Peginterferon-A_2B plus ribavirin is more effective than peginterferon-A_2A plus ribavirin in menopausal women with chronic hepatitis C

Calogero Camma', Marco Enea, Maria Rendina, Nicola De Maria, Barbara Lei, Luisa Losi, Antonio Francavilla, Veronica Bernabucci, Ranka Vukotic, Stefano Gitto, Aimilia Karampatou, Erica Villa, Vignoli, Alfredo Di Leo, Ferrari

Risultato della ricerca: Article

10 Citazioni (Scopus)

Abstract

Under-enrolment of women to randomized clinical trials, including chronic hepatitis C, has long been recognized. The aim of this study was to identify factors predictive of sustained virological response (SVR) to PEG IFN/Ribavirin antiviral therapy in relation to gender and reproductive status of female patients involved. Seven hundred and forty-six treatment-naïve patients (431 men, 315 women) treated with Peg-IFNα-2a (180 μg/week) or Peg-IFNα-2b (1.5 μg/kg/week) plus ribavirin (800–1400 mg/day) for 24 or 48 weeks were studied between 2006 and 2010. Differences in SVR rate, overall and by gender were assessed after adjustment and propensity score matching. SVR was obtained in 44.2% of Peg-IFNα-2a-treated patients and in 51.2% of Peg-IFNα-2b-treated patients (intention-to-treat; P = 0.139). Age, fibrosis stage and genotype 2 and 3 were independently associated with SVR by multivariate analysis. Analysing by gender, the difference in SVR between PEG-IFNα types was not significant in men but highly significant in women (Peg-IFNα-2a:39.1%vs Peg-IFNα-2b:54.4%, P = 0.007). This was attributable to a higher SVR rate with Peg-IFNα-2b in the difficult postmenopausal population (26.9% Peg-IFNα-2a vs 46.0% Peg-IFNα-2b, P = 0.040). In women, absence of menopause, genotype 2 hepatitis C virus infection and use of Peg-IFNα-2b were independently associated with SVR. In conclusion, predictive factors for SVR are different in men and women. Factors differing between genders are menopause, severe steatosis and peg-interferon used. The higher SVR rate with Peg-IFNα-2b in menopausal women is likely attributable to more favourable pharmacokinetics that allows Peg-IFNα-2b to reach visceral fat and oppose the increased cytokine production and enhanced inflammatory status in menopause.
Lingua originaleEnglish
pagine (da-a)-
Numero di pagine0
RivistaJournal of Viral Hepatitis
VolumeEarly view
Stato di pubblicazionePublished - 2012

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Ribavirin
Chronic Hepatitis C
Menopause
Genotype
Social Adjustment
Propensity Score
Intra-Abdominal Fat
Virus Diseases
Interpersonal Relations
Hepacivirus
Interferons
Antiviral Agents
Fibrosis
Multivariate Analysis
Randomized Controlled Trials
Pharmacokinetics
Cytokines
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Virology
  • Infectious Diseases

Cita questo

Peginterferon-A_2B plus ribavirin is more effective than peginterferon-A_2A plus ribavirin in menopausal women with chronic hepatitis C. / Camma', Calogero; Enea, Marco; Rendina, Maria; De Maria, Nicola; Lei, Barbara; Losi, Luisa; Francavilla, Antonio; Bernabucci, Veronica; Vukotic, Ranka; Gitto, Stefano; Karampatou, Aimilia; Villa, Erica; Vignoli; Di Leo, Alfredo; Ferrari.

In: Journal of Viral Hepatitis, Vol. Early view, 2012, pag. -.

