Original Article

Factors Affecting the Treatment Success of Short-Term Regimen for

Drug Resistant Tuberculosis (DR TB) Patients at Dr. Saiful Anwar
General Hospital Malang

Fahmi Adhi Prasetya1, Yani Jane Sugiri1, Teguh Rahayu Sartono1, Harun Al Rasyid2
1Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Universitas Brawijaya -
RS Dr. Saiful Anwar Malang, Indonesia
2Laboratory of Public Health and Preventive Medicine, Faculty of Medicine, Universitas Brawijaya, Indonesia

Abstract Corresponding Author:

Fahmi Adhi Prasetya |
Background: Tuberculosis/TB is a major health problem in the world. Indonesia ranks 3rd in TB Department of Pulmonology and
cases and 7th in drug resistant (DR) TB cases in the world. In 2016, WHO recommended short term Respiratory Medicine, Faculty of
(9–11 month) regimen treatment with a success rate of 84% in several Asian and African countries. Medicine, Universitas Brawijaya - RS
The purpose of this study was to determine factors that influence the success and failure of Dr. Saiful Anwar Malang, Indonesia |
treatment using short-term regimen for DR TB patients at Dr. Saiful Anwar General Hospital Malang. [email protected]
Methods: This was an analytic observational study with retrospective cohort design on 85 short-term
Submitted: January 24th, 2020
regimen DR TB patients who started treatment on October 1, 2017 to September 30, 2018 at the DR
Accepted: June 27th, 2022
TB ward of Dr. Saiful Anwar General Hospital Malang. Data analysis used chi square test with
Published: July 11th, 2022
alternative fisher exact test and logistic correlation test.
Results: Education level had a significant correlation with treatment success (P=0.036; OR=2.746;
CI 95%=1.053-7.165) while Pre XDR TB sputum drug susceptibility test had a significant correlation J Respirol Indones. 2022
with treatment failure (P=0.037; OR=1.556; CI 95%=1.180-2.050). Based on logistic correlation test, Vol. 42 No. 3: 191–8
the predictive variables for treatment outcomes were age, education, criteria for suspected DR TB https://doi.org/10.36497/jri.v40i3.360
and drug susceptibility test results of pre XDR TB.
Conclusion: The level of education affected the success treatment of DR TB short-term regimen.
The results of Pre XDR TB sputum drug susceptibility test influenced the failure of DR TB short-term Creative Commons
regimen. Attribution-
NonCommercial 4.0
Keywords: Drug Resistant TB, Short Term Regimen, Success Treatment International License

INTRODUCTION Currently in Indonesia, there has been a

decline in the success rate for DR TB treatment,
Tuberculosis (TB) is one of the world’s health
from 67.9% (2010) to 51.1% (2013), and an
problems and is one of the leading cause of death
increase in the rate of loss to follow-up (LFU) from
among the 10 most common diseases in the world.
10.7% (2009) to 28.7% (2013).3 Data at Dr. Saiful
WHO data in 2018 mentioned that Indonesia ranked
Anwar General Hospital Malang from January 2014
3rd of highest TB case in the world after India and
to December 2016 of 57 patients receiving DR TB
China.1
treatment, 17 patients recovered (29.82%), 15
Resistance to first-line Anti-Tuberculosis
patients died (26.32%), and 25 patients dropped out
Drugs (ATD) is an obstacle in achieving TB targets.
of treatment (43.86%).4
About 5% of all TB cases are drug resistant (DR) TB.
The current management of DR TB takes a
WHO data in 2007 stated that the percentage of
long time and requires high costs, both for the
primary resistance worldwide had 17.0% cases of
program and for patients. Worldwide DR TB
polyresistance, 10.3% monoresistance, and 2.9%
surveillance data also showed unsatisfactory results
multidrug resistance (MDR). Meanwhile, in
in terms of the long-term standardized treatment
Indonesia, the primary resistance to MDR TB was
success rate, which was around 62%. In 2016,
2%.2 WHO data in 2018 pointed out that Indonesia
WHO issued a recommendation for using
ranked 7th of the highest DR TB prevalence in the
standardized short-term treatment combinations of
world.1

