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Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study

BACKGROUND: Once-daily glecaprevir coformulated with pibrentasvir (glecaprevir/pibrentasvir) demonstrated high rates of sustained virologic response 12 weeks after treatment (SVR12) in patients with hepatitis C virus (HCV) genotype 1–6 infection. This phase 3 study evaluated the efficacy and safety...

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Autores principales: Rockstroh, Jürgen K, Lacombe, Karine, Viani, Rolando M, Orkin, Chloe, Wyles, David, Luetkemeyer, Anne F, Soto-Malave, Ruth, Flisiak, Robert, Bhagani, Sanjay, Sherman, Kenneth E, Shimonova, Tatiana, Ruane, Peter, Sasadeusz, Joseph, Slim, Jihad, Zhang, Zhenzhen, Samanta, Suvajit, Ng, Teresa I, Gulati, Abhishek, Kosloski, Matthew P, Shulman, Nancy S, Trinh, Roger, Sulkowski, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137115/
https://www.ncbi.nlm.nih.gov/pubmed/29566246
http://dx.doi.org/10.1093/cid/ciy220
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author Rockstroh, Jürgen K
Lacombe, Karine
Viani, Rolando M
Orkin, Chloe
Wyles, David
Luetkemeyer, Anne F
Soto-Malave, Ruth
Flisiak, Robert
Bhagani, Sanjay
Sherman, Kenneth E
Shimonova, Tatiana
Ruane, Peter
Sasadeusz, Joseph
Slim, Jihad
Zhang, Zhenzhen
Samanta, Suvajit
Ng, Teresa I
Gulati, Abhishek
Kosloski, Matthew P
Shulman, Nancy S
Trinh, Roger
Sulkowski, Mark
author_facet Rockstroh, Jürgen K
Lacombe, Karine
Viani, Rolando M
Orkin, Chloe
Wyles, David
Luetkemeyer, Anne F
Soto-Malave, Ruth
Flisiak, Robert
Bhagani, Sanjay
Sherman, Kenneth E
Shimonova, Tatiana
Ruane, Peter
Sasadeusz, Joseph
Slim, Jihad
Zhang, Zhenzhen
Samanta, Suvajit
Ng, Teresa I
Gulati, Abhishek
Kosloski, Matthew P
Shulman, Nancy S
Trinh, Roger
Sulkowski, Mark
author_sort Rockstroh, Jürgen K
collection PubMed
description BACKGROUND: Once-daily glecaprevir coformulated with pibrentasvir (glecaprevir/pibrentasvir) demonstrated high rates of sustained virologic response 12 weeks after treatment (SVR12) in patients with hepatitis C virus (HCV) genotype 1–6 infection. This phase 3 study evaluated the efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV genotype 1–6 and human immunodeficiency virus type 1 (HIV-1) coinfection, including patients with compensated cirrhosis. METHODS: EXPEDITION-2 was a phase 3, multicenter, open-label study evaluating glecaprevir/pibrentasvir (300 mg/120 mg) in HCV genotype 1–6/HIV-1–coinfected adults without and with compensated cirrhosis for 8 and 12 weeks, respectively. Patients were either HCV treatment-naive or experienced with sofosbuvir, ribavirin, or interferon, and antiretroviral therapy (ART) naive or on a stable ART regimen. Treatment-experienced genotype 3–infected patients were excluded. The primary endpoint was the SVR12 rate. RESULTS: In total, 153 patients were enrolled, including 16 (10%) with cirrhosis. The SVR12 rate was 98% (n = 150/153; 95% confidence interval, 95.8–100), with no virologic failures in 137 patients treated for 8 weeks. One genotype 3–infected patient with cirrhosis had on-treatment virologic failure. Most adverse events were mild in severity; 4 patients (2.6%) had serious adverse events, all deemed unrelated to glecaprevir/pibrentasvir. Treatment discontinuation was rare (<1%). All patients treated with ART maintained HIV-1 suppression (<200 copies/mL) during treatment. CONCLUSIONS: Glecaprevir/pibrentasvir for 8 weeks in noncirrhotic and 12 weeks in cirrhotic patients is a highly efficacious and well-tolerated treatment for HCV/HIV-1 coinfection, regardless of baseline HCV load or prior treatment with interferon or sofosbuvir. CLINICAL TRIAL REGISTRATION: NCT02738138.
