Rilpivirine (Edurant) and rilpivirine/FTC/tenofovir FDC (Eviplera) approved in Europe
1 December 2011. Related: Antiretrovirals.
In September 2011 the EMA recommended for approval for the NNRTI rilpivirine and a fixed dose combination (FDC) of a single pill formulation of rilpivirine/teneofovir/FTC. Approval has now been confirmed for rilipivirine and the 3-in1 FDA, which were launched in the UK on 1 December 2011.
Rilpvirine (tradename Edurant) has a European indication for use as part of a combination for treatment-na? patients with viral load <100,000 copies/mL.
The 25mg tablet must be taken with food and in Phase 3 studies had a tight relationship between adherence and efficacy. Low milligram medications are often vulnerable to a lower pharmacological safety buffer above the minimum effective concentration (MEC) at the end of the dosing period.
The license for rilpivirine stresses that it needs to be taken at the same time each day.
Additionally, patients who have experienced virological failure while taking rilpivirine can develop NNRTI cross-class resistance including to nevirapine and efavirenz.
The list price for rilpivirine is £200.27 per month (for 30 tablets).
A more detailed summary of the data from Phase 3 studies was included in the August edition of HTB, with announcement of approval in the US.
The FDC formulation (tradename Eviplera in Europe and Complera in the US) based on a similar indication to rilpivirine.
The list price for Eviplera is £618.77 for 30 tablets.
References and links:
- Patient information and Summary of Product Characteristics for Edurant will be published to the EMA website.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124 - FDA approve new NNRTI rilpivirine (Edurant) in the US. HTB August 2011.
https://i-base.info/htb/15538