Sebivo launched for chronic hepatitis B

Novartis has launched Sebivo, indicated for the treatment of chronic hepatitis B (HBV) in adults with compensated liver disease and evidence of viral replication, persistently elevated ALT levels and histological evidence of active inflammation and/or fibrosis.

Legal category
POM
Active ingredient
Telbivudine
Description
600mg film-coated tablets
Presentation
28 tablet pack
Indications
Chronic hepatitis B (HBV) in adults with compensated liver disease and evidence of viral replication, persistently elevated ALT levels and histological evidence of active inflammation and/or fibrosis.


Click here to view the full drug entry on MIMS online.


PHARMACOLOGY

Telbivudine is a synthetic thymidine nucleoside analogue that competes with thymidine 5'-triphosphate for incorporation into viral DNA, thereby inhibiting HBV replication.

CLINICAL STUDIES
The safety and efficacy of Sebivo has been evaluated in the phase III GLOBE study1, comparing telbivudine (LdT) with lamivudine (Lam), for up to 104 weeks in 1,367 patients with HBeAg-positive or HBeAg-negative chronic hepatitis. The primary endpoint (therapeutic response) was a composite of viral suppression (serum HBV DNA suppression <5log10 copies/ml), with either ALT normalisation or loss of detectable HBeAg.

After one year, telbivudine (600mg/day) was significantly more effective in viral suppression than lamivudine (100mg/day). Therapeutic response in HBeAg-positive patients 75.3 per cent in the LdT group, compared with 67 per cent in the Lam group. In HBeAg-negative patients, therapeutic response was non-inferior in the LdT group (75.2 per cent) compared with the Lam group (77.2 per cent).

At year two2, therapeutic response in HBeAg-positive patients was 64 per cent in the LdT group and 48 per cent in the Lam group, while in HBeAg-negative patients, therapeutic response was 78 per cent (LdT) and 66 per cent (Lam).

1. Lai C, Gane E, Thongsawat S et al. Telbivudine (LdT) vs lamivudine in the treatment of chronic hepatitis B: results from GLOBE, an international phase III trial. Poster 182, presented at Shanghai-Hong Kong International Liver Congress 2006.
2. Han S, Lai C, Gane E et al. Telbivudine GLOBE trial at year two: efficacy, safety, and predictors of outcome in patients with chronic hepatitis B. Poster presented at Digestive Disease Week, US 2007.

Further information: Novartis 01276 692255

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