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

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.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Echeverría, P., Domingo, P., Gutierrez, M. et al. Saquinavir/ritonavir monotherapy as a new nucleoside-sparing maintenance strategy. JIAS 11, P67 (2008). https://doi.org/10.1186/1758-2652-11-S1-P67

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

Keywords

  • Nucleoside
  • Acute Hepatitis
  • Trough Concentration
  • Saquinavir
  • Virological Failure