SEBIVO(R) Demonstrated Better Antiviral Activity Compared to Adefovir in Patients With Chronic Hepatitis B; New Data Pre

Actualizado 13/04/2007 20:41:18 CET

BARCELONA, Spain, April 13 /PRNewswire/ --

-- SEBIVO Suppressed Virus More Rapidly and Profoundly Than Adefovir(1)

-- Rapid and Powerful Viral Suppression Led to Better Treatment Outcomes(2)

-- SEBIVO Has Been Recommended for Approval by European Medicines Agency, Pending Final Approval by the European Commission

In a comparative study, SEBIVO(R) (telbivudine) provided more rapid and profound viral suppression than adefovir both in newly diagnosed HBeAg- positive patients and in those who switched from adefovir to SEBIVO.(1) Additionally, regardless of treatment, a substantial early reduction in virus level correlated with better outcomes such as maintained undetectable levels of virus (PCR-negativity), HbeAg seroconversion and ALT normalization, at one year.(2) A significantly greater percentage of SEBIVO patients achieved PCR- negativity (38 percent; n=17/45) compared to adefovir-treated patients (12 percent; n=11/90) by six months. These findings were presented at the Annual Meeting of the European Association for the Study of the Liver (EASL).

"These new data demonstrated that SEBIVO provided therapeutic benefit not only for previously untreated patients but also for treated patients who had not achieved sufficient viral suppression," said Professor Patrick Marcellin, M.D., Head of the Viral Hepatitis Research Unit, Hopital Beaujon, University of Paris and presenter of the study. "Suppressing the hepatitis B virus as fast and effectively as possible is emerging as an important measure of HBV treatment response. It is associated with better treatment outcomes at one year, and SEBIVO achieved this goal better than adefovir."

These new findings come from a trial comparing the efficacy of SEBIVO and adefovir in 135 HBeAg-positive patients with CHB over one year. After six months of treatment, more than twice the number of SEBIVO patients reached target levels of hepatitis B virus (HBV), defined as <3 log(10) copies/mL (49 percent with SEBIVO vs. 22 percent with adefovir). Among the 78 percent of patients in the adefovir group with suboptimal response after six months, those who switched to SEBIVO achieved a two times greater log reduction at one year compared to those who had remained on adefovir treatment (2.1 log(10) versus 0.8 log(10), respectively).

At one year, patients had the option of continuing on or switching to SEBIVO treatment in an ongoing follow-on study. Preliminary data on these patients demonstrated that patients who had a suboptimal response to adefovir (HBV DNA >3 log(10) copies/mL) at one year and then switched to SEBIVO also achieved additional viral suppression (1.95 log(10)) between one and one and a half years. Moreover, 74 percent of patients continually taking SEBIVO through one and a half years achieved PCR-negativity.(1)

Both treatments were well tolerated with no drug-attributed serious adverse events. Adverse events for both agents were similar and primarily those associated with viral respiratory infections and gastrointestinal complaints. Two patients experienced grade 3 or 4 neutropenia - one SEBIVO recipient and one patient in the switch group; both events resolved at follow-up six days later, with continued treatment.

"We are excited by the continued success of SEBIVO in clinical trials, as it further demonstrates SEBIVO's potential to fill an unmet need in chronic hepatitis B treatment and provide rapid, profound and sustained viral suppression," said Douglas Mayers, M.D., Idenix's executive vice president and chief medical officer. "We are committed to providing patients with new treatment options for serious viral diseases and eagerly anticipate a decision about the approval of SEBIVO by the European Commission in the next few months."

On February 23, 2007, SEBIVO was recommended for approval by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), which reviews drug applications for all 27 countries in the European Union as well as Iceland and Norway. The European Commission is expected to issue a final decision within two to three months. SEBIVO is already approved in 15 countries, including China, Switzerland and the United States. It is marketed as TYZEKA(R) in the U.S.

Chronic hepatitis B is becoming a major public health issue in Europe. An estimated one million people are infected with HBV every year in Europe, of whom 90,000 will become chronic carriers. Annually, 24,000 will die from cirrhosis or liver cancer.(3) The incidence of hepatitis B ranges from 29 cases for every 100,000 people in Western Europe to 523 per 100,000 in Eastern Europe.(3) HBV is 50 to 100 times more infectious than human immunodeficiency virus (HIV).(4)

Telbivudine Presentations at EASL

Additional studies pertaining to telbivudine were presented at EASL. Key presentations included:

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