Comparative efficacy, pharmacokinetic, pharmacodynamic activity, and interferon stimulated gene expression of different interferon formulations in HIV/HCV genotype-1 infected patients

Journal of Medical Virology

Volumn 86, Issue 2, 2014, Pages 177-185

  Osinusi, Anu ^a,b   Bon, Dimitra ^c   Nelson, Amy ^a   Lee, Yu Jin ^a   Poonia, Seerat ^a   Shivakumar, Bhavana ^a   Cai, Shu Yi ^a   Wood, Brad ^d   Haagmans, Bart ^e   Lempicki, Richard ^b   Herrmann, Eva ^c   Sneller, Michael ^a   Polis, Michael ^a   Masur, Henry ^d   Kottilil, Shyam ^a  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b SAIC FREDERICK INC   (United States)

^c GOETHE UNIVERSITY   (Germany)

^d NATIONAL INSTITUTES OF HEALTH   (United States)

^e ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

HCV; HIV; IFN activity; ISGs; Pharmacokinetic pharmacodynamic

Indexed keywords

ALBINTERFERON ALPHA2B; ANTIRETROVIRUS AGENT; GRANULOCYTE COLONY STIMULATING FACTOR; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; RECOMBINANT ERYTHROPOIETIN; RIBAVIRIN; VIRUS RNA;

ADULT; AMBLYOPIA; ANEMIA; ANTIVIRAL ACTIVITY; ANXIETY DISORDER; ARTICLE; BELL PALSY; CATARACT; CD4 LYMPHOCYTE COUNT; COHORT ANALYSIS; COLOR VISION DEFECT; DEPRESSION; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE TITRATION; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY EYE; ENZYME LINKED IMMUNOSORBENT ASSAY; FATIGUE; FEMALE; FEVER; FLOW CYTOMETRY; GENE EXPRESSION; GLAUCOMA; HEADACHE; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOPHENOTYPING; INSOMNIA; IRRITABILITY; LIVER FIBROSIS; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; MOOD DISORDER; NAUSEA; NEUTROPENIA; NONHUMAN; OPEN STUDY; PANIC; PATIENT COMPLIANCE; PHARMACODYNAMICS; PROSPECTIVE STUDY; PSYCHOSIS; RETINA HEMORRHAGE; SIDE EFFECT; SKIN TOXICITY; T LYMPHOCYTE; TREATMENT RESPONSE; VIRUS LOAD; VOMITING;

HEPATITIS C VIRUS;

HCV; HIV; IFN-ACTIVITY; ISGS; PHARMACOKINETIC/PHARMACODYNAMIC;

ADULT; ANTIVIRAL AGENTS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; GENE EXPRESSION PROFILING; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HIV INFECTIONS; HUMANS; INTERFERON-ALPHA; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; PROSPECTIVE STUDIES; RECOMBINANT PROTEINS; RIBAVIRIN; TREATMENT OUTCOME;

EID: 84890146079     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.23773     Document Type: Article

References (33)

