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
-- Liver function tests should be performed at initiation of therapy with
APTIVUS/r and monitored frequently throughout the duration of
-- 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
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.
The RESIST clinical trial program consists of two ongoing Phase 3 pivotal trials, RESIST-1 and RESIST-2. Comprising one of the largest study programs conducted in treatment-experienced HIV patients, RESIST-1 includes 620 patients in the U.S., Canada and Australia, and RESIST-2 includes 863 patients in Europe and Latin America. The trial design and baseline patient characteristics are similar across studies. Patients enrolled in the RESIST studies were failing their current PI-based regimen, had received at least two previous PI-based regimens, had received prior treatment from at least three classes of antiretroviral agents and had documented PI resistance.
At the time of full approval,
|SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.|
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