Indications and Usage

Indications and Usage
APTIVUS, a protease inhibitor co-administered with ritonavir (APTIVUS/r), is indicated for combination antiretroviral treatment of HIV infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.

This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of APTIVUS/r of 48 weeks duration in treatment-experienced adults and one open-label 48-week study in pediatric patients age 2 to 18 years.  The adult studies were conducted in clinically advanced, 3-class antiretroviral (NRTI, NNRTI, PI) treatment-experienced adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with APTIVUS/r:

• The use of APTIVUS/r in treatment-naïve patients is not recommended.
• The use of other active agents with APTIVUS/r is associated with a greater likelihood of treatment response.
• Genotypic or phenotypic testing and/or treatment history should guide the use of APTIVUS/r. The number of baseline primary protease inhibitor mutations affects the virologic response to APTIVUS/r.
• Use caution when prescribing APTIVUS/r to patients with elevated transaminases, hepatitis B or C co-infection or patients with mild hepatic impairment.
• Liver function tests should be performed at initiation of therapy with APTIVUS/r and monitored frequently throughout the duration of treatment.
• The drug-drug interaction potential of APTIVUS/r when co-administered with other drugs must be considered prior to and during APTIVUS/r use.
• Use caution when prescribing APTIVUS/r in patients who may be at risk for increased bleeding or who are receiving medications known to increase the risk of bleeding.
• The risk-benefit of APTIVUS/r has not been established in pediatric patients less than 2 years of age.

There are no study results demonstrating the effect of APTIVUS/r on clinical progression of HIV-1.

APTIVUS/r does not cure HIV or help prevent passing HIV to others.