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 Fahmi Adhi Prasetya: Factors Affecting the Treatment Success of Short-Term Regimen for Drug Resistant Tuberculosis (DR TB) Patients

9–11 months which indicated promising outcomes investigations, drugs adverse effects, and HIV status
based on the results of various observational studies of patients with short-term standard treatment for
in several Asian and African countries with treatment DR TB. The dependent variable was the treatment
success rate of 84%. Currently, there are two success of patients with DR TB short-term treatment.
combinations of treatment in Indonesia, namely a The recorded data were then processed,
combination of standard short-term treatment and a analyzed, and interpreted. The analysis used in this
combination of individual treatment. Treatment study were univariate, bivariate, and multivariate
success for DR TB patients can be seen from analysis. Chi-square test was used to evaluate the
several factors: health workers and TB control correlation between the independent and dependent
programs, patients, drugs, economy, comorbidity variables, while the alternative Fisher exact test was
factors, HIV/AIDS factors, and drug adverse used if requirements were not met. Logistic
effects.3 regression was applied to determine the most
In general, this study aimed to determine the influential correlation between the independent and
treatment success rate of patients with standard dependent variables. These measurements of
short-term regimen for DR TB and specifically to variables were carried out using Microsoft Office
identify the factors that influence the success and Excel 2010 program and SPSS 25.0.
failure of standard short-term regimen for DR TB
patients at Dr. Saiful Anwar General Hospital RESULTS
Malang.
The sociodemographic characteristics of the
study subjects and the sociodemographic
METHODS
correlation to the success of DR TB short-term
This study used an analytic observational treatment are shown in Table 1. Based on the
design with a cohort retrospective approach. The sociodemographic characteristics of the study
study subjects were all DR TB patients on short- subjects, the majority were male (61.2%), the mean
term combination treatment who met the inclusion age of subjects in the treatment group was 40.08
and exclusion criteria. years with a median of 42 years (Figure 1), had low
Inclusion criteria were patients aged 18 years education (61.2%), risk occupation group (84.7%),
and patients who had at least one day of treatment had low income (62.3%), domiciled outside Malang
with a short-term combination of DR TB recorded in (52.9%), had a history of smoking (55.3%), had
the MDR clinic medical record of Dr. Saiful Anwar diabetes melitus (DM) comorbidity (41.2%), came
General Hospital Malang on October 1, 2017 to from the criteria for non-relapse cases (54.1%), and
September 30, 2018. Exclusion criteria were had non-underweight BMI (55.3%).
patients who did not meet the requirements for DR
TB short-term combination treatment.
Age
The study used secondary data (review of
70
medical record documents and e-TB manager data) 60
at the MDR TB clinic of Dr. Saiful Anwar General 50
Hospital Malang from January 2019 to June 2019. 40
Age

30
The ethics committee had approved every
20
procedure.
10
The independent variables of the study were 0
age, gender, education level, occupation, income, Gagal
Failed Berhasil
Success

domicile, criteria for suspected DR TB, nutritional Treatment Results

status, comorbidities, smoking history, results of Figure 1. Age Difference in Failed Treatment and Successful
Treatment Groups

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 Fahmi Adhi Prasetya: Factors Affecting the Treatment Success of Short-Term Regimen for Drug Resistant Tuberculosis (DR TB) Patients

