A prospective, observational cohort study to elicit adverse effects of antiretroviral agents in a remote resource-restricted tribal population of Chhattisgarh

Abstract

Objective:To assess the adverse effects of antiretroviral therapy (HAART) and its adherence in HIV-infected patients, in remote and tribal area with restricted resources.Materials and Methods:This was a prospective, observational study carried out at Department of Medicine, Government Medical College, Jagdalpur. A set of questions were asked and adverse drug reactions (ADRs) were recorded for every patient.Results:79 HIV positive patients were analyzed. Among them, 68 (86%) had at least one ADR. The mean ADR per patient was 1.64 (±1.09). The most common ADR in our study was peripheral neuropathy (20.83%), followed by skin rashes (15.83%). Twenty-one patients (26.58%) had severe (grade-3 and grade-4) ADRs. Female patients had more ADRs (45.71%) than males (11.36%); severe ADRs had a statistically significant positive correlation with sex and CD4 cell count of the patients.Conclusion:In spite of high ADRs, HAART is the only answer to HIV/AIDS; thus, management requires a highly precise balance between benefits of durable HIV suppression and the risks of drug toxicity to achieve the therapeutic goals, with conventional drugs or with newer less toxic agents.

A Prospective Observational Study of Adverse Drug Reactions to Antiretroviral Therapy: Type and Risk Factors in a Tertiary Care Teaching Hospital.

“…8 In our study, anemia (55.06%) and rash (25.3%) were found to be most common type of ADR. A study from Vadodara, India unlike our study it showed that cutaneous ADR was most common (44.4%), then next was hematological ADR (32.2%).…”

“…7 The major individual toxicities include bone marrow suppression (zidovudine [AZT]), pancreatitis (didanosine), hypersensitivity (abacavir), hepatic necrosis (nevirapine [NVP]), neuropsychiatric complaints (efavirenz), and nephrolithiasis (indinavir). 8 There is a lack of awareness and inadequate training about drug safety monitoring among health care professionals in India. Often ADRs go unnoticed or are not reported.…”

Adverse drug reaction monitoring on antiretroviral therapy in human immunodeficiency virus patients in a tertiary care hospital

“…12 Study conducted in Chhattisgarh show peripheral neuropathy as most common ADR followed by cutaneous, metabolic and hematological ADRs. 10 Peripheral neuropathy was most common ADR in Chhattisgarh study because 63% of their patients were prescribed SLN regime and stavudine is responsible for peripheral neuropathy. Metabolic ADRs were common in Baroda 9 studies due to the fact that they included both treatment naive as well as experienced patients and the followup period of Baroda study was also longer (2 years).…”

“…This finding is accordance with the study conducted in Chhattisgarh which revealed 1.76 ADRs per patient. 10 The study conducted in Delhi 11 shows 2.9 ADRs per patient. While in Mysore 13 study show 1.16 ADR was developed per patient and study conducted in Nigeria 14 shows 1.5 ADR was developed per patient.…”

“…9 Furthermore, study conducted in Chhattisgarh revealed 86% of patients developed at least one ADR. 10 The study conducted in Delhi 11 shows 90.66% patient developed ADRs. This is in sharp contrast to a study conducted at tertiary care ART center Surat where incidence of ADR was only 26.75% of the patients.…”