ANALYSIS OF REGIMEN CHANGES DUE TO ADVERSE DRUG REACTIONS ASSOCIATED WITH ANTIRETROVIRAL THERAPY IN HIV PATIENTS
The adherence to antiretroviral (ARV) drug is important to achieve and prolong viral load suppression and avoid drug resistant to Human immunodeficiency virus (HIV). The objective of the study is to estimate the magnitude of regimen change due to ADRs in HIV and to describe the pattern of ARV regimen change due to ADRs in Thai HIV/AIDS patients.
Method(s):
The cross sectional study was performed in adverse drugs reactions data occurred in patients using ARV drugs from spontaneous reporting reports of drug surveillance system in Thailand until year 2014. The selected case is defined as at least 1 ARV drug reported in case reports. The individual case ADRs report which was reported to Thai Food and Drug Administration were collected as numerator.
The risk factors of adverse drugs reaction were analyzed. Number of patient/number of prescription who took ARV drug from National Health Securities Office (NHSO) was collected.
Inferential statistics hypothesis testing using Chi-square or Fisher Exact test for categorical data were performed. Reporting Odds Ratio (ROR) will be calculated. Comparison of incidence will be constructed with the HIV-NAT project to evaluate the tendency of ADRs associated ARV drug use.
Result(s):
Adverse drug reactions with ARV drugs associated were identified in 18,332 reports from the drug surveillance database of Thai FDA until year 2014. The majority of patients were from outpatients with ADRs reported around 76%. The mean age is 37.0 (IQR 31-42 years). 72% of ADRs reports were non seriousness. Total of 4,877 serious ADRs reports with ARV associated to Thai FDA, 81% of those resulted in patients to prolong hospitalization. 1% was reported death from ADRs with ARV.
GPO-Vir was the most drugs used in Thai HIV patients (39.07%). Totally, combinations drug are prescribed to patients. The combinations of drug formula were the top anti retro viral drug used from NHSO database classified by regimen in year 2010.
The incidence of ADRs associated to ARV equaled 0.056 (95%CI 0.051-0.06). The high incidence of Lipodystrophy reactions from GPO-Vir was 0.0386 (95%CI 0.0353 -0.0425).
Conclusion(s):
The incidence of ADRs cases associated ARV was also high in many combination drugs regimen. Risk communication was done and the results of this study lead to improve the guideline of treatment about ARV therapies in Thailand.