POSITIVELY AWARE MARCH/APRIL 2011
rilpivirine (TMC 278)/Truvada
(combination brand name not yet established)
common name: rilpivirine (TMC 278), emtricitabine, and tenofovir DF
class: Nucleoside/nucleotide analog reverse transcriptase inhibitor
(nucleoside/nucleotide analog, NRTI, or nuke)
and non-nucleoside reverse transcriptase inhibitor
(non-nucleoside, NNRTI, or non-nuke)—fixed dose regimen
manufacturers: Tibotec Therapeutics | (877) REACH-TT (732-2488),
www.tibotectherapeutics.com; and
Gilead Sciences | www.gilead.com, (800) GILEAD5 (445-3235)
Standard dose: One tablet (rilpivirine [25 mg] and Truvada [200 mg Emtriva and 300 mg Viread] once daily has been selected in the Phase 3 trials. Take missed dose as soon as possible, unless it is almost time for your next dose. Do not double up on your next dose. Dose cannot be adjusted for people with kidney problems.
AWP: pricing unavailable at press time
Potential side effects and toxicity
See the drugs rilpivirine and Truvada. Available data are limited due to experimental drug status.
Potential drug interactions
See the drugs rilpivirine and Truvada. Do not take this drug with Atripla, Combivir, Emtriva, Epivir, Epivir-HBV, Epzicom, rilpivirine, Trizivir, Truvada, or Viread, since these medications are already in this fixed dose pill or have equivalent medications. Again, available data is limited due to its experimental drug status.
More information
Expected to be approved by the FDA in 2011. On November 23, 2010, Gilead Sciences submitted an NDA (new drug application) to the U.S. FDA. As of press time, this medication has not yet been approved. If approved, this will be the second once-daily, single tablet, complete regimen on the market (see Atripla). The pill will be smaller in size than Atripla. The NDA is supported by a bioequivalence study showing the single tablet formulation containing rilpivirine, emtricitabine, and tenofovir disoproxil DF achieved the same drug levels in the blood as if these drugs were taken simultaneously as individual pills. Both Truvada and rilpivirine also have long half-lives (time it takes a drug in the body to be reduced by half), making them a great pairing. See package insert, once approved, for more complete information on potential side effects and drug interactions.
Doctor’s comments
It was hoped that this combination, the second single-tablet, once-daily regimen, would be approved this spring along with rilpivirine, but the FDA has asked for some additional data before they’ll approve the combination pill, which may delay approval for a short time. The advantages and disadvantages of this regimen vs. Atripla are discussed elsewhere (see rilpivirine), and a head-to-head comparison of the two regimens is in progress (the original rilpivirine studies didn’t use the single-tablet regimen). While it’s possible that this won’t achieve Atripla status in the guidelines, its better tolerability will be a big plus. It may turn out to be a good choice for people with low baseline viral loads or those who have trouble tolerating Atripla, Sustiva, or boosted PIs. —Joel Gallant, MD, MPH
Activist’s comments
Dubbed “B-tripla”, this one pill/once-a-day pairing of rilpivirine with Truvada will offer the convenience of Atripla without the crazies or high lipids. The same caveats about not starting this drug in people with high viral loads (more than 100,000) apply as with rilpivirine by itself. But this drug should prove to be an attractive option for those starting meds, without the downside of the Sustiva in Atripla. It’s in the pipeline for FDA approval—expect to see it on pharmacy shelves sometime in 2011. —Jeff Taylor
