Document Type : Original Article
Authors
1 Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Department of Gastroenterology and Hepatology, Isfahan University of Medical Sciences, Isfahan, Iran
3 Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
Abstract
Objective: Tenofovir is among the first‑line treatments for chronic hepatitis B (CHB)
virus infection. We evaluated the efficacy and safety of Tenofovir in treatment of Iranian
patients with CHB.
Methods: Forty treatment‑native patients with CHB but without concurrent hepatitis C or
human immunodeficiency virus infections were treated with Tenobiovir(™) 300 mg/day.
The hepatitis B virus (HBV) DNA load, hepatitis B e antigen (HBe Ag), anti‑hepatitis B
e antibody (HBe Ab), liver enzymes, and creatinine were measured before and at least
3 months after the treatment.
Findings: The mean age of patients was 38.1 ± 12.4 years and 65% of them were
male. Seventeen (42.5%) patients were HBe Ag‑positive and 15 (37.5%) patients had
alanine aminotransferase (ALT) of two times above the normal. The HBV DNA load was
significantly decreased after the treatment(P < 0.001). Twenty‑seven (67.5%) patients
had viral load of ≤2000 IU/ml and 22 (55%) patients had undetectable HBV DNA level
after the treatment. Among positive HBe Ag patients, the HBe Ag became negative in
15 (88.2%) patients after the treatment and HBe Ab became positive in 3 (17.6%)
patients. Liver enzymes’ levels were significantly decreased after the treatment(P <0.05)
and ALT transaminase level became normalized in 86.7% (13 out of 15) of cases with
baseline levels twice the normal.
Conclusion: Treatment response rate to Tenofovir in Iranian patients with CHB was high.
The virological and serological response rate and safety of Tenofovir in our population
was comparable to other populations. Considering availability and costs, Tenobiovir(™)
could be recommended as the first‑line therapy of chronic HBV infection in Iran.
Keywords
treatment, and current and emerging prevention and control
measures. J Viral Hepat 2004;11:97‑107.
2. Ott JJ, Stevens GA, Groeger J, Wiersma ST. Global
epidemiology of hepatitis B virus infection: New estimates of
age‑specific HBsAg seroprevalence and endemicity. Vaccine
2012;30:2212‑9.
3. Alavian SM, Fallahian F, Lankarani KB. The changing
epidemiology of viral hepatitis B in Iran. J Gastrointestin Liver
Dis 2007;16:403‑6.
4. Shakeri MT, Foghanian B, Nomani H, Ghayour‑Mobarhan M,
Nabavinia MS, Rostami S, et al. The prevalence of hepatitis B
virus infection in mashhad, iran: A population‑based study.
Iran Red Crescent Med J 2013;15:245‑8.
5. Keyvani H, Sohrabi M, Zamani F, Poustchi H, Ashrafi H,
Saeedian F, et al. A population based study on hepatitis B
virus in Northern Iran, Amol. Hepat Mon 2014;14:e20540.
6. Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH,
et al. Asian‑Pacific consensus statement on the management of
chronic hepatitis B: A 2008 update. Hepatol Int 2008;2:263‑83.
7. Lok AS, McMahon BJ. Chronic hepatitis B: Update 2009.
Hepatology 2009;50:661‑2.
8. 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.
9. Scaglione SJ, Lok AS. Effectiveness of hepatitis B treatment in
clinical practice. Gastroenterology 2012;142:1360‑8.e1.
10. Buti M, Oyagüez I, Lozano V, Casado MA. Cost effectiveness
of first‑line oral antiviral therapies for chronic hepatitis B: A
systematic review. Pharmacoeconomics 2013;31:63‑75.
11. Ghany MG, Doo EC. Antiviral resistance and hepatitis B
therapy. Hepatology 2009;49 5 Suppl:S174‑84.
12. Fontana RJ. Side effects of long‑term oral antiviral therapy for
hepatitis B. Hepatology 2009;49 5 Suppl:S185‑95.
13. Woo G, Tomlinson G, Nishikawa Y, Kowgier M, Sherman M,
Wong DK, et al. Tenofovir and entecavir are the most
effective antiviral agents for chronic hepatitis B: A systematic
review and Bayesian meta‑analyses. Gastroenterology
2010;139:1218‑29.
14. Lin CL, Kao JH. The clinical implications of hepatitis B
virus genotype: Recent advances. J Gastroenterol Hepatol
2011;26 Suppl 1:123‑30.
15. Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R,
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.
