Volume 11 Supplement 1

Abstracts of the Ninth International Congress on Drug Therapy in HIV Infection

Open Access

Saquinavir/ritonavir monotherapy as a new nucleoside-sparing maintenance strategy

  • P Echeverría1,
  • P Domingo2,
  • M Gutierrez2,
  • G Mateo2,
  • J Puig3,
  • J Moltó3,
  • N Pérez-Álvarez3,
  • B Clotet3 and
  • E Negredo3
Journal of the International AIDS Society200811(Suppl 1):P67

https://doi.org/10.1186/1758-2652-11-S1-P67

Published: 10 November 2008

Purpose of the study

The high antiviral potency and low toxicity of saquinavir/ritonavir (SQV/r), prompted us to assess the antiviral efficacy and safety of SQV/r monotherapy as a new maintenance regimen in chronically virological suppressed HIV-infected patients.

Methods

Pilot, multicenter and randomized trial of 48 weeks follow-up. Patients with undetectable viral load (VL <50 copies/mL) under a HAART, without history of virological failure to a PI-based regimen or PI-related resistances were randomly assigned (2:1) to receive SQV 1000 mg/ritonavir 100 mg BID (SQV/r group) or to continue on the same treatment (control group). They were followed monthly until week 24 and each 3 months thereafter. Comparison were performed by the Mann-Whitney test for medians and by the χ2 or Fisher's exact test for proportions.

Summary of results

A total of 28 patients were randomized: 17 to SQV/r group and 11 to control group. Only one patient from SQV/r group experienced a virological failure at week 36. Similar mean increase in CD4+ cell counts from baseline to week 48 were seen in both groups: +31 cell/mm3 in SQV/r group and +53 cell/mm3 in control group. Three patients (10.7%), from SQV/r group, interrupted prematurely the study for reason other than virological failure (an acute hepatitis B, a 2-fold increase of transaminases in a VHC co-infected patient with high baseline levels, and a voluntary cessation of therapy). Total cholesterol did not significantly vary throughout the study in any group (p = 0.794); HDLc showed a significant increase at week 48 in comparison with the baseline values only in SQV/r group (from 41 ± 11 mg/dl to 56 ± 35, p = 0.028), while patients from control group showed a decrease in LDLc (from 129 ± 37 mg/dl to 107 ± 17, p = 0.028). Median (IQR) trough concentrations of SQV in plasma were 760 (379.5–1332.25). No patient had saquinavir concentrations lower than 100 ng/mL.

Conclusion

SQV/r monotherapy, administered twice daily, may be a valid and economic option as a nucleoside-sparing strategy for virologically suppressed HIV-infected patients without prior history of virologic failure to protease inhibitor-containing regimens, especially in those with intolerance or toxicities to nucleosides.

Authors’ Affiliations

(1)
Hospital German Trias i Pujol
(2)
Hospital Universitario Santa Creu i Sant Pau
(3)
Hospital Universitario German Trias i Pujol

Copyright

© Echeverría et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.

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