Correspondence
Lamivudine for the Treatment of Chronic Hepatitis B
N Engl J Med 2000; 342:592February 24, 2000
- Article
To the Editor:
In their study of lamivudine as initial treatment for chronic hepatitis B, Dienstag and colleagues (Oct. 21 issue)1 state that 34 (52 percent) of 66 patients with compensated liver disease who were positive for serum hepatitis B e antigen and who were given 100 mg of lamivudine daily for 52 weeks had reductions of at least 2 points in the score on the Histologic Activity Index (the primary end point), as assessed by analysis of liver-biopsy specimens obtained at base line and at week 52, as compared with 16 of 71 patients given placebo (23 percent). Similarly, sustained suppression of hepatitis B virus DNA and normalization of serum alanine aminotransferase levels were observed mainly in the lamivudine group. Since 33 patients with missing biopsy data were considered to have had no response, it is essential to know whether the groups were well balanced with respect to missing data.
1 ReferencesDavid Verhelst, M.D.
Eric Goffin, M.D.
Cliniques Universitaires Saint-Luc, 1200 Brussels, Belgium1
Dienstag JL ,Schiff ER ,Wright TL , et al. Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med 1999;341:1256-1263
Full Text | Web of Science | Medline
Author/Editor Response
The authors reply:
To the Editor: The primary end point of our study was histologic improvement, and to subject this outcome variable to the most stringent test, we considered patients with missing histologic data to have had no response. The study groups were well balanced with respect to missing histologic data; of the 33 patients with missing histologic data, 18 were among the 71 patients in the placebo group (25 percent) and 15 were among the 66 patients in the lamivudine group (23 percent). Had patients with missing histologic data been excluded, the treatment effect would have been similar: histologic responses (defined as a reduction of ≥2 points in the score on the Histologic Activity Index) occurred in 16 of 53 placebo recipients (30 percent) and 34 of 51 lamivudine recipients (67 percent, P<0.001).
Jules L. Dienstag, M.D.
Massachusetts General Hospital, Boston, MA 02114Nathaniel A. Brown, M.D.
Mary Woessner, B.S.
Glaxo Wellcome, Research Triangle Park, NC 27709
