|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|| |
|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. |
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.
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
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.
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