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

March 9, 2016

Paul E. Sax, M.D.

Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.

The 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.

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This article was provided by NEJM Journal Watch. NEJM Journal Watch is a publication of the Massachusetts Medical Society.

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