interferon+etv 48 weeks (inferior to int+tnf)

AASLD 2011 Annual Meeting


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ID#

1479

Location:

Poster Hall

Time of Presentation:

Nov 07 8:00 AM - 5:30 PM

Category:

SO2. Treatment and Clinical Trials


The Effect of Combination Therapy with Peginterferon Alfa-2b plus Entecavir during 48 weeks for Chronic Hepatitis B
T. Inuzuka1; H. Takeda1; T. Kanesaka1; T. Kanesaka1; J. Nakajima1; F. Matsuda1; A. Sakamoto1; K. Hatamaru1; S. Henmi1; T. Ishikawa1; S. Saito1; S. Saito1; H. Nishikawa1; H. Nishikawa1; R. Kita1; T. Kimura1; Y. Osaki1
1. Gastroenterology, Osaka Red Cross Hospital, Osaka, Japan.

Objective:
Peginterferon (PegIFN) monotherapy and nucleotide analogue (NA) therapy are performed for the treatment of chronic hepatitis B (CHB). But the effect of combination therapy of PegIFN alfa-2b and entecavir (ETV) has never been reported worldwide. We report our experience of the administration of PegIFN alfa-2b in combination with ETV for 48 weeks in 14 CHB patients.
Methods:
In a prospective study at multicenters, patients aged 35 and older with genotype C CHB in Japan received PegIFN alfa-2b (1.5

[stef2011]

The Effect of Combination Therapy with Peginterferon Alfa-2b plus Entecavir during 48 weeks for Chronic Hepatitis B
T. Inuzuka1; H. Takeda1; T. Kanesaka1; T. Kanesaka1; J. Nakajima1; F. Matsuda1; A. Sakamoto1; K. Hatamaru1; S. Henmi1; T. Ishikawa1; S. Saito1; S. Saito1; H. Nishikawa1; H. Nishikawa1; R. Kita1; T. Kimura1; Y. Osaki1
1. Gastroenterology, Osaka Red Cross Hospital, Osaka, Japan.

Objective:
Peginterferon (PegIFN) monotherapy and nucleotide analogue (NA) therapy are performed for the treatment of chronic hepatitis B (CHB). But the effect of combination therapy of PegIFN alfa-2b and entecavir (ETV) has never been reported worldwide. We report our experience of the administration of PegIFN alfa-2b in combination with ETV for 48 weeks in 14 CHB patients.
Methods:
In a prospective study at multicenters, patients aged 35 and older with genotype C CHB in Japan received PegIFN alfa-2b (1.5 µg/kg) in combination with ETV (0.5 mg/body) over a 48 week period. We observed the patients without treatment for CHB after the end of the combination therapy till relapse. Therapeutic response was determined by the change before and after treatment (plus 24 weeks after the end of treatment) in viral load, ALT values, hepatic cccDNA load, rate of HBeAg seroconversion, rate of HBsAg loss, and activity and fibrosis based on liver biopsy.
Results:
At the end of treatment, 78.6% of patients achieved HBV DNA levels of less than 2.1 log copies/ml and 78.6% achieved ALT normalization. At 24 weeks after the end of treatment, 72.7% of patients achieved serum HBV DNA levels of 4 copies IU/ml or less and 100% achieved serum ALT normalization. A median reduction in cccDNA load of 0.9 log copies/μg , HBeAg seroconversion in 44.4% of patients and HBsAg loss in 7.1% of patients were observed at the end of treatment. Histologic improvement in activity was observed in 78.6% of patients and in fibrosis in 42.9%, with no exacerbation.
In long-term observation, however, although the viral load had been reduced, the rate of recurrence of CHB with an increase in viral load was high with the cessation of treatment.
Conclusions:
The combination therapy of CHB with peginterferon alfa-2b plus entecavir may improve the rate of HBeAg seroconversion and HBsAg loss compared to standard therapy, but the rate of recurrence of CHB with an increase in viral load was high with the cessation of treatment. The number of patients examined was limited and further examination is necessary.

[stef2011]

to note that interferon is being used at 96 weeks in other combos, since 48weeks is too little to have good results
if no hbsag decrease by 24weeks interferon is stopped, all the others are responders

[StephenCastlecrag]

There seem to be several strategies with various length of time, sequential, or together. Good to know they all seem to achieve better results.