Journal of Pharmacovigilance

Study of self-reported Adverse Drug Reactions and factors influencing it among HIV/AIDS patients on antiretroviral therapy

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Sandeep B

Scientific Tracks Abstracts: J Pharmacovigilance

Abstract:

Introduction: Antiretroviral therapy (ART) patients have higher risk of developing Adverse Drug Reactions (ADRs). ADRs have considerable influence on treatment adherence, treatment outcomes and treatment options. Hence, aim of this study was to find the common self-reported ADRs, factors influencing ADRs and the reasons for missing ART dose. Methods: Cross-sectional study was conducted at ART center, RIMS teaching hospital. Semi-structured interview questionnaire was used to extract information regarding self-reported ADRs, socio-demographic profile, reason for missing dose. Variables related to ART medication, laboratory values were obtained from patient treatment records. Proportions and logistic regression were used to determine the associations of dependent variables. Data analysis was done using SPSS version 16. Result: Among 270 patients enrolled in this study, 50% aged ≤40 years, 52.6% were male, 87% employed, 70.4% were literate, and 67 % were married. Zidovudine/Lamivudine/Nevirapine (ZDV/LMV/NVP) (28.9%) followed by Tenofovir/Lamivudine/ Nevirapine (TDF/LMV/NVP) (24.1%) were the common regimens prescribed in this study. At least one ADR was reported by 40 (14.8%) study participants. Burning sensation in stomach (14.8%) followed by anemia (13%) were the most frequently reported ADRs. Around 18.5 % of patients were non-adherent to ART during the last seven days prior to the interview. The two most common reasons for missing doses were forgetting (70%) followed by ADRs to ART (34%). In the bivariate analysis, literates, employed, married, urban patients, those with CD4 count >350, those on Non-AZT based regimen and those who are non-adherent to ART regimen showed higher rate of adverse events but this difference was statistically not significant. Only those with age more than 40years (OR=2.975(1.408, 6.283), p= 0.04) and duration of ART less than 2 years (OR= 0.364(0.148, 0.898), p=0.028) were significantly associated with self-reported ADRs. Conclusion: ADRs are one of the common occurrences among patients on ART. Except for age, no demographic variable had an influence on its occurrence. Longer the duration of ART lesser the ADRs. Hence counseling regarding the same can lead to better adherence and outcome of the therapy.

Biography :

Sandeep B has completed MBBS degree from Vijayanagara Institute of Medical Sciences, Bellary, Karnataka and presently post-graduate in MD pharmacology from Raichur Institute of Medical Sciences, Karnataka, India. He has participated in various national and international conferences - 7th Asian Conference on Pharmaco-epidemiology, Bengaluru, IPSCON-2012, Nagpur, IPSCON-2013, Bengaluru, and done poster presentation, attended workshop on Epidemiological methods and Research methodology, NIMHANS, Bengaluru, India.