The FDA ( Food and Drug Administration ) Antiviral Drugs Advisory Committee recommended the approval of the anti-HIV drug Tipranavir ( Aptivirus ), a protease inhibitor ( PI ).
Tipranavir belongs to a subclass of Pis, called nonpeptidic Pis.
Tipranavir ( TPV ) requires boosting with low-dose Ritonavir and must be used in combination with other antiretroviral agents.
The Committee's positive recommendation is based on data from two large, controlled Phase 3 clinical trials, RESIST-1 and RESIST-2, conducted in protease inhibitor-resistant treatment-experienced patients.
These patients had taken three classes of anti-HIV drugs and were failing their PI-based regimen at the time of study entry.
These trials examined the treatment response of Tipranavir boosted with ritonavir ( TPV/r ) versus a comparator group in which patients received one of several marketed Ritonavir-boosted PIs.
In addition, patients in both arms received an optimized background regimen of other antiretroviral drugs.
The most commonly ( greater than or equal to 1% ) reported adverse events in patients treated with Tipranavir in clinical trials are gastrointestinal ( diarrhea, nausea and vomiting ) as well as fatigue and headache.
Mild rash occurred more often in women than in men.
The most common ( greater than or equal to 2% ) grade 3/4 laboratory abnormalities in patients are elevated liver enzymes and lipids.
Patients treated with Tipranavir/r experienced a significantly higher rate of liver enzyme and lipid elevations.
Tipranavir co-administered with low-dose Ritonavir, has been associated with reports of clinical hepatitis and hepatic decompensation, including some fatalities. These have generally occurred in patients with advanced HIV disease taking multiple concomitant medications.
Source: Boehringer Ingelheim Pharmaceuticals, 2005