Details

Autor(en) / Beteiligte

• Chang, T.-T.
• Chao, Y.-C.
• Gorbakov, V. V.
• Han, K.-h.
• Gish, R. G.
• De Man, R.
• Cheinquer, H.
• Bessone, F.
• Brett-Smith, H.
• Tamez, R.

Titel

Results of up to 2 years of entecavir vs lamivudine therapy in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B

Ist Teil von

• Journal of viral hepatitis, 2009-11, Vol.16 (11), p.784-789

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2009

Quelle

Wiley-Blackwell Full Collection

Beschreibungen/Notizen

• Entecavir is a potent inhibitor of hepatitis B virus (HBV) polymerase. The efficacy and safety of entecavir in nucleoside‐naïve patients with hepatitis B virus e antigen (HBeAg)‐positive chronic hepatitis B was established in a large, international, double‐dummy study (ETV‐022) where patients were randomized to entecavir 0.5 mg/day (n = 354) or lamivudine 100 mg/day (n = 355) once daily. ETV‐022 had a 52‐week blinded treatment phase, followed by an extended blinded treatment phase for up to 44 additional weeks (96 weeks total). Treatment was discontinued for patients achieving a protocol‐defined response as determined by patient management criteria that intended to test the possibility of finite therapy, which has not previously been studied for entecavir or other anti‐HBV agents in a large trial. Early results from this study have been previously presented/published separately. This paper compiles the results of up to 2 years of treatment for protocol‐defined responders, virologic responders and nonresponders. For responders who discontinued therapy (per protocol), 24‐week off‐treatment evaluation is presented to provide a more ‘complete picture’ of what clinicians can expect when treating nucleoside‐naïve HBeAg‐positive patients with chronic hepatitis B. For patients who discontinued therapy because of nonresponse (nonresponders) and subsequently entered the rollover study ETV‐901, follow‐up results, including resistance profile, are provided.