Evaluating the Effects of Combination Antiretroviral Therapy Regimens and the Development of Adverse Drug Reactions in Indian Human Immunodeficiency Virus Positive patients

Background: In India, adverse drug reactions (ADRs) occur frequently with combination antiretroviral therapy (cART) leading to switching or discontinuing cART intentionally. Objective: The study was conducted to characterize the effects of cART regimen and the development of ADRs in human immunodeficiency virus positive patients (HIV) in a tertiary care teaching hospital. Materials and Methods: A prospective observational study was conducted from August 2009 to May 2012 to characterize the pattern of ADRs to cART at Kasturba Hospital, Manipal in South India. Collection of the data was done by a clinical pharmacist during daily ward rounds to identify the suspected ADRs associated with the use of cART for various parameters which included patient demographics, cART with its adverse reaction characteristics. Assessment was also done for preventability, predictability and seriousness of ADRs, system organ classes affected and causality of the suspected ADRs using the World Health Organization (WHO) Probability Scale. Results: Among 450 patients enrolled, 230 suspected ADRs to cART were reported. By Pearson Chi‑square test, higher occurrence of ADRs (P < 0.001) was noted in females, age 41‑60 years, CD4 +T‑cell counts 350‑500 cells/μl, 5 years use of cART. ADRs were highest with zidovudine + lamivudine + nevirapine (42.3%) and tenofovir + emtricitabine + efavirenz (14.2%). On bivariate analysis, (P < 0.001) were identified in 1) Anemia with zidovudine use, 2) Pancytopenia with zidovudine, lamivudine use 3) Hepatotoxicity with nevirapine, efavirenz use, 4) Peripheral neuropathy with stavudine use, 5) Renal failure with tenofovir use and 6) Maculopapular rash with emtricitabine, tenofovir, efavirenz use. The system organ class most affected with ADRs to cART was red blood cell disorders (30.9%) followed by skin and appendages disorders (16.5%). Conclusion: With increasing reports of ADRs in India, clinicians need to select a safe cART regimen with underlying illness, medicines and drug intolerances.