Abstract PE8/20
 
Raltegravir (RAL) and Nevirapine (NVP) Dual Therapy Maintains Virologic Suppression and Improves Lipid Profile and Serum Creatinine in HIV-infected ARV-pretreated Patients: 36-months Results of a Pilot Study Print
 
V. Reliquet1, S. Secher1, A. Rodallec2, C. Chirouze3, T. Jovelin1, Q. Gardiennet3, C. Allavena1, B. Hoen3, F. Raffi1
1CHU Nantes, Infectious Diseases, Nantes, France, 2CHU Nantes, Virology, Nantes, France, 3CHU Besanšon, Infectious Diseases, Besanšon, France
 
Background: NVP and RAL are potent antiretrovirals (ARV) with a favorable safety and lipid profile. We report 3-years outcome of this dual combination.
Methods: Patients on a stable NVP-containing ARV regimen, with HIV-RNA < 50 copies/mL for > 6 months and side effects to their current ARV treatment, were offered to switch to a new regimen of RAL 400 mg bid plus NVP 400 mg/day. Primary endpoint was maintenance of virologic suppression over time. Main secondary endpoints were changes in serum lipids and creatinine.
Results: 39 patients were enrolled. Baseline characteristics were as follows (median [IQR]): nadir and baseline CD4 counts, 129 [63-221] and 661 [458-894]/mm3, respectively; duration of HIV-RNA < 50 copies/mL, 50 months [22-96]; duration of ARV therapy, 14 years [10-17]; prior duration of NVP, 64 months [34-107]. RAL was mainly substituted for a ritonavir-boosted PI (n=24) or TDF/FTC (n=12). After a median follow-up of 27 months [18-36], 6 patients discontinued the dual combination for the following reasons: one virologic failure, 4 RAL-related adverse events (arthralgia, abdominal pain, weight gain and neuropsychological disorders) and one patient's request. All patients who reached M24 (n=22) or M36 (n=14) had HIV-RNA < 50 copies/mL by per-protocol analysis. HIV-RNA < 1 copy/mL was evidenced in 18/26 (69%) patients at baseline and 12/13 (92%) at M24. Lipid profile improved at M6 for all parameters (p< 0.05) except LDL-cholesterol: median total cholesterol, -21 mg/dL; HDL-cholesterol, +3.74 mg/dL; triglycerides, -41 mg/dL; total cholesterol/HDL-cholesterol ratio -0.4. Serum creatinine improved (p< 0.05) both in the whole population (- 8.6 mmol/L) and in patients switched from a TDF-containing regimen (- 9.75 mmol/L).
Conclusion: In patients with prolonged plasma HIV-RNA < 50 copies/mL on a NVP-containing regimen, switching to NVP-RAL combination maintained virologic suppression throughout 36 months and was associated with improvement in lipid profile and serum creatinine.


Assigned speakers:
Dr. Veronique Reliquet , Hotel-Dieu , Nantes , France

Assigned in sessions:
17.10.2013, 12:00-14:00, Poster Session, Poster Session 1, Exhibition
18.10.2013, 12:00-14:00, Poster Session, Poster Session 2, Exhibition