Background–HIV patients are at increased risk to develop severe hepatotoxicity following initiation of antiretroviral therapy containing HIV–1 protease inhibitors (PIs).

Objectives– To determine risk of hepatotoxicity for HIV seropositive patients on Antiretroviral Protease Inhibitor drugs.

Materials and Methods–The study includes newly diagnosed 280 HIV seropositive patients (aged between 10 and 50 years) who reported to ART centre for treatment at LLRM Medical College & Hospital, Meerut and followed inclusion and exclusion criteria. Epi–info software was used for analysis.

Results–Since after initiation to therapy, serum ALT,AST and ALP levels increased significantly in 60%,62% and 77% patients and the incidence of severe hepatotoxicity within treatment months of Protease Inhibitors was high with Lopinavir/Ritonavir (46%), Indinavir/Ritonavir (45%), Nelfinavir (37%), Saquinavir/Ritonavir (33%) and Indinavir (24%) in HIV patients. Similarly, Hepatotoxicity was significantly higher in HBs Ag and HCV coinfected patients as compared to subjects without coinfection.

Conclusion– Continuous monitoring of ARV administration is required so as to prevent fatal effects of hepatotoxicity.