March 31, 2016
- Patients with hepatitis C virus infection treated with interferon- and ribavirin-free antiviral regimens achieved increased quality of life during treatment compared with patients treated with interferon and ribavirin, according to published findings.
- “These findings have important implications for patients, their families, their providers and the policy makers to support the comprehensive advantage of these regiments for patients with [chronic HCV] infection,” Zobair M. Younossi, MD, MPH, chairman of the department of medicine, Inova Fairfax Hospital, and vice president for research at Inova Health System, and colleagues wrote.
Using validated patient-reported outcome instruments, the researchers evaluated the impact of different antiviral regimens for HCV on patients’ work productivity, fatigue and other outcomes among a cohort of 3,425 patients previously treated with Sovaldi (sofosbuvir, Gilead Sciences) or Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) with and without interferon or ribavirin.
Most patients (72.9%) had HCV genotype 1, 62.8% were men, 62.2% were treatment-naive and 18.1% had cirrhosis. A total of 546 received a regimen of sofosbuvir plus interferon and ribavirin, 1,721 received sofosbuvir plus ribavirin and 1,158 received ledipasvir/sofosbuvir without interferon or ribavirin.
At baseline, there were no differences in patient-reported outcomes between the treatment groups (P > .01 for all). Throughout treatment, patient-reported outcomes worsened by 23.6% for patients treated with interferon and ribavirin, and worsened by 7% in the for patients treated with sofosbuvir and ribavirin (P< .0001 for all). However, there was an 11.6% improvement in patient-reported outcomes for those who did not receive interferon or ribavirin (P < .0001).
Multivariate analysis showed interferon use was independently associated with worsening of patient-reported outcome scores up to 26% during treatment and ribavirin use was associated with worsening up to 9%.
Among patients who achieved sustained virologic response 12 weeks post-treatment, improvements in patient-report outcomes were observed regardless of what regimen they received. These improvements increased after 24 weeks of follow-up, according to the research.
“This analysis of a large amount of extensive [patient-reported outcome] primary data from patients with [chronic HCV] who were treated with different HCV regimens clearly shows the superiority of [interferon]-free and [ribavirin]-free regimens,” the researchers concluded. “The data also show the durability of the [patient-reported outcomes] benefits associated with HCV cure.” – by Melinda Stevens
Disclosure: Younossi is a consultant for AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and Intercept Pharmaceuticals.