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JAC Advance Access originally published online on March 11, 2009
Journal of Antimicrobial Chemotherapy 2009 63(5):992-997; doi:10.1093/jac/dkp070
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Original research

Saquinavir exposure in HIV-infected patients with chronic viral hepatitis

José Moltó1,*, Josep Maria Llibre2, Esteban Ribera3, Carlos Mínguez4, Jesús Sánchez del Río5, Enric Pedrol6, Gabriel Vallecillo7, Samandhy Cedeño8, Marta Valle9, Cristina Miranda1, Eugenia Negredo1, Bonaventura Clotet1,8,{dagger} on behalf of the SQV-HEP Study Group

1 ‘Lluita contra la SIDA’ Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Spain 2 Internal Medicine Department, Hospital Sant Jaume de Calella, Calella, Spain 3 Internal Medicine Department, Hospital de la Vall d'Hebron, Barcelona, Spain 4 Internal Medicine Department, Hospital General de Castellón, Castellón, Spain 5 Internal Medicine Department, Hospital General de Asturias, Oviedo, Spain 6 Internal Medicine Department, ‘Hospital-Asil de Granollers’ Foundation, Granollers, Spain 7 Internal Medicine Department, Hospital del Mar, Barcelona, Spain 8 ‘IrsiCaixa’ Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Spain 9 Centre d'Investigació del Medicament, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Received 5 December 2008; returned 22 January 2009; revised 6 February 2009; accepted 16 February 2009

* Corresponding author. Fundació Lluita contra la SIDA, Hospital Universitari Germans Trias i Pujol, Ctra de Canyet, s/n, 08916 Badalona, Barcelona, Spain Tel: +34-93-497-88-87; Fax: +34-93-465-76-02; E-mail: jmolto{at}flsida.org

Objectives: The aim of this study was to assess the influence of hepatitis B virus or hepatitis C virus co-infection and the extent of liver fibrosis on saquinavir and ritonavir pharmacokinetics in HIV-infected subjects without liver function impairment.

Methods: A cross-sectional, comparative study enrolling HIV-infected adults receiving saquinavir/ritonavir 1000/100 mg twice daily or 1500/100 mg once daily was conducted. Patients with chronic viral hepatitis (HEP+) were grouped as having advanced liver fibrosis (HEP+/FIB+) or not (HEP+/FIB–) based on the FIB-4 index. Saquinavir and ritonavir trough concentrations (Ctrough) in plasma were determined by HPLC. The geometric mean ratio (GMR) was used to compare saquinavir and ritonavir Ctrough between HEP– and HEP+ patients, and the influence of the extent of liver fibrosis on saquinavir and ritonavir pharmacokinetics was explored using analysis of variance.

Results: One hundred and thirty-eight patients on twice-daily saquinavir/ritonavir (67 HEP–, 71 HEP+) and 36 patients on once-daily saquinavir/ritonavir (12 HEP–, 24 HEP+) were included. Saquinavir Ctrough was comparable between HEP– and HEP+ patients receiving either saquinavir/ritonavir 1000/100 mg twice daily [GMR 0.91, 95% confidence interval (CI) 0.60–1.37; P = 0.655] or 1500/100 mg once daily (GMR 0.88, 95% CI 0.39–1.97; P = 0.752). Similarly, ritonavir Ctrough was also comparable between HEP– and HEP+ patients. The extent of liver fibrosis was not significantly related to saquinavir or ritonavir Ctrough in patients receiving either of the two studied doses.

Conclusions: Saquinavir Ctrough was not increased in HIV-infected patients with chronic viral hepatitis in the absence of liver function impairment. These results confirm that no specific dose modification of saquinavir/ritonavir should be recommended in this setting.

Keywords: saquinavir/ritonavir , clinical pharmacokinetics , HIV/HBV-HCV co-infection , liver fibrosis

{dagger} Members of the SQV-HEP Study Group are listed in the Acknowledgements section.


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