The Using of Antiretroviral And The Relationship to the CD4+ Value In HIV?AIDS-TB Patients in VCT Clinic Sanglah Hospital Denpasar.

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PENGGUNAAN KOMBINASI ANTIRETROVIRAL

TERHADAP PENINGKATAN CD4+ PASIEN HIV/AIDS-TBDI KLINIK VCT RSUP SANGLAH DENPASAR

Rini Noviyani1. Vellen Herlyana1, IGB. Gupta Widotama2

Jurusan Farmasi, Fakultas Matematika dan Ilmu Pengetahuan Alam, Universitas Udayana 2

Klinik VCT, Rumah Sakit Umum Pusat Sanglah Denpasar rini.noviyani@yahoo.co.id

______________________________________________________________________ ABSTRAK

Telah dilakukan penelitian mengenai penggunaan kombinasi ARV pada pasien dewasa HIV/AIDS dengan infeksi oportunistik TB yang bertujuan untuk mengetahui pola penggunaan kombinasi ARV yang diberikan dan hubungannya dengan peningkatan CD4+ padapasien HIV/AIDS-TB dewasa tersebut.

Penelitian ini merupakan penelitian deskriptif retrospektif yang dilakukan Rumah Sakit Umum Pusat (RSUP) Sanglah Denpasar. Penelitian ini menggunakan metode consecutive sampling dengan sampel sebanyak 22 pasien HIV/AIDS-TB yang barupertama kali mendapatkan terapi kombinasi ARV dari bulan Januari sampai Desember 2009. Hasil penelitian menunjukkan bahwa polapenggunaan kombinasi ARV padapasien dewasa HIV/AIDS-TB yang digunakan di Klinik VCT RSUP Sanglah Denpasar adalah 100% menggunakan kombinasi lini pertama dengan 19 pasien berhasil meningkatkan jumlah CD4+ dan 3 pasien gagal meningkatkan jumlah CD4+. Kombinasi AZT+3TC+EFV diberikan pada 14 pasien yang juga menggunakan OAT Rifampisin dengan jumlah CD4+ awal rata-rata pasien adalah 55,17 /µL darah, sedangkan setelah setahun pemakaian ARV rata-rata CD4+ meningkat menjadi 229 /µL darah. Kombinasi AZT+3TC+NVP diberikankepada 7 pasien yang diberikan OAT Streptomisin karena alergi terhadap Rifampisin dengan jumlah CD4+ awal rata-rata pasien adalah 96 /µl darah, sedangkan setelah setahun pemakaian ARV rataan CD4+ meningkat menjadi 226,5 /µL darah. Sedangkan kombinasi d4T+3TC+EFV diberikan kepada 1 pasien yang memiliki kadar Hb rendah dengan jumlah CD4+ awal 18/µL dan CD4+ setelah setahun pemakaian 193/µL.

Gambaran tersebut menunjukkan bahwa semua pemberian kombinasi sudah tepat sesuai dengan panduan terapi menurut WHO dan DEPKES RI. Namun dengan ditemukannya 3 pasien yang mengalami kegagalan terapi, peran farmasis maupun tenaga kesehatan lainnya yang terlibat perlu lebih dioptimalkan mengingat HIV/AIDS maupun TB memerlukan pengobatan jangka panjang. Kepatuhan pasien diharapkan meningkat dengan KIE dan follow up secara berkala oleh farmasis dan tenaga kesehatan lainnya

Kata kunci: HIV/AIDS, infeksioportunistik TB, ARV, CD4+, lini pertama

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THE USING OF ANTIRETROVIRAL AND THE RELATIONSHIP TO THE CD4+ VALUE IN HIV/AIDS-TB PATIENTS

IN VCT CLINIC SANGLAH HOSPITAL DENPASAR

Rini Noviyani1. Vellen Herlyana1, IGB. Gupta Widotama2

School of Pharmacy, Mathematics and Natural Sciences Faculty, Udayana University 2

VCT Clinic, Sanglah Hospital, Denpasar rini.noviyani@yahoo.co.id

______________________________________________________________________

ABSTRACT

A study in the use of ARV combination for adult HIV/AIDS patiens with TB opportunistic infection had been carried out. The purpose was to know the pattern of the use of ARV combination given and the increase of CD4+ in HIV/AIDS-TB adult patiens.

