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Z Gastroenterol 2003; 41(3): 249-254
DOI: 10.1055/s-2003-37902
Originalarbeit
© Karl Demeter Verlag im Georg Thieme Verlag Stuttgart · New York

Response Predictors and Results of a Long-term Treatment with Lamivudine in Patients with Chronic Hepatitis B

Prädiktive Parameter und Ergebnisse im Verlauf einer langdauernden Lamivudintherapie bei Patienten mit chronischer Hepatitis BU. Mihm1 , C. Sarrazin1 , E. Herrmann2 , G. Teuber3 , M. von Wagner1 , B. Kronenberger1 , S. Zeuzem1
  • 1Klinik und Poliklinik für Innere Medizin II, Universitätskliniken des Saarlandes, Kirrberger Str., 66421 Homburg/Saar
  • 2Fachbereich Mathematik der Technischen Universität, Schlossgartenstr. 7, 64289 Darmstadt
  • 3Medizinische Klinik II, Johann-Wolfgang-Goethe-Universität, Theodor-Stern-Kai 7, 60590 Frankfurt am Main
This work is dedicated to Prof. Dr. med. W. F. Caspary, who was Executive Editor of the Zeitschrift für Gastroenterologie from 1991 to 2003.
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Publication Date:
28 March 2003 (online)

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Zusammenfassung

Einleitung: Es liegen nur wenige europäische Daten zu einer Langzeit-Therapie mit Lamivudin sowie zu möglichen Prädiktoren für ein anhaltendes virologisches Ansprechen und die Entwicklung einer Resistenzmutante vor.

Patienten und Methoden: 39 Patienten (17 HBeAg+, 22 HBeAg-), wurden im Median 2,5 Jahre (0,5-4 Jahre) mit Lamivudin behandelt. Die Patientendaten wurden retrospektiv ausgewertet.

Ergebnisse: Eine HBsAg-/anti-HBs-Serokonversion wurde bei keinem Patienten beobachtet. Bei 14 von 17 initial HBeAg-positiven Patienten lag der HBeAg-Status zu Therapieende vor. Dabei wurden bei 8 Patienten ein Verlust des HBeAg und bei 7 von diesen 8 Patienten eine Serokonversion zu anti-HBe beobachtet. Bei 5 von 6 Patienten mit HBeAg-Serokonversion und einer dokumentierten Nachbeobachtung dauerte die Serokonversion nach Therapieende an. Bei den initial HBeAg-negativen Patienten wurde ein virologisches Ansprechen (Serum HBV DNA≤1 × 105 Kopien/ml) bei 12 von 22 Patienten nach einer medianen Therapiedauer von 2,5 Jahren beobachtet. Bei einem von zwei initial HBeAg-negativen Patienten mit einem virologischen Ansprechen und einer Nachbeobachtung nach Therapieende war das Ansprechen dauerhaft. Eine Resistenz auf Lamivudin trat bei 15 von 36 Patienten mit vorhandener HBV-DNA-Quantifizierung nach einer medianen Behandlungsdauer von 2 Jahren auf.

Schlussfolgerung: Die vorliegende retrospektive Studie bestätigt internationale Daten zur Lamivudintherapie für ein mitteleuropäisches Patientenkollektiv. Bei mehr als 50 % der Patienten mit chronischer Hepatitis B ließ sich durch Lamivudin ein virolo­gischer Therapieerfolg erzielen. Weder für ein dauerhaftes virologisches Ansprechen noch für die Resistenzentwicklung auf Lamivudin ließen sich Prädiktoren vor Therapie identifizieren.

Abstract

Introduction: European data on outcome and follow-up of long-term lamivudine treatment are sparse. Moreover, little is known about predictors for sustained virologic response and for development of drug resistance in patients with lamivudine monotherapy.

Patients and methods : 39 patients (17 HBeAg+, 22 HBeAg-) were treated with lamivudine for a median duration of 2.5 years (range: 0.5-4). Outcome to therapy and predictors for response and drug resistance were analyzed retrospectively.

Results: None of the patients lost HBsAg. In 14 of 17 initially HBeAg positive patients the HBeAg status was available at the end of treatment. Loss of HBeAg was observed in 8 patients and 7 of these 8 patients seroconverted to anti-HBe. Five of 6 patients with HBeAg seroconversion and a post-treatment follow-up period showed sustained HBeAg seroconversion. In HBeAg negative patients virologic response (serum HBV DNA≤1 × 105 copies/ml) was observed in 12 of 22 patients after a median treatment period of 2.5 years. Post-treatment follow-up data were available in only 2 patients, one of which remained below 1 × 105 HBV DNA copies/ml for one year. Resistance emerged in 15 of 36 patients with available serum HBV DNA data after a median treatment period of 2 years.

Conclusion: The present retrospective study confirms international data for lamivudine treatment in a central European setting. Lamivudine therapy achieved disease control in more than 50 % of patients treated for chronic hepatitis B. Baseline predictors could neither be identified for sustained virologic response nor for the development of drug resistance.

Schlüsselwörter

Lamivudin-Langzeittherapie - Resistenzentwicklung - Nachbeobachtung - chronische Hepatitis B

Key words

Long-term lamivudine - post-treatment follow-up - drug resistance

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Prof. Dr. med. Stefan Zeuzem

Klinik und Poliklinik für Innere Medizin II, Universitätskliniken des Saarlandes

Kirrberger Str.

66421 Homburg/Saar

Email: zeuzem@uniklinik-saarland.de