Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study

Journal of Hepatology

Volumn 66, Issue 1, 2017, Pages 11-18

  Fung, Scott ^a   Kwan, Peter ^b   Fabri, Milotka ^c   Horban, Andrzej ^d   Pelemis, Mijomir ^e   Hann, Hie Won ^f   Gurel, Selim ^g   Caruntu, Florin A ^h   Flaherty, John F ⁱ   Massetto, Benedetta ⁱ   Kim, Kyungpil ⁱ   Kitrinos, Kathryn M ⁱ   Subramanian, G Mani ⁱ   McHutchison, John G ⁱ   Yee, Leland J ⁱ   Elkhashab, Magdy ^j   Berg, Thomas ^k   Sporea, Ioan ^l   Yurdaydin, Cihan ^m   Husa, Petr ⁿ   Jablkowski, Maciej S ^o   Gane, Edward ^p   more..

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c UNIVERSITY OF NOVI SAD   (Serbia)

^d MEDICAL UNIVERSITY OF WARSAW   (Poland)

^e CLINICAL CENTER OF SERBIA   (Serbia)

^f THOMAS JEFFERSON UNIVERSITY   (United States)

^g ULUDAG UNIVERSITY   (Turkey)

^h NATIONAL INSTITUTE OF INFECTIOUS DISEASES   (Romania)

ⁱ GILEAD SCIENCES   (United States)

^j Toronto Liver Centre   (Canada)

^k UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^l VICTOR BABES UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^m ANKARA UNIVERSITY   (Turkey)

ⁿ UNIVERSITY HOSPITAL BRNO   (Czech Republic)

^o MEDICAL UNIVERSITY OF LODZ   (Poland)

^p AUCKLAND CITY HOSPITAL   (New Zealand)

more..

Author keywords

Bone mineral density; Emtricitabine; Lamivudine resistant; Renal function; Tenofovir disoproxil fumarate; Viral suppression

Indexed keywords

ALANINE AMINOTRANSFERASE; EMTRICITABINE; HEMOGLOBIN; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PLACEBO; TENOFOVIR DISOPROXIL; VIRUS DNA; ANTIVIRUS AGENT; TENOFOVIR;

ADULT; ANTIVIRAL THERAPY; ARTHRALGIA; ARTICLE; BLADDER CANCER; BONE DENSITY; CHRONIC HEPATITIS B; CONTROLLED STUDY; CREATININE CLEARANCE; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HEART ARREST; HEPATITIS B VIRUS; HIP; HUMAN; KIDNEY DISEASE; LIVER CELL CARCINOMA; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE TRAUMA; OSTEOPENIA; OSTEOPOROSIS; PANCREAS CANCER; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEROCONVERSION; SPINE; TREATMENT DURATION; TREATMENT RESPONSE; VIRUS RESISTANCE; ANTIVIRAL RESISTANCE; BLOOD; COMBINATION DRUG THERAPY; DRUG EFFECTS; DRUG MONITORING; ISOLATION AND PURIFICATION; PHYSIOLOGY; PROCEDURES; TREATMENT OUTCOME; VIROLOGY; VIRUS LOAD;

ADULT; ANTIVIRAL AGENTS; DNA, VIRAL; DOUBLE-BLIND METHOD; DRUG MONITORING; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; EMTRICITABINE; FEMALE; HEPATITIS B E ANTIGENS; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; MALE; MIDDLE AGED; TENOFOVIR; TREATMENT OUTCOME; VIRAL LOAD;

EID: 85000692609     PISSN: 01688278     EISSN: 16000641     Source Type: Journal    
DOI: 10.1016/j.jhep.2016.08.008     Document Type: Article

References (34)

