ABSTRACT
Background: Anti-Retroviral Therapy regimen (ART) is the only treatment option for treating the HIV positive patients for improving the immune system by increasing the CD4 cells. But eventually these medications lead to development of some Adverse Drug Reactions (ADRs) in seropositive patients under treatment.Methods: A prospective observational study was conducted for 6 months from March to August 2018 at ART Centre, Sri Venkateswara Ramnarayan Ruya Government General Hospital (SVRRGGH), Tirupati.Results: Out of 216 ADRs identified, majority where identified in females (54.35%). Most common regimen caused ADR was tenofovir+ lamivudine+ efavirenz (TLE) (55.55%). Data were analysed using the chi-square test were P-value was found to be 0.0024. Majority of ADRs were found in patients of age group between 31-35years was found to be 45 (20.83%) followed by age group between 41-45years was found to be 40 (18.51%). Most of the ADRs were related to central nervous system (27.31%) followed by metabolic disorders (26.38%), hematologic system (23.14%), gastrointestinal system (12.96%), dermatologic system (9.25%), renal system (0.46%) and musculoskeletal system (0.46%). On evaluation of WHO-UMC causality of ADRs, majority were found to be possible (78.7%). The Hartwig and Siegel’s severity assessment scale showed that most of the ADRs were mild (64.42%). The Schumock and Thornton preventability scale showed that 50.92% patients ADRs were probably preventable.Conclusions: As most of the ADRs were observed in patients receiving TLE regimen. So, patients receiving TLE regimen need intensive monitoring. Doctors, nurses, pharmacist must focus on early detection and prevention of ADRs, based on their severity.
ABSTRACT
Background: The introduction of highly active anti-retroviral therapy (HAART) has led to a significant reduction in AIDS related morbidity and mortality. Most of the adverse drug reactions are preventable. So continuous evaluation will benefit Antiretroviral treatment that helped to achieve ultimate goal of making treatment safer and more effective to patients. The present study was designed to monitor and analyse the incidence, type and nature of adverse events to first line Antiretroviral drugs.Methods: A cross sectional observational study was conducted at Antiretroviral treatment center of Gandhi Hospital, Secunderabd, Telangana. The study was conducted over a period of 6 months involving all HIV patients. After initiation of 1st line regimen- tenofovir 300mg + lamivudine 300mg + efavirenz 600mg (TLE), patients were followed for any adverse event. Descriptive statistics was used for analysis of data.Results: Out of 453 studied, 47 patients developed adverse events. A total of 79 adverse events were reported. The assessment of total adverse drug reaction profile revealed cutaneous 44.30%, hematological 40.50%, renal 11.39%, gastrointestinal 3.79%. WHO-UMC causality assessment scale showed 76.5% and 23.4% Adverse events as probable and possible respectively. Hartwig and Siegel severity scale revealed 93.6%, 2.1% and 4.3% as mild, moderate and severe cases respectively.Conclusions: The TLE regimen found with lower adverse events in this study. The study focuses the importance of active adverse event monitoring to detect early toxicities and to support safe use of anti-retroviral treatment.