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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
Author(s) -
Deng Yanli,
Campbell Fiona,
Han Kelong,
Theodore Dickens,
Deeg Mark,
Huang Michael,
Hamatake Robert,
Lahiri Soumi,
Chen Shuguang,
Horvath Gabor,
Manolakopoulos Spilios,
Dalekos George N.,
Papatheodoridis George,
Goulis Ioannis,
Banyai Tivadar,
Jilma Bernd,
Leivers Martin
Publication year - 2020
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.13282
Subject(s) - medicine , regimen , clinical trial , chronic hepatitis , randomized controlled trial , gastroenterology , adverse effect , single blind , hepatitis , hepatitis c , immunology , virus
Single‐visit cures for chronic hepatitis C are lacking. We conducted two clinical studies towards the goal of developing a regimen for single‐visit cure. In a randomized, open‐label, Phase 2 study (RG101‐04), investigators enrolled 26 adult chronic hepatitis C patients to evaluate safety and efficacy of single subcutaneous injection of RG‐101 (4 mg/kg) and daily oral tablets of GSK2878175 (20 mg) for 6, 9 or 12 weeks. In another randomized, double‐blind, single dose Phase 1 study (RG101‐06), investigators enrolled 18 healthy men to assess safety and PK of GSK2878175 long‐acting injectable at 100, 200 or 400 mg. In RG101‐04, SVR48 rates were 50%, 56% and 89%, for the 6, 9 and 12 weeks treatment arms, respectively. All AEs were mild or moderate in severity (≤Grade 2). In RG101‐06 at 400 mg, the mean duration of GSK2878175 plasma levels above in vitro therapeutic concentrations for GT1b was 41 days. All AEs were Grade 2 or less. In conclusion, single injection of RG‐101 combined with 12 weeks of GSK2878175 oral tablets was generally well tolerated and resulted in high SVR rates in chronic hepatitis C patients. Single injections of GSK2878175 long‐acting injectable were also well tolerated; however, higher doses would be required if used in combination with RG‐101 to achieve the SVR rates observed in the oral combination study to enable a single‐visit curative regimen.