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DewDiligence

07/31/07 2:50 AM

#1505 RE: go seek #1503

>What about Viread used for HIV? When approved for HBV... what are the concerns, if any, for those coinfected w/ HIV and considering use of Viread?<

When Viread is approved for HBV, it will probably get the same black-box warning for HIV co-infection that Hepsera already has:

http://www.fda.gov/cder/foi/label/2006/021449s006lbl.pdf (see paragraph 3 inside the black box).

Viread, in combination with two other HIV drugs, is the standard first-line regimen for HIV and is used in more than half of all patients treated for HIV in the U.S. (Note that Viread is a component of the Truvada and Atripla combination pills.)

Clearly, a patient who takes Viread as monotherapy for an extended period in order to treat HBV increases the likelihood of developing resistance to Viread before it can be used in subsequent therapy for HIV. If this occurs, the patient ends up having to take a less-potent and/or less tolerable HIV cocktail that does not include Viread.