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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.

Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis