Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients

Sebastiaan J. Hullegie; Mark A. A. Claassen; Guido E. L. van den Berk; Jan T. M. Van der Meer; Dirk Posthouwer; Fanny N. Lauw; Eliane M. S. Leyten; Peter P. Koopmans; Clemens Richter; Arne van Eeden; Wouter F. W. Bierman; Astrid M. Newsum; Joop E. Arends; Bart J. A. Rijnders

doi:10.1016/j.jhep.2015.12.004

Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients

Sebastiaan J. Hullegie^*
, Mark A. A. Claassen
, Guido E. L. van den Berk
, Jan T. M. Van der Meer
, Dirk Posthouwer
, Fanny N. Lauw
, Eliane M. S. Leyten
, Peter P. Koopmans
, Clemens Richter
, Arne van Eeden
, Wouter F. W. Bierman
, Astrid M. Newsum
, Joop E. Arends
, Bart J. A. Rijnders

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

22 Citations (Scopus)

Abstract

Background & Aims: Acute hepatitis C virus infections (AHCV) are prevalent among HIV positive men having sex with men and generally treated with pegylated interferon-alpha (PegIFN) and ribavirin (RBV) during 24 weeks. The addition of a protease inhibitor could shorten therapy without loss of efficacy.

Methods: We performed an open-label, single arm study to investigate the efficacy and safety of a 12-week course of boceprevir, PegIFN and RBV for AHCV genotype 1 infections in 10 Dutch HIV treatment centers. The primary endpoint of the study was achievement of sustained virological response rate at week 12 (SVR12) in patients reaching a rapid viral response at week 4 (RVR4) and SVR12 in the intent to treat (ITT) entire study population was the most relevant secondary endpoint.

Results: One hundred twenty-seven AHCV patients were screened in 16 months, of which 65 AHCV genotype 1 patients were included. After spontaneous clearance in six patients and withdrawal before treatment initiation in two, 57 started therapy within 26 weeks after infection. RVR4 rate was 72%. SVR12 rate was 100% in the RVR4 group. SVR12 rate in the ITT group was 86% and comparable to the SVR12 rate of 84% in 73 historical controls treated for 24 weeks with PegIFN and RBV in the same study centers.

Conclusion: With the addition of boceprevir to PegIFN and RBV, treatment duration of AHCV genotype 1 can be reduced to 12 weeks without loss of efficacy. Given the high drug costs and limited availability of interferon-free regimens, boceprevir PegIFN and RBV can be a considered a valid treatment option for AHCV. (C) 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Original language	English
Pages (from-to)	807-812
Number of pages	6
Journal	Journal of Hepatology
Volume	64
Issue number	4
DOIs	https://doi.org/10.1016/j.jhep.2015.12.004
Publication status	Published - Apr-2016

Keywords

Acute hepatitis C
HIV
Treatment
VIRUS-INFECTION
PEGYLATED INTERFERON-ALPHA-2B
POSITIVE PATIENTS
GENOTYPE 1
HCV
MEN
RECOMMENDATIONS
CLEARANCE
THERAPY
TRIAL

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Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients
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Hullegie, S. J., Claassen, M. A. A., van den Berk, G. E. L., Van der Meer, J. T. M., Posthouwer, D., Lauw, F. N., Leyten, E. M. S., Koopmans, P. P., Richter, C., van Eeden, A., Bierman, W. F. W., Newsum, A. M., Arends, J. E., & Rijnders, B. J. A. (2016). Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients. Journal of Hepatology, 64(4), 807-812. https://doi.org/10.1016/j.jhep.2015.12.004

@article{fb3b6cae9c804fb290dac988a7fbe8b2,

title = "Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients",

abstract = "Background \& Aims: Acute hepatitis C virus infections (AHCV) are prevalent among HIV positive men having sex with men and generally treated with pegylated interferon-alpha (PegIFN) and ribavirin (RBV) during 24 weeks. The addition of a protease inhibitor could shorten therapy without loss of efficacy.Methods: We performed an open-label, single arm study to investigate the efficacy and safety of a 12-week course of boceprevir, PegIFN and RBV for AHCV genotype 1 infections in 10 Dutch HIV treatment centers. The primary endpoint of the study was achievement of sustained virological response rate at week 12 (SVR12) in patients reaching a rapid viral response at week 4 (RVR4) and SVR12 in the intent to treat (ITT) entire study population was the most relevant secondary endpoint.Results: One hundred twenty-seven AHCV patients were screened in 16 months, of which 65 AHCV genotype 1 patients were included. After spontaneous clearance in six patients and withdrawal before treatment initiation in two, 57 started therapy within 26 weeks after infection. RVR4 rate was 72\%. SVR12 rate was 100\% in the RVR4 group. SVR12 rate in the ITT group was 86\% and comparable to the SVR12 rate of 84\% in 73 historical controls treated for 24 weeks with PegIFN and RBV in the same study centers.Conclusion: With the addition of boceprevir to PegIFN and RBV, treatment duration of AHCV genotype 1 can be reduced to 12 weeks without loss of efficacy. Given the high drug costs and limited availability of interferon-free regimens, boceprevir PegIFN and RBV can be a considered a valid treatment option for AHCV. (C) 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.",

keywords = "Acute hepatitis C, HIV, Treatment, VIRUS-INFECTION, PEGYLATED INTERFERON-ALPHA-2B, POSITIVE PATIENTS, GENOTYPE 1, HCV, MEN, RECOMMENDATIONS, CLEARANCE, THERAPY, TRIAL",