This is a descriptive retrospective study held in Sanglah Hospital, Denpasar. This study used consecutive sampling method with 22 sample HIV/AIDS-TB patiens who were taking the ARV combination for the first time from January until December 2009. The result shows that the pattern of the use of the ARV combination for HIV/AIDS-TB adult patiens in VCT clinic Sanglah Hospital were 100% using the first line combination, with 19 patiens successfully increased CD4+ level and 3 patiens failed to increase CD4+ level. The AZT+3TC+EFV combination given to 14 patiens who also took anti tuberculosis drug, Rifampicin with previous CD4+ level 55.17/µL blood, while after one year using ARV, mean CD4+ level increased to 229/µL blood. The AZT+3TC+NVP combination given to 7 patiens who also took anti tuberculosis drug, Streptomycin because of the allergic with Rifampicin with previous CD4+ level 96/ µL blood, while after one year using ARV, mean CD4+ level increased to 226,6/µL blood. Whereas, the combination of d4T+3TC+EFV given for one patien who has a low Hb level with previous CD4+ level 18/µL blood and after one year using ARV the CD4+ level increased to 193/µL.

The result showed that all combinations was appropriate to the therapeutic guideline of WHO and DEPKES RI. However, with therapeutic failure in 3 patiens, the role of pharmacists and other health practicians who were involved has to be optimalized, because HIV/AIDS and TB need long term therapy. Patiens obedience expected to be increase with counseling and follow up by pharmacist and other health practicians gradually.

__________________________________________________________________ Keywords: HIV/AIDS, opportunistic infection, TB, ARV, CD4+, first line

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INTRODUCTION

HIV (Human Immunodeficiency Virus) is a virus that attacks immune system of humans. Whilst AIDS (Acquired Immune Deficiency Syndrome) is a medical condition where body immune system is too weak to eradicate infection. These conditions will make people easy to be attacked by some types of diseases that does not possibly affect people having healthy body immune system. This disease is called opportunistic infection (Yunihastuti, 2005). Opportunistic infection which usually follows HIV/AIDS is a skin cancer called sarcoma Kaposi, gland cancer, pneumonia caused by Pneumocytis carinii,

inflamed brain or brain layers, and Tuberculosis (Nursalam, 2008).

HIV epidemic shows its effect toward Tuberculosis epidemic improvement (TB) all over the world as for its consequence of more and more total TB cases in society. HIV pandemic is the biggest challenge in controlling TB. In Indonesia, it is estimated about 3% Tb patient having positive HIV status. In the other hand, TB is a challenge in AIDS control as it is the most opportunistic infection (49%) to ODHA (Menkes RI, 2011). In Bali itself, AIDS prevalence is reported high enough. According to data from Depkes RI, AIDS prevalence in Bali area occupies second one after Papua, having prevalence 48.55 per 100,000 populations (Depkes RI, 2010).

One of important element in body immune system is CD4+ cell, which is one type of white blood cell. CD4+ is a marker which exists in cell surface of humans, especially limphosit cells. HIV virus destruct T CD4+ cell directly and indirectly, although T CD4+ cell is needed in order body immune system can function well. If HIV virus kills T CD4+ cell until there is less than 200 T CD4+ cell per blood micro liter, so cellular immune can disappear. This infection is initially asymptomatic and will keep on going to be latent infection until it occurs infection signal and it will then be followed by AIDS, which is identified based on total T CD4+ cell in blood and there is opportunistic infection (Yunihastuti, 2005).

HIV virus is a retrovirus type, so the

one (ARV). ARV does not kill this virus, but ARV can slow virus growth. There are 4 types of ARV referring to different work mechanism and work place, namely Nucleoside reverse Transcriptase Inhibitor (NRTI), Nonnucleoside reverse Transcriptase Inhibitor (NNRTI), Protease Inhibitor (PI), and Entry Inhibitor(Nursalam, 2008).

In 1996, it has been found an effective ARV combination (Hoffmann, 2007). ARV combination therapy can cure HIV infection through combining some medicines, or it is usually called ART (Anti Retroviral Therapy). ART combination is more effective as it has higher antivirus effect and higher decreases viral load compared to using one type of medicine only. In addition, it is possibly smaller resistance and causes smaller dosage of each medicine, so possibly smaller side effect. (Nursalam, 2008).

