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Selzentry (Maraviroc) - Summary

 
 



Hepatotoxicity has been reported with use of SELZENTRY. 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 adult patients infected with only CCR5-tropic HIV-1.

This indication is based on analyses of plasma HIV-1 RNA levels in 2 controlled studies of SELZENTRY in treatment-experienced subjects and one study in treatment-naive subjects. Both studies in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (nucleoside reverse transcriptase inhibitor [NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI], or enfuvirtide) adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

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

  • Adult patients infected with only CCR5-tropic HIV-1 should use SELZENTRY.
  • Tropism testing must be conducted with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for use of SELZENTRY. Outgrowth of pre-existing low-level CXCR4- or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on SELZENTRY [see Microbiology Clinical Studies].
  • Use of SELZENTRY is not recommended in subjects 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 pediatric patients.
  • In treatment-naive subjects, more subjects treated with SELZENTRY experienced virologic failure and developed lamivudine resistance compared with efavirenz [see Microbiology Clinical Studies].

See all Selzentry indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Selzentry (Maraviroc)

HIV infection boosted by seized cell signaling
Source: HIV / AIDS News From Medical News Today [2017.07.17]
Research on the fusion stage of HIV concludes that a component of cell membranes facilitates infection, but also provides pathway to blocking transmission.

Cell particles may help spread HIV infection, NIH study suggests
Source: HIV / AIDS News From Medical News Today [2017.05.12]
HIV appears to enlist the aid of nano-sized structures released by infected cells to infect new cells, according to a study by researchers at the National Institutes of Health.

HIV breakthrough: Scientists remove virus in animals using gene editing
Source: HIV / AIDS News From Medical News Today [2017.05.04]
Using an improved gene editing strategy, scientists managed to delete infected fragments of mouse DNA, stepping closer to finding a cure for HIV infection.

more news >>

Published Studies Related to Selzentry (Maraviroc)

Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial. [2012]
methotrexate (MTX)... CONCLUSIONS: Maraviroc was generally well tolerated over 12 weeks; however,

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.

Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial. [2011.01]
PURPOSE: We investigated the effects of maraviroc, the first approved CC-chemokine receptor 5 (CCR5) antagonist, on blood lipids in a post hoc analysis of the phase 3 MERIT study in treatment-naive patients... CONCLUSIONS: Maraviroc was not associated with elevations in TC, LDL-c, or triglycerides and showed beneficial effects on lipid profiles of dyslipidemic patients.

Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients. [2010.10.06]
CONCLUSIONS: Maraviroc-treated patients had earlier, modest decreases in certain markers of immune activation and inflammation, although in this small study, many of the differences were not statistically significant. Levels of high-sensitivity C-reactive protein remained constant in the maraviroc arm and increased in the efavirenz arm. Decreases in immune activation correlated with increased CD4(+) T cell gains. TRIAL REGISTRATION: ClinicalTrials.gov NCT00098293.

Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study. [2010.05]
BACKGROUND: The MERIT study evaluated maraviroc versus efavirenz, both with zidovudine/lamivudine, in treatment-naive patients with CCR5-tropic (R5) HIV-1. Post hoc analyses previously assessed week 48 outcomes in patients rescreened with R5 virus by a more sensitive tropism assay... CONCLUSION: Week 96 data confirm week 48 observations in MERIT.

more studies >>

Clinical Trials Related to Selzentry (Maraviroc)

Switching Undetectables to Selzentry [Completed]
This pilot single arm, single site, open-labeled switch study seeks to enroll thirty (30) HIV positive patients infected with CCR5 tropic virus that have achieved an undetectable viral load on a non-Selzentry«-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase Inhibitor (NRTI)] and switch them to once-daily Selzentry« (600mg qd) plus the same 2 NRTIs.

Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I) [Completed]

The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers [Recruiting]
Infection by both HIV and hepatitis C virus (HCV)is frequent due to similar transmission modes. Near 20% of people living with HIV are also infected by HCV. People living with HIV are treated by anti-HIV medications that may interact with numerous other medications, including new medications against HCV. Boceprevir is one of these new HCV medications and it is now considered as part of the standard of care for people infected with HCV. Previous research has shown boceprevir may influence the capacity of the liver to breakdown (metabolize) certain medications and when these medications are used in combination with boceprevir, their blood concentrations may be increased or decreased which could increase the risk of side effects or decrease efficacy. Among the drugs having a potential for an interaction with boceprevir is maraviroc, an anti-HIV medication. If concentrations of maraviroc increase, people may experience more side effects. However, if concentrations of maraviroc decrease, people living with HIV may have a lower suppression of the virus. This could increase the risk for the HIV virus to develop resistance, that is that the treatment will no longer be effective. No studies have been conducted to investigate the effects of boceprevir on blood concentrations of maraviroc. This research project addresses this research question. This project, however, cannot be done with people living with HIV since resistance may develop in these people if the concentrations of maraviroc decrease. It is for this reason that the investigators wish to recruit healthy people not infected with HIV nor HCV. Eleven healthy volunteers will be included. They will receive maraviroc 150 mg (1 tablet) every 12 hours from days 1 to 19 inclusively. On day 5, a total of ten blood samples will be drawn during the following 12 hours (at 0, 0. 5, 1, 1. 5, 2, 3, 4, 5, 6, 8 and 12 hours after maraviroc morning dose intake) to measure the blood concentrations of maraviroc. Boceprevir 800 mg (4 capsules) every 8 hours with food will be started on day 6 and continued until day 19 inclusively. On day 19, after the morning maraviroc and boceprevir dose, another ten blood samples will be drawn over a 12 hour period. A phone follow-up will be done on day 26. Thus, the total study duration for subjects is 26 days. The investigators will compare the blood concentrations of maraviroc when given alone to the blood concentrations of maraviroc when given with boceprevir.

Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects [Completed]
This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.

Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects [Terminated]
This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.

more trials >>

Reports of Suspected Selzentry (Maraviroc) Side Effects

Maternal Exposure During Pregnancy (4)Cytolytic Hepatitis (4)Atrial Fibrillation (4)Acute Myocardial Infarction (3)Mitochondrial Myopathy Acquired (3)Arthralgia (3)Blood Creatine Phosphokinase Increased (2)Chest Pain (2)Meningitis (2)Nausea (2)more >>


Page last updated: 2017-07-17

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