Open Access Maced J Med Sci. 2020 Oct 21; 8(B):1005-1009. 1005
Scientifc Foundation SPIROSKI, Skopje, Republic of Macedonia
Open Access Macedonian Journal of Medical Sciences. 2020 Oct 21; 8(B):1005-1009.
https://doi.org/10.3889/oamjms.2020.5424
eISSN: 1857-9655
Category: B - Clinical Sciences
Section: Infective Diseases
Efcacy of 24-week Administration of Tenofovir Disoproxil
Fumarate in the Management of Naïve Chronic Hepatitis B
Darmadi Darmadi, Gontar Alamsyah Siregar*
Division of Gastroenterohepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Sumatera Utara, Medan,
Indonesia
Abstract
BACKGROUND: Chronic hepatitis B (CHB) is becoming a common liver abnormality worldwide. Thus, a series
of good management is needed to prevent the progression and complications of hepatitis B infection. Tenofovir
disoproxil fumarate (TDF) is one of the drugs of choice that’s used for CHB management.
AIM: Limited studies were found regarding the efcacy of tenofovir in dealing with CHB. Hence, the aim of this study
is to determine the efcacy of TDF administration for 24 weeks in subjects with naïve CHB in Medan, Indonesia.
METHODS: Retrospective study was conducted in Haji Adam Malik Hospital Medan, Indonesia, between January
and December 2019. Subjects were CHB patients aged 18 years or older and were treated TDF for 24 weeks.
Demographic, clinical, and CHB disease progression parameters (serum alanine aminotransferase [ALT], hepatitis B
envelope antigen [HBeAg], and hepatitis B virus deoxyribonucleic acid [HBV DNA]) data were obtained.
RESULTS: One hundred and twenty subjects were obtained and divided into 2 groups: HBeAg positive and HBeAg
negative. Mean age of subjects was 46.5 ± 10.36 years in HBeAg positive group and 48.6 ± 10.67 years HBeAg
negative group, with predominant males’ subjects in both groups (58.3% vs. 61.7%, respectively). Serum ALT
normalization and undetectable serum HBV DNA were observed in more than 70% and 65% of subjects in both
groups, respectively (both p < 0.001). Serum HBeAg loss was achieved in 10.8% subjects (p < 0.001). No subject
showed serum HbsAg loss.
CONCLUSION: Our results are consonant with current clinical guidelines and other evidence literature. For both
HBeAg-positive and HBeAg-negative populations, TDF administration for 24 weeks has good efcacy in naïve CHB
patients.
Edited by: Slavica Hristomanova-Mitkovska
Citation: Darmadi D, Siregar GA. Efcacy of 24-week
Administration of Tenofovir Disoproxil Fumarate in the
Management of Naïve Chronic Hepatitis B. Open Access
Maced J Med Sci. 2020 Oct 21; 8(B):1005-1009.
https://doi.org/10.3889/oamjms.2020.5424
Keywords: Chronic hepatitis B; Efcacy; HBeAg; HBV
DNA; Tenofovir disoproxil fumarate
*Correspondence: Gontar Alamsyah Siregar, Dr. Mansyur
5, Medan, Indonesia, E-mail: gontarsir@gmail.com
Received: 06-Sep-2020
Revised: 10-Oct-2020
Accepted: 11-Oct-2020
Copyright: © 2020 Darmadi Darmadi,
Gontar Alamsyah Siregar
Funding: This research did not receive any fnancial
support
Competing Interests: The authors have declared that no
competing interests exist.
Open Access: This is an open-access article distributed
under the terms of the Creative Commons Attribution-
NonCommercial 4.0 International License (CC BY-NC 4.0)
Introduction
Hepatitis B virus, also known as HBV, is a
double-stranded deoxyribonucleic acid (DNA) virus
from the hepadnavirus family that causes acute
and chronic liver infections in human [1]. From the
epidemiological perspective, the highest prevalence
of CHB is reported in Africa and Asia [2]. According to
Baseline Health Research, the prevalence of Hepatitis
B in Indonesia increased from 0.2% in 2013 to 0.4% in
2018 [3]. Although the coverage for early detection and
immunization for hepatitis B has always reached the
target until 2017 [4], Indonesia is still categorized as a
moderate-to-highly endemic region for HBV infection [5].
The majority cases of Hepatitis B can progress to
chronic liver disease, with the chronicity depends on
the time exposure to hepatitis B virus (HBV) [6]. If left
untreated, the disease can lead to fatal complications,
including cirrhosis, liver failure, and hepatocellular
carcinoma [6], [7], [8]. In fact, after 5 years of sufering
from CHB, the risk of developing hepatocellular
carcinoma increases up to 17% in Eastern countries
compared to 10% in western countries. The 5-year
survival rate for patients with decompensated liver
cirrhosis due to HBV is 17–35% [9]. Thus, a series of
good management is needed to prevent the progression
and complications of Hepatitis B infection.
There are many diferent treatment options
available. Treatments that are used in CHB management
are peginterferon-alpha, lamivudine (LMV), adefovir
(ADV), telbivudine, entecavir (ETV), and tenofovir
(TDF) [7]. Several parameters are used to monitor CHB
progression such as serum alanine aminotransferase
(ALT) level, HBV DNA level, antigens specifc to HBV,
and histopathological examination [1], [7], [10], [11].
Viral suppression, ALT normalization, absence of viral
resistance, HBeAg loss, HBsAg seroconversion, and liver
histology improvement are the short-term goals regarding
with CHB infection [1]. Furthermore, the long-term aims
of management of CHB are to improve survival rate
and to prevent complications [2], [9], [10]. Moreover, the
treatment for this condition may need to be lifelong, thus
the drugs used must be both efcacious and safe [11].
TDF is one of the nucleotide analogue drug that is
used as the frst-line treatment of CHB [8], [12, [13], [14].