Researchers conducted a double-blind placebo-controlled study of the combination of sofosbuvir + velpatasvir (Epclusa) in participants with hepatitis C virus (HCV) infection. The term double-blind means that neither the researchers directly involved with the study nor the participants knew who received Epclusa or fake Epclusa (placebo). As part of this study, called Astral-1 sponsored by Gilead Sciences, participants completed surveys on a regular basis about such issues as physical functioning, pain, general health and vitality, emotional and mental health and fatigue. In total, 624 participants received sofosbuvir + velpatasvir and 116 received placebo for 12 consecutive weeks. After treatment cessation, participants were monitored for 24 additional weeks. Astral-1 took place in Canada, Belgium, France, Germany, Italy, the UK and the U.S.
Researchers found that among participants who received sofosbuvir + velpatasvir, aspects of mental health assessed began to improve significantly by the fourth week of the study. Among participants who received placebo, the only area of improvement was a decreased sense of worry. However, participants who received sofosbuvir + velpatasvir had a much greater decrease in their sense of worry than people who received placebo.
Improvement in quality of life, emotional and mental health and other assessments were sustained and statistically significant for participants who received sofosbuvir-velpatasvir. Furthermore, these improvements continued to be statistically significant for 12 and 24 weeks after treatment was initiated. In contrast, among placebo users scores of the same assessments generally declined significantly.
A major strength of the study was that it was placebo-controlled, which allowed researchers to draw firm conclusions about the trends in scores measured.
Researchers are not certain precisely why people treated with sofosbuvir + velpatasvir would feel better. However the research team that undertook the quality of life assessments advanced the following ideas:
HCV infection results in inflammation and activation of the immune system. Treatment that cures HCV reduces this inflammation and activation and may indirectly improve overall health and feelings of well-being.
HCV-infected cells of the immune system can travel to the brain and alter the functioning of this vital organ. Successful HCV treatment quickly reduces the amount of HCV in the blood and likely the brain, improving health and quality of life.
Younossi ZM, Stepanova M, Feld J, et al. Sofosbuvir-velpatasvir improves patient-reported outcomes in HCV patients: results from Astral-1 placebo-controlled trial. Journal of Hepatology. 2016 Jul;65(1):33-9.