OP3-5 - Evaluation of Adverse Drug Reaction and Drug-drug Interaction Profile in PLHIV after 60 months of Initiation of ART: A Cross-Sectional Study

Background: Combination antiretroviral treatment (cART) may be impacted or discontinued for a variety of reasons, chief complaints among them being affected by adverse drug reactions and drug-drug interactions that may accelerate the progression of diseases due to insufficient dosage and risk of treatment failure. Tayal et al reported 21% of individuals stopped taking medication due to toxicity and also observed that 28.9% of participants were non-adherent because of adverse drug reactions.

Purpose: Evaluation of Adverse Drug Reaction (ADRs) and Drug-drug Interaction (DDIs) Profile in PLHIV after 60 months of Initiation of cART.

Material and methods: We performed a prospective cross-sectional study in which patients with PLHIV treated with cART were enrolled between August 2019 to November 2021. We recruited 285 adult patients with a median duration of ART was 6 years (IQR, 4–9). Demographic profiles, adverse drug reactions (ADRs), and the prescription were reviewed for potential DDIs among the antiretroviral drugs using the University of Liverpool HIV Drug Interactions Web Application. Clinical data were collected and validated using Epi data and exported to SPSS Version 11 software.  

Results: Of the 285 participants, 48.4% were females. The median age of the study participants was 48.00 years (IQR, 39.50–54.00). Immunological profile CD4: The T lymphocyte median count was 500 (IQR, 332.-713). Viral status: 61 % had target not detected status, 12 % had < 20 viral copies, 23% had >20-1 lakhs copies/ml and 4 % (n=11) had above 1 lakh copies/ml. Status of comorbidity was 9.8 % (n=28), 20.7 (n=59) had diabetes mellitus, hypertension and 3.5% (n=10) with other comorbid conditions. History of Tuberculosis infection and treatment: 26.6 % (n=76) had tuberculosis, out of that 21.3 % (n=61) had Pulmonary TB and the rest 5.2 % (n=15) had extrapulmonary TB.

Adverse drug reaction: Blood dyscrasias related to ADRs were recorded in 63.49% (n=120) of which 46.66% (n=56) accounted for anaemia, 14.75% (n=27) were associated with liver function, 4.23% (n=8) are related to renal function, 3.17% (n=6) had peripheral neuropathy, 1.05% (n=2) had hyperglycaemia and 0.52% (n-1) had altered LDH level. There were 37.89% (n=108) of the subjects had adverse drug reactions (ADR) of which 1.7 % (n=5) were self-reported ADRs. Out of the 285 subjects, 18.9% (n=54) had one ADR,11.2% (n=32) had two ADRs, 5.6% (n=16) had three ADRs and 2.1% (n=6) had four ADRs. Gender distribution of patients with ADRs 58.85% (n=59) were males (out of the total 108).

Potential Drug-drug interactions: The 60.35 % (n=172) prescriptions had potential DDIs, among that 4.87 % (n=8) were pharmacodynamic drug interaction, 57.89 % (n=164) are pharmacokinetic drug interaction, 77.90 % (n=134) prescription had one drug-drug interaction, 16.86 %(n=29) prescription were two DDIs, 4.06 %(n=7) had three DDIs, 1.16 % (n=2) prescription with four DDIs, interacting medication 70.09 % (n=124) were within ART medication 28.48 % (n=49) are interacting between ART and concomitant drugs.

Conclusion: These data are crucial for defining normative guidelines and are vital for patients, carers, researchers, and healthcare policymakers as well.

Clinical Trial Registration: CTRI/2019/06/019609