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Edurant (Rilpivirine Hydrochloride) - Summary

 
 



EDURANT SUMMARY

EDURANT (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). EDURANT is available as a white to off-white, film-coated, round, biconvex, 6.4 mm tablet for oral administration. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine.

EDURANT™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients.

This indication is based on Week 48 safety and efficacy analyses from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naive subjects and Week 96 safety and efficacy analyses from a Phase 2b trial in treatment-naive subjects [see Clinical Studies].

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

  • More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy [ see Clinical Studies ].
  • The observed virologic failure rate in EDURANT treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [ see Clinical Pharmacology ].
  • More subjects treated with EDURANT developed lamivudine/emtricitabine associated resistance compared to efavirenz [ see Clinical Pharmacology ].

See all Edurant indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Edurant (Rilpivirine)

Rilpivirine: a second-generation nonnucleoside reverse transcriptase inhibitor. [2012]
CONCLUSION: Rilpivirine is a viable NNRTI for HIV-infected patients who have not

Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naive HIV-1-infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE Trials. [2012]
THRIVE trials comparing rilpivirine (TMC278) and efavirenz... CONCLUSIONS: At week 48, rilpivirine 25 mg once daily and efavirenz 600 mg once

Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. [2011]
with tenofovir-disoproxil-fumarate and emtricitabine... INTERPRETATION: Rilpivirine showed non-inferior efficacy compared with efavirenz,

A compartmental pharmacokinetic evaluation of long-acting rilpivirine in HIV-negative volunteers for pre-exposure prophylaxis. [2014]
Rilpivirine long-acting (RPV-LA) is a parenteral formulation enabling prolonged plasma exposure... PK and viral inhibition of repeated doses will be important in further dose selection.

Impact of food and different meal types on the pharmacokinetics of rilpivirine. [2013]
The objective of the study was to determine the impact of food and different meal types on the pharmacokinetics of rilpivirine, a nonnucleoside reverse transcriptase inhibitor. In this open-label, randomized, crossover study, healthy volunteers received a single, oral 75 mg dose of rilpivirine either with a normal-fat breakfast (reference), under fasting conditions, with a high-fat breakfast, or with a protein-rich nutritional drink...

more studies >>

Clinical Trials Related to Edurant (Rilpivirine)

The Rilpivirine Cerebrospinal-fluid (CSF) Study [Recruiting]
This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.

A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection [Not yet recruiting]
The purpose of this study is to assess the safety and effectiveness of rilpivirine hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human immunodeficiency virus type 1 (HIV-1) infection.

A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Efficacy of TMC278 in Human Immunodeficiency Virus Infected Adolescents [Recruiting]
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the drug), safety and effectiveness of TMC278 25 mg once daily in combination with an investigator-selected background regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine [AZT]/lamivudine [3TC] or abacavir [ABC]/3TC) in antiretroviral (ARV) treatment.

A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants [Recruiting]
The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.

A Study to Compare Efficacy in Terms of Plasma Human Immunodeficiency Virus-Type 1 (HIV-1) Ribonucleic Acid (RNA) Between 2 Fixed Dose Combinations After a Switch in Fully Suppressed Patients [Not yet recruiting]
The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).

more trials >>

Reports of Suspected Edurant (Rilpivirine) Side Effects

Pyrexia (6)Rash Generalised (6)Abortion Spontaneous (4)Cystic Lymphangioma (4)Renal Failure Acute (4)Loss of Consciousness (3)Blood Creatinine Increased (3)Nausea (3)Blood Triglycerides Increased (1)CD4 Lymphocytes Decreased (1)more >>


Page last updated: 2014-11-30

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