Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders

C. E. Walsh; K. Workowski; N. A. Terrault; P. E. Sax; A. Cohen; C. L. Bowlus; A. Y. Kim; R. H. Hyland; B. Han; J. Wang; L. M. Stamm; D. M. Brainard; J. G. McHutchison; A. von Drygalski; F. Rhame; M. W. Fried; P. Kouides; G. Balba; K. R. Reddy

doi:10.1111/hae.13178

Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders

C. E. Walsh, K. Workowski, N. A. Terrault, P. E. Sax, A. Cohen, C. L. Bowlus, A. Y. Kim, R. H. Hyland, B. Han, J. Wang, L. M. Stamm, D. M. Brainard, J. G. McHutchison, A. von Drygalski, F. Rhame, M. W. Fried, P. Kouides, G. Balba, K. R. Reddy

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26 Scopus citations

Abstract

Introduction: Chronic hepatitis C virus (HCV) infection is prevalent among patients with inherited bleeding disorders and is a leading cause of mortality in those with haemophilia. Aim: We evaluated the efficacy and safety of ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic HCV genotype 1–4 infection and an inherited bleeding disorder. Methods: Ledipasvir–sofosbuvir was administered for 12 weeks to patients with genotype 1 or 4 infection and for 12 or 24 weeks to treatment-experienced cirrhotic patients with genotype 1 infection. Patients with genotype 2 and 3 infection received sofosbuvir plus ribavirin for 12 and 24 weeks respectively. Results: The majority of the 120 treated patients had a severe bleeding disorder (55%); overall, 65% of patients had haemophilia A and 26% of patients had haemophilia B; 22% were HIV coinfected. Sustained virologic response at 12 weeks posttreatment was 99% (98/99) in patients with genotype 1 or 4 infection; 100% (5/5) in treatment-experienced cirrhotic patients with genotype 1 infection; 100% (10/10) in patients with genotype 2 infection; and 83% (5/6) in patients with genotype 3 infection. There were no treatment discontinuations due to adverse events (AEs). The most frequent non-bleeding AEs were fatigue, headache, diarrhoea, nausea and insomnia. Bleeding AEs occurred in 22 patients, of which all but one were considered unrelated to treatment. Conclusion: Treatment with ledipasvir–sofosbuvir for patients with HCV genotype 1 or 4 infection or sofosbuvir plus ribavirin for patients with genotype 2 or 3 infection was highly effective and well tolerated among those with inherited bleeding disorders.

Original language	English (US)
Pages (from-to)	198-206
Number of pages	9
Journal	Haemophilia
Volume	23
Issue number	2
DOIs	https://doi.org/10.1111/hae.13178
State	Published - Mar 1 2017

Bibliographical note

Funding Information:
The authors extend their thanks to the patients who participated in this study, as well as their families, and to the staff at the Hemophilia Treatment Centers who supported this study. Christopher E. Walsh, Robert H. Hyland, Luisa M. Stamm, Diana M. Brainard, John G. McHutchison and K. Rajender Reddy contributed to the design of the study. Christopher E. Walsh, Kimberly Workowski, Norah A. Terrault, Paul E. Sax, Alice Cohen, Christopher L. Bowlus, Arthur Y. Kim, Annette von Drygalski, Frank Rhame, Michael W. Fried, Peter Kouides, Gayle Balba and K. Rajender Reddy contributed to data collection. Jing Wang and Bin Han contributed to data analysis. All authors reviewed and approved the manuscript prior to submission. Writing and editorial support was provided by Sameera Kongara of AlphaBioCom, LLC, King of Prussia, PA, and funded by Gilead Sciences, Inc. This study was funded by Gilead Sciences, Inc.

Keywords

hepatitis C virus
ledipasvir–sofosbuvir fixed-dose combination
NS5A inhibitor
NS5B inhibitor
ribavirin
sofosbuvir

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/hae.13178

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Walsh, C. E., Workowski, K., Terrault, N. A., Sax, P. E., Cohen, A., Bowlus, C. L., Kim, A. Y., Hyland, R. H., Han, B., Wang, J., Stamm, L. M., Brainard, D. M., McHutchison, J. G., von Drygalski, A., Rhame, F., Fried, M. W., Kouides, P., Balba, G., & Reddy, K. R. (2017). Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders. Haemophilia, 23(2), 198-206. https://doi.org/10.1111/hae.13178