The first line combination for new patients of adult HIV/AIDS-TB is 2 NRTI + 1 NNRTI, who is usually used AZT + 3TC + NVP for TB patient without followed with rifampisin therapy and AZT + 3TC + EFV for patients who use rifampisin collectively with ART (Ananworanich, 2007).

Viral load measurement or total HIV in blood, will be able to show how good body responses of given ARV cure. People who suffer from HIV and do not use ARV therapy can have viral load from 1000 to 1 million per mL blood, and it will decrease total T CD4+. In the meanwhile, the usage of ARV can increase total T CD4+, so the body can make antibody and decrease viral load until 40-50 per mL blood. (NAM, 2011).

Considering relationship between the decrease of viral load and the increase of CD4+ from ARV cure, and considering that HIV-TB therapy is a long term therapy, so pharmacist has the role in monitoring therapy development assigned to patients in order to achieve rational cure.

The problem statement in this research is Was the using of Anti Retroviral combinations in HIV/AIDS-TB patients appropriate to the therapeutic guideline of WHO and Depkes RI?

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Data collection is done retrospective one by collecting medical record data in term of cohort patient at VCT (Voluntary Counselling and Testing) clinic in Sanglah Hospital from January 2009 to December 2009.

B. RESEARCH FIELD

This research is conducted at VCT Sanglah Hospital Denpasar from May to August 2011.

C. Research Tools and Materials 1. Research Tools

The tools used is a computer as data processing to make easy in research implementation, work sheet in term of table for data collection so it will be obtained information of ARV usage pattern for new patients of adult HIV/AIDS-TB and the increase of CD4+ patient for the period of January-December 2009.

2. RESEARCH MATERIALS

The materials used in this research is medical record data for adult HIV/AIDS-TB cohort patients in clinic VCT RSUP Sanglah Denpasar who were entering since January 2009-December 2009. In the meanwhile, the increase of CD4+ data is examined every 6 months, and observed for twice examinations, so period of result data collection of CD4+ improvement is from June 2009 – December 2010.

D. Inclusion Criteria

Inclusion criteria is a general characteristic of research subject toward targeted and reachable populations. Inclusion criteria in this research is all adult HIV/AIDS-TB patients for the first time using ARV.

E. Samples

Samples in this research are taken by applying consecutive sampling method for verifying the increase percentage of CD4+ from ARV combination of new adult HIV/AIDS-TB patients.

F. Permission

In sample collection, the first thing to do is to have prior permission to Director

Sanglah Hospital, and staff at Clinic VCT Sanglah Hospital Denpasar.

RESULTS AND DISCUSSION

Data collected retrospective and samples obtained by applying consecutive sampling method. Total initial data obtained by the researcher is at 62 HIV/AIDS-TB patients who were the first time to use ARV at Clinic VCT Sanglah Hospital since January to December 2009. From this total initial data is then conducted inclusion so it is obtained 22 patients.

1. Patient Demography HIV/AIDS-TB a. Sex

From 22 patients as samples, there are 16 male patients and 6 female ones.

b. Patient Age

From 22 patients, 4 patients are among 21-29 years old, 12 patients are among 30-39 years old and 6 patients are among 40-59 years old. The youngest patients as samples are 21 years old for total 1 patient only, while the oldest one is 49 years old for total 1 patient only.

c. Patient of origin

As referred hospital, so patients at Clinic VCT Sanglah Hospital are from some areas in Bali, such as from Denpasar at 10 patients, Sanur 1 patient, Gianyar 3 patients, Karangasem 2 patients, Mengwi 1 patient, Jembrana 1 patient, Tabanan 2 patients, Abiansemal 1 patient, and Batubulan 1 patient.

2. Type of TB Opportunistic Infection toward HIV/AIDS patients

From 22 samples of HIV/AIDS patients with TB opportunistic infection diagnose, it was found 2 types of TB, namely TB Pulmonary and Duplex KP. At 20 patients suffered from TB pulmonary, while 2 patients suffered from Duplex TB.

