Biotech Values

[DewDiligence]

IDIX
One-year HBV Results Reported at DDW

[These are the one-year results from the phase-3 GLOBE study of Telbivudine vs Lamivudine in chronic HBV that formed the basis of NVS/IDIX’s NDA for Telbivudine that is now pending. Because the one-year top-line data from this study were already known, what’s new in this write-up is merely additional granularity. Telbivudine bested Lamivudine on all metrics except the composite “response” endpoint in the e-negative subset, where the two drugs were approximately equal. (E-negative patients made up one-third of the patient pool in the study.) Please see abstract #482 in #msg-11265952 for even greater granularity. Final two-year data from this study will be reported at AASLD in October.

The Telbivudine results from DDW that are of greater interest than these are the ones from the head-to-head phase-3b study of Telbivudine vs GILD’s Hepsera (abstract #479 in #msg-11265952). A PR containing the one-year results from this study will presumably be issued tomorrow.]

http://www.docguide.com/news/content.nsf/news/852571020057CCF6852571780052B4BE

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Telbivudine Achieves Greater Response on Antiviral Measures Than Lamivudine in Chronic Hepatitis B Patients

By Bruce Sylvester

LOS ANGELES, C.A. -- May 24, 2006 -- Chronic hepatitis B patients treated with telbivudine achieved a significantly greater virological response compared to those treated with lamivudine, regardless of hepatitis B e-antigen (HBeAg) status, according to research presented here at Digestive Diseases Week 2006 (DDW). These data from the ongoing phase 3 GLOBE study were discussed in an oral session here on May 23rd.

Investigators randomized 1,367 adults with chronic hepatitis B to telbivudine (HBeAg positive, 458 and HBeAg negative, 222) or to lamivudine (HBeAg positive, 463 and HBeAg negative, 224).

Telbivudine achieved significantly greater [mean] reductions of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) after 52 weeks among both HBeAg-positive patients (-6.5 log10 versus -5.5 log10 with lamivudine; P <.01) and HBeAg-negative patients (-5.2 log10, versus -4.4 log10 with lamivudine; P <.01).

"Not only did we find significantly greater antiviral efficacy for telbivudine versus lamivudine…but [also] a more profound early viral suppression at 24 weeks by telbivudine was linked to better clinical efficacy outcomes at 1 year," said Steven-Huy Han, MD, associate clinical professor of medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.

The primary endpoint in GLOBE is therapeutic response, a composite endpoint coupling viral suppression (serum HBV DNA suppression <100,000 copies/mL) with either improved liver-disease markers (serum alanine aminotransferase [ALT] normalization) or loss of detectable HBeAg [i.e. conversion from e-positive to e-negative status].

For HBeAg-positive patients, the investigators reported that the therapeutic response was significantly higher among patients treated with telbivudine (75%) compared to patients treated with lamivudine (67%) (P <.05), while the response after 1 year was similar in HBeAg-negative patients taking either treatment (75% vs. 77%, respectively).

The researchers reported that telbivudine subjects achieved significantly less viral resistance and less treatment failure compared to patients receiving lamivudine. They also found that telbivudine treatment was associated with fewer and less severe resistance-associated elevations ("flares") of serum ALT levels than lamivudine treatment. Flares are a cause of liver failure in chronic hepatitis B patients, which can be fatal.
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