Table 3.
Efficacy of Currently Approved Agents for Therapy of Chronic Hepatitis B
| HBeAg positive | PegIFN (180mcg/week SC) |
Entecavir (0.5mg/day PO) |
Tenofovir disoproxil fumarate (245–300mg/day PO) | Tenofovir alafenamide (25mg/day PO) |
|---|---|---|---|---|
| Anti-HBeAg seroconversion | 32%1 | 21%2 23%3 |
21%2 27%4 |
10%2 |
| HBV DNA < 60–80 lU/mL | 14%1 | 67%2 94%3 |
76%2 98%4 |
64%2 |
| ALT normalization | 41%1 | 68%2 80%3 |
68%2 78%4 |
72%2 |
| HBsAg loss | 3–7%1 | 2%2 1.4%3 |
3%2 5%4 |
1%2 |
| HBeAg negative | PegIFN (180mcg/week) |
Entecavir (0.5mg/day) |
Tenofovir disoproxil fumarate (245–300mg/day) | Tenofovir alafenamide (25mg/day) |
| HBV DNA < 60–80 lU/mL | 19%1 | 90%2 | 93%2 100%4 |
94%2 |
| ALT normalization |
59%1 | 78%2 | 76%2 83%4 |
83%2 |
| HBsAg loss | 4%1 | 0%2 | 0%2 3%4 |
0%2 |
Table adapted from EASL Clinical practice guidelines J Hepatol 2017; 67:370–398 and Terrault N et al Hepatology 2018; 67:1560–1599.
pegIFN, pegylated interferon alfa-2a; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B s antigen; ALT, alanine aminotransferase.
ALT normalization defined by laboratory upper limit of normal
Evaluated 6 months following 48–52 weeks of treatment
Evaluated at 48–96 weeks of continuous therapy
The entecavir long-term cohort consisted of 183 HBeAg positive patients who received ≥1 year of entecavir 0.5 mg in the registration trial (ETV-022) and then entered long-term treatment (ETV-901) with a treatment gap ≤35 days. In ETV-901 the entecavir dose was increased to 1.0 mg daily.[144]
Results based on a sub-set of patients 203/641 (32%) HBeAg‐positive (n=80) and HBeAg-negative (n=118) patients who were initially randomized and treated and who were followed for 10 years.[93]