in FISSION; 0.7 ± 0.14 and 0.75 ± 0.22 in FUSION; and 0.72 ± 0.15 and 0.79 ± 0.22 in NEUTRINO. SF-6D and EQ-5D scores correlated with each other across all studies (P<.0001).

In the POSITRON trial, utility scores were similar between treated and placebo patients after 12 weeks (P>.05). In FUSION, patients who received 12 and 16 weeks of therapy had similar utility scores (P>.05). In FISSION, treated patients had better utility scores vs. those who received therapy with pegylated interferon and ribavirin (P<.001).

In the NEUTRINO trial, patients who received sofosbuvir, ribavirin and interferon had decreased utility scores during treatment (SF-6D: 0.72 to 0.62; EQ-5D: 0.79 to 0.65; P<.0001) that were comparable to patients in FISSION receiving pegylated interferon and ribavirin for 24 weeks (SF-6D: 0.72 to 0.62; EQ-5D: 0.77 to 0.65; P<.0001).

Patients who achieved sustained virologic response 12 weeks after treatment in FUSION showed improved SF-6D (0.026 from baseline) and EQ-5D (0.043 from baseline) scores. The most common predictors for lower utility scores included anxiety, fatigue, insomnia and baseline depression.

“Patients’ health utilities are minimally impacted by sofosbuvir and ribavirin treatment, as compared to interferon-based therapy, regardless of treatment duration,” the researchers wrote. “These findings can further be used in cost-utility and cost-effectiveness analyses of sofosbuvir-containing regimens by policy-making agencies, health maintenance organizations, insurance companies and patients with chronic hepatitis C infection.”

Disclosure: The researchers report no relevant financial disclosures.