Is APTIVUS a treatment option for me?
APTIVUS is a medicine called a protease inhibitor (PI) that is used to treat adults with human immunodeficiency virus (HIV). APTIVUS blocks HIV protease, an enzyme that is needed for HIV to make more virus.
APTIVUS is used in combination with at least 2 other anti-HIV medicines in adult patients. APTIVUS is indicated for use in HIV infected adult patients who are treatment- experienced and infected with HIV strains resistant to more than one PI. Your healthcare provider (HCP) does resistance tests called genotypic and phenotypic tests to determine resistance.
The use of other active agents with APTIVUS is associated with a greater likelihood of treatment response (which is a 90% or greater reduction of viral load at the start of therapy).
Two 48-week studies measured how patients responded to APTIVUS in combination therapy. These patients had taken at least 3 other classes of HIV medications, including 2 or more protease inhibitor–based regimens. They were failing to respond to the PI regimens at the time. 85% of patients may have been or were resistant to other PIs in the study—lopinavir, amprenavir, saquinavir, and indinavir.
Compared with the group of other PIs in the study:
•More than twice as many patients treated with APTIVUS saw a 90% reduction in their viral load (34% vs. 15%)
•More than twice as many patients achieved undetectable levels of their HIV with APTIVUS (23% vs. 10%)
APTIVUS does not cure HIV, and an undetectable viral load does not mean you are cured of HIV. It is still possible to pass the virus on to others. Be sure to practice safer sex and minimize other risky behaviors.
APTIVUS is not for patients who have never taken HIV treatment.
Important Safety Information for APTIVUS
Patients taking APTIVUS, together with Norvir® (ritonavir), may develop severe liver disease that can cause death. If you develop any of the following symptoms of liver problems, you should stop taking APTIVUS and Norvir® (ritonavir) and call your healthcare professional right away: tiredness, general ill feeling or “flu-like” symptoms, loss of appetite, nausea (feeling sick to your stomach), yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale stools (bowel movements), or pain, ache, or sensitivity on your right side below your ribs. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems.
Patients taking APTIVUS together with Norvir® (ritonavir) may develop bleeding in the brain that can cause death. You should report any unusual or unexplained bleeding to your healthcare professional if you are taking APTIVUS together with Norvir® (ritonavir).
The most common side effects of APTIVUS include diarrhea, nausea, fever, vomiting, tiredness, headache, and stomach pain. Rash was seen mor frequently in children.
Please consult the Full Prescribing Information as well as the Patient Package Insert (PPI) including boxed WARNINGS, and Important Safety Information for APTIVUS.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


