Clinical Characteristics and The Selection of Initial ARV Regimen Therapy for HIV-Infected Patients in VCT-CST RSUP Sanglah, Denpasar.
Clinical Characteristics and The Selection of Initial ARV Regimen
Therapy for HIV-Infected Patients in VCT-CST RSUP Sanglah,
Denpasar
I G. A. Putu Candradewi, I Ketut Agus Somia
Departement of Internal Medicine, Medical Faculty of Udayana University/RSUP
Sanglah
ABSTRACT
Number of new cases of HIV infections in Bali is still high and ARV becomes the one
and only therapy. There are many ARV drugs used globally. The selection of ARV
regimens are closely related to the patients clinical characteristics. So that, in this study,
the author investigates the clinical characteristics of initial ARV regimen therapy in
VCT-CST RSUP Sanglah so does the factors related to the selection of initial ARV
regimen. This study is retrospective study, using descriptive methods. Data of the
patients are distributed based on initial ARV regimen and other variables related to
therapy and patients clinical characteristics. The significance of differences of patients
clinical characteristics among the initial ARV regimens are also tested using ANOVA
and chi-square test to find out the factors related to the selection of inital ARV regimen
for the patients. Based on the study of 127 patient’s medical records, 69.3% (n=88) of
patients receive NVP based regimen (AZT/3TC/NVP), 21.3% (n=27) of patients receive
EFV based regimen (AZT/3TC/EFV), and 9.4% (n=12) of patients receive TDF based
regimen (TDF/3TC/NVP or TDF/3TC/EFV). Characteristics that are significantly
different among the three regimens are patients opportunistic infections ( p=0.000),
initial hemoglobin (p=0.009), side effect appearance (p=0.022) and change of regimen
during 6 months of therapy (p=0.048). Initial ARV regimens commonly used for HIVinfected patients at VCT-CST RSUP Sanglah are NVP based regimen (AZT/3TC/NVP),
EFV based regimen (AZT/3TC/EFV), and TDF based regimen (TDF/3TC/NVP or
TDF/3TC/EFV). Selection of initial ARV regimens is related to the opportunistic
infections, initial hemoglobin of the patients, the appearance of side effect, and
tendency to change ARV regimen.
Keywords. HIV infection, initation of ARV regimen therapy, ARV regimens,
characteristics of ART, treatment onset, change of regimen.
INTRODUCTION
Human Immunodeficiency Virus (HIV)
infection
has been an endemic
worldwide. An estimation of 35.3
(32.2–38.8) million people were living
with HIV all over the world in 2012.
New HIV infection cases in 2012 was
2.3 (1.9–2.7) million. However, it
declines if compared to the number of
new infections in 2001 which is 3.4
(3.1–3.7) million. The number of death
cases because of AIDS (Acquired
Immunodeficiency Syndrome) is also
declining, from 2.3 (2.1–2.6) million in
2005 to 1.6 (1.4–1.9) million AIDS
deaths in 2012.1
1
Bali as one of popular tourists
destination has been very open to global
world. So does the infection, which can
be easily spread from people who are
travelling in Bali to local people and
vice versa. It causes Bali places the top
five provinces with the highest HIV
cases in Indonesia. Many ways have
been done to prevent HIV transmission
among people in Bali, either by the
government, health care providers, or
community organization. However, the
number of new HIV infection cases is
still high eventhough it is decreasing
year by year. There haven’t been any
treatment that can eradicate HIV virus
from human body. In order to survive
with the virus inside their body, HIV
infected person needs to be treated with
drugs that can suppress the viral
repication and progression which called
antiretroviral (ARV). Suppression of
HIV replication is important in
prolonging life and improving the
quality of life in patients with HIV
infection. Patients undergoing treatment
for HIV infection have to take a daily
regimen of at least three antiretroviral
drugs.2
Antiretroviral (ARV) therapy has been
used widely around the world to treat
people who are already infected by
HIV. The number of ART receiver all
over the world is increasing year by
year.1 However, there are still many
issues
about starting antiretroviral
therapy such as the timing and regimen
for initiation of therapy. Based on a
study, early initiation of ARV therapy,
especially within the first 6 months after
HIV infection can give better outcome
compared to the therapy initiated during
chronic HIV infection.3 HHS Panel on
Antiretroviral Guidelines for Adults and
Adolescents has classified many kinds
of ARV regimens into 3 groups:
preferred
regimens,
alternative
regimens, and other regimens.4 Among
many kinds of initial ARV regimen,
patients clinical characteristics are
important to determine which initial
ARV regimens will be given to patients.
