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Selzentry (Maraviroc) - Summary

 


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WARNING: HEPATOTOXICITY

Hepatotoxicity has been reported with SELZENTRY use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of SELZENTRY should be evaluated immediately [ see Warnings and Precautions ].

 

SELZENTRY SUMMARY

SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells.

SELZENTRY, in combination with other antiretroviral agents, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of SELZENTRY of 24 weeks duration. Both studies were conducted in clinically advanced, 3-class antiretroviral (NRTI, NNRTI, PI, or enfuvirtide) treatment-experienced adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with SELZENTRY:

  • Tropism testing and treatment history should guide the use of SELZENTRY.
  • Use of SELZENTRY is not recommended in patients with dual/mixed or CXCR4-tropic HIV-1 as efficacy was not demonstrated in a phase 2 study of this patient group.
  • The safety and efficacy of SELZENTRY have not been established in treatment-naïve adult patients or pediatric patients.

There are no study results demonstrating the effect of SELZENTRY on clinical progression of HIV-1.


See all Selzentry indications & dosage >>

SELZENTRY NEWS HIGHLIGHTS

Media Articles Related to Selzentry (Maraviroc)

First days after HIV infection may hold vaccine key (Reuters)
Source: Y! Health HIV & AIDS News [2008.12.01]

Herpes Suppression May Not Prevent HIV Infection
Source: MedicineNet Genital Herpes In Women Specialty [2008.06.20]

Newly Reported HIV Cases On The Rise In Europe
Source: Health News from Medical News Today [2008.12.01]

GPs In For The Long Haul For Our Hiv/ Aids Patients - Royal Australian College Of General Practitioners
Source: HIV / AIDS News From Medical News Today [2008.12.01]

Keeping The Promise To Face HIV Globally And Locally - Wisconsin
Source: HIV / AIDS News From Medical News Today [2008.11.29]

more >>

Published Studies Related to Selzentry (Maraviroc)

Maraviroc for previously treated patients with R5 HIV-1 infection. [2008.10.02]

Maraviroc: integration of a new antiretroviral drug class into clinical practice. [2008.06]

Effect of single doses of maraviroc on the QT/QTc interval in healthy subjects. [2008.04]

Effects of CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers. [2008.04]

A novel probe drug interaction study to investigate the effect of selected antiretroviral combinations on the pharmacokinetics of a single oral dose of maraviroc in HIV-positive subjects. [2008.04]

more >>

Clinical Trials Related to Selzentry (Maraviroc)

Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue [Recruiting]

Prospective Observational Epidemiologic Study of Maraviroc's Safety [Recruiting]

Maraviroc as an Immunomodulatory Drug for Antiretroviral-Treated HIV Infected Patients Exhibiting Immunologic Failure [Recruiting]

Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function [Recruiting]

A Double-Blind, Placebo-Controlled, Crossover, Dose Escalating Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects [Not yet recruiting]

more >>

Page last updated: 2008-12-01

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