01 Set Long-term efficacy and safety of rilpivirine plus abacavir and lamivudine in HIV-1 infected patients with undetectable viral load (TMC278HTX4002 Study)
A regimen with rilpivirine (RPV), abacavir (ABC) and lamivudine (3TC) is simple and may allow the sparing of tenofovir (TDF) and protease inhibitors (PIs). Objectives of this study were to assess the durability of an antiretroviral regimen including RPV plus ABC/3TC and evaluate changes in immunological, metabolic and other safety parameters. Retrospective study on HIV patients followed at the Infectious Disease Department of the San Raffaele Scientific Institute, HBsAg-negative, HLA B5701-negative, with HIV-RNA<50 copies/mL who started RPV plus ABC/3TC since March 2013. Patients’ follow-up accrued from the date of RPV plus ABC/3TC initiation (baseline, BL) to the date of treatment failure (TF) or to the date of last visit. Time to TF was evaluated by use of the Kaplan-Meier curves. Mixed linear models were applied to evaluate changes in immunological, metabolic and other safety parameters. In this analysis 100 pts were included. By 12 and 24 months after switching to RPV plus ABC/3TC, the proportions of individuals without TF were 87% (95% CI: 78-92) and 80% (95% CI: 68-89). The time to TF was not significantly influenced by nadir CD4+ (<200 vs ≥200 cells/µl; p=0.994), viral load at ART initiation (<100000 vs ≥100000 copies/mL; p=0.188) or the previous antiretroviral regimen (PI+2NRTIs vs NNRTI+2NRTIs vs Other; p=0.482). Sixteen subjects discontinued the treatment. Simplification regimen with RPV plus ABC/3TC is effective and safe.