Efavirenz as a substitute for protease inhibitors in HIV-1-infected patients with undetectable plasma viral load on HAART: A median follow-up of 64 weeks

We investigated, in a prospective cohort follow-up study, whether substitut ing efavirenz (EFV) for protease inhibitors (Pls) could be safe in HIV-infe cted patients with optimal viral suppression achieved on PI-containing regi mens, In patients with undetectable plasma viral load (pVL) < 50 copies/ml who were naive to therapy with nonnucleoside reverse transcriptase inhibito rs (NNRTIs), PIS were replaced by EFV whereas associated nucleoside analogs (NAs) were retained. 62 patients were enrolled. Median follow-up on EFV wa s 64 weeks (2-88 weeks). Side effects due to EFV occurred in 48 patients. T wo patients experienced a high level viral rebound due to diminished compli ance 55 (88.7%) maintained a pVL < 50 copies/ml; 3 showed one episode of vi remia (52-89 copies/ml); 2 stopped EFV before any VL control. Mean CD4 cell count did not change significantly. One ADDS patient experienced a single cutaneous recurrence of Kaposi's sarcoma after 40 weeks on EFV. Replacing P I with EFV in patients with optimal pVL suppression appears to be safe both virologically and immunologically.