ADVERSE DRUG REACTIONS WITH SECOND LINE ANTIRETROVIRAL DRUG REGIMEN

Abstract

Acquired immunodeficiency syndrome (AIDS) is a disease of the human immune system caused by the human immunodeficiency virus (HIV). Because of treatment failure with first line ART, second line ART is being instituted in 10 Centers of excellence in our country, Gandhi hospital being one of them.

Aims & Objectives: The aim of this study is to gain knowledge on the profile of ADR associated with second line ARV drugs, the burden of adverse drug reactions of second line ART in our setup and factors associated with it, with the ultimate goal of improving the tolerability and effectiveness of HIV treatment.

Material & Methods: Institution based cross sectional study conducted using review of clinical records and follow up of adult patients started on second line ART from May 2010 to April 2011 at GANDHI Hospital. All adult AIDS patients of either sex aged greater than or equal to 20 years who were registered for second line anti-retroviral treatment at GANDHI Hospital were included in the study. The clinical records of study subjects were reviewed retrospectively for ADRs. Information on patient's details, the WHO clinical staging of the disease at the start of ART, duration of treatment, drug details, nature of the adverse drug reactions, severity, outcome, and results of investigations performed were collected using a data collection format (Annex I). Data were collected from May 2010 to April 2011.

Results: 58 cases were included in the study. 58 cases were included in the study. Among the total 58 patients who were on second line ARV drugs, ADRs were reported in 44 (75.86percent) patients (Table 3). The most frequently observed ADRs were nausea (12.25percent), followed by insomnia (10.29percent), loss of appetite (9.31percent) malaise (7.35percent) and vomiting (7.35percent). Out of the 44 patients who developed ADRs, 20 (45.45 percent) patients were grade II, whereas grade I and III ADRs occurred in 9 (20.45percent) and 15 (34.09percent) of the patients respectively. Grade IV was reported in none of the patients. No ADRs were noted in 14 (24.14percent) patients. Out of 44 patients who had ADRs, 32 patients (72.73percent) had less than 5 ADRs and 12 patients (27.27percent) had more than 5 ADRs.

Conclusion: Second line anti-retroviral drugs are expensive, and the majority of the world's infected individuals do not have access to medications and treatments for HIV and AIDS. Though second line ART regimens are associated with mild to moderate ADRs, these are most effective regimens as they improved  CD4 counts and reduced viral load significantly.

Keyword: NACO, HIV, Immunodeficiency, Second line, Side effects, Regimen, Reporting