Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial

The Lancet Gastroenterology and Hepatology

Volumn 1, Issue 3, 2016, Pages 185-195

  Chan, Henry L Y ^a   Fung, Scott ^b   Seto, Wai Kay ^c   Chuang, Wan Long ^d   Chen, Chi Yi ^e   Kim, Hyung Joon ^f   Hui, Aric Josun ^g   Janssen, Harry L A ^h   Chowdhury, Abhijit ⁱ   Tsang, Tak Yin Owen ^j   Mehta, Rajiv ^k   Gane, Edward ^l   Flaherty, John F ^m   Massetto, Benedetta ^m   Gaggar, Anuj ^m   Kitrinos, Kathryn M ^m   Lin, Lanjia ^m   Subramanian, G Mani ^m   McHutchison, John G ^m   Lim, Young Suk ⁿ   Acharya, Subrat K ^o   Agarwal, Kosh ^p   more..

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^b TORONTO GENERAL HOSPITAL   (Canada)

^c QUEEN MARY HOSPITAL   (Hong Kong)

^d KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^e CHIA YI CHRISTIAN HOSPITAL   (Taiwan)

^f Chung Ang University College of Medicine   (South Korea)

^g ALICE HO MIU LING NETHERSOLE HOSPITAL   (Hong Kong)

^h Toronto Liver Centre   (Canada)

ⁱ INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH   (India)

^j PRINCESS MARGARET HOSPITAL   (Hong Kong)

^k Surat Institute of Digestive Sciences (SIDS)   (India)

^l Auckland Clinical Studies   (New Zealand)

^m GILEAD SCIENCES   (United States)

ⁿ University of Ulsan College of Medicine   (South Korea)

^o ALL INDIA INSTITUTE OF MEDICAL SCIENCES   (India)

^p KING S COLLEGE HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; ENTECAVIR; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PLACEBO; TENOFOVIR ALAFENAMIDE; TENOFOVIR DISOPROXIL; VIRUS DNA; ADENINE; ANTIVIRUS AGENT; GS-7340; TENOFOVIR;

ADULT; ARTICLE; BONE DENSITY; CHRONIC HEPATITIS B; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GLOMERULUS FILTRATION RATE; HEADACHE; HEPATITIS B(E) ANTIGEN POSITIVE CHRONIC HEPATITIS B VIRUS INFECTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MASKING; OSTEOLYSIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; UPPER RESPIRATORY TRACT INFECTION; ADOLESCENT; AGED; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; FOLLOW UP; IMMUNOLOGY; MIDDLE AGED; MULTICENTER STUDY; TREATMENT OUTCOME; VERY ELDERLY; VIROLOGY; VIRUS LOAD; YOUNG ADULT;

ADENINE; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; BIOMARKERS; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HEPATITIS B E ANTIGENS; HEPATITIS B, CHRONIC; HUMANS; MALE; MIDDLE AGED; TENOFOVIR; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84996520524     PISSN: 24681253     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2468-1253(16)30024-3     Document Type: Article

References (39)