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spelling pubmed-61371152018-09-24 Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study Rockstroh, Jürgen K Lacombe, Karine Viani, Rolando M Orkin, Chloe Wyles, David Luetkemeyer, Anne F Soto-Malave, Ruth Flisiak, Robert Bhagani, Sanjay Sherman, Kenneth E Shimonova, Tatiana Ruane, Peter Sasadeusz, Joseph Slim, Jihad Zhang, Zhenzhen Samanta, Suvajit Ng, Teresa I Gulati, Abhishek Kosloski, Matthew P Shulman, Nancy S Trinh, Roger Sulkowski, Mark Clin Infect Dis Articles and Commentaries BACKGROUND: Once-daily glecaprevir coformulated with pibrentasvir (glecaprevir/pibrentasvir) demonstrated high rates of sustained virologic response 12 weeks after treatment (SVR12) in patients with hepatitis C virus (HCV) genotype 1–6 infection. This phase 3 study evaluated the efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV genotype 1–6 and human immunodeficiency virus type 1 (HIV-1) coinfection, including patients with compensated cirrhosis. METHODS: EXPEDITION-2 was a phase 3, multicenter, open-label study evaluating glecaprevir/pibrentasvir (300 mg/120 mg) in HCV genotype 1–6/HIV-1–coinfected adults without and with compensated cirrhosis for 8 and 12 weeks, respectively. Patients were either HCV treatment-naive or experienced with sofosbuvir, ribavirin, or interferon, and antiretroviral therapy (ART) naive or on a stable ART regimen. Treatment-experienced genotype 3–infected patients were excluded. The primary endpoint was the SVR12 rate. RESULTS: In total, 153 patients were enrolled, including 16 (10%) with cirrhosis. The SVR12 rate was 98% (n = 150/153; 95% confidence interval, 95.8–100), with no virologic failures in 137 patients treated for 8 weeks. One genotype 3–infected patient with cirrhosis had on-treatment virologic failure. Most adverse events were mild in severity; 4 patients (2.6%) had serious adverse events, all deemed unrelated to glecaprevir/pibrentasvir. Treatment discontinuation was rare (<1%). All patients treated with ART maintained HIV-1 suppression (<200 copies/mL) during treatment. CONCLUSIONS: Glecaprevir/pibrentasvir for 8 weeks in noncirrhotic and 12 weeks in cirrhotic patients is a highly efficacious and well-tolerated treatment for HCV/HIV-1 coinfection, regardless of baseline HCV load or prior treatment with interferon or sofosbuvir. CLINICAL TRIAL REGISTRATION: NCT02738138. Oxford University Press 2018-10-01 2018-03-16 /pmc/articles/PMC6137115/ /pubmed/29566246 http://dx.doi.org/10.1093/cid/ciy220 Text en © The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Articles and Commentaries
Rockstroh, Jürgen K
Lacombe, Karine
Viani, Rolando M
Orkin, Chloe
Wyles, David
Luetkemeyer, Anne F
Soto-Malave, Ruth
Flisiak, Robert
Bhagani, Sanjay
Sherman, Kenneth E
Shimonova, Tatiana
Ruane, Peter
Sasadeusz, Joseph
Slim, Jihad
Zhang, Zhenzhen
Samanta, Suvajit
Ng, Teresa I
Gulati, Abhishek
Kosloski, Matthew P
Shulman, Nancy S
Trinh, Roger
Sulkowski, Mark
Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study
title Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study
title_full Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study
title_fullStr Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study
title_full_unstemmed Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study
title_short Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study
title_sort efficacy and safety of glecaprevir/pibrentasvir in patients coinfected with hepatitis c virus and human immunodeficiency virus type 1: the expedition-2 study
topic Articles and Commentaries
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137115/
https://www.ncbi.nlm.nih.gov/pubmed/29566246
http://dx.doi.org/10.1093/cid/ciy220
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