Risultato della ricerca: Article

Camma', C, Enea, M, Rendina, M, De Maria, N, Lei, B, Losi, L, Francavilla, A, Bernabucci, V, Vukotic, R, Gitto, S, Karampatou, A, Villa, E, Vignoli, Di Leo, A & Ferrari 2012, 'Peginterferon-A_2B plus ribavirin is more effective than peginterferon-A_2A plus ribavirin in menopausal women with chronic hepatitis C', Journal of Viral Hepatitis, vol. Early view, pagg. -.
Camma', Calogero ; Enea, Marco ; Rendina, Maria ; De Maria, Nicola ; Lei, Barbara ; Losi, Luisa ; Francavilla, Antonio ; Bernabucci, Veronica ; Vukotic, Ranka ; Gitto, Stefano ; Karampatou, Aimilia ; Villa, Erica ; Vignoli ; Di Leo, Alfredo ; Ferrari. / Peginterferon-A_2B plus ribavirin is more effective than peginterferon-A_2A plus ribavirin in menopausal women with chronic hepatitis C. In: Journal of Viral Hepatitis. 2012 ; Vol. Early view. pagg. -.
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title = "Peginterferon-A_2B plus ribavirin is more effective than peginterferon-A_2A plus ribavirin in menopausal women with chronic hepatitis C",
abstract = "Under-enrolment of women to randomized clinical trials, including chronic hepatitis C, has long been recognized. The aim of this study was to identify factors predictive of sustained virological response (SVR) to PEG IFN/Ribavirin antiviral therapy in relation to gender and reproductive status of female patients involved. Seven hundred and forty-six treatment-na{\"i}ve patients (431 men, 315 women) treated with Peg-IFNα-2a (180 μg/week) or Peg-IFNα-2b (1.5 μg/kg/week) plus ribavirin (800–1400 mg/day) for 24 or 48 weeks were studied between 2006 and 2010. Differences in SVR rate, overall and by gender were assessed after adjustment and propensity score matching. SVR was obtained in 44.2{\%} of Peg-IFNα-2a-treated patients and in 51.2{\%} of Peg-IFNα-2b-treated patients (intention-to-treat; P = 0.139). Age, fibrosis stage and genotype 2 and 3 were independently associated with SVR by multivariate analysis. Analysing by gender, the difference in SVR between PEG-IFNα types was not significant in men but highly significant in women (Peg-IFNα-2a:39.1{\%}vs Peg-IFNα-2b:54.4{\%}, P = 0.007). This was attributable to a higher SVR rate with Peg-IFNα-2b in the difficult postmenopausal population (26.9{\%} Peg-IFNα-2a vs 46.0{\%} Peg-IFNα-2b, P = 0.040). In women, absence of menopause, genotype 2 hepatitis C virus infection and use of Peg-IFNα-2b were independently associated with SVR. In conclusion, predictive factors for SVR are different in men and women. Factors differing between genders are menopause, severe steatosis and peg-interferon used. The higher SVR rate with Peg-IFNα-2b in menopausal women is likely attributable to more favourable pharmacokinetics that allows Peg-IFNα-2b to reach visceral fat and oppose the increased cytokine production and enhanced inflammatory status in menopause.",
keywords = "central fat distribution, cytokines, metabolic syndrome, pharmacokinetics, sustained virological response",
author = "Calogero Camma' and Marco Enea and Maria Rendina and {De Maria}, Nicola and Barbara Lei and Luisa Losi and Antonio Francavilla and Veronica Bernabucci and Ranka Vukotic and Stefano Gitto and Aimilia Karampatou and Erica Villa and Vignoli and {Di Leo}, Alfredo and Ferrari",
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TY - JOUR

T1 - Peginterferon-A_2B plus ribavirin is more effective than peginterferon-A_2A plus ribavirin in menopausal women with chronic hepatitis C

