A pilot study of extended duration peginterferon alfa-2a for patients with hepatitis B e antigen-negative chronic hepatitis B.

Abstract

OBJECTIVES:

Forty-eight weeks of peginterferon alfa-2a is the approved regimen for chronic hepatitis B (CHB). Standard interferon is more effective for hepatitis B e antigen (HBeAg)-negative CHB when given for longer than 1 yr. This study evaluated peginterferon alfa-2a for 60 wk, alone or in combination with lamivudine.

METHODS:

Thirteen patients with HBeAg-negative CHB received peginterferon alfa-2a (180 microg/week) for 60 wk or peginterferon alfa-2a (180 microg/week) for 12 wk followed by 48 wk of peginterferon alfa-2a plus lamivudine. The primary end point, sustained virologic response (SVR), was defined as a reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA) of >or=2 log10 copies/mL and HBV DNA<20,000 copies/mL at 24 wk of follow-up (week 84). Hepatitis B surface antigen (HBsAg) concentrations were analyzed and compared to changes in HBV DNA.

RESULTS:

SVR was achieved by 9/13 patients (69%). At week 84, HBV DNA was undetectable by polymerase chain reaction in 5/13 (38%) patients, and 3 additional patients had a sustained 2-3 log reduction in HBV DNA. Five patients demonstrated a >90% decrease in HBsAg concentration at week 60, including 3 with undetectable HBV DNA at week 84 and a fourth who met criteria for SVR.

CONCLUSIONS:

Sixty weeks of peginterferon alfa-2a with or without lamivudine resulted in a higher rate of SVR compared to historical controls with HBeAg-negative CHB treated with 48 wk of pegylated interferon. Larger studies are necessary to assess if longer duration therapy is more effective than the standard regimen and results in a greater decline in HBsAg concentration.

• Authors: Robert G Gish, Daryl T-Y Lau, Peter Schmid, Robert Perrillo
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 102 Issue 12 Pg. 2718-23 (Dec 2007) ISSN: 0002-9270 [Print] United States
• PMID: 17662102 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Lamivudine
• Polyethylene Glycols
• Alanine Transaminase
• peginterferon alfa-2a

Topics

• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage, therapeutic use)
• DNA, Viral (blood)
• Drug Therapy, Combination
• Enzyme-Linked Immunosorbent Assay
• Female
• Hepatitis B e Antigens (blood)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Interferon alpha-2
• Interferon-alpha (administration & dosage, therapeutic use)
• Lamivudine (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Pilot Projects
• Polyethylene Glycols (administration & dosage, therapeutic use)
• Recombinant Proteins
• Treatment Outcome