3. Applied ARV Combination

From patients data obtained, there are 3 combination of ARV applied, namely

AZT+3TC+EFV, AZT+3TC+NVP, and

d4T+3TC+EFV, where the three are first line combination for HIV/AIDS-TB patients (Dekpes RI, 2007).

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Figure 1. The pattern of the First Line ARV Therapy for HIV/AIDS-TB Patients in VCT Clinic Sanglah Hospital during January-December 2009

From 22 patients as samples, there are 14 patients or 64% applying AZT+3TC-EFV combination. Further, there are 7 patients or 32% applying AZT+3TC+NVP combination. Only 1 patient or 4% applying d4T+3TC+EV combination where it is the first line combination for HIV/AIDS-TB patients that has low Hb level (Depkes RI, 2007a).

4. ARV combination used for patients with opportunistic pulmonary infections tuberculosis and KP duplex

First-line combination for pulmonary TB patients and KP Duplex is similar, namely AZT +3TC + NVP, but the use of Anti Tuberculosis Drugs and ARV combination can simultaneously cause drug interactions. One of ARV given namely nevirapine when it is used in conjunction with anti tuberculosis drug, that may result in interactions, namely Rifampicin reduces blood levels of nevirapine at 30-555/micro liter and also lowers the blood levels of most protease inhibitors (Alcorn, 2010). Thus, if patients with HIV/AIDS with TB opportunistic infection taking Rifampicin and ARV simultaneously, the combination of first-line antiretroviral Efavirenz is used (AZT +3 TC + EFV). Whereas if the HIV/AIDS patients with TB opportunistic infections does not use Rifampicin, it can still be given a combination of AZT +3 TC + NVP (Depkes RI, 2007a).

Selection of antiretroviral combination for patients with TB opportunistic infections

each patient such as anemia and allergic reactions. A total of 7 patients who are allergic to rifampin, they can be replaced with other OAT namely streptomycin, so that nevirapine can be administered to the patient without interaction. And if the patient's hemoglobin level examination is known to have anemia (N.K.N.S), then the provision of Zidovudine (AZT) is replaced with Stavudine (d4T), because AZT has side effects such as anemia. So the appropriate combination given to the patient is d4T +3TC + EFV. Overview types of TB and ARV combinations used can be seen in the figure below.

Figure 2. ARV Combination used for patients with opportunistic pulmonary infections tuberculosis and KP duplex

In this study, as shown in Figure 2, there are 2 patients who suffer from KP Duplex given the combination of AZT +3TC + EFV. For total of 12 patients with pulmonary tuberculosis use combination of AZT +3TC + EFV, 7 patients with pulmonary tuberculosis using a combination AZT +3TC + NVP, and 1 pulmonary TB patient using the combination of d4T +3 TC + EFV. Patient N.K.N.S get therapy combination d4T +3 TC + EFV as having a low hemoglobin level, namely 10 g / dl, whereas normal Hb levels in adult women is 12-16 g / dl (Depkes, 2007a).

5. The increase of CD4+ toward ARV Combination of HIV/AIDS-TB Patient

14 7 1

Applied ARV

Combina0on

AZT+3TC+EFV AZT+3TC+NVP d4T+3TC+EFV

0 2 4 6 8 10 12

1 2

0 0

mou

t of P

ati

ARV Combination

TB Pulmonary KP Duplex

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From changing of total CD4+for 1 year of using ARV, it can be monitored an increase or decrease in CD4+ patients. The increase and decrease of CD4+ according to ΔCD4+ can be seen in the table below.

Figure 3. Increase and decrease of CD4 + HIV/AIDS-TB in VCT clinic Sanglah Hospital during January-December 2009 based on ΔCD4+

From the results obtained, the combination of AZT +3 TC + EFV was given to 14 patients whom 12 patients having increased value CD4+ and 2 patients with a decline value of CD4+ after the usage of 12 months, whilst the combination of d4T +3TC + NVP given to 7 patients with 6 patients had a increased value of CD4+ and 1 patient with CD4 + values decreased after 12 months of use, while d4T +3 TC + EFV combination given to 1 new patient showed improvement.

6. The increased of CD4++ combination of AZT +3 TC + EFV

The increase of CD4+from 12 patients using a combination of AZT +3 TC + EFV can be seen in Figure 4 below.

