Intelence (Etravirine) - Summary

INTELENCE SUMMARY

INTELENCE™ (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).

INTELENCE™ [Trademark of Tibotec Pharmaceuticals Ltd.] , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.

This indication is based on Week 24 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE™. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

The following points should be considered when initiating therapy with INTELENCE™:

• Treatment history and, when available, resistance testing, should guide the use of INTELENCE™.
• The use of other active antiretroviral agents with INTELENCE™ is associated with an increased likelihood of treatment response.
• In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE™ in combination with only N[t]RTIs [ see Clinical Studies ].
• The risks and benefits of INTELENCE™ have not been established in pediatric patients or in treatment-naïve adult patients.

NEWS HIGHLIGHTS

Media Articles Related to Intelence (Etravirine)

Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection
Source: HIV / AIDS News From Medical News Today [2013.05.04]
HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...

Baby "Cured" of HIV Infection
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03]
Title: Baby "Cured" of HIV Infection
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2013 6:12:00 PM
Last Editorial Review: 4/3/2013 6:12:53 PM

Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say
Source: HIV / AIDS News From Medical News Today [2013.04.30]
Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...

Latest HIV Vaccine Fails In The US, Government Stops Study
Source: HIV / AIDS News From Medical News Today [2013.04.26]
A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...

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Published Studies Related to Intelence (Etravirine)

Cost-effectiveness of combination therapy with etravirine in treatment-experienced adults with HIV-1 infection. [2012]
treatment regimens... CONCLUSION: When compared with optimized standard of care including

Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir. [2011.07]
Dolutegravir (DTG) is an unboosted, once-daily integrase inhibitor currently in phase 3 trials. Two studies evaluated the effects of etravirine (ETR) alone and in combination with ritonavir (RTV)-boosted protease inhibitors (PIs) on DTG pharmacokinetics (PK) in healthy subjects... The combination of DTG and ETR alone should be avoided; however, DTG may be coadministered with ETR without a dosage adjustment if LPV/RTV or DRV/RTV is concurrently administered.

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.

A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population. [2011.01.28]
BACKGROUND: Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common... CONCLUSIONS: After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms.

A phase IV, double-blind, multicentre, randomized, placebo-controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing central nervous system adverse events to etravirine. [2011.01.02]
BACKGROUND: Two nucleoside reverse transcriptase inhibitors (NRTIs) and efavirenz (EFV) is a recommended initial regimen for HIV-1. Most EFV-related central nervous system (CNS) toxicity resolves early though symptoms may persist; we studied switching to etravirine (ETR) in these individuals... CONCLUSION: Switching EFV to ETR led to a significant reduction in overall G2-4 CNS adverse events, including insomnia, abnormal dreams and nervousness as individual adverse event. Lack of improvement for some events suggests other causative factors.

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Clinical Trials Related to Intelence (Etravirine)

Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection [Recruiting]
The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.

A Study to Assess the Pharmacokinetics (Blood Levels) of TMC114 (Darunavir) Taken With Ritonavir and/or TMC125 (Etravirine) and TMC278 (Rilpivirine) in HIV-1 Infected Pregnant Women [Recruiting]
The purpose of this study is to look at how changes in the body during pregnancy may change the blood levels of TMC114 (darunavir) and ritonavir taken together and TMC125 (etravirine) taken alone or with darunavir and ritonavir and rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will look at 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 and/or 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.

Safety Study of TMC-125 in HIV-Infected Children and Adolescents [Available]
Research study with a new drug called TMC 125 to be used in the treatment of HIV-infected children and adolescents.

TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents. [Recruiting]
Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the HIV virus. This drug has been tested for safety and effectiveness in adults but not in children. The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced HIV infected children and adolescents. The study design is a single arm treatment, Non-randomized, Open label, uncontrolled Safety/Antiviral activity study.

TMC125IFD3002 - The VIOLIN Study: to EValuate Etravirine TolerabIlity, PharmacOkinetics With Other AntiretroviraLs In TreatmeNt Experienced Patients [Recruiting]
The purpose of this study is to learn more about the safety and tolerability of a drug called Intelence (also known as etravirine or ETR). ETR is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown high activity against wild type Human immunodeficiency virus (HIV-1), and HIV strains resistant to other NNs. ETR has been approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMEA) and other regulatory authorities in Canada, South America and Asia for the treatment of Human Immunodeficiency Virus (HIV-1).

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Reports of Suspected Intelence (Etravirine) Side Effects

Abortion Spontaneous (17),  Maternal Exposure During Pregnancy (15),  Pyrexia (10),  Foetal Exposure During Pregnancy (8),  Exomphalos (8),  Rash (8),  Drug Interaction (7),  Renal Failure Acute (7),  Pollakiuria (7),  Neuropathy Peripheral (6), more >>