Hepatitis – Zeffix treatment

BioChem Pharma Inc. announced that new Zeffix data were presented today at the European Association for the Study of the Liver (EASL) congress, in Rotterdam.

Lifetime treatment of a chronic illness is a daunting prospect-for patient, physician and budget holders. It can also prove to be a major hurdle to effective treatment. In the case of chronic hepatitis B however, a recent study suggests this hurdle could now be removed.

The study’s results show that the vast majority (86%) of patients who lost hepatitis B virus e antigen (HBeAg), a marker of active hepatitis B virus (HBV) replication, while taking Zeffix (lamivudine) showed no evidence of disease recurrence almost two years after completing their treatment. The data provide new evidence of sustained viral suppression after stopping treatment, which could revolutionize current thinking on the duration of therapy required to successfully treat the disease. This could make a finite course of antiviral treatment with Zeffix a reality for many patients worldwide.

The international study, led by Professor Eugene Schiff from the University of Miami, Florida, tracked 43 patients who had previously lost HBeAg after an average of one year of Zeffix treatment (100 mg once daily) and had then stopped therapy, according to the study protocol. The patients were entered into this study within 12 months of stopping treatment and were followed for an average of nearly two years (21 months). The interim results presented today indicate that 86% of patients still remain HBeAg-free, with the majority (65%) of these patients also showing normal levels of the liver enzyme ALT at their last assessment.

An additional result of this study was that 21% of the patients who lost HBeAg, have also achieved HBsAg seroconversion(x). HBsAg seroconversion is widely considered to be an indicator of a probable cure of chronic hepatitis B.

We are really excited about these results, as the vast majority of our patients who had lost HBeAg and then stopped Zeffix treatment, remain in remission. This could completely change current thinking on the length of Zeffix treatment needed for many patients”, commented Professor Schiff. “The most remarkable finding from our study was that 21% of patients have also achieved HBsAg seroconversion. For the vast majority of patients, this is the best indicator that their hepatitis B has been cured.

In a separate five-year multicenter Asian trial, an interim analysis showed that out of 58 patients treated with Zeffix for up to four years, almost three quarters (73% – 19/26) of patients who had active liver disease(xx) when Zeffix treatment started successfully seroconverted during the first four years of treatment.(1) This compares with 47% achieved by the study patient population as a whole. The results from both of these studies will be welcome news for patients with chronic hepatitis B.

Zeffix is currently available in more than 25 countries including China (as Heptodin), South Korea, the USA (as Epivir-HBV), Canada (as Heptovir) and the EU, and approved in almost 50 countries worldwide.

Under agreement, BioChem Pharma receives royalties from Glaxo Wellcome on sales of its discovery lamivudine for use in treatment of both HIV/AIDS (3TC/Epivir/Combivir/Trizivir) and HBV (Zeffix/Epivir-HBV/Heptovir/Heptodin). Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership.

BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention and treatment of human diseases with a focus in the anti-infective and anticancer areas.

Heptodin, Zeffix, Epivir-HBV, Heptovir, 3TC, Epivir, Combivir and Trizivir are trademarks of the Glaxo Wellcome group of companies.

BioChem Pharma news releases and other company information can be found on the World Wide Web at www.biochempharma.com.

This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995, each of which involves risks and uncertainties that may affect the Company’s business and projects. Actual events could differ materially from those projected herein and depend on a number of factors. Investors should consult the Company’s ongoing quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements.

References:

  1. Chang TT, Lai CL, Liaw YF, et al. Incremental increases in HBeAg seroconversion and continued ALT normalisation in Asian chronic HBV (CHB) patients treated with lamivudine for four years. Antiviral Therapy 2000;5 (Suppl.1):44. Abstract 44.
  2. Loss of the hepatitis B virus antigen and gain of antibodies against the virus in the blood.
  3. With greater than twice the upper limit of the normal level of a liver enzyme called ALT.

Source BioChem Pharma Inc.

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