Table 3.
Results of Bulevirtide (BLV) therapy both in monotherapy and in combination therapy with PegIFNalpha derived from RTCs.
| Randomized Controlled Trial name, authors, year, references |
Sample size | Age, liver disease | Intervention type | Intervention time | Primary outcome: 2 log HDV RNA decline and or HDV RNA undetectable |
Percentage of patients with primary outcome (and at the EOT§) | Percentage of subjects with the specified HDV RNA undetectable data | Combined outcome | Percentage of patients who reached combined outcome (and at EOT) | % severe adverse reactions - or discontinuations |
|---|---|---|---|---|---|---|---|---|---|---|
| MYR 202, (
Wedemeyer et al., 2023b
) |
120 | Mean 39.4 (SD 8.3) 54% compensated cirrhosis |
BLV* 2mg/d+TDF** | 24weeks intervention followed by 48 wks follow up | 2 log decline or undetectable HDV RNA at 48 weeks follow up (EOT) | 4% (54%) | EoT (end of follow up) 4% (4%) | At least 2 log HDV RNA decrease and ALT normalization at the end of follow up (at the end of treatment) | 7% (21%) | 0% - 0% |
| Mean 40.9 (SD 9.5) 47% compensated cirrhosis |
BLV 5mg/d+TDF | 6% (50%) | EoT (end of follow up) 6% (3%) | 3% (28%) | 9% - 3% | |||||
| Mean 41.8 (SD 11.3) 53% compensated cirrhosis |
BLV 10mg/d+TDF | 10% (77%) | EoT (end of follow up) 3% (0%) | 3% (37%) | 7% -0% | |||||
| Mean 38.5 (SD 8.7) 46% compensated cirrhosis |
TDF | 0% (3%) | EoT (end of follow up) 0 (0%) | 0% (0%) | 4% - 4% | |||||
|
MYR 301, (
Wedemeyer et al., 2023a
) |
150 | Mean 41.8 (SD 8.4), 47% compensated cirrhosis |
144 weeks BLV 2mg/d | 144 weeks treatment | Combined response: virological (HDV RNA undetectable of at least 2 log decrease) and biochemical (ALT normalization) At 96 weeks follow up |
At week 48: 45% | At week 48: 12% | 4% - 0% | ||
| 144 weeks BLV 10mg/d | 144 weeks treatment | At week 48: 48% | At week 48: 20% | 8% - 0% | ||||||
| Delayed 96 weeks of BLV 10mg/d | 48 weeks follow up, then 96 weeks of treatment | At week 48: 2% | At week 48: 0% | 6% - 0% | ||||||
|
MYR 203, (
Wedemeyer et al., 2019a
) |
90 | Mean 34.1 (SD 7.0) 26.6% compensated cirrhosis |
pegIFNa*** 180ug/qw£ | 48 weeks | Undetectable HDV RNA at 24 weeks off therapy follow up | 0% | EoT, at week 48: 13.3% | negative HDV RNA and ALT normalization at week 72 | 0% | 0% - 0% |
| Mean 37.2 (SD 5.5) 13.2% compensated cirrhosis |
2 mg BLV + pegIFNa 180ug/qw | 53.3% | EoT, at week 48: 80% | 46.7% | 6.67% - 0% | |||||
| Mean 36.9 (SD 7.5) 26.6% compensated cirrhosis |
5 mg BLV + pegIFNa 180ug/qw | 26.7% | EoT, at week 48: 86.8% | 13.3% | 0% - 0% | |||||
| Mean 37.2 (SD 5.5) 13.2% compensated cirrhosis |
BLV 2mg/d | 6.7% | EoT, at week 48: 13.3% | 6.7% | 0% - 0% | |||||
| Mean 34.3 (SD 7.2) 13.2% compensated cirrhosis |
10 mg BLV + pegIFNa 180ug/qw | 6.7% | EoT, at week 48: 80% | 6.7% | 0% - 0% | |||||
| Mean 36.2 (SD 7.2) 13.2% compensated cirrhosis |
10 mg BLV (5mg BID) | 33.3% | EoT, at week 48: 46.7% | 13.3% | 0% - 0% | |||||
|
MYR 204, (
Asselah et al., 2024
) |
174 | Mean 41 years (SD, 8.7) 35% had compensated cirrhosis |
pegIFNa qw | 48 weeks treatment, 48 weeks follow up | Undetectable HDV RNA 24 weeks off therapy (Sustained Viral Response 24 at weeks); Undetectable HDV RNA At 48 weeks after the end of treatment |
17%; 25% | At week 48: 21%; at week 96: | Undetectable HDV RNA and ALT normalization 24 weeks off therapy | 13%, 25% | 54% - 4% |
| pegIFNa qw + BLV 2mg/d followed by 48wks BLV 2mg/d monotp | 48 weeks IFN + BLV treatment, 48 weeks BLV, 48 weeks follow up | 32%; 26% | At week 48: 40%; at week 96: 44% | 28%, 22% | 54%; 2% discontinuation for BLV; 6% discontinuation for PegIFN |
|||||
| pegIFNa qw + BLV 10mg followed by 48wks BLV 10mg monotp | 48 weeks IFN + BLV treatment, 48 weeks BLV, 48 weeks follow up | 46%; 46% | At week 48: 60%; at week 96: 70% | 42%, 40% | 60% - 2% discontinuation for BLV; 4% discontinuation for PegIFN |
|||||
| BLV 10mg/day for 96 weeks | 96 weeks of treatment, 48 weeks follow up | 12%; 12% | At week 48: 10%; at week 96: 12% | 8%, 8% | 20% - 2% |