Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection

Summary

To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection

Timeline

Start

2017-02-24

Primary completion

2019-12-18

Completion

2019-12-26

Publications

• Han K, Youssef AS, Magee M, Hood S, Tracey H, Kwoh J, Theodore D, Paff M, Nader A. Lack of Pharmacokinetic Drug-Drug Interactions Between Bepirovirsen and Nucleos(t)ide Analogs. Clin Pharmacol Drug Dev. 2025 Apr;14(4):281-291. doi: 10.1002/cpdd.1518. Epub 2025 Feb 14.
• Yuen MF, Heo J, Jang JW, Yoon JH, Kweon YO, Park SJ, Tami Y, You S, Yates P, Tao Y, Cremer J, Campbell F, Elston R, Theodore D, Paff M, Bennett CF, Kwoh TJ. Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial. Nat Med. 2021 Oct;27(10):1725-1734. doi: 10.1038/s41591-021-01513-4. Epub 2021 Oct 12.

Drugs

Indications