A Study to Evaluate the Safety of Second Line Antiretroviral Therapy Given To HIV Patients At Tertiary Care Hospital In Western India

Introduction: Prescription of multiple drugs are common in HIV positive individuals particularly after initiation of ART. Therefore, they are at a higher risk of drug interactions and adverse drug reactions. So monitoring of safety in drugs can be helpful to change or design future treatment protocols. Methods: In our ART plus centre patient had to come after 30 days of last visit to refill antiretroviral therapy for next month. After consultation with physician, patient was interviewed and details of any adverse drug reactions due to second line ART or with other drugs were recorded. Results: Most commonly documented ADRs were vomiting [17.02%] and itching [12.76%], followed by hyperbilirubinemia [10.64%] and GI upset [10.64%]. Nausea and vomiting were mainly recorded with tenofovir+lamivudine+atazanavir/ritonavir. There were more number of cases of hyperbilirubinemia with tenofovir+lamivudine+atazanavir/ritonavir than any other regimen. 87.24% of recorded ADRs were of mild severity, 12.76% were of moderate severity according to modified hartwieg and siegel scale. As per causality assessment 76.60 % ADRs were possible and 23.40% were probable ADRs. Conclusion: All the NACO prescribed regimens were well tolerated in majority of the patients, with mild and tolerable adverse effects.