Publication:

Current trends in highly active anti-retroviral therapy in an anti-retroviral therapy centre attached to a remote government medical college of Maharashtra, India: a retrospective study

Background Highly active anti-retroviral therapy (HAART) became the keystone of national AIDS program. There is lack of awareness and inadequate training about drug safety monitoring among health care professionals in India. Hence, the present study was carried out to study current trends in HAART and pattern of associated adverse drug reactions.

Methods A retrospective observational study was conducted at an anti-retroviral therapy (ART) Centre. A total of 151 HIV/AIDS Patients (old and new cases) receiving HAART during July 2015 to December 2015 were randomly included in the study. Causality and severity assessment of adverse drug reactions (ADRs) was done by using Naranjo’s ADR causality scale and modified Hartwig and Siegel scale respectively. The data was computed using MS Excel and descriptive results were expressed as counts and percentages. The study was approved by institutional ethics committee.

Results The prevalence of HIV/AIDS infection was higher in adult males (51.66%). Zidovudine+lamivudine+nevirapine (ZLN) was the most commonly prescribed HAART combination. Out of 132 ADRs reported, 76.52% of the ADRs were related to haematological system and ZLN was the commonest combination causing ADRs. 90.91% ADRs belong to possible category on causality assessment and 68.94% of the ADRs were of moderate severity. Tuberculosis (28.47%) was the commonest diagnosed opportunistic infection among the HIV/AIDS patients.

Conclusions The prescribing pattern of HAART regimens was in accordance with national guidelines for antiretroviral therapy. We recommend a pharmacovigilance system for sustainable management of ADRs in HIV/AIDS patients as we found under reporting of ADRs.