Perbandingan Profil Keamanan Tenofovir dan Telbivudin terhadap Fungsi Ginjal pada Pasien Hepatitis B di Indonesia

Abstract

ABSTRAKPendahuluan. Tenofovir disoproksil fumarat (tenofovir) dan telbivudin merupakan dua analog nukleos(t)ida yang tersedia untuk terapi pasien hepatitis B. Tenofovir telah diketahui sebagai agen nefrotoksik pada pasien HIV, namun masih menjadi kontroversi pada pasien hepatitis B kronik. Di lain sisi, telbivudin memiliki efek proteksi terhadap fungsi ginjal dan bahkan meningkatkan estimasi laju filtrasi glomerulus (eLFG). Penelitian ini bertujuan untuk mengetahui profil keamanan terhadap fungsi ginjal dari tenofovir dan telbivudin pada pasien hepatitis B kronik di Indonesia.Metode. Penelitian ini menggunakan desain studi kohort retrospektif pada pasien hepatitis B kronik yang mendapat terapi tenofovir atau telbivudin dalam rentang waktu Januari 2013-Desember 2016. Pasien yang mempunyai eLFG awal <60 mL/ menit/1,73 m 2 sebelum mulai terapi, mengalami perubahan regimen, lost to follow up, atau meninggal dalam 1 tahun tidak diikutsertakan dalam penelitian ini. Data kreatinin serum yang dinilai adalah data pada minggu ke-24 dan 48 setelah pemberian tenofovir atau telbivudin.Hasil. Sebanyak 68 pasien dalam terapi tenofovir dan 62 pasien dalam terapi telbivudin dimasukkan penelitian ini. Kadar kreatinin serum meningkat pada kelompok tenofovir dari 0,88 (simpang baku [SB] 0,17) mg/dL pada awal studi menjadi 0,93 (SB 0,22) mg/dL setelah 24 minggu (p = 0,02) dan cenderung plateau setelah penggunaan selama 48 minggu. Namun, pada kelompok telbivudin, kadar kreatinin serum menurun dari 0,85 (SB 0,21) mg/dL pada awal menjadi 0,80 (SB 0,18) mg/ dL pada minggu ke-48 (p = 0,003) Simpulan. Tenofovir berhubungan dengan peningkatan kadar kreatinin serum dan penurunan eLFG pada pasien hepatitis B kronik dengan eLFG ≥60 mL/menit/1,73 m 2 . ABSTRACTIntroduction. Tenofovir disoproxil fumarate (tenofovir) and telbivudine are two available nucleos(t)ide analogue (NA) for the treatment of chronic hepatitis B (CHB) patients. Tenofovir has been known as a nephrotoxic agent in HIV patients, but still controversy in CHB patients. On the other hand, telbivudine had a renal protective effect and increased estimated glomerular filtration rate (eGFR). This studi aimed to address the renal safety of tenofovir and telbivudine in Indonesian patients. Method.A retrospective cohort study design was conducted in CHB patients who prescribed with tenofovir or telbivudine from January 2013 to December 2016. Patients who hade baseline eGFR <60 mL/min/1.73 m 2 , change the regimen, lost to follow up, or died within a year were excluded in this study. Creatinine serum data evaluated were creatinine serum in week-24 and week-48 after the administration of tenofovir or telbivudine.Results. Among CHB patients, 68 and 62 patients that prescribed with tenofovir or telbivudine, respectively, were enrolled in this study. Serum creatinine level was increased in tenofovir group from 0.88 (SD 0.17) mg/dL at baseline to 0.93 (SD 0.22) mg/dL after 24 weeks (p = 0.02), but creatinine trend to reach plateau after 48 weeks. However, in telbivudine group, serum creatini...

Efficacy of 24-week Administration of Tenofovir Disoproxil Fumarate in the Management of Naïve Chronic Hepatitis B

“…According to literature, mean age of patients with CHB ranges from 30.3 to 40.4 years [10]. Other study reported a higher mean which was 51.3 years [16]. Shi et al reported a younger range of age which was 33.7 to 35.1 years [10].…”

“…Good efficacy of treatment is affected by HBeAgnegative status, lower baseline HBV DNA level, and lower HBsAg level [2], [19]. In addition, HBV virion is difficult to clear from hepatocytes because of the presence of covalently closed circular DNA in the host's cell nucleus [12], [16].…”

“…Other disadvantages of nucleotide analogs in treating CHB are indefinite duration of treatment, risk of developing resistance, and less HBeAg and HBsAg conversions [9], [15]. Only one single-centered study was found that has discussed the efficacy and side effects of tenofovir in Indonesia [16,17,18]. Moreover, Indonesia is a country with a diversity of cultures, religions, and races so that the research on the efficacy of TDF against CHB infection regarding that heterogeneity is in need.…”

Factors Affecting the Long-Term Protection Against Hepatitis B Immunization in Infancy: A Meta-Analysis

“…[2][3][4] One of the HBV infection transmissions, known as mother-to-child transmission (MTCT) or vertical transfer, can happen during pregnancy. 5 To stop the spread of various diseases that can be prevented by vaccination, including hepatitis B, the Indonesian government has recently included the hepatitis B vaccination for toddlers in an immunization development program known as the Expanded Program on Immunization (EPI). Vaccination efforts have been able to reduce the number of people with the HBB and acute morbidity.…”

“…According to WHO, after completing the recommended immunization schedule, Hepatitis B vaccination should result in a level of antibody protection in 95% of individuals. [3][4][5] Several related studies have shown that titers of Hepatitis B surface antibodies (anti-HBs) still provide a protective effect at 2-4 years, seven years, and even up to 12 years after primary vaccination. 8,9 Each individual's reaction to the hepatitis B vaccine's protective effect varies, and several factors, including age, male sex, obesity, chronic disease, genetic factors, alcohol use, and immunosuppressive conditions, affect how much seroprotection remains in those who have received the vaccine.…”