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

An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa