Adverse drug reactions to antiretroviral therapy (ART): an experience of spontaneous reporting and intensive monitoring from ART centre in India.
OBJECTIVE
To assess the nature, severity, predictability and preventability of adverse drug reactions (ADRs) and to identify risk factors for antiretroviral ADRs.


METHODS
Enrolled ambulatory patients were intensively monitored for ADRs. Spontaneously reported ADRs by clinicians were also included. Predictability was assessed based on history of previous exposure to the drug or literature incidence of ADRs. Preventability was assessed using Schumock and Thornton criteria and severity was assessed using modified Hartwig and Siegel scale. Bivariate analysis and subsequently multivariate logistic regression were used to identify the risk factors for ADRs. Data from spontaneous reporting was assessed using Bayesian neural network method for possible ADR signals.


RESULTS
Monitoring by active surveillance indentified 159 (52.82%) ADRs from 400 patients. One hundred and forty-two (47.17%) reactions were spontaneously reported. Anaemia and vomiting were the most commonly observed ADRs. The ADRs were severe in 10.9% of cases. A total of 88% ADRs were definitely/probably preventable. Use of Zidovudine+Lamivudine with Nevirapine or Efavirenz, CD4 <200 cells/microl, female gender, tuberculosis and illiteracy were observed as risk factors for ADRs by bivariate analysis. Concurrent tuberculosis was the only influential risk factor for development of ADRs identified by multivariate logistic regression.


CONCLUSIONS
Prevalence of ADRs in intensively monitored patients was found to be 39.7%. Tuberculosis in HIV patients is an influential risk factor for occurrence of ADRs. With the increasing access to antiretrovirals in India, ADRs to antiretrovirals require monitoring and reporting.
Modayil
Retty Rajan
RR
JSS College of Pharmacy, JSS University, Mysore 570 015, India.
Harugeri
Anand
A
Parthasarathi
Gurumurthy
G
Ramesh
Madhan
M
Prasad
Rajendra
R
Naik
Vasudeva
V
Giriyapura
Vamadeva
V
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000553:Ambulatory Care; D019380:Anti-HIV Agents / Q000009:adverse effects*; D001499:Bayes Theorem; D004522:Educational Status; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007194:India / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D014376:Tuberculosis / Q000150:complications; D055815:Young Adult
D019380:Anti-HIV Agents