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| |  Adefovir Switch to Tenofovir at 48 Weeks Improves Viral Suppression in Patients With Chronic Hepatitis B: Presented at EASL By Emma Hitt, PhD MILAN, Italy -- April 28, 2008 -- Switching from adefovir to tenofovir at week 48 of treatment results in additional viral suppression at week 72 in patients with hepatitis B virus (HBV), according to findings presented here at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) 43rd Annual Meeting. The benefits of switching to adefovir apply both to patients with the e antigen (HBeAg)-negative form and with the HBeAg-positive form, according to the investigators of Study 102 and Study 103. The studies were presented by Patrick Marcellin, MD, Professor of Medicine, Service d'Hepatologie at the Hôpital Beaujon, University of Paris, Clichy, France, and Jenny Heathcote, FRCPC, MD, Head, Division of Patient-Based Clinical Research, Toronto Western Research Institute, Toronto, Ontario, Canada. In Study 102, Dr. Marcellin and colleagues reported data on patients with HBeAg-negative chronic hepatitis B who were treated for the first 48 weeks with tenofovir (n = 250) or towith adefovir (n = 125). After 48 weeks, approximately 90% of these patients underwent biopsy and were eligible to continue treatment with tenofovir for up to 4 years. At the week-48 evaluation, 112 patients who were originally receiving adefovir were switched to tenofovir; 77 of these patients had HBV DNA <400 copies/mL at the time of the switch and 35 were viremic (>400 copies/mL). After 24 weeks of tenofovir (study week 72), 108 of the 112 patients who were switched to tenofovir had HBV DNA <400 copies/mL (75 of those with HBV DNA <400 copies/mL and 33 of the viremic subjects). Among the 250 patients treated with tenofovir during the first 48 weeks, 235 subjects continued tenofovir and 15 patients did not continue. At week 72, 222 subjects had HBV DNA <400 copies/mL and 4 subjects had HBV DNA >400 copies/mL; data were missing for 9 subjects. "Patients who had received adefovir caught up with the tenofovir group in terms of viral suppression when switched to tenofovir at week 48," Dr. Marcellin noted during his presentation on April 25. Tenofovir was well tolerated through week 72. Notably, no new adverse events were reported from week 48 onwards. Less than 1% of patients had serious adverse events; most adverse events were grade 3/4 laboratory abnormalities and the incidences were comparable between groups. In Study 103, results in patients with HBeAg-positive chronic hepatitis B demonstrated similar benefits to Study 102 with respect to switching from adefovir to tenofovir, said Dr. Marcellin. A total of 266 patients were randomised to continue on tenofovir (n = 176) or to switch from adefovir to tenofovir (n = 90) at week 48. Of the 90 patients taking adefovir, 84 went on to receive tenofovir. Of those, 66 patients had HBV DNA <400 copies/mL at week 72 (12 out of /12 subjects with HBV DNA <400 copies/mL at week 48, and 54 out of 72 subjects who were viremic at week 48). Of the 176 patients treated with tenofovir until week 48, 154 continued until week 72. At week 72, 129 subjects had HBV DNA <400 copies/mL, 16 were viremic, and 9 were missing data. As in Study 102, results of Study 103 showed that tenofovir was well tolerated. "We are expecting the final European Medicines Agency (EMEA) approval of tenofovir for chronic hepatitis B in Europe in the next few weeks," Dr. Marcellin noted. He added that "there is still a role for adefovir in patients who are achieving undetectable HBV DNA, but "I think if patients have detectable DNA with adefovir, they should now be switched to tenofovir."
[Presentation titles: Tenofovir Disoproxil Fumarate (TDF) for the Treatment of HBeAg-Negative Chronic Hepatitis B: Week 72 TDF Data and Week 24 Adefovir Dipivoxil Switch Data (Study 102) Cirrhosis. Abstract 57. Tenofovir Disoproxil Fumarate (TDF) for the Treatment of HBeAg-Positive Chronic Hepatitis B: Week 72 TDF Data and Week 24 Adefovir Dipivoxil Switch Data (Study 103). Abstract 72]
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