TABLE 1.
Virological Responses to Ritonavir‐Boosted Lonafarnib Treatment With or Without pegIFNα or pegIFNλ
| Study | Treatment Arms | Rx Duration (Weeks) | N | EOT HDV RNA ≥2‐log Decline/BLQ* | 24 Weeks Post‐Rx HDV RNA BLQ*/Undetectable | HBsAg Loss |
|---|---|---|---|---|---|---|
| LOWR‐2( 17 ) | 24 | 6 | 1/0 | NR | NR | |
| LNF 25 mg b.i.d. | ||||||
| + RTV 100 mg b.i.d. | ||||||
| LNF 50 mg b.i.d. | 24 | 13 | 06‐May | |||
| + RTV 100 mg b.i.d. | ||||||
| LNF 25 mg b.i.d. | 24 | 5 | 03‐Mar | |||
| + RTV 100 mg b.i.d. | ||||||
| + pegIFNα2a 180 μg q.w. | ||||||
| LNF 50 mg b.i.d. | 24 | 4 | 04‐Feb | |||
| + RTV 100 mg b.i.d. | ||||||
| + pegIFNα2a 180 μg q.w. | ||||||
| LOWR‐3( 18 ) | LNF 50 or 75 or 100 mg q.d. | 12 or 24 | 21 | 6/4 † | NR | NR |
| + RTV 100 mg q.d. | ||||||
| LOWR‐4( 19 ) | Starting dose LNF 50 mg b.i.d. + RTV 100 mg b.i.d., escalating every 2‐4 weeks to LNF 75 mg b.i.d. + RTV 100 mg b.i.d. followed by LNF 100 mg b.i.d. + RTV 100 mg b.i.d. | 24 | 15 | 04‐Jan | 3/0 | NR |
| LIFT HDV( 20 ) | LNF 50 mg b.i.d. | 24 | 26 | 25‐Nov | NR/5 | 0 |
| + RTV 100 mg b.i.d. | ||||||
| + pegIFNλ 180 μg q.w. | ||||||
| LIMT HDV( 21 ) | pegIFNλ 120 μg q.w. | 48 | 19 | 04‐Mar | 02‐Mar | NR |
| pegIFNλ 180 μg q.w. | 14 | 07‐May | 05‐May |
*
The quantitative HDV‐RNA assays used in the above trials had a lower limit of quantification of 40 IU/mL (LIFT HDV) or 14 IU/mL (LOWR‐2, LOWR‐3, LOWR‐4, and LIMT HDV).
†
Aggregate data from all six treatment arms.
Abbreviations: BLQ, below the limit of quantification; pegIFNα2a, pegylated interferon alfa‐2a, RTV, ritonavir; NR, not reported; Rx, treatment; EOT, end of treatment.