APTI ijopp - Indian Journal of Pharmacy Practice

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Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIijoppA prospective study comparing Total Lymphocyte Count (TLC) andCD4 counts in HIV patients in a resource limited setting in India1 2 3 4Lincy Lal , Cijo George , Anitha Yesoda , Jayakumar.B1. Pharmcoeconomic Research Specialist, Drug Use Policy and Pharmacoeconomics, UT MD Anderson CancerCenter, 1515 Holcombe Blvd, Unit 706, Houston, Texas 770302. Manager-Clinical Pharmacy, HCG Towers, P.Kalinga Rao Road, Bangalore-27, Karnataka, India3. Asso. Professor, College of Pharmaceutical sciences, Medical college, Thiruvananthapuram, Kerala, India4. Prof & Head, Dept. Of Medicine, Medical college Hospital, Thiruvananthapuram, Kerala, India*Address for correspondence: llal@mdanderson.orgINTRODUCTIONEven after 25 years of the first detection of Acquired goals of HAART are given in table 1.Immunodeficiency Syndrome (AIDS), it remains a major Various guidelines have been published on HAART to1health care problem without any cure. Extensive make sure that the therapy is appropriate. Theseresearch around the world and the subsequent guidelines give clear information on indications to start4, 5introduction of highly active antiretroviral therapy HAART(HAART) has produced dramatic reduction on Test for CD4 count is too costly for resource poormorbidity, mortality and health care utilization. HAART countries. As highly active antiretroviral therapyregimens have revolutionized the treatment of human (HAART) is now becoming available to largeimmunodeficiency virus (HIV), which consistently populations of HIV-infected patients in resource-poorresults in sustained suppression of HIV-1 RNA countries, resource-appropriate markers need to bereplication, resulting in gradual increases in CD4 T- identified for clinicians to use in deciding when to initiatelymphocyte count, sometimes to normal levels. Durable HAART. Also, monitoring individuals with HIVsuppression of viral replication and the accompanying infection/AIDS involves the use of expensive tools,increases in CD4 count, reverse HIV disease progression, including CD4, which are not readily available ineven in persons with advanced HIV infection.resource- limited settings. Previous studies suggested theDespite these great advancements, HAART poses a absolute lymphocyte count (ALC) or total lymphocytenumber of challenges. Many of the effective regimens are count (TLC, i.e. ALC plus all large lymphocytes such ascomplex and have major adverse effects leading to lymphoblast or reactive lymphocytes) might be useful inproblems with patient compliance and drug resistance. identifying patients who would benefit from initiatingThese problems continue to limit the effectiveness of prophylaxis for AIDS-related opportunistic infections.HAART and present major challenges in managing HIV6,7,8Due to the lack of enough financial as well as qualifiedinfection. Further, cost and intellectual property personnel support, initiation and monitoring of HAARTprotections effectively limit access to antiretroviral drugs based on CD4count becomes a significant challenge in2 TMin countries most heavily affected by HIV. Atripla , India. Patients may have to wait for more than two(efavirenz 600mg, emtricitabine 200mg, tenofovir months to get the CD4 count results even in Nationaldisoproxil 245 mg) a fixed dose, once a day tablet for AIDS Control Organization (NACO) supported centers.treating HIV-1 infection in adults is a promising step to This is a major obstacle in the proper management of3improve patient compliance.HAART in a country like India where the HIV estimateA HAART regimen should be able to delay disease for the year 2005 is 5.21 million infections and it isprogression, prolong survival and maintain quality of life growing at a rapid scale. 9through maximal viral suppression. Considering the Initiation and monitoring of HAART based on TLCconditions and challenges of a resource poor country, the instead of CD4 count is particularly significant in adeveloping country like India. In India the cost of CD4count by flow cytometry is approximately1500 IndianIndian Journal of Pharmacy PracticeReceived on 09/09/2008 Modified on 19/09/2008Accepted on 23/09/2008 © APTI All rights reservedRupees (INR) ($30.00 US) while the cost for TLC is lessthan 40 INR (
Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009per capita income is 34,825 Indian Rupees ($820.00 National AIDS Control Organization (NACO) of India10,11US) and the per capita expenditure for health by and subsequently, NACO is funded by various programs12government is about $27.00 US , this cost difference has under WHO. All patients attending ART clinic getsa significant impact in treating AIDS patients.treatment and related tests including CD4 count test freeWHO recommends CD4 count to monitor the patient's of cost.clinical status in AIDS cases; but in resource limited Study data was collected from patients who satisfied thesetting where there is no data on CD4 is available, TLC inclusion and exclusion criteria and gave consent for thecan be used as a substitute for symptomatic patients. study. The inclusion criteria consisted of patients whoAccording to the guideline by WHO for scaling up are 18-65 years of age and patients who are receivingantiretroviral therapy in 2003, CD4 testing is the tool for triple regimen of HAART from the clinic during themaking decision on HAART therapy and monitoring; study period. Exclusion criteria were pediatric patientshowever if this is not available, one can use TLC count less than 18years of age and pregnant patients. Perm-3less than 1200 /mm as surrogate marker for CD4 count ission to conduct the study in the ART unit was given by3 13less than 200 cells/mm .the Head of the Department of Medicine. The study wasThis recommendation was based on rigorous evaluation approved by the Human Ethical Committee ofof data obtained almost exclusively from developed Government Medical College, Thiruvananthapuram. An6, 7,8,14countries.informed consent form, approved by the Human EthicalHowever, there are also studies indicating that Committee, was signed by all patients and this processsubstitution of TLC for CD4 count monitoring might not was in accordance with Good Clinical Practice (GCP).be a good clinical decision. A study conducted in Nigeria The following demographics of the study patients wereevaluating the reliability of total lymphocyte count as a collected: HAART regimen, age, sex, urban/rural, placesubstitute for CD4 cell count found that total lymphocyte and source of infection, disability status, employmentcount is not suitable for CD4 cell count in a resource status, marital status, and income. CD4 count waslimited setting. The sensitivity of total lymphocyte count recorded from the report from the department ofas a predictor of CD4 cell count was 45.5% and the dermatology (CD4 count was ordered from thisspecificity was 62.2%. The study's author concluded that department). WBC and Total lymphocyte count were3if WHO recommendation of 1200 cells/ mm were used to obtained from medical laboratory report. (Both CD4determine treatment, 1 in 3 individuals would have been count and TLC count were done on same day).deprived of needed treatment. So in that particular setting Statistical analysisTLC is not a reliable predictor of CD4 cell count in Sensitivity, specificity, positive predictive value (PPV),HIV-infected individuals. 14 and negative predictive value (NPV) were calculated toBased on these differing evidence accounts, this study's establish the relationship between TLC and CD4 counts.primary aim was to analyze the reliability and clinical A receiver operator characteristic (ROC) curve was alsoutility of total lymphocyte count as a surrogate marker for drawn to determine the best cut-off points. StatisticalCD4 count and to check the reliability of WHO significance was calculated utilizing linear regression.recommendation in resource limited setting in India. The Paired t-test was utilized to determine statisticalmain objective was to calculate the sensitivity and significance of pre and post treatment CD4 counts. Forspecificity values of using total lymphocyte count as a all tests, p
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