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Sustained Immune Control 1 Year Post-Treatment with Peginterferon Alfa-2a [40KD] (PEGASYS) is Durable up to 5 Years Post-Treatment and is Associated with a High Rate of HBsAg Clearance in HBeAg-Negative Chronic Hepatitis B
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Reported by Jules Levin
Presented at the 20th Conference of the Asian Pacific Association for the Study of the Liver (APASL), 25-28 March 2010, Beijing, China
Piratvisuth T,1 Marcellin P,2 Brunetto M,3 Bonino F,4 Farci P,5 Yurdaydin C,6 Gurel S,7 Popescu M8. 1NKC Institute of Gastroenterology and Hepatology, Department of Internal Medicine, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand; 2Service d'Hepatologie, Hopital Beaujon APHP and Centre de Recherches Biologiques Bichat Beaujon (Inserm CRB3), University of Paris, Clichy, France; 3UO Gastroenterologia ed Epatologia, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy; 4Scientific Direction, Foundation IRCCS Policlinico of Milan and University of Pisa, Italy; 5Universita di Cagliari, Cagliari, Italy; 6University of Ankara, Faculty of Medicine, Ankara, Turkey; 7Department of Gastroenterology, Uludag University, Turkey;
8F. Hoffmann-La Roche Ltd, Basel, Switzerland
Summary
31% of HBeAg-negative patients treated with peginterferon alfa-2a achieved
sustained immune control (HBV DNA ≤10,000 copies/mL) 1 year post-treatment
This response was durable as it was sustained at 5 years post-treatment by
the majority (88%) of patients
Sustained immune control at 1 year post-treatment was associated with a high
rate of HBsAg clearance 5 years post-treatment (28%)
HBsAg clearance was seen in patients infected with all the major HBV genotypes
Conclusion
The durability of sustained immune control in patients who received a finite course of peginterferon alfa-2a was high between post-treatment years 1 and 5. Patients who achieve sustained immune control 1 year post-treatment have a high chance of achieving HBsAg clearance at year 5 post-treatment. Sustained immune control following a course of interferon-based therapy is a critical step towards subsequent HBsAg clearance - the ultimate goal of treatment in CHB
Background
A finite course of interferon-based therapy can result in sustained immune control of chronic hepatitis B (CHB) virus (HBV) infection in a proportion of patients with hepatitis B e antigen (HBeAg)-negative CHB. In these patients, sustained immune control is defined as sustained suppression of HBV DNA levels to below 10,000 copies/mL - a level of HBV DNA seen in inactive disease1,2
In contrast, treatment of patients with HBeAg-negative CHB with nucleoside analogs such as entecavir requires long-term maintenance therapy to achieve HBV DNA suppression since nearly all patients relapse if treatment is stopped after 1 year3
Objective
To investigate the durability of sustained immune control induced by peginterferon alfa-2a [40KD] (PEGASYS) from post-treatment years 1 to 5 in patients with HBeAg-negative CHB
Methods
HBeAg-negative patients had received peginterferon alfa-2a (PEGASYS; 180 µg/week) ± lamivudine (100 mg/day) for 48 weeks as part of a large-scale phase 3 study.4 Patients were followed up for 6 months post-treatment as part of the original study
A total of 230 patients entered a long-term observational follow-up study that assessed response up to 5 years post-treatment
Rates of sustained immune control (defined as HBV DNA ≤10,000 copies/mL)
at years 1 and 5 post-treatment were determined in the overall population and according to HBV genotype
Results
Sustained immune control after peginterferon alfa-2a therapy is durable
One year post-treatment, 31% of patients (72/230) had achieved sustained immune control (Figure 1)
Of these 72 patients, 41 returned for follow-up 5 years post-treatment, at which
point 88% (36/41) had sustained suppression of HBV DNA ≤10,000 copies/mL
(Figure 1)
Sustained immune control is associated with a high rate of HBsAg clearance
In the overall long-term study population, 12% of patients (28/230) achieved
HBsAg clearance at 5 years post-treatment. The rate in patients with sustained
immune control 1 year post-treatment was 28% (20/72; Figure 2)
Patients infected with any HBV genotype can clear HBsAg following treatment
with peginterferon alfa-2a
Clearance of HBsAg was seen in patients infected with all of the major HBV
genotypes (A, B, C and D)
The rates of HBsAg clearance at year 5 post-treatment according to genotype were: A (3/15; 20%), B (4/65; 6%), C (15/96; 16%); D (5/47; 11%); other (1/7; 14%)
References
1. EASL. EASL clinical practice guideline: management of chronic hepatitis B.
J Hepatol 2009;50:227-242
2. Chen C-J et al. Long-term outcomes in hepatitis B: the REVEAL-HBV study.
Clin Liver Dis 2007;11:797-816
3. Shouval D et al. Relapse of hepatitis B in HBeAg-negative chronic hepatitis B
patients who discontinued successful entecavir treatment: the case for continuous antiviral therapy. J Hepatol 2009;50:289-295
4. Marcellin P et al. Peginterferon alfa-2a alone, lamivudine alone, and the
two in combination in patients with HBeAg-negative chronic hepatitis B. New Engl J Med 2004;351:1206-1217
Disclosure information: Editorial support for the development of this poster was
funded by F. Hoffmann-La Roche, Basel, Switzerland
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