Background & Aims: Pegylated interferon (PEG-IFN) plus ribavirin combination therapy has significantly improved the successful rate in virus eradication in patients affected by chronic hepatitis C. However, only few data are available with respect to antiviral effect and safety in aged patients. This study aimed at investigating the efficacy and tolerability of pegylated interferon (Peg-IFN) plus ribavirin therapy in aged patients with chronic hepatitis C (CH-C). Methods: A total of 473 patients [319 (67.4%) naive, 195 (41,2% female) with CH-C (genotype 1, n = 266; genotype 2, n = 112, genotype 3 = 72, genotype 4=23), of whom 68 (14.4%) over 65 years old (y.o.) (mean age 69±2 years) , were treated with Peg-IFN (alfa-2a or alfa-2b) plus ribavirin according to international guidelines. These patients were assessed for sustained viral response (SVR) rate and for all known main predictors of SVR in CH-C. Results: The overall SVR rate resulted similar in both age groups (270/405 (66.6%) in subjects <65 y.o vs. 41/68 (60.3%) in subjects ≥ 65 y.o, respectively, p=0.334). No significant difference in therapy discontinuance rate was observed between patients over and under 65 y.o. (4.4% vs. 4.9%, respectively), the most common reason being anemia in both groups. The table resumes the distribution of main known SVR predictors in the two considered groups < 65 years (n=405) ≥ 65 years (n=68) p Genotype (1-4/2-3) 252/153 37/31 0.229 High viral load (cut off 500.000 UI/ml) (yes/no) 154/251 16/52 0.028 PegIFN alfa 2a / PegIFN alfa 2b use 244/161 59/9 <.001 Rapid Viral Response (RVR) (yes/no)* 106/107 28/28 1.000 Early Viral Response (EVR) (yes/no) 308/97 50/18 0.76 Naive (yes/no) 275/130 44/24 0.675 Sex (male/female) 248/157 30/38 0.011 Grading (Ishak score) 4.89±2.13 5.77±1.88 0.022 Staging (Ishak score) 2.08±1.49 2.73±1.51 0.029 Liver cirrhosis (yes/no) 42/363 13/55 0.043 Therapy reduction (yes/no) 123/282 20/48 0.888 Ribavirin reduction (yes/no) 87/318 18/50 0.430 Use of erythropoietic fatctors (yes/no) 43/362 26/42 <.001 *data not available for all patients For patients over 65 y.o., at multivariate analysis, genotype 2/3 (OR, 2.56,95% CI 1.89-5.65 p = 0.026) and EVR (OR, 45.5,95% CI 26.2-125.3 p <0.001) were significant predictors of SVR. Factors related to EVR at multivariate analysis were naive status (OR 2.58, 95%CI 1.26-3.69, p=.001), therapy with PEGIFNalfa 2a (OR 3.56, 95% CI 1.68-5.65, p=.014) and ribavirin reduction (OR 0.789, 95% CI 0.568-0.895, p=.015). Conclusions: Aged patients can be candidates for Peg-IFN plus ribavirin therapy.The appropriate use of erythropietic factors in these patients may be useful to achieve a significant reduction in the rate of therapy discontinuation due to hematological side-effects. The response-guided therapy may be applied in predicting therapy efficay in these patients.
Treatment of chronic hepatitis C by pegylated interferon plus ribavirin combination therapy in aged patients : why not ? / A., Vegetti; G., Abbati; C., Sardini; Venturelli, Giorgia; Cagnacci, Sara; Incerti, Federica; Pietrangelo, Antonello; Ventura, Paolo. - In: INTERNAL AND EMERGENCY MEDICINE. - ISSN 1828-0447. - STAMPA. - 6:(2011), pp. S187-S187. (Intervento presentato al convegno 112th National Congress of the Italian Society of Internal Medicine tenutosi a Rome nel 22-25 October 2011).
Treatment of chronic hepatitis C by pegylated interferon plus ribavirin combination therapy in aged patients : why not ?
Venturelli, Giorgia;Cagnacci, Sara;Incerti, Federica;PIETRANGELO, Antonello;VENTURA, Paolo
2011
Abstract
Background & Aims: Pegylated interferon (PEG-IFN) plus ribavirin combination therapy has significantly improved the successful rate in virus eradication in patients affected by chronic hepatitis C. However, only few data are available with respect to antiviral effect and safety in aged patients. This study aimed at investigating the efficacy and tolerability of pegylated interferon (Peg-IFN) plus ribavirin therapy in aged patients with chronic hepatitis C (CH-C). Methods: A total of 473 patients [319 (67.4%) naive, 195 (41,2% female) with CH-C (genotype 1, n = 266; genotype 2, n = 112, genotype 3 = 72, genotype 4=23), of whom 68 (14.4%) over 65 years old (y.o.) (mean age 69±2 years) , were treated with Peg-IFN (alfa-2a or alfa-2b) plus ribavirin according to international guidelines. These patients were assessed for sustained viral response (SVR) rate and for all known main predictors of SVR in CH-C. Results: The overall SVR rate resulted similar in both age groups (270/405 (66.6%) in subjects <65 y.o vs. 41/68 (60.3%) in subjects ≥ 65 y.o, respectively, p=0.334). No significant difference in therapy discontinuance rate was observed between patients over and under 65 y.o. (4.4% vs. 4.9%, respectively), the most common reason being anemia in both groups. The table resumes the distribution of main known SVR predictors in the two considered groups < 65 years (n=405) ≥ 65 years (n=68) p Genotype (1-4/2-3) 252/153 37/31 0.229 High viral load (cut off 500.000 UI/ml) (yes/no) 154/251 16/52 0.028 PegIFN alfa 2a / PegIFN alfa 2b use 244/161 59/9 <.001 Rapid Viral Response (RVR) (yes/no)* 106/107 28/28 1.000 Early Viral Response (EVR) (yes/no) 308/97 50/18 0.76 Naive (yes/no) 275/130 44/24 0.675 Sex (male/female) 248/157 30/38 0.011 Grading (Ishak score) 4.89±2.13 5.77±1.88 0.022 Staging (Ishak score) 2.08±1.49 2.73±1.51 0.029 Liver cirrhosis (yes/no) 42/363 13/55 0.043 Therapy reduction (yes/no) 123/282 20/48 0.888 Ribavirin reduction (yes/no) 87/318 18/50 0.430 Use of erythropoietic fatctors (yes/no) 43/362 26/42 <.001 *data not available for all patients For patients over 65 y.o., at multivariate analysis, genotype 2/3 (OR, 2.56,95% CI 1.89-5.65 p = 0.026) and EVR (OR, 45.5,95% CI 26.2-125.3 p <0.001) were significant predictors of SVR. Factors related to EVR at multivariate analysis were naive status (OR 2.58, 95%CI 1.26-3.69, p=.001), therapy with PEGIFNalfa 2a (OR 3.56, 95% CI 1.68-5.65, p=.014) and ribavirin reduction (OR 0.789, 95% CI 0.568-0.895, p=.015). Conclusions: Aged patients can be candidates for Peg-IFN plus ribavirin therapy.The appropriate use of erythropietic factors in these patients may be useful to achieve a significant reduction in the rate of therapy discontinuation due to hematological side-effects. The response-guided therapy may be applied in predicting therapy efficay in these patients.
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