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Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study.
AIDS. 2010 Jul 17; 24(11):1697-707.AIDS

Abstract

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+Show Affiliations

Infectious Diseases Unit, Hospital Clínic-Institut d'Investigaciones Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain. esteban@fundsoriano.esNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20467288

Citation

Martínez, Esteban, et al. "Substitution of Raltegravir for Ritonavir-boosted Protease Inhibitors in HIV-infected Patients: the SPIRAL Study." AIDS (London, England), vol. 24, no. 11, 2010, pp. 1697-707.
Martínez E, Larrousse M, Llibre JM, et al. Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AIDS. 2010;24(11):1697-707.
Martínez, E., Larrousse, M., Llibre, J. M., Gutiérrez, F., Saumoy, M., Antela, A., Knobel, H., Murillas, J., Berenguer, J., Pich, J., Pérez, I., & Gatell, J. M. (2010). Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AIDS (London, England), 24(11), 1697-707. https://doi.org/10.1097/QAD.0b013e32833a608a
Martínez E, et al. Substitution of Raltegravir for Ritonavir-boosted Protease Inhibitors in HIV-infected Patients: the SPIRAL Study. AIDS. 2010 Jul 17;24(11):1697-707. PubMed PMID: 20467288.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AU - Martínez,Esteban, AU - Larrousse,María, AU - Llibre,Josep M, AU - Gutiérrez,Felix, AU - Saumoy,Maria, AU - Antela,Antonio, AU - Knobel,Hernando, AU - Murillas,Javier, AU - Berenguer,Juan, AU - Pich,Judit, AU - Pérez,Ignacio, AU - Gatell,José M, AU - ,, PY - 2010/5/15/entrez PY - 2010/5/15/pubmed PY - 2010/8/20/medline SP - 1697 EP - 707 JF - AIDS (London, England) JO - AIDS VL - 24 IS - 11 N2 - 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. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/20467288/Substitution_of_raltegravir_for_ritonavir_boosted_protease_inhibitors_in_HIV_infected_patients:_the_SPIRAL_study_ L2 - https://doi.org/10.1097/QAD.0b013e32833a608a DB - PRIME DP - Unbound Medicine ER -