Background: The clinical benefit of newer regimens for treatment experienced patients is unknown. Methods: ADE were adjudicated by an independent panel (confirmed or probable) from 2 placebo controlled studies of ETR + darunavir + NRTI(s) +/- enfuvirtide (ENF). Pre-specified analyses were done using all patients and stratified by de novo or not de novo (including recycled ENF or not used) ENF use. Results: 1203 patients had a baseline median CD4 of 105, log₁₀HIV RNA of 4.8 and 59% had CDC C classification. Overall, 59 (9.8%) of PL and 35 (5.8%) of ETR patients had an ADE/D (P = 0.041). 22 ADE/D occurred in the first 30 days (16 in PL). Time to ADE/D was significantly shorter for PL than ETR (figure). The most common ADEs were Candida esophagitis (10), PCP (9), HSV (8), MAC, (7) CMV retinitis (6) and KS (6). Death was the first event in 8/20 PL and 8/12 ETR patients.
In the sub-group on de novo ENF (n=312), events were similar. However, in those not on de novo ENF (n=891), PL had more events than ETR (10.1% vs 5.4%; P = 0.0086). Conclusions: In addition to virologic and immunologic benefits, use of ETR was associated with a significant longer time to ADE/D compared to placebo in treatment-experienced patients.