Abstract
Background and Methods. Chronic hepatitis B is a common and often progressive liver disorder for which there is no accepted therapy. To assess the efficacy of treatment with interferon, we randomly assigned patients with chronic hepatitis B to one of the following regimens: prednisone for 6 weeks followed by 5 million units of recombinant interferon alfa-2b daily for 16 weeks; placebo followed by 5 million units of interferon daily for 16 weeks; placebo followed by 1 million units of interferon daily for 16 weeks; or observation with no treatment. Results. Hepatitis B e antigen and hepatitis B viral DNA disappeared from serum significantly more often in the patients given prednisone plus interferon (16 of 44 patients, or 36 percent) or 5 million units of interferon alone (15 of 41; 37 percent) than in the untreated controls (3 of 43; 7 percent; P<0.001); the difference between those given 1 million units of interferon (7 of 41; 17 percent) and the controls was not significant. The strongest independent predictor of a response to treatment was the amount of hepatitis B viral DNA in serum at entry (P<0.0001). Of the 38 patients who responded to interferon, 33 (87 percent) had normal serum aminotransferase levels after therapy; 11 patients who responded (29 percent), but no controls, lost the hepatitis B surface antigen. Blinded histologic assessment revealed a significant improvement in periportal necrosis in the treated patients (P = 0.03). Conclusions. In chronic hepatitis B, treatment with interferon alfa-2b (5 million units per day for 16 weeks) was effective in inducing a sustained loss of viral replication and achieving remission, assessed biochemically and histologically, in over a third of patients. Moreover, in about 10 percent of the patients treated with interferon, hepatitis B surface antigen disappeared from serum.
| Original language | English |
|---|---|
| Pages (from-to) | 295-301 |
| Number of pages | 7 |
| Journal | New England Journal of Medicine |
| Volume | 323 |
| Issue number | 5 |
| State | Published - Aug 2 1990 |
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ASJC Scopus subject areas
- Medicine(all)
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A randomized, controlled trial of interferon ALFA-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. / Perrillo, Robert P.; Schiff, Eugene R; Davis, Gary L.; Bodenheimer, Henry C.; Lindsay, Karen; Payne, John; Dienstag, Jules L.; O'Brien, Christopher B; Tamburro, Carlo; Jacobson, Ira M.; Sampliner, Richard; Feit, David; Lefkowitch, Jay; Kuhns, Mary; Meschievitz, Carlton; Sanghvi, Bharati; Albrecht, Janice; Gibas, Alexandra; Perrillo, Robert P.; Regenstein, Fredric G.; Schechtman, Kenneth; Bodicky, Carol J.; Schiff, Eugene R.; Villanueva, Steven; Davis, Gary L.; Kniffen, Joanne; Bodenheimer, Henry C.; Brodeur, Carmel A.; Lindsay, Karen L.; Milstein, Susan; Lewin, Klaus; Payne, John; Mikotis, Mary Jo; Dienstag, Jules L.; Gibas, Alexandra; Cody, Heather; Watkins, Eloise; O'Brien, Christopher; Sample, Michelle; Tamburro, Carlo H.; Miller, Barbara; Sampliner, Richard; Mackel, Cindy; Jacobson, Ira M.; Cantor, Michael; Feit, David; Lefkowitch, Jay; Kuhns, Mary C.; McNamara, Anne L.; Kilian, Ann; Bariletto, Steve; Guito, Kenneth; Albrecht, Janice; Meschievitz, Carlton; Kammer, Robert B.; Sanghvi, Bharati.
In: New England Journal of Medicine, Vol. 323, No. 5, 02.08.1990, p. 295-301.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized, controlled trial of interferon ALFA-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B
AU - Perrillo, Robert P.
AU - Schiff, Eugene R
AU - Davis, Gary L.
AU - Bodenheimer, Henry C.
AU - Lindsay, Karen
AU - Payne, John
AU - Dienstag, Jules L.
AU - O'Brien, Christopher B
AU - Tamburro, Carlo
AU - Jacobson, Ira M.
AU - Sampliner, Richard
AU - Feit, David
AU - Lefkowitch, Jay
AU - Kuhns, Mary
AU - Meschievitz, Carlton
AU - Sanghvi, Bharati
AU - Albrecht, Janice
AU - Gibas, Alexandra
AU - Perrillo, Robert P.
AU - Regenstein, Fredric G.
AU - Schechtman, Kenneth
AU - Bodicky, Carol J.
AU - Schiff, Eugene R.
AU - Villanueva, Steven
AU - Davis, Gary L.
AU - Kniffen, Joanne
AU - Bodenheimer, Henry C.
