Table 3.
Virological, biochemical and histological responses to anti‐viral agents in treatment naive patients with CHB
| Asian patients | Trial endpoints | First line agents | ||||
|---|---|---|---|---|---|---|
| Pegylated interferon alfa 2a (up to 45 weeks) | Entecavir (up to 240 weeks) | Tenofovir (up to 192 weeks) | Tenofovir alafenamide (up to 48 weeks) | |||
| HBeAg(−) | HBV DNA | Year 1 undetectable HBV DNA | 19% | 93% | 82% (ITT) | 94% |
| Long‐term undetectable DNA | N/A | 98.3% | 97% | |||
| ALT | Year 1 ALT normalisation | 59% | 76% | 72% | 83% | |
| Long‐term ALT normalisation | N/A | 85.7% | 86% (combined with e‐pos patients) @ 192 weeks | |||
| HBsAg loss / sero‐conversion | Year 1 HBsAg sero‐conversion | 0/0% | 0/0% | 0%/0% | ||
| Long‐term HBsAg loss/sero‐conversion | 0/0% | 0/0% | ||||
| Histological Improvement | Year 1 histological improvement | N/A | 68% | 77% | ||
| Long‐term histological improvement | N/A | 100% | N/A | |||
| HBeAg(+) | HBV DNA | Year 1 undetectable HBV DNA | 14% @ 24 wk post Rx | 69% (<300 c/mL) | 85% (ITT) (<400 copies/mL) | 64% (<29 IU/mL) |
| Long‐term undetectable HBV DNA | N/A | 95% | 97% | |||
| ALT | Year 1 ALT normalisation | 41% @ 24 wk post Rx | 63% | 72% | 72% | |
| Long‐term ALT normalisation | N/A | 76% | 86% | |||
| HBeAg loss/seroconversion | Year 1 HBeAg loss/seroconversion | 31%@24 wk post Rx | 16/16% | 17/17% | 14/10% | |
| Long‐term HBeAg loss/sero‐conversion | 41% @ 48 wk post Rx | 40/18% | 35/26% | |||
| HBsAg loss/seroconversion | Year 1 HBsAg seroconversion | 2% @ 24 wk post Rx | 0.5% | 0/0% | <1%/0% | |
| Long‐term HBsAg loss / sero‐conversion | N/A |
2.9% in genotype B 0.9% in genotype C |
2.28% | |||
| Histological Improvement | Year 1 histological improvement | 38% | 71% | 77% | ||
| Long‐term histological improvement | N/A | 100% | N/A | |||