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2005-06-24-FDA Approves New HIV Drug
Aptivus Is for Patients With Advanced AIDS
Aptivus is an HIV protease inhibitor. It is made in capsules.
Aptivus should be given with another drug, Norvir (ritonavir) to treat HIV-infected adults, according to an FDA news release.
When used with Norvir, Aptivus 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, says the FDA.
Taking 200 milligrams of Norvir twice daily was shown to boost the level of Aptivus and lower the amount of virus in the blood. Those effects were greater than the effects seen in patients who took other current anti-HIV medicines.
'Black Box' Warning
The labeling for Aptivus will include a 'black box' warning indicating that the drug can cause serious liver problems, especially in patients with liver disease. Black box warnings are used by the FDA to highlight special concerns about a drug and provide information about a potential medical complication associated with the use of the drug.
Other side effects seen in studies of the drug include skin rashes, higher cholesterol, and higher levels of other blood fats called triglycerides.
The skin rashes were seen more often in HIV-positive women than in HIV-positive men, says the FDA.
Tell Doctor About Other Meds
Patients using Aptivus with low-dose Norvir should tell their health care provider about any other prescription or nonprescription drugs they're taking.
That also includes herbal products, particularly St. John's Wort.
Doctors need to know about the use of such drugs or herbal products due to potential drug interactions, says the FDA.
Avoiding Dangerous Drug Interactions
Certain medicines should never be given to patients taking Aptivus plus Norvir because serious side effects can occur. The FDA's list includes:
Antiarrhythmics (medicines that treat irregular heart beats -- including quinidex or amiodarone)
Certain antihistamines such as Hisminal or Seldane
Ergot derivatives (found in some medicines to treat migraine headaches, such as Replax)
Medicines that speed up the digestive tract, such as Propulside
Herbal products which list only St. John's Wort
Statin cholesterol-lowering drugs
Medicines to treat mental problems
Aptivus will be studied further by its maker, Boehringer Ingelheim Pharmaceuticals, says the FDA.
Those postmarketing studies will cover drug interactions. They will also see how Aptivus works in other people, such as those taking HIV medicines for the first time, children, and HIV-1 positive women.