Biotech Values

[DewDiligence]

…pill-burden question on the ABBV/ENTA treatment. I saw someplace it will likely be one pill QD, plus 2 pills each BID. Is that correct?

ABT-450 and ABT-267 have been co-formulated into a qD pill; however, to keep the pill size small, each pill contains half the daily dose, so patients take two of these pills at the same time, once per day.

ABT-333—the third DAA in ABBV/ENTA’s 3-DAA regimen—is BID, and ribavirin is always given BID to reduce side effects (although it is efficacious given qD).

I would argue (and ‘dewophile’ has also stated) that any regimen that contains ribavirin gains little or nothing by having the other drugs in the regimen dosed qD rather than BID. If ribavirin is not in the mix, then qD dosing for all drugs is an advantage for compliance but not a huge advantage, IMO, in a regimen that lasts only 12 weeks.

In a 24-week regimen without ribavirin, qD dosing would be a more significant compliance advantage than in a 12-week regimen; however, 24-week regimens will be used only for the hardest-to-treat patients, and it remains to be seen if omitting ribavirin will work in these cases for either GILD’s or ABBV/ENTA’s regimens.

Whether ribavirin will be needed in ABBV/ENTA’s regimen for run-of-the-mill patients depends on the outcomes of the PEARL-2/3/4 studies (#msg-94191610).