author = "Hullegie, \{Sebastiaan J.\} and Claassen, \{Mark A. A.\} and \{van den Berk\}, \{Guido E. L.\} and \{Van der Meer\}, \{Jan T. M.\} and Dirk Posthouwer and Lauw, \{Fanny N.\} and Leyten, \{Eliane M. S.\} and Koopmans, \{Peter P.\} and Clemens Richter and \{van Eeden\}, Arne and Bierman, \{Wouter F. W.\} and Newsum, \{Astrid M.\} and Arends, \{Joop E.\} and Rijnders, \{Bart J. A.\}",

year = "2016",

month = apr,

doi = "10.1016/j.jhep.2015.12.004",

language = "English",

volume = "64",

pages = "807--812",

journal = "Journal of Hepatology",

issn = "0168-8278",

publisher = "ELSEVIER SCIENCE BV",

number = "4",

}

Hullegie, SJ, Claassen, MAA, van den Berk, GEL, Van der Meer, JTM, Posthouwer, D, Lauw, FN, Leyten, EMS, Koopmans, PP, Richter, C, van Eeden, A, Bierman, WFW, Newsum, AM, Arends, JE & Rijnders, BJA 2016, 'Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients', Journal of Hepatology, vol. 64, no. 4, pp. 807-812. https://doi.org/10.1016/j.jhep.2015.12.004

TY - JOUR

T1 - Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients

AU - Hullegie, Sebastiaan J.

AU - Claassen, Mark A. A.

AU - van den Berk, Guido E. L.

AU - Van der Meer, Jan T. M.

AU - Posthouwer, Dirk

AU - Lauw, Fanny N.

AU - Leyten, Eliane M. S.

AU - Koopmans, Peter P.

AU - Richter, Clemens

AU - van Eeden, Arne

AU - Bierman, Wouter F. W.

AU - Newsum, Astrid M.

AU - Arends, Joop E.

AU - Rijnders, Bart J. A.

PY - 2016/4

Y1 - 2016/4

N2 - Background & Aims: Acute hepatitis C virus infections (AHCV) are prevalent among HIV positive men having sex with men and generally treated with pegylated interferon-alpha (PegIFN) and ribavirin (RBV) during 24 weeks. The addition of a protease inhibitor could shorten therapy without loss of efficacy.Methods: We performed an open-label, single arm study to investigate the efficacy and safety of a 12-week course of boceprevir, PegIFN and RBV for AHCV genotype 1 infections in 10 Dutch HIV treatment centers. The primary endpoint of the study was achievement of sustained virological response rate at week 12 (SVR12) in patients reaching a rapid viral response at week 4 (RVR4) and SVR12 in the intent to treat (ITT) entire study population was the most relevant secondary endpoint.Results: One hundred twenty-seven AHCV patients were screened in 16 months, of which 65 AHCV genotype 1 patients were included. After spontaneous clearance in six patients and withdrawal before treatment initiation in two, 57 started therapy within 26 weeks after infection. RVR4 rate was 72%. SVR12 rate was 100% in the RVR4 group. SVR12 rate in the ITT group was 86% and comparable to the SVR12 rate of 84% in 73 historical controls treated for 24 weeks with PegIFN and RBV in the same study centers.Conclusion: With the addition of boceprevir to PegIFN and RBV, treatment duration of AHCV genotype 1 can be reduced to 12 weeks without loss of efficacy. Given the high drug costs and limited availability of interferon-free regimens, boceprevir PegIFN and RBV can be a considered a valid treatment option for AHCV. (C) 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

AB - Background & Aims: Acute hepatitis C virus infections (AHCV) are prevalent among HIV positive men having sex with men and generally treated with pegylated interferon-alpha (PegIFN) and ribavirin (RBV) during 24 weeks. The addition of a protease inhibitor could shorten therapy without loss of efficacy.Methods: We performed an open-label, single arm study to investigate the efficacy and safety of a 12-week course of boceprevir, PegIFN and RBV for AHCV genotype 1 infections in 10 Dutch HIV treatment centers. The primary endpoint of the study was achievement of sustained virological response rate at week 12 (SVR12) in patients reaching a rapid viral response at week 4 (RVR4) and SVR12 in the intent to treat (ITT) entire study population was the most relevant secondary endpoint.Results: One hundred twenty-seven AHCV patients were screened in 16 months, of which 65 AHCV genotype 1 patients were included. After spontaneous clearance in six patients and withdrawal before treatment initiation in two, 57 started therapy within 26 weeks after infection. RVR4 rate was 72%. SVR12 rate was 100% in the RVR4 group. SVR12 rate in the ITT group was 86% and comparable to the SVR12 rate of 84% in 73 historical controls treated for 24 weeks with PegIFN and RBV in the same study centers.Conclusion: With the addition of boceprevir to PegIFN and RBV, treatment duration of AHCV genotype 1 can be reduced to 12 weeks without loss of efficacy. Given the high drug costs and limited availability of interferon-free regimens, boceprevir PegIFN and RBV can be a considered a valid treatment option for AHCV. (C) 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

KW - Acute hepatitis C

KW - HIV

KW - Treatment

KW - VIRUS-INFECTION

KW - PEGYLATED INTERFERON-ALPHA-2B

KW - POSITIVE PATIENTS

KW - GENOTYPE 1

KW - HCV

KW - MEN

KW - RECOMMENDATIONS

KW - CLEARANCE

KW - THERAPY

KW - TRIAL

U2 - 10.1016/j.jhep.2015.12.004

DO - 10.1016/j.jhep.2015.12.004

M3 - Article

C2 - 26689767

SN - 0168-8278

VL - 64

SP - 807

EP - 812

JO - Journal of Hepatology

JF - Journal of Hepatology

IS - 4

ER -

Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients

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