New Therapy for Advanced HIV
The FDA has approved Aptivus (tipranavir) capsules to be given with ritonavir for the treatment of adults infected with HIV-I, the virus that causes AIDS. Aptivus, approved in June 2005, is the second drug approved for people with advanced HIV disease and provides a new therapy for those with limited treatment options.
When used together with ritonavir, Aptivus was shown to be an effective treatment for patients who had already used many HIV medicines and who had a type of virus resistant to available anti- HIV medicines. Taking 200 milligrams of ritonavir twice daily was shown to boost the level of Aptivus, and lowered the amount of virus in the blood more than other anti-HIV medicines.
The labeling for Aptivus includes a black box warning indicating that the drug can cause serious liver problems, especially in patients with liver disease. Other adverse events seen in clinical trials include higher cholesterol and triglyceride levels and skin rashes. The rashes were seen more often in women who are HIV- positive when compared with men who are HIV-positive.
Because of potential drug interactions, patients using Aptivus with low-dose ritonavir should tell their doctors about the use of any other prescription drug, nonprescription drug, or herbal products, particularly St. John’s wort. Certain medicines should never be given to people taking Aptivus plus ritonavir because serious side effects can occur. These include medicines that treat irregular heart beats (antiarrhythmic), antihistamines, ergot derivatives that are 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 that treat mental problems.
Boehringer Ingelheim Pharmaceuticals Inc., the manufacturer of Aptivus, will conduct additional post-marketing studies. These studies will evaluate drug-drug interactions and how Aptivus works in other patient groups, such as those taking HIV medicines for the first time, children, and women who are HIV-1 positive.
Copyright Superintendent of Documents Sep/Oct 2005