Figure 4. The increased of CD4 combination of AZT +3TC + EFV + HIV / AIDS-TB in VCT Clinic Sanglah Hospital

Figure 4 showed that 12 patients of HIV/AIDS-TB who received combination of ARV AZT +3TC + EFV has experienced of CD4+ in the two subsequent examinations. Total early average CD4+to patient was 55.17/µL of blood, whereas after one year usage, the average CD4 + ARV increased to 229/µL of blood.

7. The increased CD4+ combination of AZT +3 TC + NVP

The increase of CD4+from 6 patients using a combination of AZT +3TC + NVP can be seen in the Figure 5 below.

Figure 5. Increased CD4 combination of AZT +3 TC + NVP + HIV / AIDS-TB In VCT Clinic Sanglah Hospital

12 6 1 2 1 0 0 2 4 6 8 10 12 14 Amount Pati ent Combination Increase of CD4+ Decrease of CD4+ 0 100 200 300 400 N .M. W M. C .A M. S WAY K. S W. B W. P I. G .P G .M. S I. N .G I. M. S A .A .R CD4+

Name of Patients

0 100 200 300 400 500 S . I.G .E H .W G .K

.P S.

I.W

Amount of CD4+

Name of patients

Initial CD4+ CD4+ after 6 months CD4+ after 12 months

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Figure 5. showed that 6 patients with HIV/AIDS-TB who received an ARV combination such as AZT +3TC + NVP increased CD4+ in the two subsequent examinations. Number of early average CD4+patient is 96/µL of blood, whereas after a year, the average CD4+ ARV consumption increased to 226.5 /µL of blood.

8. Increased CD4+ Combination with d4T +3 TC + EFV

Giving combination of d4T +3TC + EFV was only found in 1 patient. Increase in CD4+ from 1 patient using combination of d4T +3TC + EFV can be seen in Figure 6 below.

Figure 6 Increased CD4+ combination of d4T +3TC + EFV patient NKNS with HIV/AIDS-TB at VCT Clinic Sanglah Hospital

Figure 6. showed that patients received N.K.N.S who combinedwith ARV d4T +3TC + EFV experienced the increased of CD4 quite rapidly in the two subsequent examinations. Patients given the combination of d4T +3TC + EFV have low hemoglobin level, namely 10 g / dl, whereas normal Hb levels in adult women is 12-16 g / dl (Depkes, 2007a). Giving Stavudine (d4T) in patients with anemia is right, due to d4T have no side effects such as anemia.

Of the three first-line drug combinations for patients with HIV/AIDS-TB above, we can see an increase of CD4+in each combination. The increase in each combination can be compared on the basis of clinical categories of patients, such as the Figure 7 below.

Figure 7. Changes in CD4+in every beginning and End span of CD4+, respectively with ARV combination

From figure 7 it can be seen that the greatest increase in CD4+in patients with HTV/AIDS-TB with C clinical category which uses a combination of AZT +3TC + EFV where the average increase amounted to 182.45 l/µL of blood. While in the same category with the combination of AZT +3TC + NVP, the average increased of CD4+ patients after three times examination seems to be the smallest visible one, namely 128.6/µL of blood.

9. Clinical Category and Increased Comparisons CD4+ Based on WHO

According to WHO, there are 3 clinical category of HIV/AIDS, namely clinical category A having initial CD4+ >500 /µL blood, clinical category B having initial CD4+between 200-499/µL blood, and clinical category C having initial CD4+<200 µL blood (WHO, 2006). From the data obtained, there 2 patients for clinical category B, 17 patients for clinical category C, and none having clinical category A.

From this initial CD4+ or clinical indication can be monitored whether ARV combination therapy that is given successful. There are 3 success indication from ARV usage, namely if within 6 months to 12 months, the usage of ARV is achievable, so (a) total increased CD4+ 100 / µL blood, (b) total CD4+ does not decrease under initial total CD4+, (c) total CD4+ is not less than 50% from the peak point of total CD4+ that has been

0 50 100 150 200

N.K.N.S

Amount of CD4+

IniMal CD4+

CD4+ aNer 6 months

CD4+ aNer 12 months

0 100 200

AZT+3TC+EFV AZT+3TC+NVP d4T+3TC+EFV

182.45 128.6

175

80 138 0

∆ CD4+ (/µl )

omb

ati

Kategori Klinis B

Kategori Klinis C

B Clinical Category C Clinical Category

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achieved during therapy. If it fulfills the one, two or three of this conditions, so therapy can be said that it has been successful (WHO, 2006).

