Idenix Pharmaceuticals (IDIX)

[gofishmarko]

VA monograph on Tyzeka , dated May 2007.

http://www.pbm.va.gov/monograph/Telbivudine.pdf

Worth a look , also. It has a chart near the end showing the VA costs for the various HBV drugs.

Summary conclusions :

"Conclusions

In the phase III trial, telbivudine was noninferior to lamivudine in achievement of Therapeutic and Histological Response in both HBeAg subpopulations. Telbivudine displayed more rapid and potent virologic activity than lamivudine. Lamivudine, at the time of study initiation, was the
appropriate comparative agent; however, it is no longer considered as a first-line agent due to high rates of resistance associated with long-term therapy. The safety profile of telbivudine was similar to lamivudine with the exception of elevations of CK. Genotypic resistance was seen with lamivudine and telbivudine at one year; resistances rates continued to increase at year two. Longer follow-up studies are needed to assess the durability of telbivudine beyond two years. Although not compared in head to head trials, resistance rates seen with telbivudine are likely
higher than with adefovir and entecavir. The VA cost of telbivudine is comparable to adefovir.

Recommendations

Although telbivudine displayed potent virologic activity, the data appear to suggest a higher incidence of resistance to telbivudine than other recommended first-line oral nucleos(t)ide options (i.e. adefovir, entecavir). Due to clinical failures associated with resistance, clinicians are
selecting first-line agents that minimize the development or selection of resistance. Thus, adefovir and entecavir are preferred oral agents for treatment of chronic hepatitis B in
nucleos(t)ide-naïve patients while telbivudine should be considered second-line oral therapy. However, telbivudine as with lamivudine may have a role in certain clinical scenarios such as short-term or combination therapy. Further studies are needed to define the role of telbivudine in combination with nucleotides or peginterferon for the treatment of chronic hepatitis B."