An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C

Salvatore Fasola, Mario Cottone, Mario Cottone, Salvatore Madonia, Giuseppe Malizia, Salvatore Patti, Fabio Tinè, Gandolfo Giannuoli, Gennaro D'Amico

Risultato della ricerca: Article

1 Citazione (Scopus)

Abstract

Purpose: Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs.Methods: Observational study of 312 patients with predominantly genotype 1 chronic hepatitis C treated openly along 5 years in a clinical practice setting.Results: Eighty-four percent of patients experienced at least one adverse event (853 events in total, 3.3 per patient on average). Incidence rate was higher during the first 90 days and decreased thereafter (<5%). Discontinuation rates at 30 and 90 days and at end of treatment were 2, 4 and 8%, respectively. Seventy percent of discontinuation cases were due to adverse events rather than to laboratory abnormalities. Serious adverse events were rare (<1%). Dose modifications were made in 158 patients (51%) on 237 occasions. After adjusting for covariates, older age was a predictor of early discontinuation, whereas HCV genotypes 1–4 and daily ribavirin dose of 1000 mg or more were predictors of dose modification.Conclusions: The majority of real-world patients with chronic hepatitis C tolerate acceptably dual therapy and very few discontinue it. Subjective decisions on dose reduction of either compound appears to have a major impact on adherence of patients. There is a need to better define, collect and analyse clinical features which may predict adverse events and safety-related decisions during therapy of chronic hepatitis C.
Lingua originaleEnglish
pagine (da-a)1113-1123
Numero di pagine11
RivistaPharmacoepidemiology and Drug Safety
Volume19
Stato di pubblicazionePublished - 2010

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Chronic Hepatitis C
Antiviral Agents
Safety
Ribavirin
Therapeutics
Genotype
Patient Compliance
Interferon-alpha
Observational Studies
Incidence
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Epidemiology
  • Pharmacology (medical)

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An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C. / Fasola, Salvatore; Cottone, Mario; Cottone, Mario; Madonia, Salvatore; Malizia, Giuseppe; Patti, Salvatore; Tinè, Fabio; Giannuoli, Gandolfo; D'Amico, Gennaro.

In: Pharmacoepidemiology and Drug Safety, Vol. 19, 2010, pag. 1113-1123.

Risultato della ricerca: Article

Fasola, S, Cottone, M, Cottone, M, Madonia, S, Malizia, G, Patti, S, Tinè, F, Giannuoli, G & D'Amico, G 2010, 'An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C', Pharmacoepidemiology and Drug Safety, vol. 19, pagg. 1113-1123.
Fasola, Salvatore ; Cottone, Mario ; Cottone, Mario ; Madonia, Salvatore ; Malizia, Giuseppe ; Patti, Salvatore ; Tinè, Fabio ; Giannuoli, Gandolfo ; D'Amico, Gennaro. / An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C. In: Pharmacoepidemiology and Drug Safety. 2010 ; Vol. 19. pagg. 1113-1123.
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abstract = "Purpose: Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs.Methods: Observational study of 312 patients with predominantly genotype 1 chronic hepatitis C treated openly along 5 years in a clinical practice setting.Results: Eighty-four percent of patients experienced at least one adverse event (853 events in total, 3.3 per patient on average). Incidence rate was higher during the first 90 days and decreased thereafter (<5{\%}). Discontinuation rates at 30 and 90 days and at end of treatment were 2, 4 and 8{\%}, respectively. Seventy percent of discontinuation cases were due to adverse events rather than to laboratory abnormalities. Serious adverse events were rare (<1{\%}). Dose modifications were made in 158 patients (51{\%}) on 237 occasions. After adjusting for covariates, older age was a predictor of early discontinuation, whereas HCV genotypes 1–4 and daily ribavirin dose of 1000 mg or more were predictors of dose modification.Conclusions: The majority of real-world patients with chronic hepatitis C tolerate acceptably dual therapy and very few discontinue it. Subjective decisions on dose reduction of either compound appears to have a major impact on adherence of patients. There is a need to better define, collect and analyse clinical features which may predict adverse events and safety-related decisions during therapy of chronic hepatitis C.",
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T1 - An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C

AU - Fasola, Salvatore

AU - Cottone, Mario

AU - Cottone, Mario

AU - Madonia, Salvatore

AU - Malizia, Giuseppe

AU - Patti, Salvatore

AU - Tinè, Fabio

AU - Giannuoli, Gandolfo

AU - D'Amico, Gennaro

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N2 - Purpose: Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs.Methods: Observational study of 312 patients with predominantly genotype 1 chronic hepatitis C treated openly along 5 years in a clinical practice setting.Results: Eighty-four percent of patients experienced at least one adverse event (853 events in total, 3.3 per patient on average). Incidence rate was higher during the first 90 days and decreased thereafter (<5%). Discontinuation rates at 30 and 90 days and at end of treatment were 2, 4 and 8%, respectively. Seventy percent of discontinuation cases were due to adverse events rather than to laboratory abnormalities. Serious adverse events were rare (<1%). Dose modifications were made in 158 patients (51%) on 237 occasions. After adjusting for covariates, older age was a predictor of early discontinuation, whereas HCV genotypes 1–4 and daily ribavirin dose of 1000 mg or more were predictors of dose modification.Conclusions: The majority of real-world patients with chronic hepatitis C tolerate acceptably dual therapy and very few discontinue it. Subjective decisions on dose reduction of either compound appears to have a major impact on adherence of patients. There is a need to better define, collect and analyse clinical features which may predict adverse events and safety-related decisions during therapy of chronic hepatitis C.

AB - Purpose: Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs.Methods: Observational study of 312 patients with predominantly genotype 1 chronic hepatitis C treated openly along 5 years in a clinical practice setting.Results: Eighty-four percent of patients experienced at least one adverse event (853 events in total, 3.3 per patient on average). Incidence rate was higher during the first 90 days and decreased thereafter (<5%). Discontinuation rates at 30 and 90 days and at end of treatment were 2, 4 and 8%, respectively. Seventy percent of discontinuation cases were due to adverse events rather than to laboratory abnormalities. Serious adverse events were rare (<1%). Dose modifications were made in 158 patients (51%) on 237 occasions. After adjusting for covariates, older age was a predictor of early discontinuation, whereas HCV genotypes 1–4 and daily ribavirin dose of 1000 mg or more were predictors of dose modification.Conclusions: The majority of real-world patients with chronic hepatitis C tolerate acceptably dual therapy and very few discontinue it. Subjective decisions on dose reduction of either compound appears to have a major impact on adherence of patients. There is a need to better define, collect and analyse clinical features which may predict adverse events and safety-related decisions during therapy of chronic hepatitis C.

KW - adverse event

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KW - prediction

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