Table 5 illustrates the changes in Ishak Fibrosis Score by treatment group.

Table 5. Changes in Ishak Fibrosis Score at Week 48

At week 48, improvement was seen with respect to mean change in serum HBV DNA (log₁₀ copies/mL), normalization of ALT, and HBeAg seroconversion as compared to placebo in patients receiving HEPSERA (Table 6).

Table 6. Change in Serum HBV DNA, ALT Normalization, and HBeAg Seroconversion at Week 48

Treatment Beyond 48 Weeks

In study 437, continued treatment with HEPSERA to 72 weeks resulted in continued maintenance of mean reductions in serum HBV DNA observed at week 48. An increase in the proportion of patients with ALT normalization was also observed in study 437. The effect of continued treatment with HEPSERA on seroconversion is unknown.

In study 438, patients who received HEPSERA during the first 48 weeks were re-randomized in a blinded manner to continue on HEPSERA or receive placebo for an additional 48 weeks. At week 96, 50 of 70 (71%) of patients who continued treatment with HEPSERA had undetectable HBV DNA levels ( < 1000 copies/mL), and 47 of 64 (73%) of patients had ALT normalization. HBV DNA and ALT levels returned towards baseline in most patients who stopped treatment with HEPSERA.

From 141 eligible patients, there were 125 (89%) patients in study 438 who chose to continue HEPSERA for up to 192 weeks or 240 weeks (4 years or 5 years). As these patients had already received HEPSERA for at least 48 weeks and appeared to be experiencing a benefit, they are not necessarily representative of patients initiating HEPSERA. Of these patients, 89/125 (71%) and 47/70 (67%) had an undetectable HBV DNA level ( < 1000 copies/mL) at week 192 and week 240, respectively. Of the patients who had an elevated ALT at baseline, 77/104 (74%) and 42/64 (66%) had a normal ALT at week 192 and week 240, respectively. Six (5%) patients experienced HBsAg loss.

Study 435 (Pre- and Post- Liver Transplantation Patients)

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