Substitution of nevirapine or raltegravir for protease inhibitor vs. rosuvastatin treatment for the management of dyslipidaemia in HIV-infected patients on stable antiretroviral therapy (Nevrast study).

OBJECTIVES: An observational, prospective, cohort study was performed to compare efficacy and safety of a switch from ritonavir-boosted protease inhibitor (PI/r) to nevirapine or raltegravir with that of rosuvastatin addition to current antiretroviral therapy in HIV-infected patients with hyperlipidaemia.

METHODS: All HIV-infected patients receiving a stable PI/r-based antiretroviral regimen, with persistently suppressed viremia, naïve to non-nucleoside analogues and to integrase strand transfer inhibitors, with mixed hyperlipidaemia, and who underwent a switch from PI/r to nevirapine (Group A) or raltegravir (Group B) or who started rosuvastatin at 10 mg daily (group C) with unchanged antiretroviral regimen were enrolled into the study.

RESULTS: Overall, 136 patients were enrolled: 43 patients were included in the group A, 46 in the group B, and 47 in the group C. The mean age was 46.6 years, and 108 (79.4%) were males. After 48 weeks of follow-up, a significantly greater reduction in the mean low-density lipoprotein (LDL) cholesterol level was reported in group C (-28.2%) than in group A (-10.2%; p < .001) and B (-12.4%; p = .021), while a significantly greater reduction in the mean concentration of triglycerides was observed in group A (-31.2%) and B (-35.5%) than in group C (-11.9%; p = .034 and p = .004, respectively). The incidence of adverse events was <10% and comparable across the three groups.

CONCLUSION: In HIV-positive subjects receiving a PI/r, the initiation of rosuvastatin treatment after 48 weeks yielded a greater decline in LDL cholesterol, while the switch from PI/r to nevirapine or raltegravir led to a greater decline in triglycerides.