Table 1. Characteristics and Sociodemographic Effects on Treatment Success

Treatment Results
Variable Failure Successful Total P
n % n % n %
Occupation No Risk 11 84.6 2 15.4 13 15.3
0.328*
At Risk 49 68.1 23 31.9 72 84.7
Gender Male 39 75 13 25 52 61.2
0.262
Female 21 63.6 12 36.4 33 38.8
Income Low 36 67.9 17 32.1 53 73.6
0.705
High 12 63.2 7 36.8 19 26.4
Education Low 41 78.8 11 21.2 52 61.2
0.036
High 19 57.6 14 42.4 33 38.8
Smoking Status Smoker 35 74.5 12 25.5 47 55.3
0.383
Non-smoker 25 65.8 13 34.2 38 44.7
Area Malang 26 65.0 14 35.0 40 47.1
0.286
Outside Malang 34 75.6 11 24.4 45 52.9
BMI Underweight 25 65.8 13 34.2 38 44.7
0.383
Non-Underweight 35 74.5 12 25.5 47 55.3
Criteria for Suspected DR TB Relapsed 30 76.9 9 23.1 39 45.9
0.238
Non-Relapse 30 65.2 16 34.8 46 54.1
Comorbid Existed 27 73 10 27 37 43.8
0.811*
Non-existent 33 68.8 15 31.2 48 56.5
HIV Existed 1 100 0 0 1 1.2
1.00*
Non-existent 59 70.2 25 29.8 84 98.8
DM Existed 25 71.4 10 28.6 35 41.2
0.887
Non-existent 35 70 15 30 50 58.8

Table 2. The Effect of Supportive Examination Results and Drugs Adverse Effects on Treatment Success
Treatment Results
Variable Failure Successful Total
P
n % n % n %
Sputum AFB Conversion Time Mean 1.318 1.40 1.351 0.511*
Median 1 1 1
Sputum Culture Conversion Time Mean 1.407 1.50 1.449 0.950*
Median 1 1 1
Chest X-Ray Extensive 59 67.9 25 32.1 84 91.8 0.100
Minimum 1 100 0 0 1 8.2
Sputum drug susceptibility test Monoresistance 0 0 1 100 1 1.6 0.379
RR 13 60.9 9 31.7 22 36.5 0.802
MDR 19 64.3 10 35.7 29 44.4 Reff
Pre-XDR 11 100 0 0 11 17.5 0.037
Drugs Adverse Effects Exist 41 66.1 21 33.9 62 72.9
0.139
None 19 82.6 4 17.4 23 27.1

To determine the correlation between with the success of short-term treatment regimen for
sociodemography and the success of short-term DR TB. Meanwhile, the Mann Whitney test results
standardized treatment for DR TB, the chi-square indicated that age was not significantly related to
test and the Mann Whitney test were carried out. In the success of short-term DR TB treatment
this study, based on the results of the chi-square (P=0.218). Only the patient education variable was
test, it was found that gender (P=0.262), occupation significantly related to the success of short-term
(P=0.328), income (P=0.705), domicile (P=0.286), treatment for DR TB (P=0.036).
smoking history (P=0.383), criteria for suspected The characteristics of AFB sputum conversion
DR TB (P=0.238), BMI (P=0.383), comorbid status time and culture, chest X-ray (CXR) results, sputum
(P=0,811), DM comorbidity (P=0.887) and HIV examination results for first line and second line
status (P=1.00) were not significantly associated drug sensitivity tests, drugs adverse effects, and

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 Fahmi Adhi Prasetya: Factors Affecting the Treatment Success of Short-Term Regimen for Drug Resistant Tuberculosis (DR TB) Patients

