Evaluation of potent antiviral therapy in patients with chronic hepatitis B.
Entry
In the treatment of chronic hepatitis B (CHB)
targeted; life expectancy of patients
prolongation and long-term illness
especially the complications
Hepatocellular Carcinoma (HSC)
is protection. Among other targets
prevention of mother-to-child transmission, HBV
reactivation and HBV-related extrahepatic
events are prevented. The most in treatment
important endpoint is HBV DNA suppression.
providing and long-term
1
probability of reaching these goals.
The time of initiation of treatment is important. This
the stage of the disease to determine the time and
patient age is taken into account. in the advanced
HBV first target in patients with cirrhosis
suppression of the second target is the development of HCC.
is to prevent. Final choice of treatment
one of the guides 2019 European
Association for the Study of the Liver (EASL),
strong and resistance barrier as the first choice
Entecavir (ETV), Tenofovir
disoproxil (TDF) or Tenofovir alafenamide
long-term application of (TAF) treatments
2 ETV since 2006, TDF
in our country since 2008.
are potent antivirals.
In this study, in our outpatient
with regular follow-up, good drug compliance
In patients who started ETV or TDF treatment,
virological, serological and
biochemically long term
evaluation of its effectiveness
intended.
Method
Study A retrospective clinical
The study was conducted between 2007 and 2015.
Infection in a tertiary hospital
Diseases and Clinical Microbiology
was done in the clinic. Erciyes for work
From the Ethics Committee of the University of Medicine
(No. 96681246) has been approved.
In the study, those diagnosed with CHB,
111 who had not received prior oral antiviral therapy
patients were included (54 in the TDF group, ETV
57 in the group).
Inclusion criteria for the study; 18
age and above, under 70 years of age, for longer than six months
HBsAg positivity at the beginning of treatment
HBV DNA 104 copies/ml, liver
Histology Ishak stage two and above histology
with an activity index (HAI) of below or above,
TDF or ETV for more than a month
used patients were included. of patients
After starting ETV/TDF therapy
follow-up times were recorded.
Exclusion Criteria in the Study;
Autoimmunity, metabolic liver disease,
decompensated cirrhotic patients, pregnancy, chronic
kidney failure, heart failure and COPD
Patients with such conditions were excluded.
Treatment response in patients
in its evaluation; For viral suppression
HBV DNA negative, biochemical
In response, ALT reduction was also checked.
In addition, changes in hepatitis serologies
was also recorded.
HBV DNA levels “Cobas
TaqManTM 48” (Roche Laboratories,
Germany) was measured with the Real-Time PCR system.
HBV DNA negative value <100 copies/ml
was accepted as ALT level biochemical
determined by the method. The lower limit is 40 IU/L
determined. As a serological indicator, HBsAg,
antiHBs, HBeAg, antiHBe positive/negative
changes are saved.
in laboratory follow-up
ratings 6. 12, 24, 36, 48, 60 and 72.
was done at monthly follow-ups.
Oral antiviral drug changes
was recorded. Patients undergoing medication changes
not working after change
removed.
Before starting treatment, patients
liver biopsy materials Ishak score
4 Patients' baseline Histological
Activity Index (HAI) and fibrosis (stage)
scores were recorded.
The diagnosis of cirrhotic patients is clinical,
biochemical (Transaminases, albumin
level, PT, hypersplenism) and histological
According to the stage (Ishak stage 4 and above)
determined.
Statistical analysis
SPSS for data evaluation
statistical package program for windows 20.0
used. Regarding the measurable variable
data mean ± standard deviation and percentage
presented with. Categorical data
Chi-square test was used for comparison.
Comparison of non-categorical data
Mann Whitney U test was used for p<0.05
values that are statistically significant
accepted.
Results
The patients included in the study
demographic characteristics are listed in Table 1.
Accordingly, age, gender, IFN use
history, ALT level, histology
statistical difference between evaluations
not seen. Initial HBV DNA of patients
level (p=0.02), HBeAg positivity rate TDF
group (p=0.05), treatment follow-up was higher.
duration was higher in the ETV group.
(p=0.04).
99 of the patients included in the study
(89%) liver biopsy was performed and 12
(11%) hemangioma and coagulation
biopsy for reasons such as
determined that it could not be done.
Virological response
Patients in both groups
HBV DNA levels during follow-up Table
It was shown in 2. Initial HBV DNA value
Although higher in the TDF group,
HBV DNA suppression at 6 and 12 months
In ETV group compared to TDF group
statistically significantly more
found to be excessive (p=0.001; p=0.03).