Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

Berden, F.A.C.; Knegt, R.J. de; Blokzijl, H.; Kuiken, S.D.; Erpecum, K.J.L. van; Willemse, S.B.; ... ; Kievit, W. (2016)

Article / Letter to editor

Nearly half of real world hepatitis C patients would have been excluded from registration trials, and these patients are at increased risk to develop serious adverse events. Hepatic decompensation and co-morbidity were important exclusion criteria, and were related to toxicity. Therefore, new drugs should also be studied in these patients, to genuinely assess benefits and risk of therapy in the real world population.

• All authors: Berden, F.A.C.; Knegt, R.J. de; Blokzijl, H.; Kuiken, S.D.; Erpecum, K.J.L. van; Willemse, S.B.; Hollander, J. den; Vonderen, M.G.A. van; Friederich, P.; Hoek, B. van; Nieuwkerk, C.M.J. van; Drenth, J.P.H.; Kievit, W.
• Date: 2016-09-06
• Journal: PLoS ONE
• Volume: 11
• Issue: 9
• DOI: doi:10.1371/journal.pone.0161821