As the effectiveness of therapy and
outcome are very closely related to the
factors mentioned before, the author
would like to discuss about the clinical
characteristics of ARV therapy and
selection of initial ARV regimen for
HIV-infected patients in VCT-CST
clinic of RSUP Sanglah, Denpasar.
METHODS
This study is a retrospective study using
descriptive method to presents the
clinical
characteristics
of
patients
among the initial ARV regimens used in
VCT-CST RSUP Sanglah, Denpasar in
2012. The study was done at VCT-CST
clinic of RSUP Sanglah, Denpasar. The
data was collected on November 21st –
25th , 2013. Population of this study is
HIV-infected patients who receive their
initial ARV regimen therapy in VCTCST RSUP Sanglah in 2012. Sample is
taken from the population after
excluding some patients whose medical
records cannot be found.
This study begins with collecting data
that is taken from the patients medical
records, then processed, analyzed and
presented in form of frequency and
descriptive tables. Data processing and
analyzing are done by distributing the
independent
variables toward
the
dependent variable. Dependent variable
is the type of ARV regimens received
by HIV patients in VCT-CST RSUP
Sanglah in 2012. Independent variables
are age, sex, pregnancy status, body
weight, clinical manifestation, x-ray
finding, opportunistic infection, initial
laboratory
result
(hemoglobin,
SGOT/SGPT, BUN/SC, and initial
CD4+ count), treatment onset, CD4+
2
after 6 months of therapy, side effect of
initial ARV regimen, change of regimen
during 6 months of therapy, CD4+
change after 6 months of therapy, and
mortality.
RESULTS
Distribution of Data Based on the
Initial ARV Regimen
Based on the study of 127 patient’s
medical records, there are 3 different
regimens of antiretroviral (ARV) used
in VCT-CST RSUP Sanglah to initiate
the treatment of HIV-infected patients
in 2012. All of the regimens contain
lamivudine (3TC), but the other two
drugs are different based on the
patient’s characteristic and doctor’s
consideration. Other ARV drugs used as
initial treatment are zidovudine (AZT),
nevirapine (NVP), efavirenz (EFV),
tenofovir disoproxil fumarate (TDF).
Data of 127 patients medical record is
distributed based on 3 ARV regimens,
which
are
nevirapine
based
(AZT/3TC/NVP),
efavirenz
based
(AZT/3TC/EFV),
and
tenofovir
disoproxil
fumarate
based
(TDF/3TC/NVP and TDF/3TC/EFV).
Frequency of the 3 kinds of regimen
used is shown in Figure 1.
69.3%
21.3%
9.4%
Figure 1. Frequency of initial ARV regimen used in VCT-CST RSUP Sanglah in 2012
(n=127)
Patients Clinical Characteristics
among the Three Initial ARV
Regimens Therapy
Based on Table 1, the mean age of
patients using NVP based therapy is
32.66 years, while the EFV based is
31.63 years and TDF based is 35.92
years. Most of the patients are male.
There are 5 patients among females who
are pregnant. Means of body weight of
the patients are 52.78 kg in NVP based
regimen, 52.41 kg in EFV based
regimen, and 52.83 kg in TDF based
regimen. Most of the patients initiate
therapy before 6 months after the date
of firstly diagnosed as positive HIVinfected. Almost all of the patients show
some clinical manifestations when
initiating
therapy.
