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INTRODUCTION: National AIDS Control Organization (NACO) has expanded the reach of anti retroviral therapy (ART) to combat the epidemic of HIV/AIDS in India which has one of the largest populations of people living with HIV/AIDS (PLWHA) in the world. One of the major challenges related to ART is a lifelong commitment by patients to adhere diligently to daily medication dosing schedules and scheduled visits to the ART center. Hence, the current study is carried out to assess the drug adherence rate and loss to follow-up (LFU) among PLWHA attending ART centre of a tertiary care hospital in Western India. MATERIALS AND METHODS: The current cross-sectional study was carried out using medical records of all patients registered at ART Center, Shree Sayaji General Hospital, Vadodara after taking Ethical Clearance from Local IRB. LFU was classified according to NACO guidelines. Data were collected using a standardized data extraction form as per NACO treatment card. Data entry and analysis were performed using Epi Info software. RESULTS: Of 755 PLWHA registered at ART center, 534 (70.7%) subjects were alive on ART, 61 (8%) were transferred out, 68 (9%) died, and 92 (17%) were LFU. Nearly, 57% PLWHA have drug adherence rate of more than 95%. Education status of the participant showed independent and significant association with drug adherence. CONCLUSION: This study showed 57.3% were adherent to ART among PLWHA, whereas 17.22% were lost to follow-up. Hence, there is a need to emphasize on increasing drug adherence rate and on outreach activities to combat LFU.
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OBJECTIVE: To evaluate the efficacy and safety of atorvastatin + hydroxychloroquine fixed-dose combination tablets in comparison with atorvastatin alone in treatment of dyslipidemia. METHODS: This double-blind, randomized, out-patient study was conducted in 328 patients with primary dyslipidemia having low-density lipoprotein cholesterol (LDL-C) ≥ 130 mg/dL (3.37 mmol/L) to ≤ 250 mg/dL (6.48 mmol/L) and triglycerides ≤ 400 mg/dL (4.52 mmol/L). Eligible patients were randomized to receive either atorvastatin 10 mg (n = 167) or atorvastatin 10 mg + hydroxychloroquine 200 mg (n = 161) for 24 weeks. CLINICAL TRIAL REGISTRATION: CTRI/2010/091/006138. MAIN OUTCOME MEASURES: To compare percentage change in LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 12 and Week 24 between groups. To compare mean change in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), high-sensitivity C-reactive protein (Hs-CRP), and percentage of patients achieving lipid goals at Week 12 and Week 24. RESULTS: At Week 24, percentage reduction in LDL-C (-32.52 [-36.13 to -28.91] vs -39.54 [-43.25 to -35.83]; p = 0.008), TC (-24.41 [-27.10 to -21.72] vs -29.30 [-32.07 to -26.54]; p = 0.013), and non-HDL-C (-30.37 [-33.71 to -27.04] vs -36.76 [-40.18 to -33.33]; p = 0.009) was significantly greater in combination treated patients. Both the treatments showed a significant reduction in triglycerides at Week 24 from baseline, however, this reduction was not statistically significantly different between treatment groups. No significant change in HDL-C was observed in patients from both the treatment groups. At Week 24, change in HbA1c (0.22 [0.07 to 0.37] vs -0.13 [-0.28 to 0.03]; p = 0.002) and FBG was also statistically significant in favor of combination therapy (0.37 [0.07 to 0.67] vs -0.29 [-0.59 to 0.03]; p = 0.003), whereas no statistically significant difference was observed in change in Hs-CRP (p = 0.310). Significantly more patients from the combination group achieved LDL-C and TC goals. Exploratory analysis in patients with pre-diabetes showed development of diabetes in 8 patients (15.09%) from the monotherapy group and 1 patient (1.96%) from the combination group (p = 0.034). Study medications were generally safe and well tolerated. CONCLUSION: Based on study results and widely reported pleiotropic benefits, hydroxychloroquine could emerge as a potential drug for combination with statins for treatment of dyslipidemia. Long duration studies with larger sample sizes are required to further explore the role of hydroxychloroquine as adjunct to statins in reducing risk of cardiovascular events and prevention of statin-induced diabetes.
