The clinical-related characteristics were baseline CD4 cell count, baseline viral load, baseline hemoglobin level, World Health Organization (WHO) clinical staging, tuberculosis co-infection, hepatitis B co-infection, hepatitis C co-infection, opportunistic infection, and duration between first HIV positive test and ART initiation. The patient-related characteristics at ART initiation were age group, gender, ethnicity, HIV transmission mode, and history of illicit drug use. The variables were patient-, clinical-, and treatment related. If any patient was confirmed dead based on the record, their LTFU status was changed to “died.” For LTFU patients, outcome event status was matched with the National Registration Department database at Clinical Research Centre, Malaysia, which receives mortality data of the prior year from the National Registration Department every March. If a patient attended after 3 months, their final status at the study closure was recorded as the outcome for the analysis, and they were marked as having a history of default.ĭeath status was verified by referring to the electronic medical records in the hospital's database e-HIS. LTFU was defined as a patient missing the scheduled follow-up and not attending for 3 months since the appointment date. For those lost to follow-up (LTFU) or alive at study closure, the observations were censored: on the date of the most recent follow-up visits for LTFU and on August 31, 2018, for those still alive. The primary event of interest was death from all causes. Accordingly, from the patients' list, which was sorted according to the date of ART initiation, patient number 7 was selected as the first subject, and every subsequent 16 thpatient was included (i.e., 7 th, 23 rd, 39 thpatient, and so on). To initiate the first selection, “7” was randomly generated in Microsoft Excel using the formula: =RANDBETWEEN (1, 16). The sampling interval (k) was 16 (calculated by dividing the total eligible patients with the required sample size). Patients' data were assessed from the inclusion cutoff period up to 31 August 2018.Ī large sample was available, but there were time constraints to process this data, thus systematic sampling method was adopted. Thus, based on the calculations, a total of 374 subjects were required for this study. Considering that an estimated 10% of the sample might have 30% or more variables with incomplete data, an additional 10% of subjects would be sampled to achieve the final required sample size. The significance level was 0.05, and the power was 80%. The sample size was determined through the survival formula in the PS: Power and Sample Size Calculations software. Only ART-naive patients aged >15 years were included, while those discharged from the hospital without ART were excluded. This tertiary hospital is one of the centers of excellence for infectious disease in Malaysia. This retrospective cohort study considered all PLHIV who were registered in Sungai Buloh Hospital, Selangor, Malaysia, between Januand December 31, 2016. Therefore, the present study was conducted to determine the overall survival rates and identify the prognostic factors for survival in antiretroviral-treated PLHIV in Malaysia. However, since then, antiretroviral drug availability and the provision policy in Malaysia have changed significantly. Few locally published studies have focused on the mortality rate and its determinants in PLHIV over a wide timeframe from as early as 1987 to 2009. In Malaysia, there is a lack of information on the prognostic factors for survival in antiretroviral-treated PLHIV. The benefits of ART in reducing mortality are well established however, the extent varies across regions. To reach more PLHIV, in 2010, the threshold for starting ART was shifted from a CD4 count of 200 cells/µL to 350 cells/µL. This policy was then upgraded to a two-drug subsidy in 2004, and in 2006, government hospitals and clinics provided free first-line ART to patients. In fact, the overall decrease in mortality in the country between 20 was only 13.7%.ĪRT was introduced in Malaysia in 1997 but was not widely used because of its cost, and only patients who fulfilled selection criteria were provided subsidy for one antiretroviral drug. However, in Malaysia, the mortality rate was 5.1% in 2017 (4400 of 87,000 PLHIV), which is twice the global rate. Nonetheless, the global efforts to expand antiretroviral therapy (ART) coverage have reduced HIV-related mortality from 50.5% in 2005 to 2.5% in 2017. In 2017, there were 36.9 million people living with HIV (PLHIV). Since then, >77 million people worldwide have been diagnosed with the acquired human immunodeficiency virus (HIV), and 35 million have died of HIV-related illnesses. The first acquired immunodeficiency syndrome cases were reported in 1981.
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