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2011, Number 1

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Rev Cubana Farm 2011; 45 (1)

Safety of recombinant interferon alpha 2b plus ribavirin in chronic hepatitis C

Sánchez RYA; Arús SE; López SP; Nodarse CH

Language: Spanish
References: 27
Page: 34-43
PDF size: 59.70 Kb.


ABSTRACT

INTRODUCTION: chronic hepatitis C has reached the category of pandemic. The hepatitis C virus is the main cause of chronic hepatitis, hepatic cirrhosis, hepatocarcinoma and liver transplantation worldwide.
OBJECTIVE: to identify the side effects of a combined therapy of recombinant interpheron alpha 2b plus ribavirin during the treatment and up to 8 weeks afterwards, as well as the main effects related to temporary or definitive withdrawal.
METHODS: a pharmacological surveillance study was performed in which 122 patients with chronic hepatitis C, who had been seen at the Institute of Gastroenterology from May 2001 to May 2006, were included. Recombinant interferon alpha 2b (3 million units administered 3 times a week) plus ribavirin (1 000 or 1 200 mg daily depending on the body weight) was the therapy used for 48 weeks.
RESULTS: of the total number of cases, 88.5 % had side effects; 79.5 % of which corresponded to pseudocold syndrome followed by hematological, neuropsychiatric and gastrointestinal manifestations, and other less frequent ailments. In the studied group, 6.6% had to interrupt their treatment temporarily due to some side effect different from anemia whereas 4 patients gave up the study, three affected by severe hemolytic anemia and one with uncontrollable hyperthyroidism.
CONCLUSIONS: the combined therapy of recombinant interferon alpha 2b plus ribavirin proved to be safe; the most frequent side effect was pseudocold syndrome in the majority of cases. The hematological manifestations that made the patients to give up the study led to recommend a strict follow-up of hemoglobin levels and thorough diagnosis and treatment of the main side effects found in other systems and associated to this combined therapy.


REFERENCES

  1. Moreno OR, Diago M. Situaciones clínicas en el manejo de las hepatitis virales. Madrid: Grupo Acción Médica; 2005. p .3-207.

  2. Common Toxicity Criteria, version 2. Bethestda, Md: National Cancer Institute. 1999. Accessed Dec 15 2004. Available from http://ctep.info.nih.gov

  3. Gervais A, Boyer N, Marcellin P. Tolerability of treatments for viral hepatitis. Drug Saf. 2001;24(5):375-84.

  4. Davis GL, Esteban-Mur R, Rustgi V. Interferon alpha-2b alone in combination with ribavirin for the treatment of relapse of chronic hepatitis C. N Engl J Med. 1998;339:1493-9.

  5. Dieperink E, Willenbring M, Ho S. Neuropsychiatric symptoms associated with hepatitis C and interferon alpha: a review. Am J Psych. 2000;157(6):867-76.

  6. Malaguarnera M, Di Fazio I, Restuccia S. Interferon alpha-induced depression in chronic hepatitis C patients:comparison between different types of interferon alpha. Neuropsychobiology. 1998;37:93-97.

  7. Nesic Z, Delic D, Prostran M. Psychiatric adverse effects induced by recombinant interferon alpha in patients with chronic hepatitis C. Med Pregl. 2004 May- Jun;57(5-6):219-26.

  8. Pawlotsky JM, Dahari H, Neumann AU. Antiviral action of ribavirin in chronic hepatitis C. Gastroenterology. 2004 Mar;126(3):703-14.

  9. De Franceschi L, Fattovich G, Turrini F. Hemolytic anemia induced by ribavirin therapy in patients with chronic hepatitis C virus infection : role of membrane oxidative damage. Hepatology. 2000;31:997-1004.

  10. Soza A, Everhart JE, Ghany MG. Neutropenia during combination therapy of interferon alpha and ribavirin for chronic hepatitis C. Hepatology. 2002;36:1273-9.

