Randomized clinical trials towards a single‐visit cure for chronic hepatitis C: Oral GSK2878175 and injectable RG‐101 in chronic hepatitis C patients and long‐acting injectable GSK2878175 in healthy participants

• DOI: 10.1111/jvh.13282
• Publication Date: 2020-02-25T06:41:07Z
• Authors: Yanli Deng; Fiona Campbell; Kelong Han; Dickens Theodore; Mark Deeg; Michael Huang; Robert Hamatake; Soumi Lahiri; Shuguang Chen; Gabor Horvath; Spilios Manolakop...; George N. Dalekos; George Papatheodo...; Ioannis Goulis; Tivadar Banyai; Bernd Jilma; Martin Leivers
• Keywords: Regimen; Single blind; Hepatitis C

Single-visit cures for chronic hepatitis C are lacking. We conducted two clinical studies towards the goal of developing a regimen single-visit cure. In randomized, open-label, Phase 2 study (RG101-04), investigators enrolled 26 adult patients to evaluate safety and efficacy single subcutaneous injection RG-101 (4 mg/kg) daily oral tablets GSK2878175 (20 mg) 6, 9 or 12 weeks. another double-blind, dose 1 (RG101-06), 18 healthy men assess PK long-acting injectable at 100, 200 400 mg. RG101-04, SVR48 rates were 50%, 56% 89%, weeks treatment arms, respectively. All AEs mild moderate in severity (≤Grade 2). RG101-06 mg, mean duration plasma levels above vitro therapeutic concentrations GT1b was 41 days. Grade less. conclusion, combined with generally well tolerated resulted high SVR patients. Single injections also tolerated; however, higher doses would be required if used combination achieve observed enable curative regimen.