Walsh, CE, Workowski, K, Terrault, NA, Sax, PE, Cohen, A, Bowlus, CL, Kim, AY, Hyland, RH, Han, B, Wang, J, Stamm, LM, Brainard, DM, McHutchison, JG, von Drygalski, A, Rhame, F, Fried, MW, Kouides, P, Balba, G & Reddy, KR 2017, 'Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders', Haemophilia, vol. 23, no. 2, pp. 198-206. https://doi.org/10.1111/hae.13178

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title = "Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders",

abstract = "Introduction: Chronic hepatitis C virus (HCV) infection is prevalent among patients with inherited bleeding disorders and is a leading cause of mortality in those with haemophilia. Aim: We evaluated the efficacy and safety of ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic HCV genotype 1–4 infection and an inherited bleeding disorder. Methods: Ledipasvir–sofosbuvir was administered for 12 weeks to patients with genotype 1 or 4 infection and for 12 or 24 weeks to treatment-experienced cirrhotic patients with genotype 1 infection. Patients with genotype 2 and 3 infection received sofosbuvir plus ribavirin for 12 and 24 weeks respectively. Results: The majority of the 120 treated patients had a severe bleeding disorder (55%); overall, 65% of patients had haemophilia A and 26% of patients had haemophilia B; 22% were HIV coinfected. Sustained virologic response at 12 weeks posttreatment was 99% (98/99) in patients with genotype 1 or 4 infection; 100% (5/5) in treatment-experienced cirrhotic patients with genotype 1 infection; 100% (10/10) in patients with genotype 2 infection; and 83% (5/6) in patients with genotype 3 infection. There were no treatment discontinuations due to adverse events (AEs). The most frequent non-bleeding AEs were fatigue, headache, diarrhoea, nausea and insomnia. Bleeding AEs occurred in 22 patients, of which all but one were considered unrelated to treatment. Conclusion: Treatment with ledipasvir–sofosbuvir for patients with HCV genotype 1 or 4 infection or sofosbuvir plus ribavirin for patients with genotype 2 or 3 infection was highly effective and well tolerated among those with inherited bleeding disorders.",

keywords = "hepatitis C virus, ledipasvir–sofosbuvir fixed-dose combination, NS5A inhibitor, NS5B inhibitor, ribavirin, sofosbuvir",

author = "Walsh, {C. E.} and K. Workowski and Terrault, {N. A.} and Sax, {P. E.} and A. Cohen and Bowlus, {C. L.} and Kim, {A. Y.} and Hyland, {R. H.} and B. Han and J. Wang and Stamm, {L. M.} and Brainard, {D. M.} and McHutchison, {J. G.} and {von Drygalski}, A. and F. Rhame and Fried, {M. W.} and P. Kouides and G. Balba and Reddy, {K. R.}",

note = "Funding Information: The authors extend their thanks to the patients who participated in this study, as well as their families, and to the staff at the Hemophilia Treatment Centers who supported this study. Christopher E. Walsh, Robert H. Hyland, Luisa M. Stamm, Diana M. Brainard, John G. McHutchison and K. Rajender Reddy contributed to the design of the study. Christopher E. Walsh, Kimberly Workowski, Norah A. Terrault, Paul E. Sax, Alice Cohen, Christopher L. Bowlus, Arthur Y. Kim, Annette von Drygalski, Frank Rhame, Michael W. Fried, Peter Kouides, Gayle Balba and K. Rajender Reddy contributed to data collection. Jing Wang and Bin Han contributed to data analysis. All authors reviewed and approved the manuscript prior to submission. Writing and editorial support was provided by Sameera Kongara of AlphaBioCom, LLC, King of Prussia, PA, and funded by Gilead Sciences, Inc. This study was funded by Gilead Sciences, Inc.",

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day = "1",

doi = "10.1111/hae.13178",

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TY - JOUR

T1 - Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders

AU - Walsh, C. E.

AU - Workowski, K.

AU - Terrault, N. A.

AU - Sax, P. E.

AU - Cohen, A.

AU - Bowlus, C. L.

AU - Kim, A. Y.

AU - Hyland, R. H.

AU - Han, B.

AU - Wang, J.

AU - Stamm, L. M.

AU - Brainard, D. M.

AU - McHutchison, J. G.

AU - von Drygalski, A.

AU - Rhame, F.

AU - Fried, M. W.

AU - Kouides, P.

AU - Balba, G.

AU - Reddy, K. R.

