CD4 entry criteria dropped for UK tipranavir named patient access
29 July 2004. Related: Antiretrovirals.
Polly Clayden, HIV i-Base
From June 14 the entry criteria for the Named Patient Supply of the investigational protease inhibitor tipranavir have broadened. There are now no restrictions on the basis of CD4 count or viral load.
Inclusion criteria that remain include being triple-class experienced with at least two previous PI based regimens. Women need to have a negative pregnancy test if they are of childbearing potential and be willing to use effective barrier method of contraception.
Exclusion criteria include:
- Female patients who are pregnant or breastfeeding
- Previous significant hypersensitivity to the active or any of the excipients of tipranavir or ritonavir
- Baseline AST/ALT > 5 x ULN OR total bilirubin > 3.5x ULN
- Baseline AST/ALT > 2.5 x ULN AND total bilirubin > 2x ULN
- Use of other investigational drugs (until TPV/r receives marketing authorisation)
Preliminary pharmacokinetic data on double boosting with saquinavir, amprenavir or lopinavir/r indicated negative interactions and significant reduction in plasma levels of these PIs (see HTB May 2004) [1]. If used, close clinical and laboratory patient monitoring should be undertaken.
If a physician wishes to start a dual boosted PI regimen the potential risks and benefits of the regimen should carefully be discussed with his patient. Clinical and laboratory monitoring of triglycerides, amylase / lipase and transaminases must be undertaken.
The safety of tipranavir in renal insufficiency is unknown. The risk/benefit for each patient has to be determined by the treating physician on a case-by-case basis.
There will be an administration fee for provision of tipranavir from August 7 2004. The cost will be £490 per 120 capsule pack.
Doctors who wish to enroll patient in this programme or who have further questions should contact Sarah Jones at Boehringer Ingelheim 01344 741282/742539.
Source: Boehringer Ingelhiem
Reference:
- Large reductions in plasma PK levels of saquinavir, amprenavir and lopinavir/r levels when given with tipranavir/ritonavir
http://www.i-base.info/pub/htb/v5/htb5-4/Large.html