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Abstract
Tipranavir/ritonavir monotherapy in patients with limited treatment options
F. Maggiolo1, M. Airoldi1, M. Andreoni2, L. Sarmati2, P. Sordillo2, D. Ripamonti1, A. Callegaro3, F. Suter1
Background: MOTO is a proof-of-concept, prospective, uncontrolled study to evaluate efficacy of tipranavir/ritonavir monotherapy in patients with limited treatment options.
Methods: patients failing their current HAART and presenting extensive mutations in the RT gene, but only secondary protease mutations (tipranavir/ritonavir mutational-score <3) were treated with tipranavir/ritonavir as single antiviral agent. Twelve-months follow-up results are reported.
Results: 13 patients (6 women) with a previous extensive exposure to NRTIs (mean 5.4 drugs), PIs (mean 2.5) and NNRTIs (mean 1.2) for a mean HAART time of 4403 days were enrolled. At baseline, they presented 7.5 (mean) IAS-recognized RT mutations not allowing the effective use of any NRTI or NNRTI and just a few secondary protease mutations (63S/P in 8 cases; 71T/V in 4; 10H/R, 24I, 35E/G, 36I, 46I, 77I, 93L in 1 case each). The mean HIV-RNA level was 28706 copies/ml and the mean CD4-count was 448 cells/mcL. Tipranavir/ritonavir monotherapy induced a marked control of HIV replication (AT analysis, graphic). No viral breakthroughs or viral blips were observed. The mean CD4 count raised to 553 cells/mcL. Three patients stopped therapy after having achieved a complete virologic suppression because of hepatitis (2) or gastro-intestinal intolerance.
[virologic response]
Conclusions: At failure, boosted-PI based HAART rarely select for mutations in the protease gene. In the future, the accumulation of reverse transcriptase mutations may, therefore, result a major limiting factor when planning rescue therapies. In patients with such a resistance profile, tipranavir/ritonavir monotherapy may act as a bridge therapy while waiting for new drugs or drug classes. The observations of this proof-of-concept study have to be confirmed by larger controlled trials.
AIDS 2008 - XVII International AIDS Conference
Abstract no.
TUPE0109
Suggested Citation
"F.Maggiolo, et al.
Tipranavir/ritonavir monotherapy in patients with limited treatment options.
:
AIDS 2008 - XVII International AIDS Conference:
Abstract no.
TUPE0109"
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