| Title: |
Treatment with bulevirtide in HIV-infected patients with chronic hepatitis D: ANRS HD EP01 BuleDelta and compassionate cohort. |
| Authors: |
De Lédinghen, V.; Fougerou-Leurent, C.; Le Pabic, E.; Pol, S.; Alfaiate, D.; Lacombe, K.; Hilleret, M. N.; Lascoux-Combe, C.; Minello, A.; Billaud, E.; Rosa, I.; Gervais, A.; Ratziu, V.; Ganne, N.; Pageaux, G. P.; Leroy, V.; Loustaud-Ratti, V.; Mathurin, Philippe; Chas, J.; Jezequel, C.; Métivier, S.; Dumortier, J.; Arpurt, J. P.; Asselah, T.; Roche, B.; Le Gruyer, A.; Valantin, M. A.; Scholtès, C.; Gordien, E.; Tual, C.; Kortebi, A.; Coulibaly, F.; Rosenthal, E.; Subic-Levrero, M.; Roulot, D.; Zoulim, F. |
| Contributors: |
Université de Lille; Inserm; CHU Lille; Centre Hospitalier Universitaire de Bordeaux CHU Bordeaux; Institute for Translational Research in Inflammation - U 1286 INFINITE; Université Claude Bernard Lyon 1 UCBL |
| Publisher Information: |
Elsevier |
| Publication Year: |
2025 |
| Collection: |
LillOA (Lille Open Archive - Université de Lille) |
| Subject Terms: |
HDV; HBV; Pegylated interferon; Hepatitis D; HDV RNA; HIV; HIV RNA; Entry inhibitors; HBV DNA |
| Description: |
Background & Aims In France, bulevirtide (BLV) became available in September 2019 through an early access program to treat patients with HDV. The aim of this analysis was to evaluate the efficacy and safety of BLV in patients with HIV and HDV coinfection. Methods Patients received BLV 2 mg ± pegylated interferon-α (pegIFNα) according to the physician’s decision. The primary endpoint (per-protocol analysis) was the virological response rate at Week 48, defined as the proportion of patients with undetectable serum HDV RNA or a HDV RNA decline >2 log10 IU/ml from baseline. Results The characteristics of the 38 patients were as follows: 28 male, mean age 47.7 years, and mean baseline HDV RNA viral load 5.7 ± 1.2 log10 IU/ml. Median HIV viral load and mean CD4 count were 32 (30–65) copies/ml and 566 ± 307/mm3, respectively. Eight patients stopped treatment before Week 48. At Week 48, 10 of 19 patients (52.6%) in the 2 mg BLV group and five of seven patients (71.4%) in the 2 mg BLV + pegIFNɑ group had reached virological response (no HDV RNA available in four patients). At Week 48, seven of 19 patients in the 2 mg BLV group and three of six patients in the 2 mg BLV + pegIFNɑ group had a combined response (virological response and normal alanine aminotransferase level). Conclusions Adults living with HIV coinfected with HDV can be treated by BLV with a virological response in more than 50% of patients. The combination of BLV and pegIFNɑ showed a strong virological response. ; 6;8 |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/octet-stream |
| Language: |
English |
| Relation: |
JHEP Reports Innovation in Hepatology; JHEP Rep |
| Availability: |
https://lilloa.univ-lille.fr/handle/20.500.12210/129588; https://hdl.handle.net/20.500.12210/129588 |
| Accession Number: |
edsbas.6355F65C |
| Database: |
BASE |