Document Type : Original Article
Authors
1 Associate Professor, School of Medicine, Gastroenterology Department, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran
2 Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran
3 Undergraduate Student of Cell and Molecular Biology, Ferdowsi University of Mashhad, Mashhad, Iran
Abstract
Background:Tenofovir is among the first-line treatments for chronic hepatitis B (CHB) virus infection. We evaluated the efficacy of Tenofovir in the treatment of Iranian adult patients with CHB.
Methods: In a retrospective study, we evaluated 154 HBsAg positive patients referred to Sadoughi hospital in Yazd-Iran for treatment during 2009-2014. Forty-five patients were naive and 109 patients were treated previously with lamivudine or interferon. HBs Ag, HBeAg, HBeAb and quantitative HBV- DNA PCR were measured. The patients with HBV DNA >10,000 copy per ml in precore mutant and HBV DNA>100,000 copy per ml in wild type and ALT >two times of normal value were included. Tenofovir disoproxil fumarate 300 mg was administered and continued for three years. Data were analyzed using SPSS19.
Results: We enrolled 154 (109 males 45 female) patients. Mean age of patients was 41± 8 years (18-58 year old). Forty-five of them were naive and the rest had previously experienced treatment. In this study, 113 of patients were of wild type and 41 patients were precore mutant variant. In wild type patients, 25 ones were naive and in precore mutant subtype, 20 patients were naive.
HBsAg disappeared in 5 patients (3.2 percent). Forty one of 45 patients in the naive group (91 percent) and 96 of 109 patients in the previously treated group (88 percent) were cured. AST and ALT levels decreased in over 80 percent of patients and means of AST and ALT levels showed more decrease in naive and precore mutant subgroups. Serum AST and ALT and HBV DNA were higher in the wild type group than in the precore mutant group. Seroconversion occurred in 69 out of 113 patients at the end of the study.
Conclusion: Treatment response rate to Tenofovir in Iranian patients with CHB was high. Tenofovir could be recommended as the first-line therapy of chronic HBV infection in Iran.
Keywords
- Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, et al. Tenofovir disoproxil fumarate versus adefovirdipivoxil for chronic hepatitis B. N Engl J Med 2008; 359(23):2442-55.
- Lok AS, McMahon BJ, Brown RS, Wong JB, Ahmed AT, Farah W, et al. Antiviral therapy for chronic hepatitis B viral infection in adults: a systematic review and meta-analysis. Hepatology 2016; 63(1):284–306.
- Alavian SM, Fallahian F, LankaraniKB. The changing epidemiology of viral hepatitis B in Iran. J Gastrointestin Liver Dis 2007; 16(4):403-406.
- Salehi-Vaziri M, Sadeghi F, Almasi Hashiani A, Gholami Fesharaki M, Alavian SM. Hepatitis B virus infection in the general population of Iran: an updated systematic review and meta-analysis. Hepat Mon 2016; 16(4):e35577.
- Cho JY, Paik YH, Sohn W, Cho HC, Gwak GY, Choi MS, et al. Patients with chronic hepatitis B treated with oral antiviral therapyretain a higher risk for HCC compared with patients with inactive estage disease. Gut 2014; 63(12):1943–50.
- European Association for the Study of the Liver. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol 2017; 67(2):370-98.
- Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009; 50(3):661-2.
- Kose S, Turken M, Cavdar G, Akkoclu G. The effectiveness of nucleoside analogues in chronic hepatitis B patients unresponsive to interferon therapy: our clinical trials for one year. Hepat Mon 2010; 10(4):289-93.
- Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006; 354(10):1001–10.
- Lai CL, Shouval D, Lok AS, Chang TT, Cheinguer H, Goodman Z, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006; 354(10):1011–20.
- Leung N, Peng CY, Hann HW, Sollano J, Lao-Tan J, Hsu CW, et al. Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: a randomized international study of entecavir versus adefovir. Hepatology 2009; 49(1):72–9.
- European Association for the Study of The Liver. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol 2012; 57(1):167–85.
- Park JW, Kwak KM, Kim SE, Jang MK, Suk KT, Kim DJ, et al. Comparison of the long-term efficacy between entecavir and tenofovir in treatment- naïve chronic hepatitis B patients. BMC Gastroenterol 2017; 17:39.
- Peters MG, Andersen J, Lynch P, Liu T, Alston‐Smith B, Brosgart CL, et al. Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127. Hepatology 2006; 44(5):1110-6.
- Petersen J, Heyne R, Mauss S, Schlaak J, Schiffelholz W, Eisenbach C, 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 2016; 61(10):3061-71.
- Marcellin P, Zoulim F, Hézode C, Causse X, Roche B, Truchi R, et al. Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis b: a 3-year, prospective, real-world study in France. Dig Dis Sci 2016; 61(10):3072-83.
- Bakhshizadeh F, Hekmat S, Keshvari M, Alavian SM, Mostafavi E, Keivani H, et al. Efficacy of tenofovir disoproxil fumarate therapy in nucleoside-analogue naive Iranian patients treated for chronic hepatitis B. Hepat Mon 2015; 15(5):e25749.
- 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(1):73-80.
- Ahn HJ, Song MJ, Jang JW, Bae SH, Choi JY, Yoon SK. Treatment efficacy and safety of tenofovir-based therapy in chronic hepatitis B: a real life cohort study in Korea. PLoS One 2017; 12(1): e0170362.
- Hann HW, Chae HB, Dunn SR. Tenofovir (TDF) has stronger antiviral effect than adefovir (ADV) against lamivudine (LAM)-resistant hepatitis B virus (HBV). Hepatol Int 2008; 2(2):244-9.
- Ataei B, Khodadoostan M, Pouria B, Adibi P. Tenofovir in treatment of Iranian patients with chronic hepatitis B virus infection: an open-label case series. J Res Pharm Pract 2016; 5(3):166-70.
- Ceylan B, Yardimci C, Fincanci M, Eren G, Tozalgan U, Muderrisoglu C, et al. Comparison of tenofovir and entecavir in patients with chronic HBV infection. Eur Rev Med Pharmacol Sci 2013; 17(18):2467-73.