A pharmacovigilance study of antiretroviral therapy in HIV positive out patients at a tertiary care teaching hospital

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.

Evaluation of Adverse Drug Events in Patients on Anti-Retroviral Therapy Regimen at Omdurman Voluntary Counselling and Testing and Anti-Retroviral Therapy Center in Sudan – A Cross-Sectional Study

“…Most of the participants (56.1%) who experienced ADEs had CNS manifestations (dizziness, anxiety, nightmares, depression), while one-third (31.8%) of them reported suffering from fatigue, this is expected as most of the patients were on 1e regimen (efavirenz, lamivudine, tenofovir) that contains efavirenz. Comparison with other studies revealed variations in the most occurring ADEs, CNS-related ADEs were the main occurrences, in some studies, 7 , 10 while in others, dermatological events ranked first, then gastro-intestinal problems and neuronal events. 11 , 15 In another study conducted in Nigeria, digestive disorders including nausea and abdominal pain were the most common ADEs followed by insomnia.…”

“…The prospective observational study mentioned above applied the WHO-UMC scale and it was found that 308 out of 369 events of ADR cases had “probable” relationships with suspected drugs. 7 Another study with the same design and scale assigned “certain” causality as the most common with a percentage of 29.8%. 10 …”

“…The introduction of anti-retroviral therapy (ART) despite having complicated regimens and not a final treatment for HIV has turned it into a controllable chronic disease. 6 , 7 …”

“…Two studies stated that close monitoring of patients is the key solution for dealing with the issue of ADEs. 7 , 9 Although adverse drug reactions (ADRs) of ART in developed countries are well known, they cannot be taken as a prediction for ART toxicity profile in developing countries. 10 , 18 The presence of opportunistic infections, malnourishment, and many other conditions and co-morbidities may alter the toxicity of ART.…”

“… 10 , 18 The presence of opportunistic infections, malnourishment, and many other conditions and co-morbidities may alter the toxicity of ART. 7 …”