N1 - Funding Information: The authors extend their thanks to the patients who participated in this study, as well as their families, and to the staff at the Hemophilia Treatment Centers who supported this study. Christopher E. Walsh, Robert H. Hyland, Luisa M. Stamm, Diana M. Brainard, John G. McHutchison and K. Rajender Reddy contributed to the design of the study. Christopher E. Walsh, Kimberly Workowski, Norah A. Terrault, Paul E. Sax, Alice Cohen, Christopher L. Bowlus, Arthur Y. Kim, Annette von Drygalski, Frank Rhame, Michael W. Fried, Peter Kouides, Gayle Balba and K. Rajender Reddy contributed to data collection. Jing Wang and Bin Han contributed to data analysis. All authors reviewed and approved the manuscript prior to submission. Writing and editorial support was provided by Sameera Kongara of AlphaBioCom, LLC, King of Prussia, PA, and funded by Gilead Sciences, Inc. This study was funded by Gilead Sciences, Inc.

PY - 2017/3/1

Y1 - 2017/3/1

N2 - Introduction: Chronic hepatitis C virus (HCV) infection is prevalent among patients with inherited bleeding disorders and is a leading cause of mortality in those with haemophilia. Aim: We evaluated the efficacy and safety of ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic HCV genotype 1–4 infection and an inherited bleeding disorder. Methods: Ledipasvir–sofosbuvir was administered for 12 weeks to patients with genotype 1 or 4 infection and for 12 or 24 weeks to treatment-experienced cirrhotic patients with genotype 1 infection. Patients with genotype 2 and 3 infection received sofosbuvir plus ribavirin for 12 and 24 weeks respectively. Results: The majority of the 120 treated patients had a severe bleeding disorder (55%); overall, 65% of patients had haemophilia A and 26% of patients had haemophilia B; 22% were HIV coinfected. Sustained virologic response at 12 weeks posttreatment was 99% (98/99) in patients with genotype 1 or 4 infection; 100% (5/5) in treatment-experienced cirrhotic patients with genotype 1 infection; 100% (10/10) in patients with genotype 2 infection; and 83% (5/6) in patients with genotype 3 infection. There were no treatment discontinuations due to adverse events (AEs). The most frequent non-bleeding AEs were fatigue, headache, diarrhoea, nausea and insomnia. Bleeding AEs occurred in 22 patients, of which all but one were considered unrelated to treatment. Conclusion: Treatment with ledipasvir–sofosbuvir for patients with HCV genotype 1 or 4 infection or sofosbuvir plus ribavirin for patients with genotype 2 or 3 infection was highly effective and well tolerated among those with inherited bleeding disorders.

AB - Introduction: Chronic hepatitis C virus (HCV) infection is prevalent among patients with inherited bleeding disorders and is a leading cause of mortality in those with haemophilia. Aim: We evaluated the efficacy and safety of ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic HCV genotype 1–4 infection and an inherited bleeding disorder. Methods: Ledipasvir–sofosbuvir was administered for 12 weeks to patients with genotype 1 or 4 infection and for 12 or 24 weeks to treatment-experienced cirrhotic patients with genotype 1 infection. Patients with genotype 2 and 3 infection received sofosbuvir plus ribavirin for 12 and 24 weeks respectively. Results: The majority of the 120 treated patients had a severe bleeding disorder (55%); overall, 65% of patients had haemophilia A and 26% of patients had haemophilia B; 22% were HIV coinfected. Sustained virologic response at 12 weeks posttreatment was 99% (98/99) in patients with genotype 1 or 4 infection; 100% (5/5) in treatment-experienced cirrhotic patients with genotype 1 infection; 100% (10/10) in patients with genotype 2 infection; and 83% (5/6) in patients with genotype 3 infection. There were no treatment discontinuations due to adverse events (AEs). The most frequent non-bleeding AEs were fatigue, headache, diarrhoea, nausea and insomnia. Bleeding AEs occurred in 22 patients, of which all but one were considered unrelated to treatment. Conclusion: Treatment with ledipasvir–sofosbuvir for patients with HCV genotype 1 or 4 infection or sofosbuvir plus ribavirin for patients with genotype 2 or 3 infection was highly effective and well tolerated among those with inherited bleeding disorders.

KW - hepatitis C virus

KW - ledipasvir–sofosbuvir fixed-dose combination

KW - NS5A inhibitor

KW - NS5B inhibitor

KW - ribavirin

KW - sofosbuvir

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Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders

Abstract

Bibliographical note

Keywords

UN SDGs

Publisher link

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