1. Appay V, Sauce D. 2008. Immune activation and inflammation in HIV-1 infection: Causes and consequences. J Pathol 214:231-241.
2. Appay V, van Lier RA, Sallusto F, Roederer M. 2008. Phenotype and function of human T lymphocyte subsets: Consensus and issues. Cytometry A 73:975-983.
3. Asahina Y, Tsuchiya K, Muraoka M, Tanaka K, Suzuki Y, Tamaki N, Hoshioka Y, Yasui Y, Katoh T, Hosokawa T, Ueda K, Nakanishi H, Itakura J, Takahashi Y, Kurosaki M, Enomoto N, Nitta S, Sakamoto N, Izumi N. 2012. Association of gene expression involving innate immunity and genetic variation in interleukin 28B with antiviral response. Hepatology 55:20-29.
4. Avidan NU, Goldstein D, Rozenberg L, McLaughlin M, Ferenci P, Masur H, Buti M, Fauci AS, Polis MA, Kottilil S. 2009. Hepatitis C viral kinetics during treatment with peg IFN-alpha-2b in HIV/HCV coinfected patients as a function of baseline CD4+ T-cell counts. J Acquir Immune Defic Syndr 52:452-458.
5. Bain VG, Kaita KD, Marotta P, Yoshida EM, Swain MG, Bailey RJ, Patel K, Cronin PW, Pulkstenis E, McHutchison JG, Subramanian GM. 2008. Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients. Clin Gastroenterol Hepatol 6:701-706.
6. Benhamou Y, Bochet M, Di Martino V, Charlotte F, Azria F, Coutellier A, Vidaud M, Bricaire F, Opolon P, Katlama C, Poynard T. 1999. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. The Multivirc Group. Hepatology 30:1054-1058.
7. Chung RT, Andersen J, Volberding P, Robbins GK, Liu T, Sherman KE, Peters MG, Koziel MJ, Bhan AK, Alston B, Colquhoun D, Nevin T, Harb G, van der Horst C. 2004. Peginterferon Alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons. N Engl J Med 351:451-459.
8. Dieterich DT, Spivak JL. 2003. Hematologic disorders associated with hepatitis C virus infection and their management. Clin Infect Dis 37:533-541.
9. Farel C, Suzman DL, McLaughlin M, Campbell C, Koratich C, Masur H, Metcalf JA, Robinson MR, Polis MA, Kottilil S. 2004. Serious ophthalmic pathology compromising vision in HCV/HIV co-infected patients treated with peginterferon alpha-2b and ribavirin. AIDS 18:1805-1809.
10. International Committee on Taxonomy of Viruses, Van Regenmortel MHV, International Union of Microbiological Societies. Virology Division. 2000. Virus taxonomy: Classification and nomenclature of viruses: Seventh report of the International Committee on Taxonomy of Viruses. San Diego: Academic Press. xii, 1162 p.
11. Jacobson IM, Brown RS, Jr., Freilich B, Afdhal N, Kwo PY, Santoro J, Becker S, Wakil AE, Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Pauly MP, Mukhopadhyay P, Griffel LH, Brass CA. 2007. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: A randomized trial. Hepatology 46:971-981.
12. Kottilil S, Yan MY, Reitano KN, Zhang X, Lempicki R, Roby G, Daucher M, Yang J, Cortez KJ, Ghany M, Polis MA, Fauci AS. 2009. Human immunodeficiency virus and hepatitis C infections induce distinct immunologic imprints in peripheral mononuclear cells. Hepatology 50:34-45.
13. Lavanchy D. 2011. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect 17:107-115.
14. Lempicki RA, Polis MA, Yang J, McLaughlin M, Koratich C, Huang DW, Fullmer B, Wu L, Rehm CA, Masur H, Lane HC, Sherman KE, Fauci AS, Kottilil S. 2006. Gene expression profiles in hepatitis C virus (HCV) and HIV coinfection: Class prediction analyses before treatment predict the outcome of anti-HCV therapy among HIV-coinfected persons. J Infect Dis 193:1172-1177.
15. Malaspina A, Moir S, Kottilil S, Hallahan CW, Ehler LA, Liu S, Planta MA, Chun TW, Fauci AS. 2003. Deleterious effect of HIV-1 plasma viremia on B cell costimulatory function. J Immunol 170:5965-5972.
16. Murphy AA, Herrmann E, Osinusi AO, Wu L, Sachau W, Lempicki RA, Yang J, Chung TL, Wood BJ, Haagmans BL, Kottilil S, Polis MA. 2011. Twice-weekly pegylated interferon-alpha-2a and ribavirin results in superior viral kinetics in HIV/hepatitis C virus co-infected patients compared to standard therapy. AIDS 25:1179-1187.
