Nebenwirkungen · Entecavir Viatris (previously Entecavir Mylan)
Entecavir Viatris 0.5 mg film-coated tablets Entecavir Viatris 1 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-226705 · Präparat HOS-217636
Exacerbations after discontinuation of treatment Acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B virus therapy, including therapy with entecavir (see section 4.4). In studies in nucleoside-naive patients, 6% of entecavir-treated patients and 10% of lamivudine-treated patients experienced ALT elevations (>10 times ULN and >2 times reference [minimum of baseline or last end-of-dosing measurement]) during post-treatment follow-up. Among entecavir-treated nucleoside-naive patients, ALT elevations had a median time to onset of 23-24 weeks, and 86% (24/28) of ALT elevations occurred in HBeAg negative patients. In studies in lamivudine-refractory patients, with only limited numbers of patients being followed up, 11% of entecavir-treated patients and no lamivudine-treated patients developed ALT elevations during post-treatment follow-up.
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