Highly Active Antiretroviral Therapy Induced Hematological and Dermatological Adverse Drug Reactions in People Living with HIV in India

Rajesh Radhakrishnan



Background:  In India, People living with Human immunodeficiency virus (PLW-HIV) are at higher risk for developing hematological and dermatological adverse drug Reactions (ADRs) to Highly Active Antiretroviral Therapy (HAART) compared general population, leading to prolonged hospitalization causing financial burden and treatment failure.

Objective: The study was to characterize the pattern of hematological and dermatological ADRs associated to HAART in PLW-HIV with regards to causality outcomes, demographics, predictability, and preventability of reported ADRs to HAART.

Methods: A prospective observational study was conducted at medicine department for reporting hematological and dermatological ADRs to HAART in PLW-HIV with Institutional Ethics Committee approval. HIV Seropositive patients (HIV-SPP) were monitored for hematological and dermatological ADRs to HAART during their hospital stay. The World Health Organization (WHO) definition of ADRs was used to assess the causality. Predictability of ADRs was assessed based on Micromedex data base. Preventability of ADRs was assessed by using Schumock and Thornton criteria.

Results: A total of 174 HIV-SPP were enrolled with 133(76.4%) males and 41 (23.6%) females. Out of which 99 ADRs were reported. ADRs to HAART were highest 70(70.7%) in males compared to 29(29.3%) in females. The CD4 T-cell count (cells/µl) at the time of reported ADRs ranges ≤ 350 cells/µl in 79(79.8%). Sixty seven hematological and Thirty two dermatological ADRs to HAART was reported. Greater number of hematological 40(59.6%) and dermatological ADRs 15(46.8) were reported with Zidovudine + Lamivudine + Navirapine based HAART regimen. In most of the reported ADRs suspected drug was withdrawn. WHO causality assessment was Probable. Severity of ADRs were moderate to mild with one Fatal ADRs. Hematological ADRs reorted are 1) Anemia with zidovudine, 35(52.2%) 2) Pancytopenia with zidovudine 20(29.9%) 3) Neutropenia with Lamivudine, 4) Leucopenia, bictyopenia, eosinophilia with zidovudine. Dermatological ADRs of maculopapular rash 7(21.8%) with Nevirapine, Tenofovir + Emtricitabine + Efavirenz and Lamivudine based HAART regimen followed by hyper pigmentation 7(21.8%) with Zidovudine, Nevirapine, lamivudine + Emtricitabine.

Conclusion: In India, with increasing use of newer and older HAART combinations, physician must focus attention in PLW-HIV for routine monitoring of all possible risk factors for early prevention of hematological and dermatological ADRs with HAART.


Human immunodeficiency virus; highly active antiretroviral therapy; adverse drug reactions; Dermatological and hematological adverse drug reactions


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