Effect of simplification from protease inhibitors to boosted atazanavir-based regimens in real-life conditions
Article first published online: 19 MAR 2010
© 2010 British HIV Association
Volume 11, Issue 9, pages 545–553, October 2010
How to Cite
Rubio, R., Serrano, O., Carmena, J., Asensi, V., Echevarría, S., Flores, J., Ribera, E., Zarraga, M., Ocampo, A., De La Fuente, B., Sepúlveda, M., Mariño, A., Minguez, C., Vicent, R., Cartón, J., Moyano, B., Esteban, H., Mahillo, B., Serrano, L., González-García, J. and for the GESIDA 44/04 SIMPATAZ study group (2010), Effect of simplification from protease inhibitors to boosted atazanavir-based regimens in real-life conditions. HIV Medicine, 11: 545–553. doi: 10.1111/j.1468-1293.2010.00827.x
- Issue published online: 3 SEP 2010
- Article first published online: 19 MAR 2010
- Accepted 15 December 2009
- antiretroviral therapy;
- HIV infection
Atazanavir (ATV) boosted with ritonavir (ATV/r) is a potent, well-tolerated, once-daily protease inhibitor (PI). Few data are available on this agent as a treatment simplification option for patients taking other PIs.
The aim of the study was to determine the effectiveness and safety of ATV-containing regimens in patients who have simplified their antiretroviral treatment.
SIMPATAZ was a multicentre, prospective, noninterventional study in patients who had undetectable HIV RNA on their current PI-containing therapy and who were switched to an ATV/r-based regimen. Patients underwent a routine physical examination, and data were collected on HIV RNA levels, CD4 cell counts, liver function, lipid parameters, adverse reactions, adherence to treatment and patient satisfaction.
A total of 183 patients were enrolled in the study and included in the analysis (80% were male, 29% had AIDS, and 52% were coinfected with HIV and hepatitis B virus or hepatitis C virus). The median baseline CD4 count was 514 cells/μL. Median exposure to previous HIV therapy was 8 years, and 32% of patients had a history of PI failures. Lopinavir boosted with ritonavir was the most frequent PI replaced (62%) and tenofovir+lamivudine /emtricitabine the backbone most used during the study (29%). The study drug was discontinued early by 25 patients (14%), two of whom discontinued as a result of adverse events (Hodgkin lymphoma and vomiting). Two patients died (lung cancer and myocardial infarction). At month 12, 93% of the study population had an undetectable HIV RNA viral load. Hyperbilirubinaemia >3 mg/dL and increased alanine aminotransferase levels>200 IU/L were observed in 38.5% and 4.4% of patients, respectively. Median changes from baseline to month 12 in total cholesterol, triglycerides and low-density lipoprotein cholesterol were −13 mg/dL (−7%; P<0.0001), −19 mg/dL (−13%; P<0.0001) and −7 mg/dL (−6%; P=0.021), respectively.
In a real-world setting, switching from other PIs to ATV/r is a well-tolerated and safe option for improving the lipid profile and for retaining virological response in controlled pretreated patients.