Patients
with
3
opportunistic infections mostly receive
NVP based therapy. Opportunistic
infections are related to the selection of
initial ARV regimen (p
Therapy for HIV-Infected Patients in VCT-CST RSUP Sanglah,
Denpasar
I G. A. Putu Candradewi, I Ketut Agus Somia
Departement of Internal Medicine, Medical Faculty of Udayana University/RSUP
Sanglah
ABSTRACT
Number of new cases of HIV infections in Bali is still high and ARV becomes the one
and only therapy. There are many ARV drugs used globally. The selection of ARV
regimens are closely related to the patients clinical characteristics. So that, in this study,
the author investigates the clinical characteristics of initial ARV regimen therapy in
VCT-CST RSUP Sanglah so does the factors related to the selection of initial ARV
regimen. This study is retrospective study, using descriptive methods. Data of the
patients are distributed based on initial ARV regimen and other variables related to
therapy and patients clinical characteristics. The significance of differences of patients
clinical characteristics among the initial ARV regimens are also tested using ANOVA
and chi-square test to find out the factors related to the selection of inital ARV regimen
for the patients. Based on the study of 127 patient’s medical records, 69.3% (n=88) of
patients receive NVP based regimen (AZT/3TC/NVP), 21.3% (n=27) of patients receive
EFV based regimen (AZT/3TC/EFV), and 9.4% (n=12) of patients receive TDF based
regimen (TDF/3TC/NVP or TDF/3TC/EFV). Characteristics that are significantly
different among the three regimens are patients opportunistic infections ( p=0.000),
initial hemoglobin (p=0.009), side effect appearance (p=0.022) and change of regimen
during 6 months of therapy (p=0.048). Initial ARV regimens commonly used for HIVinfected patients at VCT-CST RSUP Sanglah are NVP based regimen (AZT/3TC/NVP),
EFV based regimen (AZT/3TC/EFV), and TDF based regimen (TDF/3TC/NVP or
TDF/3TC/EFV). Selection of initial ARV regimens is related to the opportunistic
infections, initial hemoglobin of the patients, the appearance of side effect, and
tendency to change ARV regimen.
Keywords. HIV infection, initation of ARV regimen therapy, ARV regimens,
characteristics of ART, treatment onset, change of regimen.
INTRODUCTION
Human Immunodeficiency Virus (HIV)
infection
has been an endemic
worldwide. An estimation of 35.3
(32.2–38.8) million people were living
with HIV all over the world in 2012.
New HIV infection cases in 2012 was
2.3 (1.9–2.7) million. However, it
declines if compared to the number of
new infections in 2001 which is 3.4
(3.1–3.7) million. The number of death
cases because of AIDS (Acquired
Immunodeficiency Syndrome) is also
declining, from 2.3 (2.1–2.6) million in
2005 to 1.6 (1.4–1.9) million AIDS
deaths in 2012.1
1
Bali as one of popular tourists
destination has been very open to global
world. So does the infection, which can
be easily spread from people who are
travelling in Bali to local people and
vice versa. It causes Bali places the top
five provinces with the highest HIV
cases in Indonesia. Many ways have
been done to prevent HIV transmission
among people in Bali, either by the
government, health care providers, or
community organization. However, the
number of new HIV infection cases is
still high eventhough it is decreasing
year by year. There haven’t been any
treatment that can eradicate HIV virus
from human body. In order to survive
with the virus inside their body, HIV
infected person needs to be treated with
drugs that can suppress the viral
repication and progression which called
antiretroviral (ARV). Suppression of
HIV replication is important in
prolonging life and improving the
quality of life in patients with HIV
infection. Patients undergoing treatment
for HIV infection have to take a daily
regimen of at least three antiretroviral
drugs.2
Antiretroviral (ARV) therapy has been
used widely around the world to treat
people who are already infected by
HIV. The number of ART receiver all
over the world is increasing year by
year.1 However, there are still many
issues
about starting antiretroviral
therapy such as the timing and regimen
for initiation of therapy. Based on a
study, early initiation of ARV therapy,
especially within the first 6 months after
HIV infection can give better outcome
compared to the therapy initiated during
chronic HIV infection.3 HHS Panel on
Antiretroviral Guidelines for Adults and
Adolescents has classified many kinds
of ARV regimens into 3 groups:
preferred
regimens,
alternative
regimens, and other regimens.4 Among
many kinds of initial ARV regimen,
patients clinical characteristics are
important to determine which initial
ARV regimens will be given to patients.
