drugset / Trial / NCT03282474
HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)
Phase 2
Completed
10 enrolled
Hannover Medical School
German Center for Infection Research · collabGilead Sciences · collabHepNet Study House, German Liverfoundation · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm multicenter pilot study to provide preliminary evidence whether sofosbuvir (SOF) is efficacious and can be safely used in patients with chronic Hepatitis E virus infection.
Timeline
- Start
- 2017-12-07
- Primary completion
- 2018-11-26
- Completion
- 2019-02-18
Outcome
Missed primary endpoint
paper Sofosbuvir monotherapy fails to achieve HEV RNA elimination in patients with chronic hepatitis E PMID 32624195 ↗
paper During the study, antiviral therapy reduced virus RNA levels initially but did not lead to a sustained virologic response. PMID 37334496 ↗
Publications
- Wahid A, Meyer N, Wundes C, Huffner L, Janshoff S, Frericks N, Friesland M, Dinkelborg K, Aliabadi E, Laue F, Cornberg M, Maasoumy B, Bremer B, Pischke S, Muller T, Wiesch JZS, Benckert J, Ulrich RG, Hardtke S, Dorge P, Vondran F, Lohse A, Manns MP, Todt D, Wedemeyer H, Pietschmann T, Steinmann E, Gomer A, Behrendt P. Extrahepatic Replication and Genomic Signatures of the Hepatitis E Virus in the Kidney. Liver Int. 2025 Jul;45(7):e70183. doi: 10.1111/liv.70183.
- Gomer A, Klohn M, Jagst M, Nocke MK, Pischke S, Horvatits T, Schulze Zur Wiesch J, Muller T, Hardtke S, Cornberg M, Wedemeyer H, Behrendt P, Steinmann E, Todt D. Emergence of resistance-associated variants during sofosbuvir treatment in chronically infected hepatitis E patients. Hepatology. 2023 Dec 1;78(6):1882-1895. doi: 10.1097/HEP.0000000000000514. Epub 2023 Jun 20.
- Cornberg M, Pischke S, Muller T, Behrendt P, Piecha F, Benckert J, Todt D, Steinmann E, Papkalla A, von Karpowitz M, Koch A, Lohse A, Hardtke S, Manns MP, Wedemeyer H. Sofosbuvir monotherapy fails to achieve HEV RNA elimination in patients with chronic hepatitis E - The HepNet SofE pilot study. J Hepatol. 2020 Sep;73(3):696-699. doi: 10.1016/j.jhep.2020.05.020. Epub 2020 Jul 2. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |