Antiretroviral treatment simplification with nevirapine in protease inhibitor-experienced patients with HIV-associated lipodystrophy

Background: Simpler and less toxic antiretroviral strategies: are needed to maximize treatment compliance without sacrificing potency, at least for dr ug-experienced HIV-infected patients currently on regimens containing prote ase inhibitors (PIs). Small nonrandomized studies have suggested a benefici al role of PI-sparing regimens on lipodystrophy. Objectives: To assess the virologic, immunologic, and clinical benefit of s witching the PI to nevirapine in patients: with HIV-associated lipodystroph y and sustained viral suppression before entry in the study. Design: Open-labeled, prospective, randomized, multicenter study. Setting: Seven reference inpatient centers for HIV/AIDS in Spain. Patients: One hundred six HIV-infected adults with clinically evident lipod ystrophy who sustained HIV-RNA suppression for at least 6 months with PI-co ntaining antiretroviral combinations. Intervention: Replacement of the PI with nevirapine during 48 weeks (Group A) versus continuing the prior PI (Group B). Measurements: Several virologic and immunologic analyses, standard and spec ific biochemical tests, and anthropometric and dual X-ray absorptiometry me asurements. Results: At week 48, an HIV-I RNA level < 400 copies/ml was maintained in 7 9% and 77% of patients in Groups A and B, respectively, whereas 74% and 72% of patients had viral load levels < 50 copies/ml. Absolute CD4(+) counts s ignificantly increased in both groups compared with baseline values, and a significant decrease in CD38(+)CD8(+) cells was observed ill Group A (p < . 01) but not in group B. Overall, no significant changes in anthropometric o r body shape measurements were found after 48 weeks. Fasting total choleste rol and triglyceride levels decreased in Group A (but not in Group B) compa red with baseline values (p < .05), although no significant differences wer e seen between groups at the end of the study. Subjects in Group A reported a better quality of life (QOL) index than controls (p < .001), with the ma in reason reported being the greater simplicity of the new drug regimen. Conclusions: Protease inhibitor-sparing regimens, including nevirapine, see m to be an effective alternative for PI-experienced patients. Nevirapine-ba sed triple therapies allow maintained control of HIV-I RNA levels and impro ve the immunologic response at 48 weeks of follow-up in patients with prior sustained virologic suppression. The switch to nevirapine significantly im proved the lipidic profile in Group A. although there were no differences b etween groups at the end of the study. Additionally, no significant changes were seen in terms of lipodystrophy-related body shape changes 1 year afte r the PI substitution. Finally, nevirapine-containing regimens have a simpl er dosing schedule, and this facilitates high adherence and improves QOL.