Lamivudine monotherapy for chronic hepatitis B infection with acute exacerbation revisited.
BACKGROUND
Acute exacerbation (AE) of chronic hepatitis B virus (HBV) infection in cancer chemotherapy patients and in organ transplant recipients receiving immunosuppressants may cause catastrophe and high mortality. Hence, immediate treatment with nucleoside analogues for such patients has become a consensus. Anti-HBV therapeutic trials in Asia have shown that AE of chronic hepatitis B (CH-B) may result in increased sustained remission (SR) rate with lamivudine monotherapy. Nonetheless, AE episodes in CH-B patients may evolve uneventfully and lead to spontaneous remission. Thus, the policy of immediate anti-HBV therapy for AE patients reaches an impasse. Once treatment is initiated, life long HBV suppression may be necessary.


OBJECTIVE
To determine whether lamivudine monotherapy during an AE of CH-B results in an increase in SR compared with no therapy.


METHODS
A cohort of 154 CH-B patients seropositive for hepatitis B e antigen with AE formed the study group. This included 102 cases receiving a nationwide therapeutic trial of 18-month lamivudine monotherapy that were compared with 52 cases with no therapy. All were observed for at least 30 months, which encompassed the 18-month on treatment period and a 12-month posttreatment follow-up.


RESULTS
No significant increase was observed in the SR rate in the lamivudine treatment group compared with the spontaneous remission rate in the untreated patients (P=0.782, Fisher's exact test).


CONCLUSIONS
AE does not increase the SR rate during 18-month lamivudine monotherapy. Immediate lamivudine therapy for AE patients is not justified as mandatory. The policy should be only applied to AE patients with impending liver failure.
Sheu
Ming-Jen
MJ
Division of Hepatogastroenterology, Department of Internal Medicine, Chi-Mei Medical Center, Tainan, Taiwan.
Kuo
Hsing-Tao
HT
Lin
Ching-Yih
CY
Koay
Lok-Beng
LB
Lee
Chuan
C
Chen
Jyh-Jou
JJ
Tang
Ling-Yu
LY
Tsai
Sun-Lung
SL
D000208:Acute Disease; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D030041:Hepatitis A virus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D006514:Hepatitis B Surface Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D055815:Young Adult
D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D019259:Lamivudine