Abstract
The objective of this study was to estimate the potential economic and clinical effects of treatment of chronic hepatitis B with lamivudine and a-interferon in the Russian military healthcare system based on computer-generated decision analysis model. The main outcome of this analysis was to provide the rationale for more effective use of limited healthcare resources. The analysis showed that the use of lamivudine for treatment of chronic hepatitis B was more advantageous that a-interferon in increase of the life expectancy and reduction of life-time risk of development of both compensated and non-compensated cirrhosis and hepatocellular carcinoma.
-
1.
Лобзин Ю.В. Руководство по инфекционным болезням. Санкт-Петербург: Фолиант; 2000.
-
2.
Lok A.S.F. Lamivudine therapy for chronic hepatitis B: is longer duration of treatment better? Gastroenterology 2000; 119: 263-6.
-
3.
Wong J.B., Koff R.S., Time F., et al. Cost-effectiveness of interferon-alpha 2B treatment for hepatitis B e antigen-positive chronic hepatitis B. Ann Intern Med 1995; 122:664-75.
-
4.
Heathcote J., Schalm S.W., Cianciara J., et al. Lamivudine and Intron A combination treatment in patients with chronic hepatitis B infection. J Hepatol 1998; 28 (Suppl. 1):43.
-
5.
Schalm S.W., Heathcote J., Cianciara J., et al. Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomized trial. Gut 2000; 46(4):562-8.
-
6.
Goodman Z., Dhillon A.P., Wu P.C., et al. Lamivudine treatment reduces progression to cirrhosis in patients with chronic hepatitis B [abstract]. J Hepatol 1999; 30 (Suppl. 1):59.
-
7.
Nevens F., Main J., Honkoop P., et al. Lamivudine therapy for chronic hepatitis B: a six month randomized dose-ranging study. Gastroenterology 1997; 113:1258-63.
-
8.
Lai C.L., Chien R.N., Leung N.W., et al. A one-year trial of lamivudine for chronic hepatitis B. N Engl J Med 1998; 339:61-8.
-
9.
Dienstag J., Schiff E., Wright T., et al. Lamivudine treatment for one year in previously untreated US hepatitis B patients: histological improvement and hepatitis e-antigen (HBeAg) seroconversion. Gastroenterology 1998; 114:1235.
-
10.
Dienstag J.F., Schiff E.R., Wright T.L., et al. Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med 1999; 341:1256-63.
-
11.
Schiff E., Cianciara J., Kowdley K., et al. Durability of HBeAg seroconversion after lamivudine monotherapy in controlled phase II and III trials. Hepatology 1998; 28:163A.
-
12.
Chang T.T., Lai C.L., Liaw Y.F., et al. Incremental increases in HBeAg seroconversion and continued ALT normalization in Asian chronic HBV patients treated with lamivudine for four years. Antiviral Ther 2000; 5 (Suppl. 1):44.
-
13.
Lueng N., Wu P.C., Tsang S., et al. Continued histological improvement in Chinese patients with chronic hepatitis B with 2 years lamivudine. Hepatology 1998; 28:489A.
-
14.
Lueng N.W.Y., Lai C.L., Chang T.T., et al. Three year lamivudine therapy in chronic HBV. J Hepatol 1999; 30 (Suppl. 1):59.
-
15.
Liaw Y.F., Leung N.W.Y., Chang T.T., et al. Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. Gastroenterology 2000; 119:172-80.
-
16.
Allen M.I., Deslauriers M., Andrews C.W., et al. Identification and characterization of mutations in hepatitis B virus resistant to lamivudine: Lamivudine Clinical Investigation Group. Hepatology 1998; 27:1670-7.
-
17.
Peters M.G., Singer G., Howard T., et al. Fulminant hepatic failure resulting from lamivudine-resistant hepatitis B virus in a renal transplant recipient: durable response after orthotopic liver transplantation on adefovir dipivoxil and hepatitis B immune globulin. Transplantation 1999; 68:1912-4.
-
18.
Liaw Y.F., Chien R.N., Yeh C.T., et al. Acute exacerbation and hepatitis B virus clearance after emergence of YMDD motif mutation during lamivudine therapy. Hepatology 1999; 30:567-72.
-
19.
Seta T., Yokosuka O., Imazeki F., et al. Emergence of YMDD motif mutants of hepatitis B virus during lamivudine treatment of immunocompetent type B hepatitis patients. J Med Virol 2000; 60:8-16.
-
20.
Mutimer D., Pillay D., Cook P., et al. Selection of multiresistant hepatitis B virus during sequential nucleoside-analogue therapy. J Infect Dis 2000; 181:713-6.
