Response-guided long-term treatment of chronic hepatitis D patients with bulevirtide-Results of A "real world" Study

被引：41

作者：

Jachs, Mathias ^{[1
,2
]}

Schwarz, Caroline ^{[3
]}

Panzer, Marlene ^{[4
]}

Binter, Teresa ^{[1
,2
]}

Aberle, Stephan W. ^{[5
]}

Hartl, Lukas ^{[1
,2
]}

Dax, Kristina ^{[6
]}

Aigner, Elmar ^{[7
,8
]}

Staettermayer, Albert F. ^{[1
,2
]}

Munda, Petra ^{[1
]}

Graziadei, Ivo ^{[9
]}

Holzmann, Heidemarie ^{[5
]}

Trauner, Michael ^{[1
,2
]}

Zoller, Heinz ^{[4
]}

Gschwantler, Michael ^{[3
]}

Mandorfer, Mattias ^{[1
,2
]}

Reiberger, Thomas ^{[1
,2
]}

Ferenci, Peter ^{[1
]}

机构：

[1] Med Univ Vienna, Dept Med 3, Div Gastroenterol & Hepatol, Wahringer Gurtel 18-20, A-1090 Vienna, Austria

[2] Med Univ Vienna, Rare Liver Dis RALID Ctr European Reference Netwo, Vienna, Austria

[3] Klin Ottakring, Dept Med 4, Vienna, Austria

[4] Med Univ Innsbruck, Innsbruck, Austria

[5] Med Univ Vienna, Ctr Clin Virol, Vienna, Austria

[6] Kepler Univ Klinikum, Linz, Austria

[7] SALK, Salzburg, Austria

[8] Paracelsus Med Univ, Salzburg, Austria

[9] Landeskrankenhaus Hall, Dept Med, Hall in Tirol, Austria

来源：

ALIMENTARY PHARMACOLOGY & THERAPEUTICS | 2022年 / 56卷 / 01期

关键词：

SUSTAINED VIROLOGICAL RESPONSE; WEEKS INTERIM DATA; PEGINTERFERON ALPHA-2A; MYRCLUDEX B; ALANINE AMINOTRANSFERASE; CLINICAL-TRIAL; ASSESS SAFETY; INTERFERON; EFFICACY; MONOTHERAPY;

D O I：

10.1111/apt.16945

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background Bulevirtide (BLV) blocks the uptake of the hepatitis D virus (HDV) into hepatocytes via the sodium/bile acid cotransporter NTCP. BLV was conditionally approved by the EMA but real-life data on BLV efficacy are limited. Methods Patients were treated with BLV monotherapy. Patients who did not achieve further decreases in HDV-RNA after 24 weeks were offered PEG-IFN as an add-on therapy in a response-guided manner. Results Twenty-three patients (m: 10, f: 13; mean age: 47.9 years, cirrhosis: 16; median ALT: 71 IU/ml; median HDV-RNA: 2.1 x 10(5)copies/ml) started BLV monotherapy (2 mg/day: 22; 10 mg/day: 1). Twenty-two completed >= 24 weeks of treatment (24-137 weeks): Ten (45%) were classified as BLV responders at week 24. BLV was stopped in two patients with >6 months HDV-RNA undetectability, but both became HDV-RNA positive again. One patient was transplanted at week 25. One patient terminated treatment because of side effects at week 60. Ten patients are still on BLV monotherapy. Adding PEG-IFN in eight patients induced an HDV-RNA decrease in all (1.29 +/- 0.19 [SD] log within 12 weeks). HDV-RNA decreased by >2log or became undetectable in 45%(10/22), 55%(11/20), 65% (13/20) and 69% (9/13); and ALT levels normalised in 64% (14/22), 85% (17/20), 90% (18/20) and in 92% (12/13) patients at weeks 24, 36, 48 and 60, respectively. Portal pressure decreased in 40% (2/5) of patients undergoing repeated measurement under BLV therapy. Conclusion Long-term BLV monotherapy is safe and effectively decreases HDV-RNA and ALT-even in patients with cirrhosis. The optimal duration of BLV treatment alone or in combination with PEG-IFN remains to be established. An algorithm for a response-guided BLV treatment approach is proposed.

引用

页码：144 / 154

页数：11

共 44 条

[1] Effectiveness of pegylated interferon monotherapy in the treatment of chronic hepatitis D virus infection: A meta-analysis [J].