their effects on the success of DR TB treatment can results and sputum drug susceptibility test results
be seen in Table 2. Percentage of treatment results affected the success of DR TB treatment, as
the effect of supporting examination results and drug confirmed by the Chi-Square test. AFB sputum
side effects on success treatment: the most conversion time (P=0.511), sputum culture
extensive CXR results (91.8%), the results of conversion time (P=0.950), CXR results (P=0.100),
sputum examinations for line 1 and 2 drug sensitivity sputum results from monoresistance drug sensitivity
tests with the most MDR (34.1%), many have side test (P=0.379), rifampicin resistance/RR (P=0.802)
effects of treatment (72.9%). and drug adverse effects (P=0.139) were not
significantly related to the success of DR TB short-
Table 3. Treatment Outcome, Causes of Switching to
Individualized Regimens, Treatment Dropout, Drugs term treatment. Only pre-XDR drug susceptibility
Adverse Effects
Parameter n Percentage (%) test results were significantly associated with DR TB
Treatment End Result short-term treatment failure (P=0.037).
Complete treatment 11 12.9
The final results of treatment, causes of
Recovered 14 16.5
Dropout 26 30.6 switching individual regimens, causes of treatment
Treatment failure 2 2.4 discontinuation, and drug adverse effects of study
Died 13 15.3 subjects are shown in Table 3.
Switched to individualized regimen 19 22.3
Most of the treatment outcome was treatment
Causes of Switching to individualized regimen
Pre XDR 11 12.9 dropout (30.59%), while the most common cause of
Drugs adverse effects 8 9.4 switching from standard short-term treatment
Causes of treatment dropout regimens to individualized treatment regimens was
Drugs adverse effects 20 23.5
the pre-XDR result of sputum susceptibility test in
No family supports 2 2.4
Refusing treatment 4 4.7 first and second lines (12.9%). The cause of
Drugs adverse effects treatment dropout of short-term combinations was
Nausea/vomiting 56 65.9 mostly due to drugs adverse effects (23.5%), while
Injection site pain 10 11.8
the most common adverse effect was
Weakness 2 2.4
Vertigo 12 14.1 nausea/vomiting (65.9%).
Anorexia 3 3.5
Visual impairment 5 5.9
Hearing disorder 10 11.8
Headache 10 11.8
No Smoking
Electrolyte disturbance 7 8.2
Impaired kidney function 4 4.7
Arthralgia 2 2.4
Peripheral neuropathy 4 4.7
Insomnia 4 4.7

The Mann Whitney test was used to analyze

the effect of AFB sputum conversion time and
sputum culture conversion time on the success of Occupation Smoking Status

Figure 2. Successful treatment results in multiple variable groups

DR TB treatment. On the other hand, the CXR

Table 4. Logistics Regression Test for Treatment Success of Standard Guidelines for DR TB Short-Term Regimen
95% CI
Parameter B S.E. Wald df P OR
Lower Upper
Age -0.002 0.030 0.004 1 0.950 0.998 0.941 1.059
Education -0.309 0.825 0.140 1 0.708 0.734 0.146 3.701
Criteria for suspected DR TB -0.470 0.801 0.345 1 0.557 0.625 0.130 3.002
Pre XDR -20.879 12059.579 0.000 1 0.999 0.000 0.000 -
Constant -0.045 1.577 0.001 1 0.977 0.956 - -

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 Fahmi Adhi Prasetya: Factors Affecting the Treatment Success of Short-Term Regimen for Drug Resistant Tuberculosis (DR TB) Patients

