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

This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of APTIVUS/ritonavir 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/ritonavir:

• The use of APTIVUS/ritonavir in treatment-naïve patients is not recommended.

• The use of other active agents with APTIVUS/ritonavir is associated with a greater likelihood of treatment response.

• Genotypic or phenotypic testing and/or treatment history should guide the use of APTIVUS/ritonavir.

• The number of baseline primary protease inhibitor mutations affects the virologic response to APTIVUS/ritonavir.

• Use caution when prescribing APTIVUS/ritonavir 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/ritonavir and monitored frequently throughout the duration of treatment.

• The drug-drug interaction potential of APTIVUS/ritonavir when co-administered with other drugs must be considered prior to and during APTIVUS/ritonavir use .

• Use caution when prescribing APTIVUS/ritonavir 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/ritonavir has not been established in pediatric patients <2 years of age.

• There are no study results demonstrating the effect of APTIVUS/ritonavir on clinical progression of HIV-1.^[1]

Adapted from the FDA Package Insert.