7th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013)


WEPE516 - Poster Exhibition

Raltegravir/etravirine dual therapy as a virologically safe treatment option in suppressed HIV-1-infected patients without previous NNRTI failure

R. Calin1, M.-A. Valantin1,2, A. Simon2,3, L. Paris1, R. Tubiana1,2, L. Schneider1,2, H. Stitou1, C. Delanoe1, M. Wirden2,4, R. Agher1, C. Katlama1,2,5

1AP-HP, Hôpital Pitié-Salpêtrière, Infectious Diseases, Paris, France, 2INSERM U 943, Paris, France, 3AP-HP, Hôpital Pitié-Salpêtrière, Internal Medicine, Paris, France, 4AP-HP, Hôpital Pitié-Salpêtrière, Virology, Paris, France, 5Pierre et Marie Curie University Paris VI, Paris, France

Background: Novel treatment options are needed in aging HIV-1-infected patients with long-term exposure to standard therapies. The objective of this study was to evaluate the virological efficacy of a dual RAL/ETR combination in patients with suppressed HIV plasma viral load (pVL< 50 copies/mL) switching from a standard regimen.
Methods: This observational single-centre study enrolled from January 2008 all HIV-infected patients with pVL< 50 cp/mL who were switched from an NRTI, PI or NNRTI-based regimen to a dual RAL 400 mg twice daily/ETR 200 mg twice daily combination. Treatment failure was defined as two consecutive pVL>50 cp/mL. The primary end point was the maintenance of viral suppression.
Results: Ninety-one patients were included. The main reasons for switch were metabolic toxicity/lipodystrophy, renal impairment or toxicity prevention. Median (IQR) follow-up was 11.5 months (4.6-22.7). A total of 65 patients reached 6 months of follow-up and 48 patients 12 months of follow-up. At 6 and 12 months respectively, in per-protocol analysis 98.2% (55/56, 95%CI: 90.5-99.6) and 92.3% (36/39, 95%CI: 79.6-97.3) of patients receiving RAL/ETR had a pVL< 50 copies/mL. Five virological failures occurred in a median (IQR) delay of 7 months (6-16). Viral loads at the time of failure had a median (IQR) of 576 copies/mL (51-3063). All 5 patients had prior exposition to NNRTI with NNRTI treatment failure in 4 patients. Genotypic resistance test prior to RAL/ETR initiation was available in 4/5 patients showing in 2 patients pre-existing mutations conferring resistance to ETR (K103N and Y181C in both cases). The other 2 patients harbored single mutations impacting, but not compromising, ETR activity (V179I or A98G). In 3/5 cases virologic failure was followed by acquired RAL (N155H, Q148H) and ETR (Y181V) mutations. During follow-up, among the other reasons for treatment discontinuation (n=18), a possible causal relation with RAL/ETR therapy could only be established in 5 patients (headache, dizziness, arthralgias, erectile dysfunction and ETR hypersensitivity).
Conclusion: Dual therapy with RAL plus ETR represents a potential virologically safe NRTI/PI-sparing option in suppressed patients with sensitive strains.

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