The variables included in the multivariate to make decisions about the use of existing health
analysis were variables with P-value of <0.25 in the services and the views about treatment.8
bivariate analysis, namely age, education level, We also observed that most of the DR TB on
criteria for suspected DR TB and pre-XDR (Table 4). treatment had low income (73.6%), and the income
variable was not related to the success of DR TB
DISCUSSION treatment (P=0.705). This result was the same as
study from Tirtana which stated that there was no
Based on this study results, most of DR TB
correlation between level of income and the DR TB
patients was male (61.2%), and the gender variable
treatment success (P=1.00).9 Resistance to ATD is
was not significantly correlated to the DR TB
broadly developed in countries with poor socio-
treatment success (P=0.262). There were no clear
economic conditions, where the condition of
correlations that could explain the incidence of DR
incompetent purchasing power affects the fulfillment
TB with gender. Men are more at risk for developing
of nutritional needs. Resistance causes M.Tb to
DR TB because women tend to seek health services
multiply easily and ultimately inhibits sputum
more and are considered to be more obedient in
conversion.10
taking medications.5
Based on the education status, it was
Descriptively, it could be seen that patients
observed that most of the patients with DR TB
with risk of failure were in the mean age of 43.98
treatment had low education (61.2%), and the level
years with a median of 45.5 years, and for those
of education was significantly related to DR TB
who recovered, the mean age was 40.08 years with
treatment success (P=0.036). According to Kondoy
a median age of 42 years. From this study, it was
et al., education level was related to medication
observed that age was not associated with DR TB
adherence, which increased the treatment success
treatment success (P=0.218). This result was similar
for TB patients.11 Higher education will support a
to study from Elisabeth et al. that the mean age of
person to understand the knowledge given. 12
DR TB patients was 42.76 years. In the productive
Absorption of knowledge about DR TB greatly
age, the rate of TB transmission is very high and
influences patients compliance behavior and leads
extensive because the patient's interactions with
the patient to optimize and pay more attention to
other people and high work mobility might induce
their health and nutrition, including the prevention
the patients to tend not to adhere to ATD in their
and treatment of DR TB.13
previous TB treatment.6
In this study, most DR TB patients on
Based on the occupations of DR TB patients,
treatment had a history of smoking (55.3%), and the
it was noticed that most of them had risky jobs
smoking history variable was not associated with the
(84.7%), and the work variable was not related to
success of DR TB treatment (P=0.383). Khan et al.
the success of DR TB treatment (P=0.328).
concluded that smoking was a risk factor for
Elisabeth et al. obtained no association between
developing DR TB (P<0.05), and cases of multiple
occupational status and treatment success, while on
drug resistance were more common in smokers than
the contrary, patients who worked reduced the DR
in non-smokers. In smokers, macrophage disruption
TB treatment success (OR=0.87; 95% CI 0.67–1.14;
increases airway resistance and pulmonary
P=0.314).7 All types of work which account study
epithelial permeability. Cigarette smoking will reduce
subjects to be exposed to substances that interfere
the responsiveness to antigens. The incidence and
with lung function and works that allow study
severity of TB were related to smoking.14
subjects to have contact with TB patients are
The study subjects were DR TB patients
considered as risky jobs. A person's occupation
mostly from outside Malang (52.9%), and the
reflects the amount of information received about
variable of domicile was not related to the success
illness as well as health services and helps a person
of DR TB treatment (P=0.286). It was similar to

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 Fahmi Adhi Prasetya: Factors Affecting the Treatment Success of Short-Term Regimen for Drug Resistant Tuberculosis (DR TB) Patients

