TY - JOUR
T1 - Durability of serologic response after lamivudine treatment of chronic hepatitis B
AU - Dienstag, Jules L.
AU - Cianciara, Janusz
AU - Karayalcin, Selim
AU - Kowdley, Kris V.
AU - Willems, Bernard
AU - Plisek, Stanilav
AU - Woessner, Mary
AU - Gardner, Stephen
AU - Schiff, Eugene
N1 - Funding Information:
Abbreviations: HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; anti-HBe, antibody to hepatitis B e antigen; HBsAg, hepatitis B surface antigen; anti-HBs, antibody to hepatitis B surface antigen; ALT, alanine aminotransferase; ULN, upper limit of normal; bDNA, branched DNA; CPK, creatine phosphokinase; SAE, serious adverse event. From the 1Gastrointestinal Unit (Medical Services), Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, MA; 2Medical Academy, Warsaw, Poland; 3Ankara University Medical School, Ankara, Turkey; 4University of Washington, Seattle, WA; 5Hospital Saint-Luc du Centre Hosp de l’Univ de Montreal, Montreal, Quebec, Canada; 6Infekeni Klinika, Hradec Kralove, Czech Republic; 7GlaxoSmithKline, Research Triangle Park, NC; and 8University of Miami, Miami, FL. Received June 7, 2002; accepted January 3, 2003. Supported by GlaxoSmithKline (Protocol NUCA/B3016). Address reprint requests to: Jules L. Dienstag, M.D., Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA 02114. E-mail: jdienstag@partners. org; fax: 617-726-3673. Copyright © 2003 by the American Association for the Study of Liver Diseases. 0270-9139/03/3704-0007$30.00/0 doi:10.1053/jhep.2003.50117
PY - 2003/4/1
Y1 - 2003/4/1
N2 - Forty subjects with chronic hepatitis B and hepatitis B e antigen (HBeAg) seroconversion following lamivudine therapy in previous trials were monitored after treatment to assess the durability of serologic responses. Patient follow-up began a median of 4.3 months after completion of therapy in previous trials. At months 2, 4, 6, 9, and 12 of year 1, and every 6 months thereafter, we tested for HBeAg and hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV) DNA, and alanine aminotransferase (ALT). After a median (range) of 36.6 (4.8-45.6) months of follow-up monitoring, HBeAg seroconversion was demonstrated at the last visit by 77% (30 of 39) of patients. In a post hoc analysis of a slightly different population of all 65 patients with HBeAg seroconversion in previous trials, the 3-year durability of HBeAg seroconversion measured from the time immediately after discontinuing lamivudine therapy was 64%. Nine (9 of 40, 23%) patients were HBsAg negative at the last assessment. Seventy-four percent (17 of 23) of patients with baseline undetectable HBV DNA and normal ALT maintained these responses at the last visit. Eight patients (8 of 40, 20%) initiated retreatment for reappearance of HBV markers, and 7 showed biochemical and/or virologic improvement (including regained HBeAg seroconversion in 2). No safety issues of concern emerged. In conclusion, most HBeAg responses achieved during lamivudine therapy were durable, and most responders experienced prolonged clinical benefit after HBeAg seroconversion and subsequent discontinuation of lamivudine. Lamivudine retreatment for reappearance of hepatitis B markers can achieve resumption of viral suppression.
AB - Forty subjects with chronic hepatitis B and hepatitis B e antigen (HBeAg) seroconversion following lamivudine therapy in previous trials were monitored after treatment to assess the durability of serologic responses. Patient follow-up began a median of 4.3 months after completion of therapy in previous trials. At months 2, 4, 6, 9, and 12 of year 1, and every 6 months thereafter, we tested for HBeAg and hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV) DNA, and alanine aminotransferase (ALT). After a median (range) of 36.6 (4.8-45.6) months of follow-up monitoring, HBeAg seroconversion was demonstrated at the last visit by 77% (30 of 39) of patients. In a post hoc analysis of a slightly different population of all 65 patients with HBeAg seroconversion in previous trials, the 3-year durability of HBeAg seroconversion measured from the time immediately after discontinuing lamivudine therapy was 64%. Nine (9 of 40, 23%) patients were HBsAg negative at the last assessment. Seventy-four percent (17 of 23) of patients with baseline undetectable HBV DNA and normal ALT maintained these responses at the last visit. Eight patients (8 of 40, 20%) initiated retreatment for reappearance of HBV markers, and 7 showed biochemical and/or virologic improvement (including regained HBeAg seroconversion in 2). No safety issues of concern emerged. In conclusion, most HBeAg responses achieved during lamivudine therapy were durable, and most responders experienced prolonged clinical benefit after HBeAg seroconversion and subsequent discontinuation of lamivudine. Lamivudine retreatment for reappearance of hepatitis B markers can achieve resumption of viral suppression.
UR - http://www.scopus.com/inward/record.url?scp=0037381547&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0037381547&partnerID=8YFLogxK
U2 - 10.1053/jhep.2003.50117
DO - 10.1053/jhep.2003.50117
M3 - Article
C2 - 12668966
AN - SCOPUS:0037381547
VL - 37
SP - 748
EP - 755
JO - Hepatology
JF - Hepatology
SN - 0270-9139
IS - 4
ER -