1. [1] European Association for the Study of the Liver, EASL Clinical Practice Guidelines: management of hepatitis B virus infection. J Hepatol 57 (2012), 167–185.
2. [2] 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.
3. [3] Terrault, N.A., Bzowej, N.H., Chang, K.M., et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology 63 (2016), 261–283.
4. [4] European Medicines Agency. Epivir (lamivudine). Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000107/human_med_000767.jsp&mid=WC0b01ac058001d124. Date accessed: 12/02/2016.
5. [5] Lok, A.S.F., Lai, C.L., Leung, N., et al. Long-term safety of lamivudine treatment in patients with chronic hepatitis. Gastroenterology 125 (2003), 1714–1722.
6. [6] World Health Organization 2015. Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Available at: www.who.int/iris/handle/10665/154590#sthash.E2tZ8jX9.dpuf. Date accessed: 12/02/2016.
7. [7] Chao, D.C., Hu, K.Q., Update on rescue therapies in patients with lamivudine-resistant chronic hepatitis B. Drug Des Dev Ther 7 (2013), 777–788.
8. [8] Lee, Y.B., Lee, J.H., Choi, W.M., et al. Efficacy of adefovir-based combination therapy for patients with lamivudine- and entecavir-resistant chronic hepatitis B virus infection. Antimicrob Agents Chemother 57 (2013), 6325–6332.
9. [9] Tenney, D.J., Rose, R.E., Baldick, C.J., et al. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naïve patients is rare through 5 years of therapy. Hepatology 49 (2009), 1503–1514.
10. [10] Yun, T.J., Jung, J.Y., Kim, C.H., et al. Treatment strategies using adefovir dipivoxil for individuals with lamivudine-resistant chronic hepatitis B. World J Gastroenterol 18 (2012), 6987–6995.
11. [11] Corsa, A.C., Liu, Y., Flaherty, J.F., et al. No resistance to tenofovir disoproxil fumarate through 96 weeks of treatment in patients with lamivudine-resistant chronic hepatitis B. Clin Gastroenterol Hepatol 12 (2014), 2106–2112.
12. [12] 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.
13. [13] Lee, Y.B., Jung, E.U., Kim, B.H., et al. Tenofovir monotherapy versus tenofovir plus lamivudine or telbivudine combination therapy in treatment of lamivudine-resistant chronic hepatitis B. Antimicrob Agents Chemother 59 (2015), 972–978.
14. [14] van Bömmel, F., Wünsche, T., Mauss, S., et al. Comparison of adefovir and tenofovir in the treatment of lamivudine-resistant hepatitis B virus infection. Hepatology 40 (2004), 1421–1425.
15. [15] van Bömmel, F., Zöllner, B., Sarrazin, C., et al. Tenofovir for patients with lamivudine-resistant hepatitis B virus (HBV) infection and high HBV DNA level during adefovir therapy. Hepatology 44 (2006), 318–325.
16. [16] Lee, J.H., Cho, Y., Lee, D.H., et al. Prior exposure to lamivudine increases entecavir resistance risk in chronic hepatitis B patients without detectable lamivudine resistance. Antimicrob Agents Chemother 58 (2014), 1730–1737.
17. [17] Berg, T., Zoulim, F., Moeller, B., et al. Long-term efficacy and safety of emtricitabine plus tenofovir DF vs tenofovir DF monotherapy in adefovir-experienced chronic hepatitis B patients. J Hepatol 60 (2014), 715–722.
18. [18] Ke, W., Liu, L., Zhang, C., et al. Comparison of efficacy and safety of tenofovir and entecavir in chronic hepatitis b virus infection: a systematic review and meta-analysis. PLoS One, 9, 2014, e98865.
19. [19] Buti, M., Tsai, N., Petersen, J., et al. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci 60 (2015), 1457–1464.
20. [20] Clark, J.M., Brancati, F.L., Diehl, A.M., The prevalence and etiology of elevated aminotransferase levels in the United States. Am J Gastroenterol 98 (2003), 960–967.
21. [21] Jacobson IM, Washington MK, Thompson A, et al. Presence of steatosis and HBeAg-positive status are independently associated with persistently elevated serum ALT levels in chronic HBV patients during antiviral therapy. 49th Annual Meeting of the European Association for the Study of the Liver; April 9–13 2014; London, UK; Poster #1084.
22. [22] Idilman, R., Gunsar, F., Koruk, M., et al. Long-term entecavir or tenofovir disoproxil fumarate therapy in treatment-naïve chronic hepatitis B patients in the real-world setting. Viral Hepat 22 (2015), 504–510.
23. [23] 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.
24. [24] Kuo, A., Dienstag, J.L., Chung, R.T., Tenofovir disoproxil fumarate for the treatment of lamivudine-resistant hepatitis B. Clin Gastroenterol Hepatol 2 (2004), 266–272.
25. [25] Lin, B., Ha, N.B., Liu, A., et al. Low incidence of hepatitis B e antigen seroconversion in patients treated with oral nucleos(t)ides in routine practice. J Gastroenterol Hepatol 28 (2013), 855–860.
26. [26] Sherman, M., Yurdaydin, C., Sollano, J., et al. Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 130 (2006), 2039–2049.
27. [27] van Bömmel, F., de Man, R.A., Wedemeyer, H., et al. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology 51 (2010), 73–80.
28. [28] Marcellin, P., Buti, M., Krastev, Z., et al. Kinetics of hepatitis B surface antigen loss in patients with HBeAg-positive chronic hepatitis B treated with tenofovir disoproxil fumarate. J Hepatol 61 (2014), 1228–1237.
29. [29] Ze, E., Baek, E.K., Lee, J.J., et al. Long-term outcomes of two rescue therapies in lamivudine-refractory patients with chronic hepatitis B: combined lamivudine and adefovir, and 1-mg entecavir. Clin Mol Hepatol 20 (2014), 267–273.
30. [30] Ong, A., Wong, V.W., Wong, G.L., et al. Management options for lamivudine-resistant chronic hepatitis B patients with suboptimal virological suppression by adefovir. Aliment Pharmacol Ther 34 (2011), 972–981.
31. [31] Iloeje, U.H., Yang, H.I., Su, J., et al. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 130 (2006), 678–686.
32. [32] Marcellin, P., Ahn, S.H., Ma, X., et al. Combination of tenofovir disoproxil fumarate and peginterferon α-2a increases loss of hepatitis B surface antigen in patients with chronic hepatitis B. Gastroenterology 150 (2016), 134–144.
33. [33] Petersen, J., Heyne, R., Mauss, S., et al. Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B: a 3-year prospective field practice study in Germany. Dig Dis Sci 61 (2016), 3061–3071.
34. [34] Kohler, J.J., Hosseini, S.H., Green, E., et al. Tenofovir renal proximal tubular toxicity is regulated by OAT1 and MRP4 transporters. Lab Invest 91 (2011), 852–858.