Purpose: Proven clinical efficacy of protease-sparing regimens (PSR) has been shown. Concerns exist about broad applicability of these regimens in advanced naïve patients. Recent reports have associated a rise in liver enzymes with nevi rapine; however, no data exist with efavirenz.
Method: 17 consecutive antiretroviral-naïve HIV patients were started on a PSR with efavirenz plus two nucleoside reverse transcriptase inhibitors. Baseline liver enzymes, serum CD38, CD4, and HIV viral load data were collected. Correlation between change in viral load and immune reconstitution on therapy were compared to baseline laboratory values.
Results: All patients had a mean viral load decrease of >2 logs, including patients with low initial CD4% or high viral load, and there was no increase of liver enzymes observed at a median follow-up of 42 weeks (range 17-78). There was a perfect correlation between the change in viral load and the initial viral load (p <.0001, r = 1.00) including patients with viral load > or =100,000 copies/mL and CD4 count< or =50 (n = 5). Even patients with low initial CD4 had a significant percentage increase in CD4 count (p <.0002, r = 0.7880). CD38% showed a positive correlation with change in viral load (p =.046, r = 0.522).
Conclusion: All patients experienced a mean viral load decrease of >2 logs (88% less than 400 copies/mL and 35% less than 20 copies/mL). There were no observed increases in liver enzymes. Patients with low CD4 counts, high initial viral load, or high CD38 expression still experienced a significant change in viral load.