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HIV and Coverage of the
45th Annual Meeting of the European
Association for the Study of the Liver (EASL 2010)

April 14 - 18, 2010, Vienna, Austria
Longer Treatment with Pegylated Interferon Works Better for Hepatitis B Genotype D

SUMMARY: HBeAg negative people with hepatitis B virus (HBV) genotype D doubled their rate of sustained response when treated with pegylated interferon for 2 years instead of 1 year, and HBsAg clearance was also more likely with longer therapy, according to study results presented at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) last month in Vienna.

By Liz Highleyman

Pietro Lampertico and colleagues from Italy assessed the influence of treatment duration on response rates among hepatitis B "e" antigen (HBeAg) negative chronic hepatitis B patients with genotype D virus.

Treatment with pegylated interferon for 1 year leads to long-term virological response in a proportion of HBeAg negative chronic hepatitis B patients, but genotype D has been shown to be less responsive to interferon compared with genotypes A, B, or C, the researchers noted as background.

Prior research showed that an extended duration of therapy with conventional interferon led to improved response rates, and the present study aimed to determine whether the same would be true for pegylated interferon.

The analysis included 127 Italian hepatitis B patients who were randomly allocated to receive 3 regimens:

180 mcg/week pegylated interferon alfa-2a (Pegasys) for 48 weeks;
180 mcg/week pegylated interferon for 48 weeks, followed by a lower dose of 135 mcg/week for an additional 48 weeks (total 96 weeks);
180 mcg/week pegylated interferon plus 100 mg/day lamivudine (Epivir-HBV) for 48 weeks, followed by the lower dose for an additional 48 weeks.

About 70% of study participants were men and the average age was 45 years. Almost all (94%) had HBV genotype D, ALT was elevated (median 95 IU/mL), the median baseline HBV viral load level was about 6 logs, and 12% had liver cirrhosis.


In an intent-to-treat analysis, virological response rates at the end of treatment were similar in patients treated for 48 and 96 weeks (59% vs 67%, respectively; not a statistically significant difference).
Rates were also statistically similar at 6 months post-treatment (22% vs 29%, respectively).
Patients in the 48 week group, however, were more likely to experience viral relapse after 6 months.
After 1 year of post-treatment follow-up, participants treated for 48 weeks had a significantly lower sustained virological response rate than those treated for 96 weeks (12% vs 29%, respectively; P = 0.03).
ALT normalization rates at the end of treatment were similar in the 48 week and 96 week groups (29% vs 31%, respectively).
No patients in the 48 week group experienced hepatitis B surface antigen (HBsAg) clearance, while in the 96 week group 2% did at the end of treatment and 6% did so during 1 year of follow-up.
At the end of treatment, 4% of participants in the 48 week group and 8% in the 96 week group had HBsAg < 10 IU/mL, but after 1 year of follow-up the respective rates diverged to 0 and 10%, respectively.
Treatment discontinuation rates were similar regardless of duration.
Extended duration pegylated interferon was well-tolerated, with no observed increase in adverse events or safety issues.
Adding lamivudine to extended duration pegylated interferon did not improve treatment response rates.
Combination pegylated interferon/lamivudine was also well-tolerated overall, but was associated with more serious adverse events.

Based on these findings, the investigators concluded, "In HBeAg negative genotype D patients with chronic hepatitis B, 2 year treatment with pegylated interferon alfa-2a was safe and improved significantly the rates of post-treatment virological and serological response."

First Division Gastroenterology, IRCCS Fondazione Policlinico, Milan; Liver Unit, Cardarelli Hospital, Naples; Infectious Disease Unit, SS Anna and Sebastiano Hospital, Caserta; Clinic of Infectious Disease, Universita di Bari, Bari; Gastroenterology and Hepatology Unit, Universita di Palermo, Palermo; Department of Surgical and Gastroenterological Sciences, Universita di Padova, Padova; Medical Science Department, Universita di Cagliari, Cagliari; Department of Internal Medicine, IRCCS Fondazione Policlinico, Universita di Studi di Milano, Milan; Unit of Infectious Diseases and Hepatology, Azienda Ospedaliera di Parma, Parm; Biostatistics Unit of Quintiles, Milan, 11Roche, Monza, Italy.


P Lampertico, M Vigano, G Di Costanzo, and others. Extended (2 years) treatment with peginterferon alfa-2a [40kd] improves sustained response rates in genotype D patients with HBeAg negative chronic hepatitis B. 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010). Vienna, Austria. April 14-18, 2010. (Abstract 98).