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Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults
Date:10/26/2008

red in 10.3 percent of subjects treated with PREZISTA. Discontinuation due to rash was 0.5 percent. PREZISTA should be discontinued if severe rash develops.

PREZISTA should be used with caution in patients with known sulfonamide allergy.

New-onset or exacerbations of pre-existing diabetes mellitus, hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. A causal relationship between protease inhibitors and these events has not been established.

Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.

Immune reconstitution syndrome has been reported in patients treated with ARV therapy.

The potential for HIV cross-resistance among protease inhibitors has not been fully explored in PREZISTA/r treated patients.

PREZISTA/r is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic or safety data available in patients with severe hepatic impairment.

PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women.

In treatment-naive adult patients receiving a PREZISTA/r-containing regimen, the most common adverse drug reactions (> or = 2 percent) reported of at least moderate to severe intensity (> or = Grade 2) were diarrhea (6 percent), headache (5 percent), abdominal pain (4 percent), nausea (3 percent), vomiting (2 percent), and rash (2 percent).

In treatment-experienced adult patients receiving a PREZISTA/r-containing regimen, the most common adverse drug reactions (> or = 2 percent) reported of at least moderate to severe intensity (> or = Grade 2) were diarrh
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SOURCE Tibotec Therapeutics
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