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HCV patients had better outcomes on sofosbuvir-based treatment without interferon
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Patient-reported outcomes and work productivity were more negatively affected by hepatitis C treatment regimens that included pegylated interferon compared with interferon-free regimens, according to recent study data.
Zobair Younossi, MD, of the Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Virginia, and colleagues evaluated the patient-reported outcomes (PROs) obtained from questionnaires completed during two recent phase 3 clinical trials of sofosbuvir-based treatments with and without interferon. The FUSION study included 201 patients infected with HCV who received sofosbuvir and ribavirin for 12 or 16 weeks. The NEUTRINO study included 327 patients infected with HCV who received sofosbuvir and ribavirin plus interferon for 12 weeks.
Zobair Younossi
In FUSION, an active-control blinded study, patients had comparable PRO and work productivity (WP) scores throughout the study period (P>.05), and had small reductions in fatigue, HCV-specific QoL and WP and Activity Index scores throughout the treatment period (P=.02 to <.0001), but scores returned to or exceeded baseline levels after 4 weeks.
In NEUTRINO, patients had larger reductions in all scores, and most persisted beyond 4 weeks (all P<.05). PROs improved in patients with sustained virologic response (SVR) 12 weeks after treatment in both study groups (all P<.05). Adjusting for confounding variables, IFN was found to be independently associated with worse PROs after 12 weeks.
“Our data have suggested the superiority of interferon-free regimen from a patient-related outcome standpoint,” the researchers concluded. “In addition, we have shown that fatigue was the most important driver of these patient outcomes before treatment and during treatment. Finally, achievement of SVR 12 weeks after treatment had not only clinical benefits but also PRO benefits. These data can be used to provide a more comprehensive assessment of a treatment regimen that not only includes efficacy and safety but also patients’ experiences derived through PRO assessment.”
Disclosure: Drs. Younossi, Jacobson, Lawitz and Nelson have received research grants and/or serve on the advisory board/consulting capacity to Gilead Sciences.
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