What the infectious disease physician needs to know about pegylated interferon and ribavirin

Clinical Infectious Diseases

Volumn 56, Issue 11, 2013, Pages 1629-1636

  Gara, Naveen ^a   Ghany, Marc G ^a  

^a NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

Author keywords

adverse events; chronic hepatitis C treatment; peginterferon; ribavirin

Indexed keywords

ALPHA INTERFERON; CREATININE; ELTROMBOPAG; ERYTHROPOIETIN; ESCITALOPRAM; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PAROXETINE; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; RIBAVIRIN; TELAPREVIR; VIRUS RNA;

AGGRESSION; ALOPECIA; ANEMIA; ANGINA PECTORIS; ANOREXIA; ANTIVIRAL THERAPY; ARTHRALGIA; ARTICLE; AUTOIMMUNE THROMBOCYTOPENIA; BACKACHE; BLINDNESS; BODY WEIGHT; BONE MARROW SUPPRESSION; BRONCHIOLITIS OBLITERANS; CARDIOMYOPATHY; CENTRAL RETINA VEIN THROMBOSIS; CEREBROVASCULAR ACCIDENT; CHILL; COMORBIDITY; COUGHING; CREATININE CLEARANCE; DEPRESSION; DIABETES MELLITUS; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG CONTRAINDICATION; DRUG DEPENDENCE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG FORMULATION; DRUG MEGADOSE; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; FACIAL NERVE PARALYSIS; FAINTNESS; FATIGUE; FETUS MALFORMATION; FETUS WASTAGE; FLU LIKE SYNDROME; GALLSTONE; GASTROENTERITIS; GASTROINTESTINAL SYMPTOM; GENOTYPE; GOUT; HAIR LOSS; HEADACHE; HEART INFARCTION; HEART SUPRAVENTRICULAR ARRHYTHMIA; HEMOGLOBIN BLOOD LEVEL; HEMOGLOBINOPATHY; HEMOLYTIC ANEMIA; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HYPERGLYCEMIA; HYPERPARATHYROIDISM; HYPERTENSION; HYPOTHYROIDISM; INJECTION SITE INFLAMMATION; INJECTION SITE NECROSIS; INSOMNIA; INTERSTITIAL NEPHRITIS; IRRITABILITY; ISCHEMIC HEART DISEASE; LABORATORY TEST; LIBIDO; LOW DRUG DOSE; LUPUS LIKE SYNDROME; MENTAL CONCENTRATION; MENTAL INSTABILITY; MUSCULOSKELETAL PAIN; MYALGIA; NASAL STIFFNESS; NAUSEA; NEUTROPENIA; NOSE DISEASE; OPTIC NEURITIS; PANCREATITIS; PERICARDIAL EFFUSION; PHOTOTOXICITY; PHYSICIAN; PLEURA EFFUSION; PORTAL VEIN THROMBOSIS; PREGNANT WOMAN; PRIORITY JOURNAL; PRURITUS; PSORIASIS; PSYCHOSIS; PURE RED CELL ANEMIA; QT PROLONGATION; RASH; RETINA ARTERY THROMBOSIS; RETINA ISCHEMIA; RETINAL DISEASE; RHEUMATOID ARTHRITIS; RIGOR; SARCOIDOSIS; SEPSIS; SIDE EFFECT; SUICIDAL IDEATION; SUICIDE ATTEMPT; THROMBOCYTOPENIA; TRANSIENT ISCHEMIC ATTACK; TREATMENT DURATION; TREATMENT RESPONSE; TREATMENT WITHDRAWAL; URTICARIA; VASCULITIS; VENOUS THROMBOEMBOLISM; VIRUS GENE; VISUAL ACUITY; WEAKNESS;

ADVERSE EVENTS; CHRONIC HEPATITIS C TREATMENT; PEGINTERFERON; RIBAVIRIN;

ANTIVIRAL AGENTS; HEPATITIS C, CHRONIC; HUMANS; INFECTIOUS DISEASE MEDICINE; INTERFERONS; POLYETHYLENE GLYCOLS; RIBAVIRIN;

EID: 84877248581     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cit074     Document Type: Article

References (53)

