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Adding pegylated interferon to entecavir improves hepatitis B treatment response
Liz Highleyman, 2012-12-13 10:30:00
Intensifying entecavir (Baraclude) treatment for hepatitis B by adding pegylated interferon lowers HBV viral load and increases the likelihood of hepatitis B "e" antigen (HBeAg) loss, according to a presentation at The Liver Meeting 2012, the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) last month in Boston. A related study found that hepatitis B surface antigen (HBsAg) levels during treatment can predict response.
Nucleoside/nucleotide analogue antiviral drugs are standard treatment for chronic hepatitis B. They perform well at lowering HBV viral load, but only a minority of patients have serological response including HBeAg and HBsAg loss or seroconversion.
Interferon – long the mainstay of hepatitis C treatment – stimulates the natural immune response against viral infections and may contribute to improved outcomes for hepatitis B as well.
Milan Sonneveld from Erasmus University Medical Centre in Rotterdam and the ARES study team conducted a controlled trial that enrolled 184 HBeAg-positive participants with compensated liver disease at 15 sites in Europe and China. About 60% were of Asian ethnicity and all major HBV genotypes were represented.
One group was randomly assigned to take 0.5mg/day entecavir monotherapy for 48 weeks. The other group received the same dose of entecavir, but after 24 weeks of monotherapy they added 180mcg/week pegylated interferon alfa-2a (Pegasys) and continued on triple therapy through to week 48.
At 48 weeks, 74% of participants in the entecavir monotherapy group and 83% in the interferon add-on group achieved HBV DNA below 200 IU/mL, but the difference did not reach statistical significance; 53 and 61%, respectively, reached HBV viral load below 20 IU/mL, again not significant.
Fewer than half as many people in the entecavir-only group experienced HBeAg loss than in the add-on group (8 vs 18%), which fell just short of statistical significance (P=0.07).
The only factors independently associated with combined virological and serological response in a multivariate analysis were lower HBsAg level at baseline and addition of pegylated interferon, which nearly quadrupled the likelihood of response (odds ratio=3.78).
Adding pegylated interferon to entecavir was generally safe, though it led to increased side-effects. Five people experienced serious adverse events, including three with ALT flares during the entecavir monotherapy phase. Neutropenia (0 vs 23%) and thrombocytopenia (0 vs 8%) were significantly more common in the add-on group and two people developed severe neutropenia while on pegylated interferon. No one in either treatment group developed anaemia.
"Addition of pegylated interferon alfa-2a to entecavir monotherapy increases HBV DNA, HBeAg, and HBsAg decline," the researchers concluded. "Addition of pegylated interferon alfa-2a to potent [nucleoside/nucleotide] analogue therapy may increase chances of finite therapy".
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