Question of ALT flare during switch to adefovir from lamivudine: A single center open-label, randomized, safety study (June 17, 2005 to February 5, 2009)

Journal of Medical Virology
Hie-Won L HannSo Young Park

Abstract

Earlier clinical studies have reported an ALT flare greater than 10 times the upper limit of normal in some patients with chronic hepatitis B when their lamivudine (LAM) treatment was switched to adefovir (ADV) therapy. The current study compared the safety of switching directly to ADV versus overlapping LAM and ADV for 3 months followed by ADV monotherapy. Patients with chronic hepatitis B receiving LAM therapy for > or = 6 months were eligible for the study regardless of the presence of LAM resistance, HBeAg status or serum ALT levels. Eighteen patients (13 males) were randomized to direct switch to ADV and 17 patients (10 males) to overlap. HBV-DNA, ALT, albumin, and total bilirubin were assayed at baseline, 3, 6, 9, and 12 months. Study drugs were discontinued at the end of 12 months with the follow up at 3 and 6 months. The decision to continue antiviral therapy was made at the discretion of the investigator. Baseline ALT levels were similar between the direct switch and overlap group: median ALT (U/L) was 44.0 (16-266) and 33.0 (19-367) for direct switch for overlap group, respectively (P = 0.42). No ALT flare was noted at 3 months in either group: median ALT decreased from 44.0 to 34.5 U/L in the direct switch group, and...Continue Reading

References

Jul 3, 2002·Annals of Internal Medicine·Daniele PratiGirolamo Sirchia
Jan 30, 2007·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Irene RaptiStephanos J Hadziyannis
Nov 9, 2007·Alimentary Pharmacology & Therapeutics·S ManolakopoulosD Tzourmakliotis
Dec 5, 2008·The New England Journal of Medicine·Patrick MarcellinFranck Rousseau

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Citations

Mar 10, 2018·Journal of Pharmacokinetics and Pharmacodynamics·Sebastian PolakDebra Hanna
Jan 24, 2020·The Journal of Analytical Psychology·Robert Tyminski

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