The European Commission has approved Sebivo (telbivudine) as a new first-line treatment for chronic hepatitis B that has been shown to provide rapid and powerful viral suppression within six months of starting therapy.
Approval was based on one-year data from the GLOBE study demonstrating the benefits of Sebivo over lamivudine, the most widely prescribed therapy worldwide, in achieving rapid and powerful suppression of the hepatitis B virus (HBV).
"Chronic hepatitis B is a serious condition that can lead to liver cirrhosis, liver cancer, liver failure, and ultimately death," said Thierry Poynard, MD, PhD, Professor of Medicine and Head of the Department of Hepato-Gastroenterology, Hôpital Pitié-Salpêtrière, France. "There is no cure for chronic hepatitis B, but high viral load increases the risk of serious complications. To reduce this risk, the goal of therapy is therefore to suppress the hepatitis B virus as much as possible, and to maintain that decrease over time. The GLOBE study shows that telbivudine does this more effectively than lamivudine."
Every year in Europe an estimated one million people are infected with HBV and 90,000 will become chronic carriers. The incidence of chronic hepatitis B (CHB) ranges from 29 cases for every 100,000 people in Western Europe to 523 per 100,000 people in Eastern Europe. Approximately 24,000 people in Europe die each year from complications of CHB, including cirrhosis or liver cancer.
GLOBE is the largest worldwide registration trial ever conducted in patients with CHB and included 1,367 adult patients at 112 clinical centres in 20 countries. In the European Union, participating countries included the Czech Republic, France, Germany, Greece, Italy, Poland, Spain and the UK.
Data from the study also indicated that Sebivo works very quickly, suppressing HBV to undetectable levels in more than half of patients at six months of treatment, and that 95 per cent of patients who achieved PCR negativity within this time retained their undetectable virus levels at one year1,2. Preliminary two-year results from the GLOBE trial, completed after the EU submission, demonstrated that these benefits were maintained through two years of treatment.
"The results of the GLOBE trial showed that the rapid viral suppression achieved with Sebivo at six months can predict outcomes through two years of study," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "This is encouraging news for patients and physicians due to the fact that powerful viral suppression, early in the course of treatment, has been shown to be predictive of long-term viral suppression and minimal resistance. We are excited that Sebivo has now been approved in the European Union and can be made available to patients there."
Sebivo delivers this rapid, powerful and sustained viral suppression with an overall clinical safety profile similar to that of lamivudine. It is given once-daily with or without food, helping to ensure better compliance and patient convenience.