Marcellin, PatrickLau, GeorgeBonino, FerruccioFarci, PatriziaHadziyannis, StephanosJin, R.Lu, ZMPiratvisuth, TeerhaGermanidis, GeorgiosYurtaydin, CihanMoises, DiagoMingyang, LaiButton, P.Pluck, Nigel2021-06-212021-06-212004-09-16Marcellin, P. vd. (2004). ''Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B''. New England Journal Of Medicine, (351)12, 1206-1217.0028-4793https://doi.org/10.1056/NEJMoa040431https://www.nejm.org/doi/full/10.1056/NEJMoa040431http://hdl.handle.net/11452/20681Background: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. Methods: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. Results: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. Conclusions: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates.eninfo:eu-repo/semantics/openAccessInterferon treatmentUntreated patientsDrug- resistanceViral- hepatitisHBV- DNA40 KDAAlpha-2aTherapyMonotherapyManagementArticle0002238613000092-s2.0-4544239807120612173511215371578Medicine, general & internal