A randomized, open-label clinical study of combined pegylated interferon alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B

Clinical Infectious Diseases

Volumn 59, Issue 12, 2014, Pages 1714-1723

  Xie, Qing ^a   Zhou, Huijuan ^a   Bai, Xuefan ^b   Wu, Shuhuan ^c   Chen, Jian Jie ^d   Sheng, Jifang ^e   Xie, Yao ^f   Chen, Chengwei ^g   Chan, Henry Lik Yuen ^h   Zhao, Mianzhi ⁱ  

^a SHANGHAI JIAO TONG UNIVERSITY   (China)

^b FOURTH MILITARY MEDICAL UNIVERSITY   (China)

^c THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY   (China)

^d SHUGUANG HOSPITAL AFFILIATED TO SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

^e ZHEJIANG UNIVERSITY   (China)

^f CAPITAL MEDICAL UNIVERSITY   (China)

^g No 85 Hospital of PLA   (China)

^h CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

ⁱ Shanghai Roche Pharmaceutucals Ltd   (China)

Author keywords

clinical pharmacology; hepatitis B; liver; viral hepatitis

Indexed keywords

ALANINE AMINOTRANSFERASE; ENTECAVIR; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; PEGINTERFERON ALPHA2A; VIRUS DNA; ALPHA INTERFERON; ANTIVIRUS AGENT; GUANINE; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; MACROGOL DERIVATIVE; RECOMBINANT PROTEIN;

ABDOMINAL DISTENSION; ADD ON THERAPY; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANTIVIRAL THERAPY; ARTICLE; ASTHENIA; CHINESE; CONTROLLED STUDY; DECREASED APPETITE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EPISTAXIS; FEMALE; FEVER; FOLLOW UP; GINGIVA BLEEDING; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; HYPERTHYROIDISM; LEUKOCYTE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUSCULOSKELETAL PAIN; NAUSEA; NEUTROPHIL COUNT; OPEN STUDY; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SIDE EFFECT; THROMBOCYTE COUNT; ANALOGS AND DERIVATIVES; BLOOD; HEPATITIS B, CHRONIC; IMMUNOLOGY; MIDDLE AGED;

ADULT; ANTIVIRAL AGENTS; FEMALE; GUANINE; HEPATITIS B E ANTIGENS; HEPATITIS B, CHRONIC; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; INTERFERON-ALPHA; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS;

EID: 84919621940     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciu702     Document Type: Article

References (32)

1. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat 2004; 11:97-107.
2. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009; 50:661-2.
3. Liaw YF, Kao JH, Piratvisuth T, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int 2012; 6:531-61.
4. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol 2012; 57:167-85.
5. Lau GKK, Piratvisuth T, Luo KX, et al. Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med 2005; 352:2682-95.
6. Liaw YF, Jia JD, Chan HL, et al. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology 2011; 54:1591-9.
7. Moucari R, Korevaar A, Lada O, et al. High rates of HBsAg seroconversion in HBeAg-positive chronic hepatitis B patients responding to interferon: a long-term follow-up study. J Hepatol 2009; 50:1084-92.
8. Van Zonneveld M, Honkoop P, Hansen BE, et al. Long-term follow-up of alpha-interferon treatment of patients with chronic hepatitis B. Hepatology 2004; 39:804-10.
9. Peters MG, Hann HW, Martin P, et al. Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 2004; 126:91-101.
10. Reijnders JG, PerquinMJ, Zhang N, Hansen BE, JanssenHL. Nucleos(t)ide analogues only induce temporary hepatitis B e antigen seroconversion in most patients with chronic hepatitis B. Gastroenterology 2010; 139:491-8.
11. Heathcote EJ, Marcellin P, Buti M, et al. Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology 2011; 140:132-43.
12. Marcellin P, Heathcote EJ, Buti M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008; 359:2442-55.
13. Chang TT, Chao YC, Gorbakov VV, et al. Results of up to 2 years of entecavir vs lamivudine therapy in nucleoside-naive HBeAg-positive patients with chronic hepatitis B. J Viral Hepat 2009; 16:784-9.
14. Chang TT, Gish RG, de Man R, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006; 354:1001-10.
15. Ha NB, Ha NB, Garcia RT, et al. Medication nonadherence with long-term management of patients with hepatitis B e antigen-negative chronic hepatitis B. Dig Dis Sci 2011; 56:2423-31.
16. Peters M. Actions of cytokines on the immune response and viral interactions: an overview. Hepatology 1996; 23:909-16.
17. Thimme R, Wieland S, Steiger C, et al. CD8(+) T cells mediate viral clearance and disease pathogenesis during acute hepatitis B virus infection. J Virol 2003; 77:68-76.
18. Piratvisuth T, Lau G, Chao YC, et al. Sustained response to peginterferon alfa-2a (40 kD) with or without lamivudine in Asian patients with HBeAg-positive and HBeAg-negative chronic hepatitis B. Hepatol Int 2008; 2:102-10.
19. Chang T-T, Chao YC, Kaymakoglu S, et al. Entecavir maintained virologic suppression through 3 years of treatment in antiviral-naive HBeAg (+) patients (ETV 022/901) [abstract 109]. In: 57th Annual Meeting of the American Association for the Study of Liver Diseases, Boston, MA, 27 October 2006.
20. Wursthorn K, Lutgehetmann M, Dandri M, et al. Peginterferon alpha-2b plus adefovir induce strong cccDNA decline and HBsAg reduction in patients with chronic hepatitis B. Hepatology 2006; 44:675-84.
21. Chan HL, Leung NW, Hui AY, et al. A randomized, controlled trial of combination therapy for chronic hepatitis B: comparing pegylated interferon-alpha2b and lamivudine with lamivudine alone. Ann Intern Med 2005; 142:240-50.
22. Roche. Summary of product characteristics for Pegasys, 2006. Available at: http://www.medicines.org.uk/emc/medicine/10081. Accessed June 2014.
23. Marcellin P, Lau GKK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004; 351:1206-17.
24. Lai CL, Shouval D, Lok AS, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. NEngl JMed 2006; 354:1011-20.
25. FriedMW, Piratvisuth T, LauGK, et al. HBeAg and hepatitis B virus DNA as outcome predictors during therapy with peginterferon alfa-2a for HBeAg-positive chronic hepatitis B. Hepatology 2008; 47:428-34.
26. Fattovich G, Rugge M, Brollo L, et al. Clinical, virologic and histologic outcome following seroconversion from HBeAg to anti-HBe in chronic hepatitis type B. Hepatology 1986; 6:167-72.
27. Niederau C, Heintges T, Lange S, et al. Long-term follow-up of HBeAgpositive patients treated with interferon alfa for chronic hepatitis B. N Engl J Med 1996; 334:1422-7.
28. Sarin SK, Sood A, Kumar M, et al. Effect of lowering HBV DNA levels by initial antiviral therapy before adding immunomodulator on treatment of chronic hepatitis B. Am J Gastroenterol 2007; 102: 96-104.
29. Ning Q, Han MF, Sun YT. New treatment strategy; switching from longterm entecavir to peginterferon alfa 2-a induces HBeAg seroconversion/ HBsAg clearance in patients with HBeAg-positive chronic hepatitis B. Hepatology 2012; 56:300A.
30. Cooksley WGE, Piratvisuth T, Lee SD, et al. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003; 10:298-305.
31. Brunetto MR, Marcellin P, Cherubini B, et al. Response to peginterferon alfa-2a (40KD) in HBeAg-negative CHB: on-treatment kinetics of HBsAg serum levels vary by HBV genotype. J Hepatol 2013; 59: 1153-9.
32. Sonneveld MJ, Hansen BE, Piratvisuth T, et al. Response-guided peginterferon therapy in HBeAg-positive chronic hepatitis B using serum hepatitis B surface antigen levels. Hepatology 2013; 58:872-80.