Background: Antiretroviral treatment (ART) has been effective in reducing HIV/AIDS related morbidity and\nmortality. However, the use and uptake of ART has resulted in adverse reactions, due mainly to the medicineââ?¬â?¢s\ntoxicity and interactions with other medicines. The timing of adverse drug reactions (ADRs) among these patients is\na critical public health issue for antiretroviral (ARV) treatment adherence and retention. Reliable monitoring of HIV\npatients on ART is through a structured pharmacovigilance surveillance system. However, recurrent nature of these\ndata pose challenges in their analyses. This study aimed at modelling the timing of ADR events in HIV patients on\nART using correlated time-to-event models.\nMethods: The data concern 590 HIV patients registered onto the Medunsa National ARV Pharmacovigilance\nSurveillance System within 6 months of ART initiation between February 2007 and July 2011. Recurrent times of\nADRs and baseline characteristics: patient gender, and age, ART regimen, clinic and initiation period were extracted\nfrom the data. The recurrent ADR events data were modelled using both shared frailty and marginal models on\nthe five patientsââ?¬â?¢ characteristics as covariates.\nResults: Out of 590 patients, 67% were female, 68% started on regimen: Stavudine, Lamivudine and Efavirenz; 37% had\nexperienced at least one ADR and 67% started ART in 2009ââ?¬â??2011. Age (p-value = 0.0210), clinic (p-value < 0.0001) and\nperiod of ART initiation (p-value = 0.0002) were significantly associated with timing of first ADR. There was a significantly\nhigher rates of ADR recurrences in patients aged 38ââ?¬â??44 years [HR = 2.45; 95% CI = (1.47; 4.10)] vs. 30 years and less,\npatients taking regimen: Zidovudine, Lamivudine and Nevarapine) vs. regimen: Stavudine, Lamivudine and Efavirenz\n[HR = 2.09; 95% CI = (1.35; 3.22)], while the rate was lower among those who started ART in 2009ââ?¬â??2011 vs. those who\ninitiated in 2007ââ?¬â??2008 [HR = 0.55; 95% CI = (0.40; 0.76)].\nConclusion: More realistic time-to-event models for recurrent events data have been used to analyse timing of ADR\nevents in HIV patients taking ARV treatment. Age, antiretroviral regimen type and period of initiation of ART were\nassociated with the timing of HIV/AIDS drug related adverse reactions regardless of the analysis model used. This study\nhas public health policy implications in addressing the added morbidity among HIV patients taking ARV treatment in the\ncontext of universal scaling up of ARV treatment.
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