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Evaluation of adverse drug reaction profile of antiretrovirals in HIV-positive patients in a tertiary care hospital

Chaithanya Malalur, Smita Shenoy, Muralidhar Varma, Asha Kamath, Hasitha Manohar, Kavitha Saravu.


Background: Adverse drug reactions (ADRs) to antiretrovirals have been a matter of concern as they can affect patient compliance and treatment outcome. Hence, it is important to detect them early and institute appropriate treatment.

Aims and Objective: To assess the prevalence, distribution, causality, severity, predictability and preventability of ADRs to antiretrovirals and to identify risk factors for their development in a tertiary care hospital in South India.

Materials and Methods: This was a descriptive observational study. Data were collected from the case records of adult, treatment naïve HIV-positive patients, newly initiated on antiretroviral drugs, January 2012 onward and closure of data set was on 31st December 2014.

Results: A total of 238 cases met the inclusion criteria. Overall, 56 ADRs were noted. ADRs were observed in 39 males and 17 females. They were common in the age group 51-60 years. Anemia was the most common ADR followed by rash and hyperpigmentation. Most of the ADRs observed were of mild severity, requiring neither change in regimen nor any specific treatment. Zidovudine caused the highest number of ADRs, followed by nevirapine and stavudine. Most ADRs occurred within 6 months of starting antiretroviral therapy (ART). Causality relationship between drug and ADR was graded as “possible” according to WHO causality assessment scale. No statistically significant correlation of age, gender, weight, hemoglobin, CD4 count and the presence of opportunistic infections to the development of ADRs were noted.

Conclusion: Regular monitoring, early detection of ADRs to antiretrovirals and their treatment is essential to optimize ART.

Key words: Pharmacovigilance; Antiretroviral Therapy; Zidovudine; Tenofovir

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