1. 1 Schweitzer, A, Horn, J, Mikolajczyk, RT, Krause, G, Ott, JJ, Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet 386 (2015), 1546–1555.
2. 2 Kuo, A, Gish, R, Chronic hepatitis B infection. Clin Liver Dis 16 (2012), 347–369.
3. 3 McMahon, BJ, Chronic hepatitis B virus infection. Med Clin North Am 98 (2014), 39–54.
4. 4 Gish, RG, Given, BD, Lai, C-L, et al. Chronic hepatitis B: virology, natural history, current management and a glimpse at future opportunities. Antivir Res 121 (2015), 47–58.
5. 5 Lozano, R, Naghavi, M, Foreman, K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 380 (2012), 2095–2128.
6. 6 Terrault, NA, Bzowej, NH, Chang, K-M, Hwang, JP, Jonas, MM, Murad, MH, AASLD guidelines for treatment of chronic hepatitis B. Hepatology 63 (2016), 261–283.
7. 7 European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol 57 (2012), 167–185.
8. 8 Liaw, Y-F, Kao, J-H, Piratvisuth, T, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int 6 (2012), 531–561.
9. 9 Marcellin, P, Gane, E, Buti, M, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet 381 (2013), 468–475.
10. 10 Peng, CY, Chien, RN, Liaw, YF, Hepatitis B virus-related decompensated liver cirrhosis: benefits of antiviral therapy. J Hepatol 57 (2012), 442–450.
11. 11 Wong, GL, Chan, HL, Mak, CW, et al. Entecavir treatment reduces hepatic events and deaths in chronic hepatitis B patients with liver cirrhosis. Hepatology 58 (2013), 1537–1547.
12. 12 Trépo, C, Chan, HLY, Lok, A, Hepatitis B virus infection. Lancet 384 (2014), 2053–2063.
13. 13 Delaney, WE 4th, Ray, AS, Yang, H, et al. Intracellular metabolism and in vitro activity of tenofovir against hepatitis B virus. Antimicrob Agents Chemother 50 (2006), 2471–2477.
14. 14 Marcellin, P, Gane, E, Flisiak, R, et al. Long-term treatment with tenofovir disoproxil fumarate for chronic hepatitis B infection is safe and well tolerated and associated with durable virologic response with no detectable resistance: 8 year results from two phase 3 trials. Hepatology 60:suppl (2014), 313A–314A.
15. 15 Fung, S, Kwan, P, Fabri, M, et al. Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 146 (2014), 980–988.
16. 16 Fung, S, Hann, HWL, Elkhashab, M, et al. Long term efficacy and safety of tenofovir (TDF) in chronic hepatitis B patients (CHB) with documented lamivudine resistance (lam-r): 5 year results from a randomized, controlled trial. Hepatology 62:suppl (2015), 1184A–1185A.
17. 17 Babusis, D, Phan, TK, Lee, WA, Watkins, WJ, Ray, AS, Mechanism for effective lymphoid cell and tissue loading following oral administration of nucleotide prodrug GS-7340. Mol Pharm 10 (2013), 459–466.
18. 18 Murakami, E, Wang, T, Park, Y, et al. Implications of efficient hepatic delivery by tenofovir alafenamide (GS-7340) for hepatitis B virus therapy. Antimicrob Agents Chemother 59 (2015), 3563–3569.
19. 19 Agarwal, K, Fung, SK, Nguyen, TT, et al. Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection. J Hepatol 62 (2015), 533–540.
20. 20 Ruane, PJ, DeJesus, E, Berger, D, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults. J Acquir Immune Defic 63 (2013), 449–455.
21. 21 Sax, PE, Wohl, D, Yin, MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet 385 (2015), 2606–2615.
22. 22 Marcellin, P, Heathcote, EJ, Buti, M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 359 (2008), 2442–2455.
23. 23 Buti, M, Gane, E, Seto, WK, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol, 2016 published online Sept 22. http://dx.doi.org/10.1016/S2468-1253(16)30107-8.
24. 24 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 354 (2006), 1001–1010.
25. 25 Berg, T, Marcellin, P, Zoulim, F, et al. Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection. Gastroenterology 139 (2010), 1207–1217.
26. 26 Cassetti, I, Madruga, JV, Suleiman, JM, et al. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients. HIV Clin Trials 8 (2007), 164–172.
27. 27 Bernardino, JI, Mocroft, A, Mallon, PW, et al. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV 2 (2015), e464–e473.
28. 28 Brown, TT, Moser, C, Currier, JS, et al. Changes in bone mineral density after initiation of antiretroviral treatment with tenofovir disoproxil fumarate/emtricitabine plus atazanavir/ritonavir, darunavir/ritonavir, or raltegravir. J Infect Dis 212 (2015), 1241–1249.
29. 29 Gill, US, Zissimopoulos, A, Al-Shamma, S, et al. Assessment of bone mineral density in tenofovir-treated patients with chronic hepatitis B: can the fracture risk assessment tool identify those at greatest risk?. J Infect Dis 211 (2015), 374–382.
30. 30 Chen, CH, Lin, CL, Kao, CH, Association between chronic hepatitis B virus infection and risk of osteoporosis: a nationwide population-based study. Medicine (Baltimore), 94, 2015, e2276.
31. 31 Maggi, P, Montinaro, V, Leone, A, et al. Bone and kidney toxicity induced by nucleotide analogues in patients affected by HBV-related chronic hepatitis: a longitudinal study. J Antimicrob Chemother 70 (2015), 1150–1154.
32. 32 Cooper, RD, Wiebe, N, Smith, N, Keiser, P, Naicker, S, Tonelli, M, Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis 51 (2010), 496–505.
33. 33 Hall, AM, Hendry, BM, Nitsch, D, Connolly, JO, Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence. Am J Kidney Dis 57 (2011), 773–780.
34. 34 Viganò, M, Brocchieri, A, Spinetti, A, et al. Tenofovir-induced Fanconi syndrome in chronic hepatitis B monoinfected patients that reverted after tenofovir withdrawal. J Clin Virol 61 (2014), 600–603.
35. 35 Gracey, DM, Snelling, P, McKenzie, P, Strasser, SI, Tenofovir-associated Fanconi syndrome in patients with chronic hepatitis B monoinfection. Antivir Ther 18 (2013), 945–948.
36. 36 Gara, N, Zhao, X, Collins, MT, et al. Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B. Aliment Pharmacol Ther 35 (2012), 1317–1325.
37. 37 Hall, AM, Edwards, SG, Lapsley, M, et al. Subclinical tubular injury in HIV-infected individuals on antiretroviral therapy: a cross-sectional analysis. Am J Kidney Dis 54 (2009), 1034–1042.
38. 38 Mallet, V, Schwarzinger, M, Vallet-Pichard, A, et al. Effect of nucleoside and nucleotide analogues on renal function in patients with chronic hepatitis B virus monoinfection. Clin Gastroenterol Hepatol 13 (2015), 1181–1188.
39. 39 Bernard, AM, Moreau, D, Lauwerys, R, Comparison of retinol-binding protein and beta 2-microglobulin determination in urine for the early detection of tubular proteinuria. Clin Chim Acta 126 (1982), 1–7.