Peginterferon Alfa-2a plus Ribavirin vs Peginterferon Alfa-2b plus Ribavirin for Chronic Hepatitis C...
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Peginterferon Alfa-2a plus Ribavirin vs Peginterferon Alfa-2b plus Ribavirin for
Chronic Hepatitis C Virus Infection in HIV-Infected Patients
Peginterferon Alfa-2a plus Ribavirin vs Peginterferon Alfa-2b plus Ribavirin for
Chronic Hepatitis C Virus Infection in HIV-Infected Patients
J Berenguer*1, J González2, J López-Aldeguer3, MA Von-Wichman4, C Quereda5, F Pulido6, J Sanz7, C Tural8, E Ortega9, J Mallolas10, I Santos11, JM Bellón1 and The GESIDA 3603 Study Group
Hosp Gregorio Marañón, Madrid, Spain1; Hosp La Paz, Madrid, Spain2; Hosp La Fé, Valencia, Spain3; Hosp Donostia, San Sebastián, Spain4; Hosp Ramón y Cajal, Madrid, Spain5; Hosp 12 de Octubre, Madrid, Spain6; Hosp de Alcalá, Alcalá de Henares,
Spain7; Hosp Germans Trias i Pujol, Badalona, Spain8; Hosp Clínico Universitario, Valencia, Spain9; Hosp Clinic, Barcelona, Spain10; and Hosp La Princesa, Madrid, Spain11.
J Berenguer*1, J González2, J López-Aldeguer3, MA Von-Wichman4, C Quereda5, F Pulido6, J Sanz7, C Tural8, E Ortega9, J Mallolas10, I Santos11, JM Bellón1 and The GESIDA 3603 Study Group
Hosp Gregorio Marañón, Madrid, Spain1; Hosp La Paz, Madrid, Spain2; Hosp La Fé, Valencia, Spain3; Hosp Donostia, San Sebastián, Spain4; Hosp Ramón y Cajal, Madrid, Spain5; Hosp 12 de Octubre, Madrid, Spain6; Hosp de Alcalá, Alcalá de Henares,
Spain7; Hosp Germans Trias i Pujol, Badalona, Spain8; Hosp Clínico Universitario, Valencia, Spain9; Hosp Clinic, Barcelona, Spain10; and Hosp La Princesa, Madrid, Spain11.
Funding sources:Fundación para la Investigación y la Prevención del SIDA en España (FIPSE) (Ref. 36443/03)
Funding sources:Fundación para la Investigación y la Prevención del SIDA en España (FIPSE) (Ref. 36443/03)
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BackgroundBackground• The most effective therapy for CHC in HIV+ patients is peg-IFN plus RBV
1-4. • There are two approved brands of peg-IFN: peg-IFN -2a (PEG2A) with
a molecular weight of 40 kDa and peg-IFN -2b (PEG2B) with a molecular weight of 12 kDa.
– PEG2B has a larger Vd and higher renal clearance than PEG2A. – PEG2A is administered as a flat dose whereas PEG2B is administered according
to body weight. • It is unknown how these differences affect to sustained viral response
(SVR) to therapy.
1) Torriani FJ, et al . N Engl J Med 2004;351(5):438-50.2) Chung RT, et al. N Engl J Med 2004;351(5):451-9.3) Carrat F, et al. JAMA 2004;292(23):2839-48.4) Laguno M, et al. AIDS 2004;18(13):F27-36.
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ObjectiveObjective• To compare the efficacy/safety of PEG2A-RBV and PEG2B-RBV
against chronic HCV infection in HIV-infected patients.
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Methods (I)Methods (I)Design• Cohort studyGESIDA 3603 Study Cohort• Established to follow HIV/HCV+ patients who started IFN-RBV RX between Jan 2000 and Dec 2005 and with active follow-
up every 6 mo.• Primary objective: to determine the effect of achieving a SVR on long-term clinical outcomes including liver-related
complications, and liver-related mortality.• Secondary objetive: to assess the efficacy/safety of different IFN-RBV strategiesSetting• 11 clinical centers in SpainPatients• For the purpose of this study we analyzed patients naïve for IFN who were treated with either PEG2A-RBV (N = 315) or
PEG2B-RBV (N = 242).
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Methods (II)Methods (II)Assessment• End of treatment response (ETR): Undetectable HCV-RNA at the end of therapy
with IFN-RBV • SVR: Undetectable HCV-RNA 24 wk after the end of therapy with IFN-RBV
• Safety: Assessed by lab tests and evaluation of AE at least monthly during IFN-RBV therapy
Statistics• Differences between groups: Chi square, Student’s T or Mann Whitney-U as
appropriate.• Analyses were on an ITT and OT basis• Logistic-regression models were used to explore baseline factors predicting an
SVR and discontinuation of RX due to AE.
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Patient characteristics (I) Patient characteristics (I)
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Patient characteristics (II) Patient characteristics (II)
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Treatment DetailsTreatment Details
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Treatment Response(All Genotypes)
Treatment Response(All Genotypes)
P = 0.02
ETR: End of Treatment Response. SVR: Sustained Virologic Response
%
P < 0.01
%
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Treatment Response(According to Genotype)
Treatment Response(According to Genotype)
N = 127 N = 156 N = 19 N = 37 N = 9 N = 8 N = 76 N = 99 N = 146 N = 193 N = 85 N = 107
% %
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Sustained Virologic Response according to HCV Genotype and Baseline HCV RNA LevelSustained Virologic Response according to
HCV Genotype and Baseline HCV RNA Level
N = 37 N = 51 N = 96 N = 125 N = 32 N = 33 N = 50 N = 60
% %
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Independent Factors Associated with a SVR by Multiple Logistic-Regression Analysis
Independent Factors Associated with a SVR by Multiple Logistic-Regression Analysis
OR CI 95% pIFN PEG 2a + RBV 1.35 (0.81; 2.26) 0.250CDC disease state (A/B vs C) 2.45 (1.16;5.21) 0.019CD4 + cells nadir 1 (1; 1) 0.099Current intake of > 50 EtOH daily 1.87 (0.39;8.96) 0.432Fibrosis F3-F4 1.19 (0.63; 2.22) 0.595HCV genotype 2-3 3.77 (2.23; 6.36) <0.001HCV-RNA ≥ 500 K IU/ml 1.27 (0.74; 2.17) 0.390
OR: Odds ratio. CI 95%: 95% Confidence Interval
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Reason for interruption of Peg-IFN/RBV therapyReason for interruption of Peg-IFN/RBV therapy
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Dose Reductions and Discontinuation of Peg-IFN/RBV During Treatment
Dose Reductions and Discontinuation of Peg-IFN/RBV During Treatment
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ART Adverse Events During Treatment ART Adverse Events During Treatment
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Deaths, HIV Disease Progression, Liver DecompensationDeaths, HIV Disease Progression, Liver Decompensation
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ConclusionsConclusions• No significant differences were found in efficacy/safety
between PEG2A-RBV and PEG2B-RBV for the treatment of chronic HCV infection in HIV-infected patients