16. Janssen HL, van Zonneveld M, Senturk H, Zeuzem S,
Akarca US, Cakaloglu Y, et al. Pegylated interferon alfa‑2b
alone or in combination with lamivudine for HBeAg‑positive
chronic hepatitis B: A randomised trial. Lancet 2005;365:123‑9.
17. Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S,
Cooksley G, et al. Peginterferon Alfa‑2a, lamivudine, and the
combination for HBeAg‑positive chronic hepatitis B. N Engl
J Med 2005;352:2682‑95.
18. Dienstag JL, Schiff ER, Wright TL, Perrillo RP, Hann HW,
Goodman Z, et al. Lamivudine as initial treatment for chronic
hepatitis B in the United States. N Engl J Med 1999;341:1256‑63.
19. ChangTT, GishRG, de ManR, GadanoA, SollanoJ, ChaoYC, et al.
A comparison of entecavir and lamivudine for HBeAg‑positive
chronic hepatitis B. N Engl J Med 2006;354:1001‑10.
20. Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H,
Goodman Z, et al. Entecavir versus lamivudine for patients
with HBeAg‑negative chronic hepatitis B. N Engl J Med
2006;354:1011‑20.
21. Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y,
et al. Telbivudine versus lamivudine in patients with chronic
hepatitis B. N Engl J Med 2007;357:2576‑88.
22. Köklü S, Tuna Y, Gülsen MT, Demir M, Köksal AS, Koçkar MC,
et al. Long‑term efficacy and safety of lamivudine, entecavir,
and tenofovir for treatment of hepatitis B virus‑related
cirrhosis. Clin Gastroenterol Hepatol 2013;11:88‑94.
23. Lai CL, Chien RN, Leung NW, Chang TT, Guan R,
Tai DI, et al. A one‑year trial of lamivudine for chronic
hepatitis B. Asia Hepatitis Lamivudine Study Group. N Engl
J Med 1998;339:61‑8.
24. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT,
Kitis G, Rizzetto M, et al. Adefovir dipivoxil for the treatment
of hepatitis B e antigen‑negative chronic hepatitis B. N Engl J
Med 2003;348:800‑7.
25. Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W,
Shiffman ML, et al. Adefovir dipivoxil for the treatment of
hepatitis B e antigen‑positive chronic hepatitis B. N Engl J
Med 2003;348:808‑16.
26. Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA,
Krastev Z, et al. Tenofovir disoproxil fumarate versus adefovir
dipivoxil for chronic hepatitis B. N Engl J Med 2008;359:2442‑55.
27. Chan HL, Chan CK, Hui AJ, Chan S, Poordad F, Chang TT,
et al. Effects of tenofovir disoproxil fumarate in hepatitis
B e antigen‑positive patients with normal levels of alanine
aminotransferase and high levels of hepatitis B virus DNA.
Gastroenterology 2014;146:1240‑8.
28. van Bömmel F, Wünsche T, Mauss S, Reinke P, Bergk A,
Schürmann D, et al. Comparison of adefovir and tenofovir
in the treatment of lamivudine‑resistant hepatitis B virus
infection. Hepatology 2004;40:1421‑5.
29. van Bömmel F, de Man RA, Wedemeyer H, Deterding K,
Petersen J, Buggisch P, et al. Long‑term efficacy of tenofovir
monotherapy for hepatitis B virus‑monoinfected patients
after failure of nucleoside/nucleotide analogues. Hepatology
2010;51:73‑80.
30. Murray KF, Szenborn L, Wysocki J, Rossi S, CorsaAC, Dinh P,
et al. Randomized, placebo‑controlled trial of tenofovir
disoproxil fumarate in adolescents with chronic hepatitis B.
Hepatology 2012;56:2018‑26.
31. Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P,
et al. Efficacy of tenofovir disoproxil fumarate at 240 weeks
in patients with chronic hepatitis B with high baseline viral
load. Hepatology 2013;58:505‑13.
32. Fung S, Kwan P, Fabri M, Horban A, Pelemis M, Hann HW,
et al. Randomized comparison of tenofovir disoproxil
fumarate vs emtricitabine and tenofovir disoproxil fumarate
in patients with lamivudine‑resistant chronic hepatitis B.
Gastroenterology 2014;146:980‑8.
33. Gao L, Trinh HN, Li J, Nguyen MH. Tenofovir is superior
to entecavir for achieving complete viral suppression in
HBeAg‑positive chronic hepatitis B patients with high HBV
DNA. Aliment Pharmacol Ther 2014;39:629‑37.