Prezista
This inhibitor of human immunodeficiency virus type 1 (HIV-1) protease selectively inhibits the cleavage of HIV-encoded Gag-Pol polyproteins in infected cells, thereby preventing the formation of mature virus particles.
Darunavir tablets
TIBOTEC
Protease inhibitor receives approval in treatment-experienced patients
Efficacy. The efficacy of darunavir was evaluated in 2 ongoing, randomized, controlled trials in antiretroviral treatment-experienced HIV-1-infected adult patients (N=637). Patients received either darunavir/rtv (600/100 mg BID) plus an optimized background regimen (OBR) or an investigator-selected PI plus an OBR. The OBR consisted of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) with or without enfuvirtide. Efficacy analyses were based on patients who had completed 24 weeks of treatment or discontinued earlier. Virologic response (confirmed at least 1 log10 HIV-1 RNA below baseline through Week 24) was achieved by 69.5% of patients receiving darunavir/rtv plus an OBR compared with 21.0% of patients receiving a comparator PI plus an OBR. Through 24 weeks of treatment, the proportion of patients with HIV-1 RNA <400 copies/mL (<50 copies/mL) in the darunavir arm was 63% (45%) versus 19% (12.1%) in the comparator arm. The proportion of patients experiencing virologic failure in the darunavir arm was 26.0% compared with 71.0% in the comparator arm. Additional efficacy data for darunavir have been obtained in 2 nonrandomized trials of treatment-experienced subjects (N=246). In these 2 studies, 65% of patients treated with the darunavir regimen experienced virologic response as defined as a decrease of at least 1.0 log10 in plasma viral load versus baseline and 40% of the patients reached <50 HIV-1 RNA copies/mL.
Safety. As darunavir and rtv are both potent inhibitors of CYP3A, coadministration of darunavir/rtv is contraindicated with drugs that are extensively metabolized CYP3A, including: astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, and triazolam. Darunavir contains a sulfonamide moiety and should therefore be used with caution in patients with a known sulfonamide allergy. Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in association with darunavir therapy. In some cases, fever and elevations of transaminases have also been reported. New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported in patients receiving therapy with PIs. Because darunavir is primarily metabolized by the liver, caution should be exercised when darunavir/rtv is administered to patients with hepatic impairment. There are reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in patients with hemophilia type A and B treated with PIs. The most common adverse events reported in association with darunavir/rtv include diarrhea, nausea, headache, and nasopharyngitis.
Dosing. The recommended oral dose of darunavir is 600 mg (two 300-mg tablets) twice daily taken with rtv 100 mg twice daily and food. Darunavir must be coadministered with rtv and food to exert its therapeutic effect.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
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Management of antipsychotic medication polypharmacy
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Medical innovation improves outcomes
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