17. Nelson DR, Rustgi V, Balan V, Sulkowski MS, Davis GL, Muir AJ, Lambiase LR, Dickson RC, Weisner RH, Fiscella M, Cronin PW, Pulkstenis E, McHutchison JG, Subramanian GM. 2009. Safety and antiviral activity of albinterferon alfa-2b in prior interferon nonresponders with chronic hepatitis C. Clin Gastroenterol Hepatol 7:212-218.
18. Nelson DR, Benhamou Y, Chuang WL, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JW, Kryczka W, Lee CM, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. 2010. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3. Gastroenterology 139:1267-1276.
19. Osinusi A, Rasimas JJ, Bishop R, Proschan M, McLaughlin M, Murphy A, Cortez KJ, Polis MA, Masur H, Rosenstein D, Kottilil S. 2010. HIV/hepatitis C virus-coinfected virologic responders to pegylated interferon and ribavirin therapy more frequently incur interferon-related adverse events than nonresponders do. J Acquir Immune Defic Syndr 53:357-363.
20. Pau AK, McLaughlin MM, Hu Z, Agyemang AF, Polis MA, Kottilil S. 2006. Predictors for hematopoietic growth factors use in HIV/HCV-coinfected patients treated with peginterferon alfa 2b and ribavirin. AIDS Patient Care STDS 20:612-619.
21. Rozenberg L, Haagmans BL, Neumann AU, Chen G, McLaughlin M, Levy-Drummer RS, Masur H, Dewar RL, Ferenci P, Silva M, Viola MS, Polis MA, Kottilil S. 2009. Therapeutic response to peg-IFN-alpha-2b and ribavirin in HIV/HCV co-infected African-American and Caucasian patients as a function of HCV viral kinetics and interferon pharmacodynamics. AIDS 23:2439-2450.
22. Samuel CE. 2001. Antiviral actions of interferons. Clin Microbiol Rev 14:778-809, table of contents.
23. Sherman KE, Rouster SD, Chung RT, Rajicic N. 2002. Hepatitis C Virus prevalence among patients infected with Human Immunodeficiency Virus: A cross-sectional analysis of the US adult AIDS Clinical Trials Group. Clin Infect Dis 34:831-837.
24. Shire NJ, Horn PS, Rouster SD, Stanford S, Eyster ME, Sherman KE. 2006. HCV kinetics, quasispecies, and clearance in treated HCV-infected and HCV/HIV-1-coinfected patients with hemophilia. Hepatology 44:1146-1157.
25. Shudo E, Ribeiro RM, Perelson AS. 2009. Modeling hepatitis C virus kinetics under therapy using pharmacokinetic and pharmacodynamic information. Expert Opin Drug Metab Toxicol 5:321-332.
26. Sipsas NV, Sfikakis PP, Touloumi G, Pantazis N, Choremi H, Kordossis T. 2003. Elevated serum levels of soluble immune activation markers are associated with increased risk for death in HAART-naive HIV-1-infected patients. AIDS Patient Care STDS 17:147-153.
27. Soriano V, Perez-Olmeda M, Rios P, Nunez M, Garcia-Samaniego J, Gonzalez-Lahoz J. 2004a. Hepatitis C virus (HCV) relapses after anti-HCV therapy are more frequent in HIV-infected patients. AIDS Res Hum Retroviruses 20:351-353.
28. Soriano V, Puoti M, Sulkowski M, Mauss S, Cacoub P, Cargnel A, Dieterich D, Hatzakis A, Rockstroh J. 2004b. Care of patients with hepatitis C and HIV co-infection. AIDS 18:1-12.
29. Soriano V, Vispo E, Labarga P, Medrano J, Barreiro P. 2010. Viral hepatitis and HIV co-infection. Antiviral Res 85:303-315.
30. Subramanian GM, Fiscella M, Lamouse-Smith A, Zeuzem S, McHutchison JG. 2007. Albinterferon alpha-2b: A genetic fusion protein for the treatment of chronic hepatitis C. Nat Biotechnol 25:1411-1419.
31. Torriani FJ, Rodriguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-Garcia J, Lazzarin A, Carosi G, Sasadeusz J, Katlama C, Montaner J, Sette H, Jr., Passe S, De Pamphilis J, Duff F, Schrenk UM, Dieterich DT. 2004. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 351:438-450.
32. Voigt E, Schulz C, Klausen G, Goelz J, Mauss S, Schmutz G, Jessen H, Weitner L, Mutz A, Schranz D, Rockstroh JK. 2006. Pegylated interferon alpha-2b plus ribavirin for the treatment of chronic hepatitis C in HIV-coinfected patients. J Infect 53:36-42.
33. Zeuzem S, Sulkowski MS, Lawitz EJ, Rustgi VK, Rodriguez-Torres M, Bacon BR, Grigorescu M, Tice AD, Lurie Y, Cianciara J, Muir AJ, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. 2010. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 1. Gastroenterology 139:1257-1266.