Monitoring of Early Field Hepatic Tolerance to NNRTI-Based Regimens with Multiple Biochemical Parameters in Ivorian HIV-1-Infected Patients: A Pilot Study

Background: Multiple biochemical parameters related to cytolysis, cholestasis and/or liver failure, can be used to evaluate liver tolerance to antiretroviral (ARV) drugs. What parameters are most suitable for monitoring early hepatic tolerance in the developing countries? Objective: To evaluate liver tolerance to NVP (nevirapine) or EFV (efavirenz)based regimens during the first six months. Method: This is a preliminary prospective cohort study with 125 naive ivorian HIV1-infected patients, by observing the level of ALT (alanine aminotransferase), AST (aspartate aminotransferase), ALP (alkaline phosphatase), GGT (gamma-glutamyl transferase), and TBR (total bilirubin). Results: Variable changes are noticed in the level of various biochemical parameters from M0 to M6. Nevertheless, we found that the values of these parameters studied fall within normal ranges except for GGT which showed an increased level with NVP-based regimen. Biological liver tolerance to NVP or EFV-based regimen was good at M3 and M6 during therapy. The percentage of patients who had elevated ALT activity had tripled with each ARV regimen from M3 to M6. We noticed a decrease in the median value of transaminases (ALT and AST) from M0 to M6. This decrease was statistically significant for patients on EFV-based regimen from M0 to M3 and from M0 to M6. The ALP enzymes were the least affected after initiation of therapy, regardless of the regimen taken. In general,we noticed an hepatotoxicity of grade 1 or 2, in the two ARV regimens. The hepatotoxicity of grade 3 or 4 were rare (only with transaminases and GGT). Conclusion: We suggest a study of longer duration involving more patients, probably limited to the monitoring of transaminases (ALT and AST) and GGT, due to the results more or less sensitive about them in our analysis.