Switching from suppressive protease inhibitor-based regimens to nevirapine-based regimens: a meta-analysis of randomized controlled trials

Objectives We performed a meta-analysis to assess the efficacy and safety of switching from protease inhibitor (PI)- to nevirapine (NVP)-based regimens in HIV-infected patients in whom virological suppression had been achieved. Methods Six trials (550 patients) were analysed. The demographics showed that 11-48% of participants were female and 40-53% had hepatitis C or B virus infection, and the mean CD4 lymphocyte count was >500 cells/mu L at study entry. Results NVP-based regimens showed noninferiority compared with continuation of PI therapy to maintain virological suppression in 'intention to treat' (80 vs. 78%; P = 0.35) and 'on treatment' analyses (91 vs. 89%; P = 0.10). Overall rates of discontinuation because of adverse events were similar in the two groups (11 vs. 10%; P = 0.79). However, NVP-based therapies caused more discontinuations because of liver toxicity than PI-based therapies (7 vs. 0%; P = 0.0009). At the end of follow-up there was no statistical difference in CD4, cholesterol, triglyceride and body shape measurements between the two groups. Two studies reported greater improvement in quality of life in patients who were switched to the NVP group. Conclusions Switching from suppressive PI- to NVP-based regimens is virologically and immunologically safe; however, the risk of liver toxicity requires monitoring of clinical symptoms and liver chemistry during NVP therapy.