HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)

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

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

Indications