An ongoing dialogue on HIV/AIDS, infectious diseases,
May 23rd, 2011
Rilpivirine Approved — the “iPod” of NNRTIs?
From the FDA on Friday (it’s always on Friday, isn’t it):
FDA approved Edurant (rilpivirine) 25 mg tablets, a new non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. Rilpivirine is an antiviral drug that helps to block reverse transcriptase, an enzyme necessary for HIV replication. The recommended dose of rilpivirine is one 25 mg tablet once daily taken orally with a meal.
This approval comes as little surprise, as the large ECHO and THRIVE studies clearly demonstrated that rilpivirine (RPV seems to be the preferred abbreviation) was “non-inferior” to efavirenz as initial therapy.
More controversial were the details of the aggregate study results, which demonstrated a trade-off between antiviral activity at high viral loads (which favored efavirenz) and the overall safety and tolerability (which favored rilpivirine).
So how will clinicians use the drug?
The answer may be like the debate about iPods (and CDs vs records before that, boy I am showing my age): Audiophiles knew that the compressed sound required for iPods led to inferior sound, but the new devices were so easy to use that in most cases it didn’t really matter. Today CDs are rapidly on their way out.
So is RPV the iPod of NNRTIs? Both better and worse than current options? Maybe — that would be the best case scenario.
But if the complete iPod effect is going to take place, we probably need the single-tablet formulation of TDF/FTC/RPV, which is currently under development.
2 Responses to “Rilpivirine Approved — the “iPod” of NNRTIs?”
Paul E. Sax, MD
Associate Editor
NEJM Clinician
Biography | Disclosures & Summaries
Learn more about HIV and ID Observations.
FROM NEJM — Recent Infectious Disease Articles- Interactive Perspective: Measles December 18, 2025This Double Take video reviews evidence-based recommendations on measles prevention and management and explores commonly asked questions about the measles virus and infection.
- Noninferiority of One HPV Vaccine Dose to Two Doses December 18, 2025In this trial, one dose of an HPV vaccine was noninferior to two doses in preventing HPV type 16 or 18 infection.
- From Crisis to Action — Policy Pathways to Reverse the Rise in Congenital Syphilis December 18, 2025In recent years, cases of congenital syphilis have surged. This trend reflects both prenatal care gaps and systemic issues, including failures in testing, treatment, and public health infrastructure.
- Contact Precautions for MRSA and Vancomycin-Resistant Enterococcus December 18, 2025This feature about the use of contact precautions in the hospital for patients with MRSA or VRE offers a case vignette accompanied by two essays, one supporting continuing the use of contact precautions and the other recommending discontinuing them.
- Evidence to Action — Single-Dose HPV Vaccination and Cervical HPV Infection December 18, 2025Kreimer and colleagues now report in the Journal1 the results of the ESCUDDO trial, which showed that the efficacy of a single dose of either a bivalent human papillomavirus (HPV) vaccine or a nonavalent formulation was similar to that of the standard two-dose schedule. This randomized trial...
- Interactive Perspective: Measles December 18, 2025
Paul, a complete Ipod effect in a single TABLET would probably be an Ipad
and this is the time for disclosure regarding your business with Apple
great review!
David
Hi Paul,
Important to remind that this situation is very similar to what occurred with triple nukes (AZT/3TC/ABC and in some extension, AZT/3TC/TDF) in the past. However, the position of the expert community was very different… Despite of the quality of evidence be low, the criticism and negative feelings around the lower virologic potency of 3NRTI when compared with EFV containing ( not observed in all studies), particularly in situations of very high VL at baseline, was the main justification for a big “crusade” against the use of these very friendly ART regimens, that were virtually banished from many parts of the North and considered by many as a ” 2nd class or sub-optimal therapy”… now the “mood” seems quite different with Rilpivirnine. The potential reasons are: 1) Experts are putting more value on tolerability/side effects and are less virologically obsessive than in the past (which seems to be a positive issue in my view); 2) The major triple nuke used in the past was AZT-3TC-ABC, which was the first FDC available in the North, but composed drugs manufactired by a European-based pharma and EFV, which was not available as a full FDC at that time, were a US based product… many of yours cannot agree with this second argument based on marketing disputes, but this kind of negative propaganda based on local interests already occurred with other drug products in the past (the classical episode between oral anti-diabetic drugs – sulfonylureas (produced by a US company) versus biguanides (produced by an European company), occurred in mid 50’s, when biguanides were banished from US during more than 20 years because of an alleged high risk of lactic acidosis (later, an elevated risk of CV events was associated with sulfonylureas and today metformin (the major biguanide available for clinical use), has a better safety profile is one of the most used antidiabetic drugs, even in US)… probably , the real reason is a mix of both arguments… let see how this new history with RPV will evolve…
Marco