Table 2.
Clinical efficacy of TDF and TAF in phase 3 and 4 studies of treatment-naïve patients infected with HBV.
| Disease | Clinical trial | Clinical endpoint | Treatment | Clinical efficacy | Ref. |
|---|---|---|---|---|---|
| HBeAg-positive HBV | Trial 0103 (phase 3) | HBV DNA < 69 IU/mL at 48w | TDF 300 mg | 67% (177/176) | [137] |
| Adefovir 10 mg | 12% (11/90) | [137] | |||
| NCT01300234 (phase 3) | HBV DNA < 69 IU/mL at 48w | TDF 300 mg | 76.7% (79/103) | [138] | |
| Adefovir 10 mg | 18.2% (18/99) | [138] | |||
| NCT01937806 (phase 3) | HBV DNA < 69 IU/mL at 48w | TDF 300 mg | 84.9% (79/93) | [139] | |
| Besifovir 150 mg | 80.9% (76/94) | [139] | |||
| NCT00736190 (phase 4) | HBV DNA < 69 IU/mL at 48w | TDF 300 mg | 70% (37/53) | [140] | |
| Trial 110 (phase 3) | HBV DNA < 29 IU/mL at 48w | TDF 300 mg | 67% (195/292) | [50] | |
| TAF 25 mg | 64% (371/581) | [50] | |||
| HBeAg-negative HBV | Trial 0102 (phase 3) | HBV DNA < 69 IU/mL at 48w | TDF 300 mg | 71% (177/250) | [137] |
| Adefovir 10 mg | 49% (61/125) | [137] | |||
| NCT01300234 (phase 3) | HBV DNA < 69 IU/mL at 48w | TDF 300 mg | 96.8% (149/154) | [138] | |
| Adefovir 10 mg | 71.2% (109/153) | [138] | |||
| NCT00736190 (phase 4) | HBV DNA < 69 IU/mL at 48w | TDF 300 mg | 100% (37/37) | [140] | |
| Trial 108 (phase 3) | HBV DNA < 29 IU/mL at 48w | TDF 300 mg | 93% (130/140) | [51] | |
| TAF 25 mg | 94% (268/285) | [51] | |||