Combination therapy with thymosin α1 and interferon for the treatment of chronic hepatitis C infection: A randomized, placebo-controlled double- blind trial

Hepatology

Volumn 27, Issue 4, 1998, Pages 1128-1135

  Sherman, Kenneth E ^a,e   Sjogren, Maria ^b   Creager, Robin L ^c   Damiano, Melissa A ^c   Freeman, Stephen ^c   Lewey, Scot ^c   Davis, Dirk ^c   Root, Spencer ^c   Weber, Frederick L ^a   Ishak, Kamal G ^d   Goodman, Zachary D ^d  

^a UNIVERSITY OF CINCINNATI   (United States)

^b WALTER REED ARMY MEDICAL CENTER   (United States)

^c FITZSIMONS ARMY MEDICAL CENTER   (United States)

^d ARMED FORCES INSTITUTE OF PATHOLOGY   (United States)

^e UNIVERSITY OF CINCINNATI MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA2B INTERFERON; IMMUNOMODULATING AGENT; PLACEBO; THYMOSIN ALPHA1; VIRUS RNA;

ADULT; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; HEPATITIS C; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MYALGIA; NEUTROPENIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOCYTOPENIA;

ADULT; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HEPATITIS C, CHRONIC; HUMANS; INTERFERON ALFA-2B; MALE; MIDDLE AGED; RNA, VIRAL; THYMOSIN;

EID: 17344368726     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1002/hep.510270430     Document Type: Article

References (20)

1. Koretz RL, Abbey H, Coleman E, Gitnick G. Non-A, non-B post-transfusion hepatitis: looking back in the second decade. Ann Intern Med 1993;119:110-115.
2. Alter MJ. Epidemiology of hepatitis C in the West. Semin Liver Dis 1995;15:5-14.
3. Belle SH, Beringer KC, Detre KM. Liver transplantation in the United States: results from the national PITT-UNOS liver transplant registry. In: Terasaki, Cecka, eds. Clinical Transplants. Chap. 2. 1994:19-35.
4. Poynard T, Bedossa P, Chevallier M, Mathurin P, Lemonnier C, Trepo C, Couzigou P, et al. A comparison of three Interferon alfa-2b regimens for the long-term treatment of chronic non-A, non-b hepatitis. N Engl J Med 1995:332:1457-1462.
5. Nishiguchi S, Kuroki T, Nakatani S, Morimoto H, Takeda T, Nakajima S, Shiomi S, et al. Randomized trial of effects of interferon-a on incidence of hepatocellular carcinoma in chronic active hepatitis C with cirrhosis. Lancet 1995;346:1051-1055.
6. Davis GL, Balart LA, Schiff ER, Lindsay K, Bodenheimer H, Perrillo R, Carey W, et al. Treatment of chronic hepatitis C with recombinany interferon alfa: a multicenter randomized controlled trial. N Engl J Med 1989;321:1501-1506.
7. DiBisceglie AM, Martin P, Kassianides C, Lisker-Melman M, Murray L, Waggoner J, Goodman Z, et al. Recombinant interferon alfa therapy for chronic hepatitis C. A randomized double-blind, placebo-controlled trial. N Engl J Med 1989;321:1506-1510.
8. Schulof RA, Low TLK, Thurman GB, Goldstein AL. Thymosins and other hormones of the thymus gland. In: Sell K, ed. The lymphocyte. New York: Liss, 1981:191-215.
9. Low TLK, Goldstein AL. Thymosins: structure, function, and therapeutic applications. Thymus 1984;6:27-43.
10. Gravenstein S, Duthie EH, Miller BA, Roeker E, Drinka P, Prathipati K, Ershler WB, et al. Augmentation of influenza antibody response in elderly men by thymosin alpha one: a double-blind placebo-controlled clinical study. J Am Geriatr Soc 1989;37:l-8.
11. Barrett DJ, Wara DW, Ammann AJ, Cowan JM. Thymosin therapy in DeGeorge syndrome. J Pediatr 1980;97:66-71.
12. Mutchnick MG, Appelman HD, Chung HT, Aragona E, Gupta TP, Cummings GD, Waggoner JG, et al. Thymosin treatment of chronic hepatitis B: a placebo controlled pilot trial. HEPATOLOGY 1991;14:409415.
13. 1 versus interferon alfa treatment in patients with hepatitis B e antigen antibody-and hepatitis B virus DNA-positive chronic hepatitis B. HEPATOLOGY 1996;24:774-777.
14. Andreone P, Cursaro C, Gramenzi A, Buzzi A, Covarelli MG, DiGiammairno L, Miniero R, et al. A double-blind, placebo-controlled, pilot trial of thymosin alpha 1 for the treatment of chronic hepatitis C. Liver 1996:16:207-210.
15. Bianchi L, DeGroote J, Desmet V, Gedigk P, Korb G, Popper H, Paulsen H, et al. Acute and chronic hepatitis revisited. Lancet 1977;11:714-719.
16. Beach MJ, Meeks EL, Mimms LT, Vallari D, DuCharme L, Spelbring J, Taskar S, et al. Temporal relationships of hepatitis C virus RNA and antibody responses following experimental infection of chimpanzees. J Med Virol 1992;36:226-237.
17. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. HEPATOLOGY 1981;l;431-435.
18. Poynard T, Leroy V, Cohard M, Thevanot T, Mathurin P, Opolon P, Zarski P. Meta-analysis of interferon randomized trials in the treatment of viral hepatitis C: effects of dose and duration. HEPATOLOGY 1996;24:778-789.
19. Shindo M, DiBisceglie AM, Cheung L, Shih W-K, Cristiano K, Feinstone SM, Hoofnagle JH. Decrease in serum hepatitis C viral RNA during alpha-interferon therapy for chronic hepatitis C. Ann Intern Med 1991;115:700-704.
20. Aiyama T, Yoshioka K, Hirofuji H, Kusakabe A, Yamada M, Tanaka K, Kakumu S. Changes in serum hapatitis C virus RNA titer and response to interferon therapy in patients with chronic hepatitis C. Dig Dis Sci 1994;39:2244-2249.