Table 1.
Randomized, controlled studies with Bulevirtide in chronic hepatitis D.
| Study | Phase | Treatment | Duration | End of Tx Virologic Response */** | Follow-Up |
|---|---|---|---|---|---|
| Myr202 [14] | 2 | BLV 2 mg + TDF vs. BLV 5 mg + TDF vs. BLV10 mg + TDF vs. TDF |
24 | 54% 55% 77% 0 |
Not reported |
| Myr203 [13] | 2 | BLV 5 mg BID + TDF vs. BLV10 mg + PEGIFN |
48 | 40% 87% |
Not reported |
| Myr204 [15] ** | 2b | PEGIFN (48 weeks) BLV 2 mg (96 weeks) + PEGIFN (48 weeks) BLV 10 mg (96 weeks) + PEGIFN (48 weeks) BLV 10 mg (96 weeks) |
48 96 96 96 |
ongoing | ongoing |
| Myr301 [16] ** | 3 | BLV 10 mg (48 weeks) BLV 2 mg (144 weeks) BLV 10 mg (144 weeks) |
48 144 144 |
ongoing | ongoing |
* Defined as > 2 log drop or undetectable HDV-RNA. ** For interim data after 24 or 48 weeks of treatment, see [17].