1. McHutchison JG, Lawitz EJ, Shiffman ML, et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009; 361:580-93.
2. Awad T, Thorlund K, Hauser G, Stimac D, Mabrouk M, Gluud C. Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: systematic review of randomized trials. Hepatology 2010; 51:1176-84.
3. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009; 49:1335-74.
4. US Food and Drug Administration. Available at: http://www.fda.gov/ ForConsumers/ByAudience/ForPatientAdvocates/ucm267594.htm. Accessed 30 November 2012.
5. US Food and Drug Administration. Available at: http://www.accessdata. fda.gov/drugsatfda-docs/label/2011/202258lbl.pdf. Accessed 20 February 2013.
6. US Food and Drug Administration. Available at: http://www.accessdata. fda.gov/drugsatfda-docs/label/2011/201917lbl.pdf. Accessed 20 February 2013.
7. Di Bisceglie AM, Conjeevaram HS, Fried MW, et al. Ribavirin as therapy for chronic hepatitis C. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995; 123:897-903.
8. Lai MY, Kao JH, Yang PM, et al. Long-term efficacy of ribavirin plus interferon alfa in the treatment of chronic hepatitis C. Gastroenterolo-gy 1996; 111:1307-12.
9. Feld JJ, Hoofnagle JH. Mechanism of action of interferon and ribavi-rin in treatment of hepatitis C. Nature 2005; 436:967-72.
10. Lutchman G, Danehower S, Song BC, et al. Mutation rate of the hepatitis C virus NS5B in patients undergoing treatment with ribavirin monotherapy. Gastroenterology 2007; 132:1757-66.
11. Lau JY, Tam RC, Liang TJ, Hong Z. Mechanism of action of ribavirin in the combination treatment of chronic HCV infection. Hepatology 2002; 35:1002-9.
12. Thomas E, Feld JJ, Li Q, Hu Z, Fried MW, Liang TJ. Ribavirin potentiates interferon action by augmenting interferon-stimulated gene induction in hepatitis C virus cell culture models. Hepatology 2011; 53:32-41.
13. De Franceschi L, Fattovich G, Turrini F, et al. Hemolytic anemia induced by ribavirin therapy in patients with chronic hepatitis C virus infection: role of membrane oxidative damage. Hepatology 2000; 31:997-1004.
14. Fellay J, Thompson AJ, Ge D, et al. ITPA gene variants protect against anaemia in patients treated for chronic hepatitis C. Nature 2010; 464:405-8.
15. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002; 347:975-82.
16. Hezode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009; 360:1839-50.
17. Zeuzem S, Buggisch P, Agarwal K, et al. The protease inhibitor, GS-9256, and non-nucleoside polymerase inhibitor tegobuvir alone, with ribavirin, or pegylated interferon plus ribavirin in hepatitis C. Hepa-tology 2012; 55:749-58.
18. Gane EJ, Roberts SK, Stedman CA, et al. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet 2010; 376:1467-75.
19. Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012; 366:216-24.
20. Nachnani JS, Rao GA, Bulchandani D, Pandya PK, Alba LM. Predictors of hematological abnormalities in patients with chronic hepatitis C treated with interferon and ribavirin. Ann Hematol 2010; 89:121-5.
21. Hadziyannis SJ, Sette H Jr., Morgan TR, et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004; 140:346-55.
22. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358:958-65.
23. Afdhal NH, Dieterich DT, Pockros PJ, et al. Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study. Gastroenterology 2004; 126:1302-11.
24. Pockros PJ, Shiffman ML, Schiff ER, et al. Epoetin alfa improves quality of life in anemic HCV-infected patients receiving combination therapy. Hepatology 2004; 40:1450-8.
25. Shiffman ML, Salvatore J, Hubbard S, et al. Treatment of chronic hepatitis C virus genotype 1 with peginterferon, ribavirin, and epoetin alpha. Hepatology 2007; 46:371-9.
26. Bennett CL, Silver SM, Djulbegovic B, et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbe-poetin administration for the treatment of cancer-associated anemia. JAMA 2008; 299:914-24.
27. Locatelli F, Del Vecchio L. Pure red cell aplasia secondary to treatment with erythropoietin. J Nephrol 2003; 16:461-6.
28. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364:2405-16.
29. Poordad F, McCone J Jr., Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364:1195-206.
30. Sulkowski MS, Poordad F, Manns MP, et al. Anemia during treatment with peginterferon alfa-2b/ribavirin and boceprevir: analysis from the sprint-2 trial. Hepatology 2012 [Epub ahead of print]. doi:10.1002/hep.26096.
