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Abstract
Coagulation factor levels are not affected by tipranavir (TPV/r) capsules or vitamin E-containing solution formulations nor by comparator protease inhibitors (PI)
J. Weitz1, V. Kohlbrenner2, M. Johnston3, D. Neubacher4, P. Robinson5
Background: PI may increase bleeding in hemopheliac HIV-infected patients (pts). In rats, TPV/r reduced levels of vitamin K-dependent (vitK-dep) coagulation (coag) factors an effect enhanced with co-administration of vitamin E (vitE) and associated with bleeding. To examine whether these findings are relevant to humans, we measured levels of coag factors in stored plasma from pts randomized to TPV/r or comparator PI (CPI/r) in RESIST trials, and from children administered either vitE-containing TPV/r oral solution (TPV/r+VitE-OS) or TPV/r capsules.
Methods: Plasma samples (baseline[bsl], weeks 8, 24, and 48 of treatment) from randomly selected pts in RESIST and pediatric trial 1182.14 were assayed for levels of vitK-dep coag factors (prothrombin[FII] + factor VII[FVII] antigen and activity) and a non vitK-dep factor V(FV), as were PT/aPTT. Geometric mean on-treatment values (gMean) were compared to bsl. Analyses were powered to detect a clinically relevant >=30% reduction in the levels of FII and FVII.
Results: 25 TPV/r and 25 CPI/r pts in RESIST had samples assayed. Compared with bsl, gMean FII and FVII levels increased by 1.4% and 2.7%, respectively, in those given TPV/r and decreased by 1% and increased by 3.3%, respectively, in those receiving CPI/r. 25 TPV/r+VitE-OS children and 19 treated with TPV/r capsules had samples assayed. Compared with bsl, gMean FII and FVII levels decreased by 3.8% and 4.1%, respectively, with TPV/r+VitE OS, and increased by 0.6% and 3.4%, respectively, with TPV/r capsules. There was no systematic change in PT/aPTT values nor change in FV levels in adults or children. None of these changes were statistically significant or clinically important. Additionally, in a subgroup of RESIST pts with bleeding events, there was no TPV/r effect on coag.
Conclusions: Neither TPV/r nor CPI/r produced decreases in levels or activity of vitK-dep coag factors or FV. TPV/r+VitE-OS had no effect on coag factors in children. Findings observed in rats appear to be species specific.
AIDS 2008 - XVII International AIDS Conference
Abstract no.
TUPE0051
Suggested Citation
"J.Weitz, et al.
Coagulation factor levels are not affected by tipranavir (TPV/r) capsules or vitamin E-containing solution formulations nor by comparator protease inhibitors (PI).
:
AIDS 2008 - XVII International AIDS Conference:
Abstract no.
TUPE0051"
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