An analysis of several phase III clinical trials suggests that health-related quality-of-life scores decrease less when patients receive sofosbuvir therapy than interferon therapy.
An analysis of several phase III clinical trials suggests that health-related quality of life scores decrease less when patients receive sofosbuvir therapy than interferon therapy.
Sofosbuvir therapy appears to impact health-related quality of life in hepatitis C patients less significantly than interferon regimens, despite longer treatment duration, the results of a recent study suggest.
Published in the April 2014 edition of Journal of Hepatology, the study results suggest patients tolerate sofosbuvir-based treatments better than current regimes, which could lead to better treatment adherence.
Although the research showed a slight decrease in health-related quality of life on the sofosbuvir regimens, the decrease was significantly lower than that of interferon-based therapies, researchers noted.
The study analyzed data from 4 phase III clinical trials of sofosbuvir: POSITRON, which involved sofosbuvir and ribavirin combination therapy versus placebo for 12 weeks; FISSION, involving sofosbuvir and ribavirin for 12 weeks versus pegylated interferon and ribavirin for 24 weeks; FUSION, which involved sofosbuvir and ribavirin for either 12 weeks or 16 weeks; and NEUTRINO, involving sofosbuvir, ribavirin, and pegylated interferon for 12 weeks.
Participants were randomized into treatment or control groups in each of the studies. Participants received self-administered quality-of-life questionnaires at the beginning of the studies, and at several different points during each study. In each study, participants and site staff did not know the participants’ viral load when the questionnaires were administered, researchers noted.
The FISSION study found a slight decline in health-related quality of life in participants receiving sofosbuvir and ribavirin; however, the decline was greater in participants receiving ribavirin and pegylated interferon, researchers noted.
The FUSION study found that minimal treatment duration had minimal effect on health-related quality of life, because the moderate decrease in quality-of-life associated with therapy initiation disappeared once therapy stopped.
Results from the POSITRON study showed a mild decline in participants’ mental health quality-of-life scores, particularly in the social functioning subscore. Researchers attributed the slight decline to anemia associated with the ribavirin portion of the therapy, a conclusion reinforced by the score evening out after 4 weeks—the time associated with hemoglobin levels returning to normal after stopping ribavirin. Despite this, health-related quality of life scores were not significantly different in the study’s treatment or placebo arms, indicating that treatment did not appear to place a significant hardship on participants.
Meanwhile, results from the NEUTRINO study suggest that interferon-based treatment results in a significant decrease in health-related quality of life. When results from this study were compared with the interferon and ribavirin arm of the FISSION study, however, adding sofosbuvir did not appear to impact health-related quality of life, researchers noted.
A multivariate analysis found depression, fatigue, and insomnia tended to result in low health-related quality of life scores during therapy, which is consistent with previous research. An assessment of cirrhosis status on health-related quality of life found no significant differences between participants with early cirrhosis and participants without cirrhosis, although researchers noted that participants with advanced cirrhosis were excluded from the studies.
“Overall, regardless of duration, interferon-free regimens are superior to interferon-based regimens in terms of [health-related quality-of-life], resulting in improved patients’ experience, potentially lower risks of treatment discontinuation, and lower overall burden of chronic [hepatitis C virus] infection.”