PREZISTA (darunavir) is a Protease Inhibitor (PI) drug used to treat human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral medications. The mechanism of action of PREZISTA is that of inhibition of the dimerization and the catalytic activity of the HIV-1 protease. It has been shown to selectively inhibit the cleavage of HIV-encoded Gag-Pol polyproteins in virus-infected cells. This action prevents the formation of mature infectious virus particles.
PREZISTA is indicated for use in adults and children age 3 and up weighing at least 10kg. The 600mg tablet can be taken by treatment-experienced adult patients with at least one darunavir resistance associated substitution, pregnant patients, and pediatric patients based on age and weight. This product is not recommended for use in patients with severe hepatic impairment.
Darunavir has been associated with potentially fatal drug-induced hepatitis and hepatic injury. Patients with pre-existing liver abnormalities may be at increased risk. PREZISTA may be used with caution in patients with mild or moderate hepatic impairment without dose adjustment, but should not be used in patients with severe liver dysfunction. Likewise, PREZISTA may be used without dose adjustment in patients with mild to moderate renal dysfunction. Dose adjustments for severe renal impairment are not known, but the drug is not significantly cleared by the kidneys. PREZISTA is probably not significantly dialyzed.
In treatment-experienced patients, treatment history, genotypic and/or phenotypic testing is recommended to assess drug susceptibility of the HIV-1 virus. Laboratory testing such as serum liver biochemistries should be done before starting therapy.
All patients who test positive for HIV infection should be screened for comorbid hepatitis B virus (HBV) infection. Co-infected patients should be started on an antiretroviral regimen targeting both viruses, regardless of cluster of differentiation (CD4) counts or HBV viral loads. Treatment should be continued indefinitely to achieve HIV suppression and prevention of HBV activation. Co-infected patients should be offered vaccination against Hepatitis A and HBV, and should avoid alcohol. Likewise, testing HIV-positive patients for Hepatitis C virus (HCV), and regular ongoing testing for those deemed to be at high risk should be done. If HIV/HCV co-infection is identified, consideration should be given to treating both infections concurrently.
Highly active retroviral combination treatment can be used in pregnant women. It is unknown if darunavir is excreted in the breast milk. The Centers of Disease Control (CDC) recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus.
PREZISTA is a sulfonamide drug, and so should be used with caution in sulfa-sensitive patients. Other potential adverse effects and drug-drug interactions are detailed in the package insert and should be consulted by prescribers.
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