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 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 treatment and CALL your HCP 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 HCP should check your blood tests more often because you have an increased chance of developing liver problems. Tell your HCP if you have liver disease, are infected with hepatitis B or C infection, or reduced liver function because you may have increased chance of liver disease problems while taking APTIVUS.
• Patients taking APTIVUS may develop severe bleeding in the brain that can cause death. You should report any unusual or unexplained bleeding to your HCP if you are taking APTIVUS.
• APTIVUS capsules and oral solution are always taken with Norvir^® (ritonavir)
• APTIVUS taken with ritonavir capsules or solution can be taken with or without meals
• APTIVUS taken with ritonavir tablets must only be taken with meals
• Your HCP will prescribe at least 2 other anti-HIV medicines with APTIVUS. This usually will increase the likelihood of treatment response.
• Baseline HIV resistance may affect your response to APTIVUS. Therefore, your HCP should conduct resistance tests and know your treatment history before prescribing APTIVUS.
• Tell your healthcare professional about all the medications you take. Taking APTIVUS with certain drugs can reduce the effectiveness of your treatment and can result in serious or life-threatening events.
• Tell your HCP if you have hemophilia or other medical conditions that increase the chances of bleeding. Tell your HCP about medicines you are taking to find out if they may increase your chance of bleeding.
• If you are taking APTIVUS oral solution, which contains vitamin E, you should not take additional vitamin E other than that contained in a standard multivitamin.
• Tell your HCP immediately if you develop or if you suspect you have a skin rash. APTIVUS should be used with caution in patients with a known sulfa allergy.
• Patients may develop new or worsening diabetes, high blood sugar (hyperglycemia), immune reconstitution syndrome, changes in body fat, and elevated lipids. Your HCP may monitor your cholesterol and triglycerides before starting APTIVUS and while on treatment.
• Women taking APTIVUS and estrogen-based hormonal contraceptives are advised to use alternative methods of contraception during therapy with APTIVUS. Women using estrogens for birth control or hormone replacement have an increased chance of developing a skin rash while taking APTIVUS. If a rash occurs, it is usually mild to moderate, but you should call your HCP.
• Tell your HCP if you are thinking about becoming pregnant, if you are pregnant, or are thinking about breast-feeding. Breastfeeding can result in passing the HIV virus to your baby.
• The most common side effects of APTIVUS include diarrhea, nausea, fever, vomiting, tiredness, headache, and stomach pain. Rash was seen more frequently in children.
• APTIVUS should not be used in children under 2 years of age.