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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-31
June 23, 2005

Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

FDA Approves New Therapy for HIV Patients with Advanced Disease

The Food and Drug Administration (FDA) announced the approval of Aptivus (tipranavir) capsules, an HIV protease inhibitor, to be given with ritonavir for treatment of HIV-1 infected adults. This is the second drug approved for patients with advanced HIV disease, and provides a new therapy for patients with limited treatment options.

Aptivus, when used together with ritonavir, was shown to be an effective treatment for patients who had already used many HIV medicines and had a type of virus resistant to currently available anti-HIV medicines. Taking 200 mg of ritonavir twice daily was shown to boost the level of Aptivus, and lowered the amount of virus in the blood - more than patients who took other currently available anti-HIV medicines.

The labeling for Aptivus will include a black box warning indicating the drug can cause serious liver problems, especially in patients with liver disease.

Additional adverse events seen in clinical trials include skin rashes (seen more often in HIV positive women as compared to HIV positive men) and higher cholesterol and triglycerides levels.

Patients using Aptivus with low-dose ritonavir should report to their health care provider the use of any other prescription drug, non-prescription, or herbal products, particularly St. John’s Wort, due to potential drug interactions.

Certain medicines should never be given to patients taking Aptivus plus ritonavir because serious side effects can occur. These include antiarrhythmics (medicines that treat irregular heart beats), antihistamines, ergot derivatives (found in some medicines to treat migraine headaches), medicines that speed up the digestive tract, herbal products, some medicines that lower cholesterol levels, and medicines to treat mental problems.

Boehringer Ingelheim Pharmaceuticals, Inc., the manufacturer of Aptivus, will conduct additional post-marketing studies of Aptivus. These studies will look at drug-drug interactions and see how Aptivus works in other people, such as patients taking HIV medicines for the first time, children, and HIV-1 positive women.

More information on HIV and AIDS is available online at FDA’s website:
http://www.fda.gov/oashi/aids/hiv.html.

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