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Rilpivirine

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Rilpivirine is a next-generation non-nucleoside drug developed by Tibotec Pharmaceuticals.

Like etravirine (TMC 125) also developed by Tibotec, rilpivirine has been designed to remain effective against HIV which has become resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to first generation NNRTIs like nevirapine and efavirenz.

Update: Rilpivirine was granted approval by the U.S. Food and Drug Administration (FDAThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA).) in May 2011 for adults with HIV-1One of two distinct HIV species, HIV-1 is the predominant type in Australia and around the world. infection. It is intended for use in initial therapy, in combination with other antiretroviralA medication or other substance which is active against retroviruses such as HIV. agents. Approval was based primarily on 48-week results of 2 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. studies showing that previously untreated individuals who received rilpivirine + 2 nucleoside/nucleotide analogues (NRTIs) had rates of viral suppression and CD4 T-cell increases that were similar to those of individuals who received efavirenz + NRTIs.

Generic name: rilpivirine (TMC 278)
Pronunciation:rill-PYE-ver-een
Also known as:Edurant
Drug class:non-nucleoside
Availability in Australia:
  • Not available on the Pharmaceutical Benefits Scheme (PBS).
  • This drug may be available through clinical trials in Australia.
  • You may be able to import this drug from overseas for your personal use.
Links:

Like most anti-HIV drugs, rilpivirine must be taken in combination with other drugs to be completely effective. Commonly, rilpivirine 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 recommended dose for rilpivirine has not yet been established. Different doses are being studied in clinical trials – 25mg, 75mg and 150mg once daily, in tablet form.

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.

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 Central Nervous System (CNS) related side effects including dizziness, difficulty with concentration, sleep disturbances, vivid dreams, agitation., nausea (upset stomach, feeling sick to the stomach), dizziness, sleep disturbances.
  • Less common side effects may include rash.

    • 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

An acidic gastric environment is necessary for absorption of rilpivirine. Medications that increase gastric pH may substantially reduce serum rilpivirine concentrations. Proton pump inhibitors should not be given to persons taking rilpivirine. If H2 receptor antagonists are coadministered, they should be given at least 12 hours before or at least 4 hours after rilpivirine; antacids should be given at least 2 hours before or at least 4 hours after rilpivirine. Rilpivirine is a substrate of hepatic cytochrome P450 3A, so drugs that induce or inhibit the action of this isoenzyme may alter serum rilpivirine levels. In some cases, these interactions may be therapeutically significant. For example, rifamycins (eg, rifampin and rifabutin), certain anticonvulsants (eg, carbamazepine and phenytoin), and St. John's wort may substantially decrease rilpivirine concentrations and should not be given to persons taking rilpivirine.(2) Macrolides and azole antifungals may increase rilpivirine levels. Of the antiretrovirals, protease inhibitors may increase rilpivirine concentrations, whereas the NNRTIs efavirenz, etravirine, and nevirapine may decrease rilpivirine concentrations. The effect of efavirenz may be significant and prolonged, even after efavirenz is discontinued; the management of this interaction (eg, when discontinuing efavirenz and starting rilpivirine) has not been established.(5) Rilpivirine may affect the levels of other medications. For example, it decreases serum levels of ketoconazole and increases levels of atorvastatin.

Rilpivirine as good as efavirenz

Positive Living article • David Menadue • 24 November 2011

Dr Mark Bloch from Holdsworth House in Sydney presented the 48-week results of the combined ECHO and THRIVE studies which determined that the new NNRTI rilpivirine (RPV) is as effective as efavirenz (EFV) for first-line treatment.

Everyone in the studies received a nucleoside backbone to their treatment – in ECHO it was Truvada, in THRIVE it was tenfovir/3TC or abacavir/3TC. read more »

News from IAS 2010

Positive Living article • Adrian Ogier • 2 September 2010

Adrian Ogier gives a round up of treatments news from the Vienna Conference. read more »

Rilpivirine (TMC-278)

Positive Living article • John Daye • 24 September 2008

Follow-up results from a Phase IIA smaller clinical 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. designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. 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 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. study is undertaken, with a larger number of participaants, to confirm this. study of rilpivirine (TMC-278), Tibotec’s experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. next generation NNRTI, indicate that when combined with Truvada or Combivir, rilpivirine has comparable results to the leading NNRTI, efavirenz. 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 »

Good news, bad news: report from CROI

Positive Living article • John Daye • 26 March 2008

John Daye, NAPWA's Health, Treatments & Research Portfolio Co-Convenor reports from the 15th Conference on Retroviruses and Opportunistic Infections (CROI) held in Boston, USA from 3-6 February 2008 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 »

The bleeding edge

Positive Living article • John Daye • 19 May 2005

The annual Retrovirus Conference is a key event on the HIV scientific calendar, and regularly highlights the most exciting ‘bleeding edge’ developments from the world of HIV science. read more »

The table below shows all the clinical trials in the database with the keyword rilpivirine (TMC 278).

Short titleStatus
TMC278 (rilpivirine) versus efavirenz (2 trials) Concluded
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This Treatments database entry was first published on 3 June 2009 — more than two years ago.

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.

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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.

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