31. Soza A, Everhart JE, Ghany MG, et al. Neutropenia during combination therapy of interferon alfa and ribavirin for chronic hepatitis C. Hepatology 2002; 36:1273-9.
32. Van Thiel DH, Faruki H, Friedlander L, et al. Combination treatment of advanced HCV associated liver disease with interferon and G-CSF. Hepatogastroenterology 1995; 42:907-12.
33. Koliouskas D, Didiropoulos I, Masmanidou M, et al. Comparative analysis and effect of GM-CSF on neutropenia in peg-interferon alpha-2b and ribavirin-treated chronic hepatitis C patients. Hepatol-ogy 2002; 36:587A.
34. Carey E, Rosati M, Anderson M, et al. Use of G-CSF allows for optimal PEG-INF dosing during therapy for hepatitis C virus with pe-gylated interferon and ribavirin. Hepatology 2002; 36:604A.
35. McHutchison JG, Dusheiko G, Shiffman ML, et al. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med 2007; 357:2227-36.
36. Afdhal NH, Dusheiko G, Giannini EG, Chen P, Han KH, et al. Final-Results of Enable 1, a phase 3, multicenter study of eltrombopag as an adjunct for antiviral treatment of hepatitis C virus-related chronic liver disease associated with thrombocytopenia. Hepatology 2011; 54:1427A.
37. US Food and Drug Administration. Safety information. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlerts forHumanMedicalProducts/ucm211796.htm. Accessed 30 April 2012.
38. Schaefer M, Schmidt F, Folwaczny C, et al. Adherence and mental side effects during hepatitis C treatment with interferon alfa and riba-virin in psychiatric risk groups. Hepatology 2003; 37:443-51.
39. Schaefer M, Schwaiger M, Garkisch AS, et al. Prevention of interfer-on-alpha associated depression in psychiatric risk patients with chronic hepatitis C. J Hepatol 2005; 42:793-8.
40. Kraus MR, Schafer A, Scheurlen M. Paroxetine for the prevention of depression induced by interferon alfa. N Engl J Med 2001; 345:375-6.
41. Diez-Quevedo C, Masnou H, Planas R, et al. Prophylactic treatment with escitalopram of pegylated interferon alfa-2a-induced depression in hepatitis C: a 12-week, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2011; 72:522-8.
42. Raison CL, Woolwine BJ, Demetrashvili MF, et al. Paroxetine for prevention of depressive symptoms induced by interferon-alpha and riba-virin for hepatitis C. Aliment Pharmacol Ther 2007; 25:1163-74.
43. de Knegt RJ, Bezemer G, Van Gool AR, et al. Randomised clinical trial: escitalopram for the prevention of psychiatric adverse events during treatment with peginterferon-alfa-2a and ribavirin for chronic hepatitis C. Aliment Pharmacol Ther 2011; 34:1306-17.
44. Schaefer M, Sarkar R, Knop V, et al. Escitalopram for the prevention of peginterferon-alpha2a-associated depression in hepatitis C virus-infected patients without previous psychiatric disease: a randomized trial. Ann Intern Med 2012; 157:94-103.
45. Schaefer M, Hinzpeter A, Mohmand A, et al. Hepatitis C treatment in "difficult-to-treat" psychiatric patients with pegylated interferon-alpha and ribavirin: response and psychiatric side effects. Hepatology 2007; 46:991-8.
46. Roberts SS, Miller RK, Jones JK, et al. The Ribavirin Pregnancy Registry: findings after 5 years of enrollment, 2003-2009. Birth Defects Res A Clin Mol Teratol 2010; 88:551-9.
47. Mauss S, Valenti W, DePamphilis J, et al. Risk factors for hepatic decompensation in patients with HIV/HCV coinfection and liver cirrhosis during interferon-based therapy. AIDS 2004; 18:F21-5.
48. Bani-Sadr F, Carrat F, Pol S, et al. Risk factors for symptomatic mitochondrial toxicity in HIV/hepatitis C virus-coinfected patients during interferon plus ribavirin-based therapy. J Acquir Immune Defic Syndr 2005; 40:47-52.
49. Garcia-Benayas T, Blanco F, Soriano V. Weight loss in HIV-infected patients. N Engl J Med 2002; 347:1287-8.
50. Nunez M, Ocampo A, Aguirrebengoa K, et al. Incidence of anaemia and impact on sustained virological response in HIV/HCV-coinfected patients treated with pegylated interferon plus ribavirin. J Viral Hepat 2008; 15:363-9.
51. Vispo E, Barreiro P, Pineda JA, et al. Low response to pegylated interferon plus ribavirin in HIV-infected patients with chronic hepatitis C treated with abacavir. Antivir Ther 2008; 13:429-37.
52. Bani-Sadr F, Denoeud L, Morand P, et al. Early virologic failure in HIV-coinfected hepatitis C patients treated with the peginterferon-ribavirin combination: does abacavir play a role?. J Acquir Immune Defic Syndr 2007; 45:123-5.
53. Rodriguez-Torres M, Slim J, Bhatti L, et al. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials 2012; 13:142-52.