As the effectiveness of therapy and
outcome are very closely related to the
factors mentioned before, the author
would like to discuss about the clinical
characteristics of ARV therapy and
selection of initial ARV regimen for
HIV-infected patients in VCT-CST
clinic of RSUP Sanglah, Denpasar.
METHODS
This study is a retrospective study using
descriptive method to presents the
clinical
characteristics
of
patients
among the initial ARV regimens used in
VCT-CST RSUP Sanglah, Denpasar in
2012. The study was done at VCT-CST
clinic of RSUP Sanglah, Denpasar. The
data was collected on November 21st –
25th , 2013. Population of this study is
HIV-infected patients who receive their
initial ARV regimen therapy in VCTCST RSUP Sanglah in 2012. Sample is
taken from the population after
excluding some patients whose medical
records cannot be found.
This study begins with collecting data
that is taken from the patients medical
records, then processed, analyzed and
presented in form of frequency and
descriptive tables. Data processing and
analyzing are done by distributing the
independent
variables toward
the
dependent variable. Dependent variable
is the type of ARV regimens received
by HIV patients in VCT-CST RSUP
Sanglah in 2012. Independent variables
are age, sex, pregnancy status, body
weight, clinical manifestation, x-ray
finding, opportunistic infection, initial
laboratory
result
(hemoglobin,
SGOT/SGPT, BUN/SC, and initial
CD4+ count), treatment onset, CD4+
2
after 6 months of therapy, side effect of
initial ARV regimen, change of regimen
during 6 months of therapy, CD4+
change after 6 months of therapy, and
mortality.
RESULTS
Distribution of Data Based on the
Initial ARV Regimen
Based on the study of 127 patient’s
medical records, there are 3 different
regimens of antiretroviral (ARV) used
in VCT-CST RSUP Sanglah to initiate
the treatment of HIV-infected patients
in 2012. All of the regimens contain
lamivudine (3TC), but the other two
drugs are different based on the
patient’s characteristic and doctor’s
consideration. Other ARV drugs used as
initial treatment are zidovudine (AZT),
nevirapine (NVP), efavirenz (EFV),
tenofovir disoproxil fumarate (TDF).
Data of 127 patients medical record is
distributed based on 3 ARV regimens,
which
are
nevirapine
based
(AZT/3TC/NVP),
efavirenz
based
(AZT/3TC/EFV),
and
tenofovir
disoproxil
fumarate
based
(TDF/3TC/NVP and TDF/3TC/EFV).
Frequency of the 3 kinds of regimen
used is shown in Figure 1.
69.3%
21.3%
9.4%
Figure 1. Frequency of initial ARV regimen used in VCT-CST RSUP Sanglah in 2012
(n=127)
Patients Clinical Characteristics
among the Three Initial ARV
Regimens Therapy
Based on Table 1, the mean age of
patients using NVP based therapy is
32.66 years, while the EFV based is
31.63 years and TDF based is 35.92
years. Most of the patients are male.
There are 5 patients among females who
are pregnant. Means of body weight of
the patients are 52.78 kg in NVP based
regimen, 52.41 kg in EFV based
regimen, and 52.83 kg in TDF based
regimen. Most of the patients initiate
therapy before 6 months after the date
of firstly diagnosed as positive HIVinfected. Almost all of the patients show
some clinical manifestations when
initiating
therapy.
Patients
with
3
opportunistic infections mostly receive
NVP based therapy. Opportunistic
infections are related to the selection of
initial ARV regimen (p