Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection

Research output: Contribution to journalArticlepeer-review

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Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. / Reau, Nancy; Kwo, Paul Y; Rhee, Susan; Brown, Robert S; Agarwal, Kosh; Angus, Peter; Gane, Edward; Kao, Jia-Horng; Mantry, Parvez S; Mutimer, David; Reddy, K Rajender; Tran, Tram T; Hu, Yiran B; Gulati, Abhishek; Krishnan, Preethi; Dumas, Emily O; Porcalla, Ariel; Shulman, Nancy S; Liu, Wei; Samanta, Suvajit; Trinh, Roger; Forns, Xavier.

In: Hepatology, 25.07.2018.

Research output: Contribution to journalArticlepeer-review

Harvard

Reau, N, Kwo, PY, Rhee, S, Brown, RS, Agarwal, K, Angus, P, Gane, E, Kao, J-H, Mantry, PS, Mutimer, D, Reddy, KR, Tran, TT, Hu, YB, Gulati, A, Krishnan, P, Dumas, EO, Porcalla, A, Shulman, NS, Liu, W, Samanta, S, Trinh, R & Forns, X 2018, 'Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection', Hepatology. https://doi.org/10.1002/hep.30046

APA

Reau, N., Kwo, P. Y., Rhee, S., Brown, R. S., Agarwal, K., Angus, P., Gane, E., Kao, J-H., Mantry, P. S., Mutimer, D., Reddy, K. R., Tran, T. T., Hu, Y. B., Gulati, A., Krishnan, P., Dumas, E. O., Porcalla, A., Shulman, N. S., Liu, W., ... Forns, X. (2018). Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. Hepatology. https://doi.org/10.1002/hep.30046

Vancouver

Author

Reau, Nancy ; Kwo, Paul Y ; Rhee, Susan ; Brown, Robert S ; Agarwal, Kosh ; Angus, Peter ; Gane, Edward ; Kao, Jia-Horng ; Mantry, Parvez S ; Mutimer, David ; Reddy, K Rajender ; Tran, Tram T ; Hu, Yiran B ; Gulati, Abhishek ; Krishnan, Preethi ; Dumas, Emily O ; Porcalla, Ariel ; Shulman, Nancy S ; Liu, Wei ; Samanta, Suvajit ; Trinh, Roger ; Forns, Xavier. / Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. In: Hepatology. 2018.

Bibtex

@article{43c81cf8e45c4585926e9874e75674bd,
title = "Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection",
abstract = "Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response for 12 weeks post-treatment (SVR12) across all major HCV genotypes (GT). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ≥3 months post-transplant. Patients without cirrhosis who were HCV treatment-na{\"i}ve (GT1-6) or treatment-experienced (GT1, 2, 4-6; with interferon-based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0-F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N=98/100; 95% confidence interval, 95.3%-100%), which exceeded the pre-specified historic standard of care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity and laboratory abnormalities were infrequent.CONCLUSION: Once-daily glecaprevir/pibrentasvir for 12 weeks is a well-tolerated and efficacious, ribavirin-free treatment for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. ClinicalTrials.gov NCT02692703. This article is protected by copyright. All rights reserved.",
keywords = "Journal Article, Glecaprevir, Pibrentasvir",
author = "Nancy Reau and Kwo, {Paul Y} and Susan Rhee and Brown, {Robert S} and Kosh Agarwal and Peter Angus and Edward Gane and Jia-Horng Kao and Mantry, {Parvez S} and David Mutimer and Reddy, {K Rajender} and Tran, {Tram T} and Hu, {Yiran B} and Abhishek Gulati and Preethi Krishnan and Dumas, {Emily O} and Ariel Porcalla and Shulman, {Nancy S} and Wei Liu and Suvajit Samanta and Roger Trinh and Xavier Forns",
note = "Notification of acceptance received 16/03/2018",
year = "2018",
month = jul,
day = "25",
doi = "10.1002/hep.30046",
language = "English",
journal = "Hepatology",
issn = "0270-9139",
publisher = "Wiley",

}

RIS

TY - JOUR

T1 - Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection

AU - Reau, Nancy

AU - Kwo, Paul Y

AU - Rhee, Susan

AU - Brown, Robert S

AU - Agarwal, Kosh

AU - Angus, Peter

AU - Gane, Edward

AU - Kao, Jia-Horng

AU - Mantry, Parvez S

AU - Mutimer, David

AU - Reddy, K Rajender

AU - Tran, Tram T

AU - Hu, Yiran B

AU - Gulati, Abhishek

AU - Krishnan, Preethi

AU - Dumas, Emily O

AU - Porcalla, Ariel

AU - Shulman, Nancy S

AU - Liu, Wei

AU - Samanta, Suvajit

AU - Trinh, Roger

AU - Forns, Xavier

N1 - Notification of acceptance received 16/03/2018

PY - 2018/7/25

Y1 - 2018/7/25

N2 - Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response for 12 weeks post-treatment (SVR12) across all major HCV genotypes (GT). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ≥3 months post-transplant. Patients without cirrhosis who were HCV treatment-naïve (GT1-6) or treatment-experienced (GT1, 2, 4-6; with interferon-based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0-F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N=98/100; 95% confidence interval, 95.3%-100%), which exceeded the pre-specified historic standard of care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity and laboratory abnormalities were infrequent.CONCLUSION: Once-daily glecaprevir/pibrentasvir for 12 weeks is a well-tolerated and efficacious, ribavirin-free treatment for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. ClinicalTrials.gov NCT02692703. This article is protected by copyright. All rights reserved.

AB - Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response for 12 weeks post-treatment (SVR12) across all major HCV genotypes (GT). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ≥3 months post-transplant. Patients without cirrhosis who were HCV treatment-naïve (GT1-6) or treatment-experienced (GT1, 2, 4-6; with interferon-based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0-F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N=98/100; 95% confidence interval, 95.3%-100%), which exceeded the pre-specified historic standard of care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity and laboratory abnormalities were infrequent.CONCLUSION: Once-daily glecaprevir/pibrentasvir for 12 weeks is a well-tolerated and efficacious, ribavirin-free treatment for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. ClinicalTrials.gov NCT02692703. This article is protected by copyright. All rights reserved.

KW - Journal Article

KW - Glecaprevir

KW - Pibrentasvir

U2 - 10.1002/hep.30046

DO - 10.1002/hep.30046

M3 - Article

C2 - 29672891

JO - Hepatology

JF - Hepatology

SN - 0270-9139

ER -