By Arushi Sinha
SAN FRANCISCO -- November 6, 2008 -- Entecavir treatment appears to result in high rates of viral suppression in patients with chronic hepatitis B virus (HBV) infection, according to research presented here at the Liver Meeting 2008, the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
One of the challenges in the process of developing effective therapies for patients with chronic HBV is translating agents from clinical trials into clinical practice, said lead investigator Pietro Lampertico, MD, Division of Gastroenterology, Fondazione IRCCS Maggiore Hospital, Policlinico, Mangiagalli, Regina Elena, University of Milan, Milan, Italy.
"This is the first study looking at the effectiveness of this therapy in field practice," he explained during his presentation on November 2 on behalf of the research team.
The study enrolled 182 patients who were diagnosed with chronic hepatitis B at 9 liver centres across Italy. Patients were treated with the oral nucleoside analogue entecavir 0.5 mg for 1 year.
Patients were aged a median of 57 years (male, 74%), 83% were hepatitis B e antigen (HBeAg)-positive, and 47% were diagnosed with cirrhosis. Patients were tested for liver function and HBV DNA loads at 3-month intervals.
Results showed that 68% of patients achieved undetectable levels of HBV DNA at 24 weeks and increased to 85% at 48 weeks. Rates of DNA clearance among HBeAg-positive patients were 75% at 24 weeks and 80% at 48 weeks, and for HBeAg-negative patients they were 30% at 24 weeks and 54% at 48 weeks.
It was also found that patients who exhibited a high viral load (>8 log U/mL) at baseline were more likely to have incomplete responses at 24 weeks (33% vs 70%) and at 48 weeks (40% vs 90%) compared with patients with lower viral loads (P < .01).
In terms of genetic profiles, the researchers found that 22% of patients had mutations at baseline that had the potential to influence clinical outcomes.
Based on these findings, the researchers concluded that entecavir treatment resulted in high rates of HBV suppression, noting that patients with a high viral load at baseline were more likely to exhibit an incomplete response after 48 weeks of treatment. In addition, genetic mutations did not seem to influence the clinical outcomes of this therapy.
"We found that the rates of mutation in general practice have been similar to those we have seen in clinical trials," summarised Dr. Lampertico.
[Presentation title: Effectiveness of Entecavir for the Treatment of NUC-Naïve Chronic Hepatitis B Patients: A Large Multicenter Cohort Study in Clinical Practice. Abstract 896]
E-Mail this DGDispatch to a colleague
