March 9th, 2016

Approval of TAF/FTC/RPV, Another Single Pill HIV Treatment Option

2001-yellow-suitThe approval last week of TAF/FTC/RPV — that’s coformulated tenofovir alafenamide, emtricitabine, and rilpivirine — brings us another one-pill, once-daily option for HIV treatment.

It’s essentially the same as the existing TDF/FTC/RPV, with similar pros/cons, but with three notable differences coming with the substitution of TAF for TDF.


  1. Likely reduced renal and bone toxicity. Since approval was based on bioequivalnce, this hasn’t (yet) been proven in clinical trials — switch-studies are ongoing, comparing TAF/FTC/RPV to both TDF/FTC/RPV, and TDF/FTC/EFV. Note that this might end up being a more relevant consideration with TDF/FTC/RPV than TDF/FTC/EFV, since the former is taken with food and hence leads to higher tenofovir levels.
  2. A smaller tablet size. TDF/FTC/RPV was already the smallest coformulated pill for complete HIV treatment, and with 25 mg of TAF replacing 300 mg of TDF, the new pill is quite a bit smaller. For some patients, this matters a lot.
  3. A weird new brand name. It’s called Odefsey, which sounds kind of like the famous Stanley Kubrick film, without the “2001:  A Space …”

We can assume (for now) that carried over from TDF/FTC/RPV is the generally well-tolerated profile (low risk of rash, GI side effects, metabolic abnormalities). As with TDF/FTC/RPV, TAF/FTC/RPV should be taken with food and without concomitant PPIs to maximize RPV absorption. It is not intended for treatment-naive patients who have HIV RNA > 100,000 copies/mL.

So this is a nice advance, especially for those patients at risk for renal and/or bone disease. Little reason not to switch existing TDF/FTC/RPV-treated patients to this new formulation, at least once payers add it to their formularies. (As with ECF-TAF, the listed price of TAF/FTC/RPV is the same as TDF/FTC/RPV.)

Note that arguably a bigger TAF-related approval — the TAF/FTC pill, already nicknamed “TAF-ada” — is expected next month.


One Response to “Approval of TAF/FTC/RPV, Another Single Pill HIV Treatment Option”

  1. Agnes says:

    Hi Dr. Sax,
    Absolutely adore your blog. Thanks for the CROI update entry (excellent as usual), especially since I’ll be sadly missing your talk at IAS.
    Question – any idea why TAF is “boosted” by RTV and COBI requiring the dose to be 10mg? Can’t figure out the mechanism considering it’s not a CYP interaction. Does it have to do with gut efflux transporters?

HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

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