Abstract PE7/8
Efficacy of PI Monotherapy in Randomised Trials: Differences between Switch Equals Failure and Switch Included Analysis Print
A. Hill1, J. Arribas2, Y. van Delft3, C. Moecklinghoff4
1Janssen Research and Development, Statistics, High Wycombe, United Kingdom, 2Hospital La Paz, IdIPaz, Madrid, Spain, 3Janssen, EMEA, Tilburg, Netherlands, 4Janssen, EMEA, Neuss, Germany
Background: Previous systematic reviews have shown a higher risk of HIV RNA elevations during Protease Inhibitor (PI) monotherapy compared to triple therapy. However the longer-term follow up of patients in these trials, including efficacy outcomes on subsequent treatments, has not been analysed.
Methods: A MEDLINE search identified six randomised trials of PI monotherapy versus triple therapy in patients with HIV RNA < 50 copies/mL at baseline, which had follow up data available after patients had HIV RNA elevations. The percentage of patients with HIV RNA suppression < 50 copies/mL was analysed by treatment arm, using two endpoints: 1. Switch=Failure - a patient is a failure if HIV RNA rises above 50 copies/mL at any time 2. Switch included - HIV RNA < 50 copies/mL at the end of treatment is counted as success, even if treatment has been changed or intensified.
Results: There were three randomised trials of lopinavir/r monotherapy (n=446) and three of darunavir/r monotherapy (n=511). Summary efficacy results are shown in the table below. Overall the absolute difference in efficacy between PI monotherapy and triple therapy was -5.6% (95% CI -0.4 , -10.7%, p=0.04) using switch=failure analysis, but +3.2% (95% CI -1.4%, +7.7%, p=n.s.) using switch included analysis.
Conclusions: In 6 randomised trials of 957 patients with HIV RNA suppression at baseline, the risk of HIV RNA elevations on PI monotherapy was higher than for triple therapy for the “switch equals failure” analysis. However the “switch included” analysis showed no difference between the arms in the HIV RNA suppression rates at the end of the trials, after treatment intensification in some patients.
TrialSwitch=failure Switch included 
[HIV RNA <50 in PI monotherapy trials]

Assigned speakers:
Andrew Hill , Janssen Research and Development , High Wycombe , United Kingdom

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