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Safety and efficacy of tipranavir co-administered with low-dose ritonavir in patients with advanced HIV-1 infection and limited treatment options

Purpose of the study

To assess the safety and efficacy of tipranavir co-administered with low-dose ritonavir (TPV/r) in clinical settings.

Methods

Data from the German open-label study (EAP). To be included in the study, adult patients (pts) had to be triple antiretroviral (ARV) class experienced having failed at least two previous PI-based regimens. TPV/r 500/200 mg, twice daily, was added to a background regimen chosen by the treating physician. All adverse events (AE) were reported regardless of causal relationship and degree of seriousness.

Summary of results

Data of 254 HIV-1 infected pts (median age 44 years; 229 males, 25 females) from 70 centres were available for analysis. Most pts were in advanced stages: CDC B3 (28%) and C3 (57.1%). Hepatitis B and C co-infection was reported for 12.6% and 3.9% of the pts, respectively. Median baseline HIV-RNA (VL) was 4.7 log10 copies/mL and median CD4157 cells/μL. After 12 months of TPV/r treatment, median change from baseline in VL was -1.9 log10 copies/mL and +71.5 CD4 cells/μL. Median TPV/r exposure was 35.4 weeks (1.1–76). 117 (46.1%) pts experienced AEs considered related to TPV/r; 53 (20.9%) pts developed serious AEs; 47 (18.5%) pts discontinued TPV/r due to AEs. Most commonly reported AEs in 33.5% of pts were gastrointestinal disorders, the majority of which were mild or moderate intensity. In regard to ALT and AST elevations, 4.3% and 2% of pts had a maximum Grade 3 and 3.1% and 0.2% of pts had maximum Grade 4 elevation, respectively. No cases of jaundice or liver failure were reported.

Conclusion

Patients treated in the TPV EAP had advanced HIV-1 infection and were heavily pretreated. Nevertheless, they show remarkable decrease in VL and increase in CD4 cells/μL The analysis of AEs did not reveal any new safety findings or change in the known AE profile of TPV/r. Notably, in this real world treatment setting, the rate of TPV/r discontinuations due to AEs was relatively low.

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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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Esser, S., Moll, A., Cairns, V. et al. Safety and efficacy of tipranavir co-administered with low-dose ritonavir in patients with advanced HIV-1 infection and limited treatment options. JIAS 11, P41 (2008). https://doi.org/10.1186/1758-2652-11-S1-P41

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-P41

Keywords

  • Ritonavir
  • Adverse Event Profile
  • Median CD4157
  • Median Baseline
  • Tipranavir