Elorehaladott májbetegséggel járó krónikus C-vírushepatitises betegek kezelésével nyert tapasztalataink a telaprevir Korai Hozzáférési Program keretében: Interim analízis

István Tornai, Tivadar Bányai, Judit Gervain, Gábor Horváth, Mihály Makara, Tibor Martyin, Zsuzsanna Nemes, A. Pár, G. Pár, Zoltán Péterfi, F. Szalay, Zsolt Szinku, T. Tóth, A. Vincze, Isabelle Lonjon-Domanec, Ralph Demasi, B. Hunyady

Research output: Article

Abstract

The approval of the first two direct acting antiviral agents, boceprevir and telaprevir, has been a major step forward in the treatment of chronic hepatitis C. Both protease inhibitors must be added to the dual peginterferon and ribavirin combination therapy. The triple combination therapy resulted in significantly higher rates of recovery both in naive patients and in those previously unresponsive to therapy. Following the approval of telaprevir, an Early Access Program has been initiated in 16 countries. In Hungary 132 patients were enrolled into this program. In the first interim analysis, data from the first 16 weeks of treatment of 92 patients are included. Liver cirrhosis (F4) was detected in 70% of the patients and severe fibrosis (F3) was found in the other 30%, on the basis of either liver biopsy or transient elastography. During their previous antiviral treatment, 64% of the patients were non-responders (partial and nullresponders), 26% were relapsers, and only 10% were treatment naives. The efficacy of the triple combination was excellent, as 82% of the patients had undetectable HCV RNA at week 12. Further - more, 48% had negative HCV RNA at week 4 as well as at week 12. Cessation of i.e. negative HCV RNA at week 4 through week 12. Only 5.4% of the patients had virologic failure and needed to stop therapy prematurely. The most frequent adverse event was anemia, hemoglobin level decreased below 100 g/l in 40% of the patients. In the majority of these patients ribavirin dose reduction was sufficient to treat anemia, only 16% needed blood transfusion. The rate of severe rash was 6%. Although this group of patients represents a difficult-to-treat population, both efficacy and safety data are similar to published data in international clinical trials. A very effective, triple combination therapy with telaprevir, peginterferon and ribavirin can be provided for patients with advanced liver disease, to reduce the risk of liver failure and hepatocellular carcinoma.

Original languageHungarian
Pages (from-to)35-41
Number of pages7
JournalLege Artis Medicinae
Volume24
Issue number1-2
Publication statusPublished - 2014

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Chronic Hepatitis C
Genotype
Liver
Ribavirin
Therapeutics
RNA
Antiviral Agents
Anemia
telaprevir
Elasticity Imaging Techniques
Hungary
Liver Failure
Exanthema
Protease Inhibitors
Blood Transfusion
Liver Cirrhosis
Liver Diseases
Hepatocellular Carcinoma
Hemoglobins
Fibrosis

Keywords

  • Chronic hepatitis
  • Interim analysis
  • Peginterferon
  • Ribavirin
  • Telaprevir

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Elorehaladott májbetegséggel járó krónikus C-vírushepatitises betegek kezelésével nyert tapasztalataink a telaprevir Korai Hozzáférési Program keretében : Interim analízis. / Tornai, István; Bányai, Tivadar; Gervain, Judit; Horváth, Gábor; Makara, Mihály; Martyin, Tibor; Nemes, Zsuzsanna; Pár, A.; Pár, G.; Péterfi, Zoltán; Szalay, F.; Szinku, Zsolt; Tóth, T.; Vincze, A.; Lonjon-Domanec, Isabelle; Demasi, Ralph; Hunyady, B.

In: Lege Artis Medicinae, Vol. 24, No. 1-2, 2014, p. 35-41.

Research output: Article

Tornai, István ; Bányai, Tivadar ; Gervain, Judit ; Horváth, Gábor ; Makara, Mihály ; Martyin, Tibor ; Nemes, Zsuzsanna ; Pár, A. ; Pár, G. ; Péterfi, Zoltán ; Szalay, F. ; Szinku, Zsolt ; Tóth, T. ; Vincze, A. ; Lonjon-Domanec, Isabelle ; Demasi, Ralph ; Hunyady, B. / Elorehaladott májbetegséggel járó krónikus C-vírushepatitises betegek kezelésével nyert tapasztalataink a telaprevir Korai Hozzáférési Program keretében : Interim analízis. In: Lege Artis Medicinae. 2014 ; Vol. 24, No. 1-2. pp. 35-41.
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abstract = "The approval of the first two direct acting antiviral agents, boceprevir and telaprevir, has been a major step forward in the treatment of chronic hepatitis C. Both protease inhibitors must be added to the dual peginterferon and ribavirin combination therapy. The triple combination therapy resulted in significantly higher rates of recovery both in naive patients and in those previously unresponsive to therapy. Following the approval of telaprevir, an Early Access Program has been initiated in 16 countries. In Hungary 132 patients were enrolled into this program. In the first interim analysis, data from the first 16 weeks of treatment of 92 patients are included. Liver cirrhosis (F4) was detected in 70{\%} of the patients and severe fibrosis (F3) was found in the other 30{\%}, on the basis of either liver biopsy or transient elastography. During their previous antiviral treatment, 64{\%} of the patients were non-responders (partial and nullresponders), 26{\%} were relapsers, and only 10{\%} were treatment naives. The efficacy of the triple combination was excellent, as 82{\%} of the patients had undetectable HCV RNA at week 12. Further - more, 48{\%} had negative HCV RNA at week 4 as well as at week 12. Cessation of i.e. negative HCV RNA at week 4 through week 12. Only 5.4{\%} of the patients had virologic failure and needed to stop therapy prematurely. The most frequent adverse event was anemia, hemoglobin level decreased below 100 g/l in 40{\%} of the patients. In the majority of these patients ribavirin dose reduction was sufficient to treat anemia, only 16{\%} needed blood transfusion. The rate of severe rash was 6{\%}. Although this group of patients represents a difficult-to-treat population, both efficacy and safety data are similar to published data in international clinical trials. A very effective, triple combination therapy with telaprevir, peginterferon and ribavirin can be provided for patients with advanced liver disease, to reduce the risk of liver failure and hepatocellular carcinoma.",
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AU - Bányai, Tivadar

AU - Gervain, Judit

AU - Horváth, Gábor

AU - Makara, Mihály

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AU - Nemes, Zsuzsanna

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AU - Péterfi, Zoltán

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AU - Szinku, Zsolt

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AU - Vincze, A.

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