study from Elisabeth et al. which pointed out that the between sputum smear conversion time with the
distance from which the patient lived was not related success of DR TB treatment (P=0.511). The sputum
to the DR TB treatment success (OR=1.01; 95% culture conversion time was 1.449 months with a
CI=0.57-1.77; P=0.973).7 Most patients chose health median of 1 month. There was also no significant
facilities that were relatively close to their homes. association between sputum culture conversion time
The distance from home to health facilities is indeed and the success of DR TB treatment (P=0.950). This
an important factor.15 result was the same as study from Sinaga which
We also found that most DR TB patients on stated that among 85 study subjects, the largest
treatment had non-underweight BMI (55.35%), and AFB growth occurred in the fourth week of 43
the BMI variable was not associated to DR TB samples (50.59%).18
treatment success (P=0.383). According to A high conversion rate will be followed by a
Elisabeth et al., nutritional status of patients was not high cure rate.19 Factors that could prolong sputum
associated with successful treatment of DR TB conversion time such as bacterial load at the start of
(OR=2.07; 95% CI=0.47-3.02; P=0.718).7 treatment, lung cavities, smoking, chronic symptoms,
Tuberculosis patients who were underweight had a age, inappropriate medication, gender, BCG score,
higher risk of relapse after completion of treatment. and erythrocyte sedimentation rate, could also affect
Drug resistant TB treatment has more severe side the length of conversion.20
effects than drug sensitive-TB treatment, thus Based on CXR lesions, most of the CXR
affecting the patient's poor nutritional status. lesions obtained were extensive (91.8%), and the
Therefore, regular monitoring of patients’ nutritional CXR lesion variable was not associated with the
status is very important.16 success of DR TB treatment (P=0.100). Cha et
Based on research data, the criteria for al.mentioned that radiographic features in CXR of
suspected DR TB were mostly non-relapse case patients with MDR TB and XDR TB were multiple
(54.1%). The criteria for suspected DR TB were not cavities, nodules, and bronchial dilatation. Both
associated with DR TB successful treatment radiographic features of MDR TB and XDR TB
(P=0.238). The incidence of DR TB is mostly caused patients were not significantly different and had
by secondary resistance from primary resistance, various forms, which were called multiforms.21
and recurrence of TB patients allows drug The resistance pattern of the sputum results
resistance to occur. Resistant organisms can arise of drug susceptibility tests on first and second lines
due to several factors, and human error is the was mostly MDR (44.4%). Based on the pattern of
biggest contribution.17 resistance, the results of monoresistance and RR
In this study, the most common comorbidity of had no significant correlation to treatment success
DR TB patients was DM (41.2%), and the (P=0.379; P=0.802) while patients with pre-XDR
comorbidities variables were not related to the DR pattern were associated with treatment failure for
TB treatment success (P=0.672). According to DR TB (P=0.037) .22
Manurung et al., comorbidities (DM and HIV) did not Marais et al. in their study pointed out that
affect the success rate of DR TB patients (OR=0.73; polyresistance and RR did not have significant
95% CI=0.27-1.97; P=0.53). Comorbidities in DR TB success rate, meaning that as long as DR TB
patients cause a worse quality of life than patients patients received the appropriate therapeutic
without comorbidities. DM is a risk factor for DR TB, regimen, the success rate was not much different
and patients with DM have deficiencies of cellular from patients diagnosed with RR and
immunity.6 polyresistance.22 DR TB patients with sputum drug
Our study obtained the mean AFB sputum susceptibility test results of resistant (or intolerance)
conversion time of 1.351 months with a median of 1 to fluoroquinolones and/or second-line injection
month. There was no significant association drugs do not meet the criteria to continue short-term

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 Fahmi Adhi Prasetya: Factors Affecting the Treatment Success of Short-Term Regimen for Drug Resistant Tuberculosis (DR TB) Patients

standardized treatment and will be switched to ACKNOWLEDGMENTS

individualized treatment.23
None.
Most of the study subjects experienced drugs
adverse effects (72.9%), and the drugs adverse
CONFLICT OF INTEREST
effects variable was not related to the success of DR
TB treatment (P=0.139). Deshmuck et al. expressed None.
that many factors affected the adherence to DR TB
treatment, including the adverse effects of drugs FUNDING
experienced by DR TB patients.24 Management of None.
adverse effects starts with patient education. Prior to
starting treatment, patients should be well informed
REFFERENCES
in detail about the potential side effects of the ATD
regimen and when to report them to healthcare 1. World Health Organization. Global tuberculosis
professionals. Even for the harmless adverse effects, report 2018. World Health Organization.
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multidrug-resistant tuberculosis MDR-TB. 2008.
LIMITATION p. 1–10.
3. Direktorat Pencegahan dan Pengendalian
This study used secondary data from patients
Penyakit Kementerian Kesehatan Republik
medical records with some incomplete medical
Indonesia. Petunjuk teknis pengobatan pasien
record data so that it could affect the final results of
TB resistan obat dengan paduan standar
the study. The study was conducted in a limited time.
jangka pendek di fasyankes TB resistan obat.
The study only analyzed patients factors,
2017. p. 1–37.
investigations results, adverse effects, and HIV
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2016. Universitas Brawijaya; 2017.
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