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.