  11. Ong JP, Younossi ZM. Managing the hematologic side effects of antiviral therapy for chronic hepatitis C: anemia, neutropenia, and thrombocytopenia. Cleve Clin J Med. 2004 May;71Suppl3:S17-21

  12. Tod M, Farcy- Afif M, Stocco J. Pharmacokinetic/pharmacodynamic and time-toevent models of ribavirin-induced anemia in chronic hepatitis C. Clin Pharmacokinet. 2005;44(4):417-28.

  13. McHutchison JG, Gordon SC, Schiff ER. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med. 1998;339:1485-92.

  14. Rebetron (combination therapy containing rebetol [Ribavirin, USP] capsules and Intron A [interferon alpha-2b, recombinant injection]) prescribing information. Kenilworth: Shering; 2001.

  15. Hsieh MC, Yu ML, Chuang WL. Virologic factors related to interferon-alphainduced thyroid dysfunction in patients with chronic hepatitis C. Eur J Endocrinol. 2000;142:431-7.

  16. Morisco F, Mazziotti G, Rotondi M. Interferon-related thyroid autoimmunity and long-term clinical outcome of chronic hepatitis C. Dig Liver Dis 2001;33:247-253.

  17. Antonelli A, Ferri CL, Pamapara A. Thyroid disorders in chronic hepatitis C. Am J Med. 2004;117:10-3.

  18. Moncoucy X, Leymarie F, Delemer B. Risk factors and long-term course of thyroid dysfunction during antiviral treatment in 221 patients with chronic hepatitis C. Gastrenterol Clin Biol. 2005 Apr;29(4):339-45.

  19. Kee KM, Lee CM, Wang JH. Thyroid dysfunction in patients with chronic hepatitis C receiving a combined therapy of interferon and ribavirin: incidence, associated factors and prognosis. Gastroenterol Hepatol. 2006 Jan;21(1 Pt 2):319- 26.

  20. Nadeem A, Aslam M, Khan DA, Hussain T, Khan SA. Effects of combined interferon alpha and ribavirin therapy on thyroid functions in patients with chronic hepatitis C. J Coll Physicians Surg Pak. 2009 Feb;19(2):86-9.

  21. Friedrich-Rust M, Theobald J, Zeuzem S, Bojunga J. Thyroid function and changes in ultrasound morphology during antiviral therapy with pegylated interferon and ribavirin in patients with chronic hepatitis C. J Viral Hepat. 2009 Mar;16(3):168-77.

  22. Bini EJ, Mehandru S. Incidence of thyroid dysfunction during interferon alfa-2b and ribavirin therapy in men with chronic hepatitis C: a prospective cohort study. Arch Intern Med. 2004;164:2371-2376.

  23. Gelu-Simeon M, Burlaud A, Young J, Pelletier G, Buffet C. Evolution and predictive factors of thyroid disorder due to interferon alpha in the treatment of hepatitis C. World J Gastroenterol. 2009 Jan 21;15(3):328-33.

  24. Yoshida K, Alagbe O, Wang X. Promoter polymorphisms of the interferon-alpha receptor gene and development of interferon-induced depressive symptoms in patients with chronic hepatitis C: preliminary findings. Neuropsychobiology. 2005;52(2):55-61.

  25. Majer M, Welberg LAM, Capuron L, Pagnoni G, Raison LCH, Hiller AH. IFNalpha- induced motor slowing is associated with increased depression and fatigue in patients with chronic hepatitis C. Brain Behav Immun. 2008 Aug;22(6): 870-80.

  26. Musselman D, Lawson D, Gumnick J. Paroxetine for the prevention of depression induced by high-dose interferon alpha. N Engl J Med. 2001;344(13):961-6.

  27. Mead GE, Morley W, Campbell P, Greig CA, McMurdo M, Lawlor DA. Exercise for depression. Cochrane Database Syst Rev. 2008;(4):CD004366.




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