Efficacy and safety of switching from enfuvirtide to raltegravir in patients with virological suppression.

OBJECTIVE

To assess the Efficacy and safety of switching from HAART containing enfuvirtide to raltegravir as a simplification strategy in patients with viral suppression and intolerance to enfuvirtide.

METHODS

Thirty-six patients with sustained plasma HIV RNA levels <50 copies/mL for at least 3 months with injection site reactions and/or injection fatigue while receiving an enfuvirtide-containing optimized background regimen switched from enfuvirtide to raltegravir (400 mg bid).

RESULTS

Patientshad received enfuvirtide for a median of 96 weeks and had sustained HIV RNA <50 copies/ mL for a median of 95 weeks. One patient discontinued raltegravir due to the appearance of cutaneous rash (grade 2) unresponsive to antihistamines after 19 days of starting raltegravir. The remaining 35 patients were followed for 24 weeks and 18 of them for 48 weeks. All patients maintained virological suppression <50 copies/mL at Weeks 24 and 48. No patient had blips in their viral load after switching to raltegravir. There were no grade 3 or 4 adverse events related to raltegravir.

CONCLUSIONS

A switch from enfuvirtide to raltegravir in virologically suppressed patients who are highly treatment-experienced maintained both virologic and immunologic efficacy up to 48 weeks.