-
21.
Doo E., Liang T.J. Molecular anatomy and pathophysiologic implications of drug resistance in hepatitis B virus infection. Gastroenterology 2001; 120:1000-8.
-
22.
Kiyosawa K., Tanaka E. Strategy for lamivudine-resistant YMDD mutant-associated chronic hepatitis B. J Gastroenterol 2001; 36:139-41.
-
23.
De Man R.A., Bartholomeusz A.J., Niester H.G., et al. The sequential occurrence of viral mutations in a liver transplant recipient re-infected with hepatitis B: hepatitis B immune globulin escape, famciclovir non-response, followed by lamivudine resistance resulting in graft loss. J Hepatol 1998; 29:669-75.
-
24.
Crowley S.J., Tognarini D., Desmond P.V., Lees M. Cost-effectiveness analysis of lamivudine for the treatment of chronic hepatitis B. Pharmacoeconomics 2000; 17:409-27.
-
25.
Lok A.S.F. Treatment of chronic hepatitis. J Viral Hepatitis 1994; 1:105-24.
-
26.
Chien R.N., Liaw Y.F., Atkins M., for the Asian Hepatitis Lamivudine Trial Group. Pretherapy alaninetransaminase level as determinant for hepatitis Be antigen seroconversion during lamivudine therapy in patients with chronic hepatitis B. Hepatology 1999; 30:770-4.
-
27.
Perrillo R. P., Clin A. L. O., Schalm S. W., et al. Predictors of HBeAg seroconversion in chronic hepatitis B patients treated with lamivudine. Hepatology 1999; 30:317A.
-
28.
Lok A.S., Lai C.L., Wu P.C., Leung E.K. Long-term follow-up in a randomized controlled trial of recombinant alpha 2-interferon in Chinese patients with chronic hepatitis B infection. Lancet 1988; 2:298-302.
-
29.
Wong D.K., Cheung A.M., O’Rourke K., et al. Effect of alpha interferon treatment in patients with hepatitis Be antigen-positive chronic hepatitis B: a meta-analysis. Ann Intern Med 1993; 119:312-23.
-
30.
Lok A.S., Chung H.T., Liu V.W., et al. Long-term follow-up of chronic hepatitis B patients treated with interferon-alpha. Gastroenterology 1993; 105:1833-8.
-
31.
Krogsgaard K., Binsdlev N., Christensen E., et al. The treatment effect of alpha interferon in chronic hepatitis B is independent of pretreatment variables: results based on individual patient data from 10 clinical controlled trials. J Hepatol 1994; 21:646-55.
-
32.
Zhang X., Zoulim F., Halberseber I., et al. Analysis of hepatitis B virus genotypes and pre-core region variability during interferon treatment of HВe antigen negative chronic hepatitis B. J Med Virol 1996; 48:8-16.
-
33.
Hoofnagle J.H. Therapy of viral hepatitis. Digestion 1998; 59:563-78.
-
34.
Krogsgaard K. The long-term effect of treatment with interferon-alpha 2 a in chronic hepatitis B. The long-term Follow-up Investigator Group. The European Study Group on Viral Hepatitis (EUROHEP) Executive Team on Antiviral Treatment. The long term effect of treatment with interferon alpha 2A in chronic hepatitis B. J Viral Hepat 1998; 5:389-97.
-
35.
Guptan R.K., Thakur V., Malhortra V., et al. Low-dose recombinant interferon therapy in anti HВe-positive chronic hepatitis B in Asian Indians. J Gastroenterol Hepatol 1998; 13:675-9.
-
36.
Lau D.T., Everhart J., Kleiner D.L., et al. Long term follow-up of patients with chronic hepatitis B treated with interferon alpha. Gastroenterology 1997; 113:1660-7.
-
37.
Korenman J., Baker B., Waggoner J., et al. Long-term remission of chronic hepatitis B after alpha-interferon therapy. Ann Intern Med 1991; 114:629-34.
-
38.
Carreflo V., Bartolome J., Calstillo I. Long-term effect of interferon therapy in chronic hepatitis B. J Hepatol 1994; 20:431-5.
-
39.
Hope R.L., Welman M., Dingley J., et al. Interferon alpha for chronic active hepatitis B., long term follow-up of 62 patients: outcomes and predictors of response. Med J Aust 1995; 162:8-11.
-
40.
Schiff E., Karayalcin S., Grimm I., et al. A placebo controlled study of lamivudine and interferon alpha-2b in patients with chronic hepatitis B who previously failed interferon therapy. Hepatology 1998; 28:388A.
-
41.
