Long-term entecavir (Baraclude, Bristol-Myers Squibb) therapy induces durable virologic suppression and his-tologic benefit, including reversal of fibrosis or cirrhosis, in both HBeAg-positive and -negative chronic hepatitis B. Tong and colleagues evaluated long-term histologic outcomes following entecavir therapy in a nucleoside-naive Asian patient population. The investigators analyzed patients who completed the clinical trials ETV-022 or -027 and subsequently received entecavir 1.0 mg daily in the rollover study ETV-901. The group included 31 patients with baseline and follow-up biopsies, including 24 patients with HBeAg-positive disease. At baseline, the mean HBV DNA level was 9.5 log10 copies/mL; mean ALT was 127 U/L; mean Knodell necroinflammatory score was 7.5, and mean Ishak fibrosis score was 2.2. After a median entecavir treatment duration of 283 weeks, histologic improvement was observed in 100% of patients, representing an increase from the 71% histologic improvement rate observed at Week 48. The mean reductions from baseline in Knodell necroinflammatory score at Week 48 and at long-term follow-up were 3.4 and 6.2, respectively. The proportion of patients with improvements in Ishak fibrosis score was 29% and 87%, respectively, and the mean change in Ishak fibrosis score from baseline was -0.2 and -1.5, respectively. The proportion of patients with HBV DNA levels less than 300 copies/mL was 68% at Week 48 and 100% at long-term follow-up; ALT of no more than 1 times the upper limit of normal was observed in 61% and 77% of patients, respectively. No new safety issues were reported.
Efficacy of FTC/TDF Administered With or Without Hepatitis B Immune Globulin in Patients Undergoing Orthotopic Liver Transplantation
The randomized trial Study 107 is evaluating fixed-dose FTC/TDF with or without hepatitis B immune globulin (HBIG) for the prevention of hepatitis B recurrence in patients undergoing orthotopic liver transplantation (OLT). The trial enrolled 40 patients with chronic hepatitis B who had undergone OLT, received at least 12 weeks of post-transplant prophylaxis, including HBIG, and had no evidence of chronic recurrence after transplant. Patients had not received TDF or FTC/TDF after transplant. Other eligibility criteria included creatinine clearance of at least 40 mL/min, adequate organ function, and no co-infection with hepatitis C, hepatitis D, or HIV. All patients received FTC/TDF and HBIG for 24 weeks and then were randomly assigned to continue FTC/TDF plus HBIG (19 patients) or switch to FTC/TDF alone (18 patients) for an additional 72 weeks, for a total treatment period of 2 years. In a safety analysis, no FTC/TDF-related serious or grade 3/4 adverse events were reported. Grade 2-4 adverse events considered to be related to FTC/TDF included 1 case of a moderate increase in creatinine level/decrease in creatinine clearance and 1 case of moderate ulcerative colitis. Three patients did not receive the full 24 weeks of therapy: 1 patient discontinued due to an increase in ALT/aspartate aminotransferase, 1 patient discontinued due to worsening colitis, and 1 patient died from a stroke. Serum creatinine and creatinine clearance remained stable; 4 of 24 patients with a baseline creatinine clearance of 50-80 mL/min (17%) had creatinine clearance of less than 50 mL/min. No patient had detectable HBV DNA levels (>169 copies/mL) or hepatitis B surface antigen (HBsAg) positivity.
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