Pegylated Interferon-alfa-2a Plus Adefovir Combination Therapy Is Superior to P

[Guest guest]

www.hbvadvocate.org

AASLD 2006

#981. Pegylated Interferon-alfa-2a Plus Adefovir Combination Therapy Is

Superior to Pegylated Interferon-alfa-2a Alone or Adefovir Monotherapy in

Reducing HBsAg Levels in HDV-Coinfected Patients with Low HBV Viremia

H. Wedemeyer; C. Yurdaydin; K. Zachou; A. Erhardt; U. Drebber; Y. Cakaloglu;

H. Degertekin; S. Gurel; S. Zeuzem; T. Bock; G. Dalekos; M. P. Manns

Introduction:

Serum HBsAg levels are considered as a surrogate marker for intrahepatic

HBV-cccDNA levels and have been shown to be reduced by adefovir therapy in

HBV-monoinfected patients. The hepatitis D virus (HDV) uses the HBsAg for

virion formation. Thus, the best treatment option for HDV infection would be

clearance of HBsAg. So far, there are no data available on HBsAg-levels

during pegylated-interferon alfa therapies alone or in combination with

nucleos(t)es in HBV infection.

Methods:

We investigated HBsAg levels in 90 patients with HBV-HDV coinfection being

treated for 48 weeks with 180µg PEG-interferon-alfa-2a qw plus 10mg adefovir

dipivoxil qd (group A, n=31), 180µg PEG-interferon-alfa-2a qw plus placebo

(group B, n=29,) or 10mg adefovir dipivoxil qd alone (group C, n=30).

Patients were treated in the Hep-Net/International Delta Hepatitis

Intervention Trial (H-IT) in Germany, Turkey and Greece. At week 48, HDV-RNA

was negative in 21%, 30% and 8% of patients in the H-IT trial, respectively.

Results:

HBeAg tested positive in 14 patients at baseline. 48% of patients had

HBV-DNA levels below 100 IU/ml, 37% had a HBV viremia between 101 and 10.000

IU/ml and 15% showed HBV-DNA levels above 10.000 IU/ml.

Mean baseline HBsAg-levels were 3.9±0.6, 4.0±0.6 and 4.0±0.5 log10-IU/ml in

groups A, B and C, respectively, ranging from 184 to 79591 IU/ml. HBsAg

levels dnot correlate with HBV viremia but were positively correlated with

HDV-RNA levels (r=0.324, p=0.002). While patients receiving pegylated

interferon alfa-2a alone or adefovir monotherapy had similar mean HBsAg

levels at week 0 and week 48, the PEG-IFN alfa-2a/adefovir combination group

showed a 1.0 log10-IU/ml decline of HBsAg levels by week 48 (p<0.001). 40%

of patients in group A but only 5% of patients in group B and none of the

patients treated in group C displayed at least a 10-times reduction of HBsAg

in serum (p<0.001). Importantly, HBsAg was lost by week 48 in 2 patients,

both patients were treated with a combination of PEG-IFN alfa-2a and

adefovir and had also developed anti-HBs antibodies with titers of 58 and

413 IU/L, respectively.

Conclusion:

This is the first trial demonstrating that a combination therapy of

pegylated interferon with a nucleote is superior to either monotherapy in

reducing HBsAg levels in HBV-infected patients. HBsAg clearance can be

achieved by combination therapy in some HDV-coinfected patients after only

48 weeks of therapy. Future trials will have to investigate whether longer

treatment regimes can increase HBs-seroconversion rates in HDV-coinfected as

well as in HBV mono-infected patients.

http://www.hbvadvocate.org/news/reports/HBV_AASLD_2006/HBV%20Abstracts/treatment\

Oct30.htm#treat974

_________________________________________________________________

Share your latest news with your friends with the Windows Live Spaces

friends module.

http://clk.atdmt.com/MSN/go/msnnkwsp0070000001msn/direct/01/?href=http://spaces.\

live.com/spacesapi.aspx?wx_action=create & wx_url=/friends.aspx & mk