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Prezista (Darunavir Ethanolate) - Summary

 
 



PREZISTA SUMMARY

PREZISTA™ (darunavir) is an inhibitor of the human immunodeficiency virus (HIV) protease. PREZISTA™ (darunavir), in the form of darunavir ethanolate, has the following chemical name: [(1 S,2 R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1- (phenylmethyl)propyl]-carbamic acid (3 R,3a S,6a R)-hexahydrofuro[2,3- b ]furan-3-yl ester monoethanolate.

PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from 2 controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with PREZISTA/rtv:

  • Treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/rtv (see MICROBIOLOGY).
  • The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response (see MICROBIOLOGY and INDICATIONS AND USAGE, Description of Clinical Studies).
  • The risks and benefits of PREZISTA/rtv have not been established in treatment-naïve adult patients or pediatric patients.

See all Prezista indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Prezista (Darunavir)

96 week results from the MONET trial: a randomized comparison of darunavir/ritonavir with versus without nucleoside analogues, for patients with HIV RNA <50 copies/mL at baseline. [2011.08]
BACKGROUND: In virologically suppressed patients, switching to darunavir/ritonavir monotherapy could avoid resistance and adverse events from continuing nucleoside analogues. METHODS: Two hundred and fifty-six patients with HIV RNA <50 copies/mL on current antiretrovirals were switched to darunavir/ritonavir 800/100 mg once daily, either as monotherapy (n = 127) or with two nucleoside analogues (n = 129)...

Effects of tipranavir, darunavir, and ritonavir on platelet function, coagulation, and fibrinolysis in healthy volunteers. [2011.06.01]
The use of HIV protease inhibitors (PIs) as part of antiretroviral therapy in the treatment of HIV-1 infection may be associated with an increased risk of bleeding... There was large inter-patient variability in antiplatelet effect for all PI treatments, ranging from no effect to complete inhibition of AA-induced platelet aggregation.

Pharmacokinetic interactions of maraviroc with darunavir-ritonavir, etravirine, and etravirine-darunavir-ritonavir in healthy volunteers: results of two drug interaction trials. [2011.05]
The effects of darunavir-ritonavir at 600 and 100 mg twice daily (b.i.d.) alone, 200 mg of etravirine b.i.d... when coadministered with darunavir-ritonavir with or without etravirine.

Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. [2011.04.24]
OBJECTIVE: ODIN (Once-daily Darunavir In treatment-experieNced patients) was a phase III, 48-week, open-label study comparing once-daily vs. twice-daily darunavir/ritonavir (DRV/r) in treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening... CONCLUSION: Once-daily DRV/r 800/100 mg was noninferior in virologic response to twice-daily DRV/r 600/100 mg at 48 weeks in treatment-experienced patients with no DRV RAMs, and with a more favorable lipid profile. These findings support use of once-daily DRV/r in this population.

The effect of lopinavir/ritonavir and darunavir/ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants. [2011.02]
S/GSK1349572 is an unboosted, once-daily integrase inhibitor with a novel resistance profile. As standard of care for patients infected with HIV is combination therapy, the potential interaction between S/GSK1349572 and ritonavir-boosted protease inhibitors was evaluated... The most frequent drug-related AEs were diarrhea, dizziness, and headache.

more studies >>

Clinical Trials Related to Prezista (Darunavir)

An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients [Completed]
The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are nave to these medications and in patients who have experienced tolerability issues on their current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by switching the patients from their previous or current combination antiretroviral therapy (cART) to either darunavir or etravirine.

A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women [Recruiting]
The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.

Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals [Recruiting]
The purpose of this study is to assess whether a boosting by cobicistat results in similar concentrations of darunavir in the brain compared to a boosting by ritonavir.

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz [Active, not recruiting]
The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.

A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista [Recruiting]

more trials >>

Reports of Suspected Prezista (Darunavir) Side Effects

Maternal Exposure During Pregnancy (33)Foetal Exposure During Pregnancy (20)Pyrexia (19)Abortion Spontaneous (16)Rash (16)Renal Failure Acute (14)Premature Baby (14)Foetal Growth Restriction (13)Depression (13)Gamma-Glutamyltransferase Increased (12)more >>


Page last updated: 2011-12-09

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