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Etravirine

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Etravirine is a new non-nucleoside drug, the first new NNRTI to be developed in recent years. Unlike earlier non-nucleoside drugs – nevirapine and efavirenz – etravirine has been designed to remain active against HIV in people who have developed resistanceHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to the other non-nucleosides.

People who have taken several previous treatment regimens, and those with identified pre-existing resistance to other non-nucleoside drugs, are the most likely to benefit from etravirine.

Etravirine has been available in Australia under a Special Assistance Scheme for some time, and from 1 July 2009 is available on the PBS[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs..

Generic name: etravirine
Pronunciation:et-ra-VY-reen
Brand name:Intelence
Also known as:TMC-125 (former code name)
Drug class:non-nucleoside
Availability in Australia:
  • Available on the Pharmaceutical Benefits Scheme (PBS) through S100 prescribers since 2009.
Presentation:100mg tablet
Links:

Like all anti-HIV drugs, etravirine must be taken in combination with other drugs to be completely effective. Commonly, etravirine is combined with two nucleoside (NRTI) drugs, although other combinations are sometimes used. Your doctor will advise you on the right combination of drugs to suit your circumstances.

Dosage

The normal adult dosage is 400mg per day – two 100mg tablets taken twice each day, with food.

Regardless of what you read on this website or elsewhere, you should always take your medications according to your doctor's instructions. If you're unsure, speak to your doctor or pharmacist.

With or without food?

Etravirine should be taken with food.

Side effects

All drugs can produce side effects in some people. These may be mild, moderate or severe, so you should be aware of potential side effects before starting any drug, and speak to your doctor if you experience side effects that concern you.

  • Common side effects may include nausea (upset stomach, feeling sick to the stomach), rash.
  • Less common side effects may include diarrhoea, vomiting, headache, fatigue, abdominal pain, tingling or pain in the hands or feet, numbness, raised blood pressure.
  • Rare side effects may include serious hypersensitivity reaction which may be life-threatening.
  • It's unlikely you will experience all of these side effects, and you may not experience any side effects at all. Before starting any new drug, ask your doctor about side effects you might experience and discuss strategies for dealing with side effects if they do occur. If you experience any significant side effect you should continue taking your medicine and see your doctor as soon as possible.

Interactions with other drugs

Drugs to watch out for include other ARVs, including all protease inhibitors. Also be careful with drugs to treat tuberculosis, for erectile dysfunction (such as Viagra), for heart rhythm (antiarrhythmics) or angina. Interactions are also possible with several drugs to lower cholesterol. Etravirine does not appear to affect blood levels of oral contraceptives, antacids, methadone. Etravirine has not been studied with buprenorphine. The herb St. John's Wort lowers the blood levels of some nonnucleoside reverse transcriptase inhibitors. Do not take it with Etravirine.
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Consumer Medical Information for etravirine (Intelence)42.08 KBjccintel11208.pdfPDF

New non-nuke approved

Positive Living article • Adrian Ogier • 5 June 2009

A new Non-Nucleoside Reverse Transcriptase InhibitorA type of anti-HIV drug which works by interfering with an enzyme, reverse transcriptase, that HIV needs to reproduce. – etravirine – will be listed on the Pharmaceutical Benefits Scheme[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs. (PBS) from July 1. read more »

AIDS 2008: Is the HIV drug pipeline drying up?

Positive Living article • David Menadue • 24 September 2008

The International AIDS Conference heard promising reports about the newer HIV treatments designed to help treat people with advanced and drug-resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. HIV, all of which are now available in Australia. read more »

Etravirine promising for those with NNRTI resistance

Positive Living article • David Menadue • 22 July 2008

An encouraging outcome of the DUET studies is that etravirine is effective against HIV mutations resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to existing NNRTIs, efavirenz and nevirapine. read more »

CROI 2007: A great leap forward

Positive Living article • Paul Kidd • 22 March 2007

A major scientific conference on HIV has wound up with promising news on treatments which could signal a significant improvement in HIV treatment for the first time in some years. read more »

ASHM 2006: Strategies for coping with multiple drug resistance

Positive Living article • Paul Kidd • 21 December 2006

Finding effective treatment options for people who have taken many treatments and have multiple resistanceHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant.. mutations continues to be a significant challenge for HIV clinicians, and their patients. read more »

New tricks

Positive Living article • Kirsty Machon • 21 December 2006

Two new drugs have recently become available through the Special Access SchemeBefore a drug has been approved, manufacturers often provide the drug free of charge to people who cannot participate in a clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. and who meet certain criteria under a Special Access Scheme (SASBefore a drug has been approved, manufacturers often provide the drug free of charge to people who cannot participate in a clinical trial and who meet certain criteria under a Special Access Scheme (SAS). ). , providing people with limited treatment options two important new possibilities. KIRSTY MACHON reports. read more »

SAS programs open for TMC-125, MK-0518

Story • Kirsty Machon • 2 November 2006

Special Access Scheme (SASBefore a drug has been approved, manufacturers often provide the drug free of charge to people who cannot participate in a clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. and who meet certain criteria under a Special Access Scheme (SAS). ) programs are now open to allow early access to two new antiretroviralA medication or other substance which is active against retroviruses such as HIV. drugs. This scheme allows for access to these medications while they are still in the final stages of clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. research. read more »

Time to deliver

Positive Living article • John Daye • 5 October 2006

The 16th International AIDS Conference highlighted numerous important and promising developments in HIV treatments. JOHN DAYE reports. read more »

Rocky Mountain CROI

Positive Living article • Paul Kidd • 27 April 2006

The 13th annual Conference on Retroviruses and Opportunistic Infections (CROI) took place in Denver, Colorado, from February 5 to 8. The major breaking news from this conference was the premature cancellation of the SMART studyA clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase IA clinical trial designed to establish whether an experimental drug is safe for humans to take. Phase I studies determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and look for early evidence of effectiveness; these studies may include either people with HIV, HIV-negative volunteers, or both tests a new drug or treatment in a small group; Phase IIA smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. expands the study to a larger group of people; Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. expands the study to an even larger group of people; and Phase IVPost-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. takes place after the drug or treatment has been licensed and marketed. , but as usual, this important conference produced a great deal more than a single story. read more »

The table below shows all the clinical trials in the database with the keyword etravirine (TMC-125).

Sorry, no clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trials database entries were found that matched your request.

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This Treatments database entry was first published on 21 May 2009.

While the content of this treatments database entry was checked for accuracy at the time of publication, NAPWA recommends checking to determine whether the information is the most up-to-date available, especially when making decisions which may affect your health.

This article may contain medical information. NAPWA makes every reasonable effort to ensure the information on this website is accurate, reliable and up-to-date, including obtaining technical reviews by medically-qualified reviewers, however the authors of information on this website are not qualified to give medical advice, except where explicitly stated.

The content of this website is intended to support, not replace, the relationship between people living with HIV/AIDS and their medical advisers, and is not intended as a substitute for medical advice.

HIV Clinical Trials update