Abstract
Background: Human immunodeficiency virus (HIV) is the causative agent of acquired immunodeficiency syndrome (AIDS). HIV/AIDS is a significant worldwide medical issue. Patients on highly active antiretroviral therapy (HAART) generally encounter adverse drug reactions (ADRs). Various aspects of HAART such as adherence of the patient to the therapy, results of the therapy, and their treatment alternatives are considerably influenced by the presence of ADRs.

Aim and Objectives: To estimate the commonly encountered self-reported ADRs among the patient on HAART, to know the various factors which influence the ADRs, the reasons behind missing ART doses and to know the relationship among ADRs and different factors to HAART.

Materials and Methods: The present study was conducted in HIV/AIDS patients on HAART attending ART center at Raichur Institute of Medical Sciences, Raichur, after getting the ethical clearance. This was a cross-sectional, observational study conducted among the two hundred and seventy HIV/AIDS patients on HAART during the 12-month study period from December 2013 to November 2014. After obtaining the informed consent, the information pertaining to the sociodemographic profile of the patient, ADRs to HAART, and explanations behind missing ART dose were collected using a semi-structured interview questionnaire. The patient treatment record was used to collect the information regarding variables related to HAART and the laboratory values. Data were interpreted by applying descriptive analysis after collecting in Microsoft Excel sheet. The relationships of dependent variables to ADRs were determined by logistic regression analysis.

Results: Of 270 enrolled patients, 135 (50%) patients aged less than 40 years, 190 (70.4%) were literate, 142 (52.6%) were male, and 194 (71.9%) were from rural background. Zidovudine based regimens 117 (43.3%) were the most commonly prescribed regimen in this study. The most frequently self-reported ADRs were burning sensation in stomach 40 (14.8%). The two most normal explanations behind missing ART dosages were simply forgot 35 (70%) trailed by ADRs 17 (34%) to HAART. Two variables were found to have a significant relationship to the self-reported ADRs on bivariate analysis. These were patients on HAART who aged more than or equal to 40 years (24.4%, P = 0.04) and when the duration of HAART was under 2 years (17.8%, P = 0.028).

Conclusions: The most common self-reported ADR was a burning sensation in stomach. The ADR encounter was more common when the duration of HAART was lesser than 2 years. Aside from the age of the patient, no other sociodemographic variable has an impact on ADR occurrence. Therefore, it is the responsibility of the health care service providers to have the knowledge of frequently occurring ADRs and the factors influencing it to enhance the effectiveness of HAART.

Key words: Self-reported Adverse Drug Reactions; Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome; Antiretroviral Therapy; Adherence; Drug Resistance, Mortality