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 GT3 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 (SVR12) were assessed. The analysis included 693 patients with GT3 infection. SVR12 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) SVR12 rate with 12-week G/P. Treatment-experienced, non-cirrhotic patients had SVR12 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 SVR12. No serious adverse events (AEs) were attributed to G/P; AEs leading to study drug discontinuation were rare (<1%). G/P was well-tolerated and efficacious for patients with chronic HCV GT3 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. This article is protected by copyright. All rights reserved.

Glecaprevir/Pibrentasvir in Patients with Chronic HCV Genotype 3 Infection: An Integrated Phase 2/3 Analysis / Flamm, Steven; Mutimer, David; Asatryan, Armen; Wang, Stanley; Rockstroh, Jurgen; 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; Kopecky-Bromberg, Sarah; Trinh, Roger; Mensa, Federico J; Wyles, David L. - In: JOURNAL OF VIRAL HEPATITIS. - ISSN 1352-0504. - 26:3(2019), pp. 337-349. [10.1111/jvh.13038]

Glecaprevir/Pibrentasvir in Patients with Chronic HCV Genotype 3 Infection: An Integrated Phase 2/3 Analysis

Villa, Erica;
2019

Abstract

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 GT3 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 (SVR12) were assessed. The analysis included 693 patients with GT3 infection. SVR12 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) SVR12 rate with 12-week G/P. Treatment-experienced, non-cirrhotic patients had SVR12 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 SVR12. No serious adverse events (AEs) were attributed to G/P; AEs leading to study drug discontinuation were rare (<1%). G/P was well-tolerated and efficacious for patients with chronic HCV GT3 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. This article is protected by copyright. All rights reserved.
12-nov-2018
26
3
337
349
Glecaprevir/Pibrentasvir in Patients with Chronic HCV Genotype 3 Infection: An Integrated Phase 2/3 Analysis / Flamm, Steven; Mutimer, David; Asatryan, Armen; Wang, Stanley; Rockstroh, Jurgen; 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; Kopecky-Bromberg, Sarah; Trinh, Roger; Mensa, Federico J; Wyles, David L. - In: JOURNAL OF VIRAL HEPATITIS. - ISSN 1352-0504. - 26:3(2019), pp. 337-349. [10.1111/jvh.13038]
Flamm, Steven; Mutimer, David; Asatryan, Armen; Wang, Stanley; Rockstroh, Jurgen; 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; Kopecky-Bromberg, Sarah; Trinh, Roger; Mensa, Federico J; Wyles, David L
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