AU - Brodeur, Carmel A.
AU - Lindsay, Karen L.
AU - Milstein, Susan
AU - Lewin, Klaus
AU - Payne, John
AU - Mikotis, Mary Jo
AU - Dienstag, Jules L.
AU - Gibas, Alexandra
AU - Cody, Heather
AU - Watkins, Eloise
AU - O'Brien, Christopher
AU - Sample, Michelle
AU - Tamburro, Carlo H.
AU - Miller, Barbara
AU - Sampliner, Richard
AU - Mackel, Cindy
AU - Jacobson, Ira M.
AU - Cantor, Michael
AU - Feit, David
AU - Lefkowitch, Jay
AU - Kuhns, Mary C.
AU - McNamara, Anne L.
AU - Kilian, Ann
AU - Bariletto, Steve
AU - Guito, Kenneth
AU - Albrecht, Janice
AU - Meschievitz, Carlton
AU - Kammer, Robert B.
AU - Sanghvi, Bharati
PY - 1990/8/2
Y1 - 1990/8/2
N2 - Background and Methods. Chronic hepatitis B is a common and often progressive liver disorder for which there is no accepted therapy. To assess the efficacy of treatment with interferon, we randomly assigned patients with chronic hepatitis B to one of the following regimens: prednisone for 6 weeks followed by 5 million units of recombinant interferon alfa-2b daily for 16 weeks; placebo followed by 5 million units of interferon daily for 16 weeks; placebo followed by 1 million units of interferon daily for 16 weeks; or observation with no treatment. Results. Hepatitis B e antigen and hepatitis B viral DNA disappeared from serum significantly more often in the patients given prednisone plus interferon (16 of 44 patients, or 36 percent) or 5 million units of interferon alone (15 of 41; 37 percent) than in the untreated controls (3 of 43; 7 percent; P<0.001); the difference between those given 1 million units of interferon (7 of 41; 17 percent) and the controls was not significant. The strongest independent predictor of a response to treatment was the amount of hepatitis B viral DNA in serum at entry (P<0.0001). Of the 38 patients who responded to interferon, 33 (87 percent) had normal serum aminotransferase levels after therapy; 11 patients who responded (29 percent), but no controls, lost the hepatitis B surface antigen. Blinded histologic assessment revealed a significant improvement in periportal necrosis in the treated patients (P = 0.03). Conclusions. In chronic hepatitis B, treatment with interferon alfa-2b (5 million units per day for 16 weeks) was effective in inducing a sustained loss of viral replication and achieving remission, assessed biochemically and histologically, in over a third of patients. Moreover, in about 10 percent of the patients treated with interferon, hepatitis B surface antigen disappeared from serum.
AB - Background and Methods. Chronic hepatitis B is a common and often progressive liver disorder for which there is no accepted therapy. To assess the efficacy of treatment with interferon, we randomly assigned patients with chronic hepatitis B to one of the following regimens: prednisone for 6 weeks followed by 5 million units of recombinant interferon alfa-2b daily for 16 weeks; placebo followed by 5 million units of interferon daily for 16 weeks; placebo followed by 1 million units of interferon daily for 16 weeks; or observation with no treatment. Results. Hepatitis B e antigen and hepatitis B viral DNA disappeared from serum significantly more often in the patients given prednisone plus interferon (16 of 44 patients, or 36 percent) or 5 million units of interferon alone (15 of 41; 37 percent) than in the untreated controls (3 of 43; 7 percent; P<0.001); the difference between those given 1 million units of interferon (7 of 41; 17 percent) and the controls was not significant. The strongest independent predictor of a response to treatment was the amount of hepatitis B viral DNA in serum at entry (P<0.0001). Of the 38 patients who responded to interferon, 33 (87 percent) had normal serum aminotransferase levels after therapy; 11 patients who responded (29 percent), but no controls, lost the hepatitis B surface antigen. Blinded histologic assessment revealed a significant improvement in periportal necrosis in the treated patients (P = 0.03). Conclusions. In chronic hepatitis B, treatment with interferon alfa-2b (5 million units per day for 16 weeks) was effective in inducing a sustained loss of viral replication and achieving remission, assessed biochemically and histologically, in over a third of patients. Moreover, in about 10 percent of the patients treated with interferon, hepatitis B surface antigen disappeared from serum.
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UR - http://www.scopus.com/inward/citedby.url?scp=0025347975&partnerID=8YFLogxK
M3 - Article
C2 - 2195346
AN - SCOPUS:0025347975
VL - 323
SP - 295
EP - 301
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 5
ER -