AU - Camma', Calogero

AU - Enea, Marco

AU - Rendina, Maria

AU - De Maria, Nicola

AU - Lei, Barbara

AU - Losi, Luisa

AU - Francavilla, Antonio

AU - Bernabucci, Veronica

AU - Vukotic, Ranka

AU - Gitto, Stefano

AU - Karampatou, Aimilia

AU - Villa, Erica

AU - Vignoli, null

AU - Di Leo, Alfredo

AU - Ferrari, null

PY - 2012

Y1 - 2012

N2 - Under-enrolment of women to randomized clinical trials, including chronic hepatitis C, has long been recognized. The aim of this study was to identify factors predictive of sustained virological response (SVR) to PEG IFN/Ribavirin antiviral therapy in relation to gender and reproductive status of female patients involved. Seven hundred and forty-six treatment-naïve patients (431 men, 315 women) treated with Peg-IFNα-2a (180 μg/week) or Peg-IFNα-2b (1.5 μg/kg/week) plus ribavirin (800–1400 mg/day) for 24 or 48 weeks were studied between 2006 and 2010. Differences in SVR rate, overall and by gender were assessed after adjustment and propensity score matching. SVR was obtained in 44.2% of Peg-IFNα-2a-treated patients and in 51.2% of Peg-IFNα-2b-treated patients (intention-to-treat; P = 0.139). Age, fibrosis stage and genotype 2 and 3 were independently associated with SVR by multivariate analysis. Analysing by gender, the difference in SVR between PEG-IFNα types was not significant in men but highly significant in women (Peg-IFNα-2a:39.1%vs Peg-IFNα-2b:54.4%, P = 0.007). This was attributable to a higher SVR rate with Peg-IFNα-2b in the difficult postmenopausal population (26.9% Peg-IFNα-2a vs 46.0% Peg-IFNα-2b, P = 0.040). In women, absence of menopause, genotype 2 hepatitis C virus infection and use of Peg-IFNα-2b were independently associated with SVR. In conclusion, predictive factors for SVR are different in men and women. Factors differing between genders are menopause, severe steatosis and peg-interferon used. The higher SVR rate with Peg-IFNα-2b in menopausal women is likely attributable to more favourable pharmacokinetics that allows Peg-IFNα-2b to reach visceral fat and oppose the increased cytokine production and enhanced inflammatory status in menopause.

AB - Under-enrolment of women to randomized clinical trials, including chronic hepatitis C, has long been recognized. The aim of this study was to identify factors predictive of sustained virological response (SVR) to PEG IFN/Ribavirin antiviral therapy in relation to gender and reproductive status of female patients involved. Seven hundred and forty-six treatment-naïve patients (431 men, 315 women) treated with Peg-IFNα-2a (180 μg/week) or Peg-IFNα-2b (1.5 μg/kg/week) plus ribavirin (800–1400 mg/day) for 24 or 48 weeks were studied between 2006 and 2010. Differences in SVR rate, overall and by gender were assessed after adjustment and propensity score matching. SVR was obtained in 44.2% of Peg-IFNα-2a-treated patients and in 51.2% of Peg-IFNα-2b-treated patients (intention-to-treat; P = 0.139). Age, fibrosis stage and genotype 2 and 3 were independently associated with SVR by multivariate analysis. Analysing by gender, the difference in SVR between PEG-IFNα types was not significant in men but highly significant in women (Peg-IFNα-2a:39.1%vs Peg-IFNα-2b:54.4%, P = 0.007). This was attributable to a higher SVR rate with Peg-IFNα-2b in the difficult postmenopausal population (26.9% Peg-IFNα-2a vs 46.0% Peg-IFNα-2b, P = 0.040). In women, absence of menopause, genotype 2 hepatitis C virus infection and use of Peg-IFNα-2b were independently associated with SVR. In conclusion, predictive factors for SVR are different in men and women. Factors differing between genders are menopause, severe steatosis and peg-interferon used. The higher SVR rate with Peg-IFNα-2b in menopausal women is likely attributable to more favourable pharmacokinetics that allows Peg-IFNα-2b to reach visceral fat and oppose the increased cytokine production and enhanced inflammatory status in menopause.

KW - central fat distribution, cytokines, metabolic syndrome, pharmacokinetics, sustained virological response

UR - http://hdl.handle.net/10447/63526

M3 - Article

VL - Early view

SP - -

JO - Journal of Viral Hepatitis

JF - Journal of Viral Hepatitis

SN - 1352-0504

ER -