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Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis
Author(s) -
Flamm Steven,
Mutimer David,
Asatryan Armen,
Wang Stanley,
Rockstroh Jürgen,
Horsmans Yves,
Kwo Paul Y.,
Weiland Ola,
Villa Erica,
Heo Jeong,
Gane Edward,
Ryder Stephen D.,
Welzel Tania M.,
Ruane Peter J.,
Agarwal Kosh,
Ng Teresa I.,
Xue Zhenyi,
Lovell Sandra S.,
Krishnan Preethi,
KopeckyBromberg Sarah,
Trinh Roger,
Mensa Federico J.,
Wyles David L.
Publication year - 2019
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.13038
Subject(s) - medicine , cirrhosis , gastroenterology , hepatocellular carcinoma , discontinuation , sofosbuvir , adverse effect , hepatitis c virus , hepatitis c , immunology , virus , ribavirin
Summary Glecaprevir coformulated with pibrentasvir (G/P) is approved to treat hepatitis C virus ( HCV ) infection and was highly efficacious in phase 2 and 3 studies. Treating HCV genotype ( GT ) 3 infection remains a priority, as these patients are harder to cure and at a greater risk for liver steatosis, fibrosis progression and hepatocellular carcinoma. Data were pooled from five phase 2 or 3 trials that evaluated 8‐, 12‐ and 16‐week G/P in patients with chronic HCV GT 3 infection. Patients without cirrhosis or with compensated cirrhosis were either treatment‐naïve or experienced with interferon‐ or sofosbuvir‐based regimens. Safety and sustained virologic response 12 weeks post‐treatment ( SVR 12) were assessed. The analysis included 693 patients with GT 3 infection. SVR 12 was achieved by 95% of treatment‐naïve patients without cirrhosis receiving 8‐week (198/208) and 12‐week (280/294) G/P. Treatment‐naïve patients with cirrhosis had a 97% (67/69) SVR 12 rate with 12‐week G/P. Treatment‐experienced, noncirrhotic patients had SVR 12 rates of 90% (44/49) and 95% (21/22) with 12‐ and 16‐week G/P, respectively; 94% (48/51) of treatment‐experienced patients with cirrhosis treated for 16 weeks achieved SVR 12. No serious adverse events ( AE s) were attributed to G/P; AE s leading to study drug discontinuation were rare (<1%). G/P was well‐tolerated and efficacious for patients with chronic HCV GT 3 infection, regardless of cirrhosis status or prior treatment experience. Eight‐ and 12‐week durations were efficacious for treatment‐naïve patients without cirrhosis and with compensated cirrhosis, respectively; 16‐week G/P was efficacious in patients with prior treatment experience irrespective of cirrhosis status.