BACKGROUND: Switching to raltegravir in selected patients treated with ritonavir-boosted protease inhibitors may result in similar efficacy and lower plasma lipids. METHODS: SPIRAL is a 48-week multicentre, open-label trial in which HIV-infected adults with less than 50 copies/ml of plasma HIV RNA for at least the previous 6 months on ritonavir-boosted protease inhibitor-based therapy were randomized (1: 1) to switch from the ritonavir-boosted protease inhibitor to raltegravir or to continue on ritonavir-boosted protease inhibitor-based therapy. Primary endpoint was the proportion of patients free of treatment failure (noncompleter = failure) at 48 weeks. SPIRAL study was powered to show noninferior efficacy of raltegravir-based therapy with a margin of -12.5%. RESULTS:Two hundred and seventy-three patients assigned to switch to raltegravir (n = 139) or tocontinue ritonavir-boosted protease inhibitor (n = 134) were included in the efficacy analysis. At 48 weeks, 89.2% (raltegravir-based therapy) and 86.6% (ritonavir-boosted protease inhibitor-based therapy) of the patients remained free of treatment failure [difference 2.6%; 95% confidence interval (CI) -5.2 to 10.6]. A total of 96.9% (raltegravir-based therapy) and 95.1% (ritonavir-boosted protease inhibitor-based therapy) of the patients remained free of virological failure (difference 1.8%; 95% CI -3.5 to 7.5). Switching to raltegravir was associated with significant decreases in plasma lipids and total-to-HDL cholesterol ratio relative to continuing ritonavir-boosted protease inhibitor. Severe adverse events and study drug discontinuations due to any adverse event occurred in 4 and 2% of the patients in each group. CONCLUSION: In patients with sustained virological suppression on ritonavir-boosted protease inhibitor-based therapy, switching fromritonavir-boosted protease inhibitor to raltegravir demonstrated noninferior efficacy and resulted in a better lipid profile at 48 weeks than continuing ritonavir-boosted protease inhibitor.
RCT Entities:
BACKGROUND: Switching to raltegravir in selected patients treated with ritonavir-boosted protease inhibitors may result in similar efficacy and lower plasma lipids. METHODS: SPIRAL is a 48-week multicentre, open-label trial in which HIV-infected adults with less than 50 copies/ml of plasma HIV RNA for at least the previous 6 months on ritonavir-boosted protease inhibitor-based therapy were randomized (1: 1) to switch from the ritonavir-boosted protease inhibitor to raltegravir or to continue on ritonavir-boosted protease inhibitor-based therapy. Primary endpoint was the proportion of patients free of treatment failure (noncompleter = failure) at 48 weeks. SPIRAL study was powered to show noninferior efficacy of raltegravir-based therapy with a margin of -12.5%. RESULTS: Two hundred and seventy-three patients assigned to switch to raltegravir (n = 139) or to continue ritonavir-boosted protease inhibitor (n = 134) were included in the efficacy analysis. At 48 weeks, 89.2% (raltegravir-based therapy) and 86.6% (ritonavir-boosted protease inhibitor-based therapy) of the patients remained free of treatment failure [difference 2.6%; 95% confidence interval (CI) -5.2 to 10.6]. A total of 96.9% (raltegravir-based therapy) and 95.1% (ritonavir-boosted protease inhibitor-based therapy) of the patients remained free of virological failure (difference 1.8%; 95% CI -3.5 to 7.5). Switching to raltegravir was associated with significant decreases in plasma lipids and total-to-HDL cholesterol ratio relative to continuing ritonavir-boosted protease inhibitor. Severe adverse events and study drug discontinuations due to any adverse event occurred in 4 and 2% of the patients in each group. CONCLUSION: In patients with sustained virological suppression on ritonavir-boosted protease inhibitor-based therapy, switching from ritonavir-boosted protease inhibitor to raltegravir demonstrated noninferior efficacy and resulted in a better lipid profile at 48 weeks than continuing ritonavir-boosted protease inhibitor.
Authors: Ighovwerha Ofotokun; Anandi N Sheth; Sara E Sanford; Kirk A Easley; Neeta Shenvi; Kelly White; Molly E Eaton; Carlos Del Rio; Jeffrey L Lennox Journal: AIDS Res Hum Retroviruses Date: 2012-04-20 Impact factor: 2.205
Authors: Corrilynn O Hileman; Bruce Kinley; Valeska Scharen-Guivel; Kathy Melbourne; Javier Szwarcberg; Janet Robinson; Michael M Lederman; Grace A Mccomsey Journal: J Infect Dis Date: 2015-01-12 Impact factor: 5.226
Authors: Ighovwerha Ofotokun; Lumine H Na; Raphael J Landovitz; Heather J Ribaudo; Grace A McComsey; Catherine Godfrey; Francesca Aweeka; Susan E Cohn; Manish Sagar; Daniel R Kuritzkes; Todd T Brown; Kristine B Patterson; Michael F Para; Randi Y Leavitt; Angelina Villasis-Keever; Bryan P Baugh; Jeffrey L Lennox; Judith S Currier Journal: Clin Infect Dis Date: 2015-03-12 Impact factor: 9.079
Authors: Esteban Martínez; Polyana M d'Albuquerque; Ignacio Pérez; Judit Pich; José M Gatell Journal: AIDS Res Hum Retroviruses Date: 2012-09-24 Impact factor: 2.205