From the increased data of CD4+ patients, there are 19 patients successful in fulfilling therapy success indication. 16 patients are successful in fulfilling the all three criteria of therapy success (a, b, c) while 3 patients are successful in fulfilling criteria 2 and 3 (b, c) which can be seen below

Figure 8. Clinical Category and Successful Therapy in HIV/AIDS-TB Patients who got the increasing of CD 4+

This is due to interaction between OAT consumed by patients, namely Rifampicin with NVP, where rifampicin decreases blood level from nevirapine at 0-555/macro liter and also decreases most of protease inhibitor (Alcorn, 2010). While the most increase of CD4+ to HIV/AIDS-TB patients having clinical category B is patients who have AZT=3TC+NVP combination where the increased average level is at 138/ µL blood. In the meanwhile, at similar category with AZT+3TC+EFV, the average increased of CD4+ patients are seen smallest, namely 80 / µL blood.

10. The decreased of CD4+ based on Indonesia Health Department (Depkes)

After ARV therapy is done, CD4+ monitoring is done to prevent therapy failure especially the first year usage and to determine whether it is necessary to change therapy or not. According to Depkes, the indication of ARV therapy failure is if it fulfills at least one of the three pattern of therapy failure. The first pattern of therapy failure indication is on the first year of ARV usage, the increased of CD4+

patients < 100 /µL blood. The second pattern is if it takes place for the total decreased of CD4+ after one year therapy, namely total returned CD4+ or less than initial ARV therapy. Whilst the third pattern is if the decreased of total CD4+ after 12 months usage at 50% from its increased for 6 months ARV usage (Depkes RI, 2007a).

From 22 HIV/AIDS-TB patients who have first line ARV combination therapy, there are 3 patients having total decreased of CD4+ after third checking or after a year usage of ARV combination, as the following table.

Patient ARV

Initial CD4+

(µL) CD4+

6 months

(µL) Final CD4+ (µL)

Clinical Category

K.P.B AZT+3TC+EFV 20 94 73 C I.W.R AZT+3TC+EFV 4 75 22 C M.P AZT+3TC+NVP 119 239 97 C

K.P.B. patients who have the decreased CD4+ after one year therapy and they represent the first therapy failure according to Depkes, where this pattern shows total initial CD4+ below 100 /µL blood who increased for 6 months usage of ARV, then it shows the decrease after 12 months of ARV usage.

I.W.R patients who have the decreased CD4+ after one year therapy and they represent the third therapy failure according to Depkes, where this pattern shows the decreased of total CD4+after one year therapy, they are back or lower from the ARV initial therapy.

MP patients who experienced the decrease in CD4+ after one year of therapy and represent second failure of therapy patterns according to Depkes, where this pattern shows the decline in the number of CD4+ after one year therapy, back or lower from the ARV initial therapy.

CONCLUSION

The result showed that all combinations was appropriate to the therapeutic guideline of WHO and Indonesia Health Department (Depkes) which 19 patients could increase their CD4+ based on WHO category and 3

15 1 2 ₁ 0 5 10 15 20 abc bc A m ount of P at ie nt s Succesfull Therapy Kategori Klinis C Kategori Klinis B C Clinical category B clinical Category

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patients failed to increase their CD4+ based on Depkes category

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Figure 1. The pattern of the First Line ARV Therapy for HIV/AIDS-TB Patients in VCT Clinic Sanglah Hospital during January-December 2009

4. ARV combination used for patients with opportunistic pulmonary infections tuberculosis and KP duplex

Selection of antiretroviral combination for patients with TB opportunistic infections are also based on the specific circumstances of

Figure 2. ARV Combination used for patients with opportunistic pulmonary infections tuberculosis and KP duplex

5. The increase of CD4+ toward ARV Combination of HIV/AIDS-TB Patient 14

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