Hepsera Proves Safe and Effective

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Hepsera (adefovir dipivoxil) Proves Safe and Effective in Treating HBeAg Positive HBV Patients By Brian Boyle, MD Hepatitis B virus (HBV) infection is one of the most common viral pathogens in the world and a common cause of liver disease associated morbidity and mortality, especially in Asian countries and other parts of the world where transmission or infection occurs early in life. Fortunately, treatment options for HBV continue to increase, with 3 FDA approved medications and many new and highly effective agents, including entecavir, in the pipeline. In a study published in The New England Journal of Medicine, the efficacy and safety of Hepsera (adefovir dipivoxil) in the treatment of patients with hepatitis B e antigen (HBeAg) positive chronic HBV was assessed. In this prospective study, 515 patients with hepatitis B e antigen (HBeAg) positive chronic hepatitis B to receive 10 mg of adefovir dipivoxil (172 patients), 30 mg of adefovir dipivoxil (173), or placebo (170) daily for 48 weeks. At the end of 48 weeks of treatment, the improvement in liver histology was significantly higher in the patients that receive either 10 mg or 30 mg of Hepsera per day than those who received placebo (53 percent [P<0.001], 59 percent [P<0.001], and 25 percent, respectively). | In addition, the 10mg and 30mg Hepsera treated patients had higher reductions in serum HBV DNA levels than those who received placebo, with a median decrease of 3.52 [P<0.001], 4.76 [P<0.001], and 0.55 log10 copies/mL, respectively. Finally, the Hepsera treated patients also showed higher rates of HBV DNA levels <400 copies/mL (21 percent [P<0.001], 39 percent [P<0.001], and 0 percent, respectively); higher rates of normalization of alanine aminotransferase (ALT) levels (48 percent [P<0.001], 55 percent [P<0.001], and 16 percent, respectively), and higher rates of HBeAg seroconversion (12 percent [P=0.049], 14 percent [P=0.01], and 6 percent, respectively). No Hepsera-associated resistance mutations were identified at the end of the 48 week treatment period. Finally, while the 10 mg dose of Hepsera was as safe as the placebo, there was a higher rate of adverse events and renal laboratory abnormalities in the group given 30 mg of Hepsera per day. The authors conclude, "In patients with HBeAg-positive chronic hepatitis B, 48 weeks of 10 mg or 30 mg of adefovir dipivoxil per day resulted in histologic liver improvement, reduced serum HBV DNA and alanine aminotransferase levels, and increased the rates of HBeAg seroconversion. The 10-mg dose has a favorable risk-benefit profile for long-term treatment. No adefovir-associated resistance mutations were identified in the HBV DNA polymerase gene." 02/18/03 Reference P Marcellin and others. Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Positive Chronic Hepatitis B. The New England Journal of Medicine 2003;348:808-816.