Liaw Y.F., Tai D.J., Chu C.M., et al. The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Hepatology 1988; 5:493-6.
-
42.
Fattovich G., Brollo L., Giustina G., et al. Natural history and prognostic factors for chronic hepatitis type B. Gut 1991; 32:294-8.
-
43.
Beasley R.P., Hwang L.Y., Lin C.C., et al. Hepatocellular carcinoma and hepatitis B virus. Lancet 1981; 2:1129-33.
-
44.
Niederau C., Heintges T., Lange S., et al. Long term follow up of HBeAg-positive patients treated with interferon alpha for chronic hepatitis B. N Engl J Med 1996; 334:1422-7.
-
45.
Lo K.-J., Toy M.J., Chien M.-C., et al. The natural course of hepatitis B surface antigen-positive chronic active hepatitis in Taiwan. J Infect Dis 1982; 146:205-10.
-
46.
Liaw Y.-F., Lin D.-Y., Chen T.-J., Chu C.M. Natural course after the development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Liver 1989; 9:235-41.
-
47.
McMahon B.J., Alberts S.R., Wainwright R.B., et al. Hepatitis B related sequelae: prospective study in 1400 hepatitis B surface antigen-positive Alaskan native carriers. Arch Intern Med 1990; 150:1051-4.
-
48.
Dejongh F.E., Janssen H.L., De Man R.A., et al. Survival and prognostic indicators in hepatitis B surface antigen-positive cirrhosis of the liver. Gastroenterology 1992; 103:1630-5.
-
49.
International Interferon-alpha Hepatocellular Carcinoma Study Group. Effect of interferon-alpha on progression to cirrhosis to hepatocellular carcinoma: a retrospective cohort study. Lancet 1998; 351:1535-9.
-
50.
Fattovich G., Giustina G., Schalm S.W., et al. Occurence of hepatocellular carcinoma and decompensation in Western European patients with cirrhosis type B: the EUROHEP Study Group in hepatitis B virus and cirrhosis. Hepatology 1995; 21:77-82.
-
51.
Columbo M., De Franchis R., Del Ninno E., et al. Hepatocellular carcinoma in patients with cirrhosis. N Engl J Med 1991; 325:675-80.
-
52.
Realdi G., Fattovich G., Hadziyannis S., et al. Survival and prognostic factors in 366 patients with compensated cirrhosis type B: a multicenter study. J Hepatol 1994; 21:656-6.
-
53.
Gow P.J., Mutimer D. Treatment of chronic hepatitis. BMJ 2001; 323:1164-7.
-
54.
Marinos G., Naoumov N., Williams R. Impact of complete inhibition of viral replication on the cellular immune response in chronic hepatitis B virus infection. Hepatology 1996; 24:991-5.
-
55.
Mutimer D., Naoumov N., Honkoop P., et al. Combination alpha-interferon and lamivudine therapy for alpha-interferon-resistant chronic hepatitis B infection: results of a pilot study. J Hepatol 1998; 28: 923-9.
-
56.
Alexopoulou A., Zafiropolou R., Papakonstantinou A., et al. Randomized trial in HBeAg negative patients with replicating virus with ganciclovir vs lamivudine in combination with interferon: evaluation of long-term efficacy. Hepatology 1998; 45:2282-94.
-
57.
Serfaty L., Thabut D., Zoulim F., et al. Sequential treatment with lamivudine and interferon monotherapies in patients with chronic hepatitis B not responding to interferon alone: results of a pilot study. Hepatology 2001; 34:573-7.
-
58.
Barbaro G., Zechini F., Pellicelli A.M., et al. Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial. J Hepatol 2001; 35:406-11.
-
59.
Schalm S.W. Lamivudine-interferon combination therapy for chronic hepatitis B: further support but no conclusive evidence. J Hepatol 2001; 35:419-20.
-
60.
Lau G.K., Tsiang M., Hou J., et al. Combination therapy with lamivudine and famciclovir for chronic hepatitis B-infected Chinese patients: a viral dynamics study. Hepatology 2000; 32:394-9.
-
61.
Ono-Nita S.K., Kato N., Shiratori Y., et al. Susceptibility of lamivudine-resistant hepatitis B virus to other reverse transcriptase inhibitors. J Clin Invest 1999; 103:1635-40.
-
62.
Perrillo R., Schiff E., Yoshida E., et al. Adefovir dipivoxil for the treatment of lamivudine-resistant hepatitis B mutants. Hepatology 2000; 32:129-34.
-
63.
Torresi J., Locarnini S. Antiviral chemotherapy for the treatment of hepatitis B virus infections. Gastroenterology 2000; 118:S83-103.