Pharmacovigilance of highly active antiretroviral therapy among adult patients in a large urban HIV treatment center in Nigeria

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1 Abstract no. A Pharmacovigilance of highly active antiretroviral therapy among adult patients in a large urban HIV treatment center in Nigeria I.O. Abah 1, P. Ugoagwu, V. Ojeh, L. Ogwuche, J. Musa, M. Akanbi, P. Agaba, O. Agbaji, P. Kanki, J. Idoko 1 AIDS Prevention Initiative in Nigeria, Jos University Teaching Hospital, Pharmacy, Jos, Nigeria

2 Background Pharmacovigilance provides a means of surveillance to ensure safety in the use of antiretrovirals. Pharmacovigilance is well established in most highincome countries, but its practice in low and middle income countries is variable. Aim: We evaluated the incident events of adverse drug reaction (ADR) in a cohort of adult Nigerian patients on antiretroviral therapy (ART).

3 Methods A retrospective cohort of HIV infected adults (age 15years), initiated on non nucleoside reverse transcription based ART, between January 2004 and December 2011, at the PEPFAR supported HIV treatment center, Jos University Teaching Hospital, were evaluated. Patients had been monitored every month (approximately) for ADRs. Identified ADRs were assessed for causality and graded on a four point scale according to WHO severity grading and pharmacovigilance definition Multivariable logistic regression assessed factors associated with the development of severe ADRs (grade 3 or 4).

4 Results A total of 13,746 patients were evaluated Median (range) duration on ART was 45 (0-107) months, providing 67,9383 person-years of follow-up. In all, 1312 ADRs were reported (incidence rate 1.9 per 1000 personyears), comprising of 11.1%, 32.8%, 54.4% and 1.7% grade 1,2,3, and 4 ADRs respectively. Table 1: Baseline demographic and clinical characteristics of 13,746 patients on ART in Jos Variable Group Number Percent Sex Female Age, median (IQR) 35 (30-42) Marital status Married Single Divorced/Widowed NNRTI EFV NVP NRTI AZT/3TC TDF/3TC D4T/3TC DDI/3TC ABC HIV transmission Heterosexual risk Transfusion Others HBV status Negative Positive WHO stage Employment Employed Student Unemployed/Retire Education dprimary/nfe Secondary Tertiary

5 Results Reported adverse drug reactions Adverse drug reactions Number % Lipodystrophy 658 (50.8) 50.8 Anaemia 227 (17.5) 17.5 Skin rash/ Itching/SJS/ Erythema 128 (9.9) 9.9 Multiforme Peripherral Neuropathy 87 (6.7) 6.7 Sleep disorder/hallucination/mood 74 (5.7) 5.7 changes Nausea/ Vomiting / Diarrhea 56 (4.4) 4.4 Ascitis/Jaundice 26 (2) 2 Oligouria/body swelling 13 (1) 1 Hyperpigmentation (Skin/Nail) 11 (0.8) 0.8 Hypersensitivity 8 (0.6) 0.6 Myalgia/Bone pain 3 (0.3) 0.2 Seizures 2 ( Fever/Malaise 2 (0.2) 0.2 Photosensitivity 1 (0.1) 0.1 Overall, 745(57.3%) of the ADRs were reported by patients on stavudine (d4t). Independent predictors of severe ADRs were first year of ART [adjusted odd ratio (AOR) 1.4; 95% CI:1.1-2], being on d4t based regimen (AOR 14.5; 95% CI: ) and efavirenz backbone (AOR 1.4; 95% CI:1-1.9) compared to nevirapine. CD4 cell count of < 350 cells/mm 3 at ART initiation was associated with Lower odds of severe ADRs (AOR 0.73; 95% CI: ). Sex, NNRTI backbone, HBV status and TB treatment were not significantly associated with severe ADRs.

6 Conclusion HIV infected patients should be monitored more closely in the first year of commencement of ART as severe ADRs are more likely during this period. Compared with NVP, the use of EFV in adults was associated with higher risk of severe adverse events in our setting. Acknowledgement This work was funded in part by the US Department of Health and Human Services, Health Resources and Services Administration (U51HA02522) and CDC through APIN (PS ). The contents are solely the responsibility of the authors and do not represent the official views of the funding institutions