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Viread - the once a day no side effect drug?
Nov 13, 2001

What do you know about this Viread drug that the FDA approved on Friday Oct. 26th.? Does it have to be taken in combination with other drugs, or is it a drug that has three or more drugs in one?

Response from Dr. Cohen

Well, we know something about it. Since it is new, it is worth some review to see what role it can have for readers out there. It is fair to say, as an intro, that there is some excitement about this drug based on what we know now about it.

First - the chemical name is tenofovir. Brand name is Viread, pronounced vih-ree-ad, not Vi-Reed, if that matters to readers... Like any antiviral - it can help stop the growth of HIV - but is only a single drug and so is not powerful enough to be used alone - it would be part of a combination with other meds - usually two others to create the standard "cocktail". It is not a combo tablet - we do have two other meds that are combo tablets - these are meds that are combined into simpler combination tablets - and include Combivir - a combination of AZT and 3TC - as well as Trizivir - which is Combivir plus a third antiviral called Ziagen (or abacavir). (Kaletra is another type of combo capsule but in that case, the ritonavir in the capsule is used mainly to "boost" the primary drug lopinavir to active amounts, while the ritonavir is, at this low dose, not active as an antiviral.)

So what of Viread? Well, it is just one pill once a day taken with some food. Side effects are thankfully pretty unlikely - only about 5% do have some GI upset (nausea, diarrhea) and this has been reported as mild only. So far no serious toxicities have been linked to this drug and it is pretty easy for virtually all to start on and stay with. In addition, there are few lab tests needed to monitor it - a few can have transient low phosphates which can be monitored, but that is about it. There is ongoing monitoring of bone density as well based on some animal data suggesting a possibility of bone changes - but at this point there are no human data yet to support a need to worry on this issue - and we are continuing our monitoring to be sure on this issue.

And so what of its benefits? In the two studies which lead to approval - it shows a pretty reliable average 0.6 log drop in viral load in pre-treated persons. As it is related to the nucleoside family of meds, it shows some loss of response as a result of mutations created by AZT and/or D4T - and those with such mutations still have this average 0.6 log drop. However, for those with either none or few mutations (like only the 184V from 3TC, or 74V from ddI for example), this drug can offer over a one log drop in viral load. And it is still active despite a mutation known as 151M - an important issue since, while rare, none of the other nucleosides are effective once this mutation shows up - within this class of meds, only tenofovir will work at that point.

So the discussions are ongoing about how to use this new kid on the block. Do we use it for "salvage" e.g. after resistance has developed to the other meds? Do we use it up front? The trials studying it as a first line drug are underway and info from these are expected next year - what to do until then is an ongoing discussion. As it is just once a day - there is interest in using it whenever - to simplify med combinations. However - it should be noted that combining it with Videx EC - the newer once a day form of ddI - is a bit tricky as ddI needs to be taken without food, while this needs some food. And the studies about combining these two taken together are underway - until then, they should probably be taken separately by about 30-45 minutes or so...

But it does increase the ways in which we can establish-reestablish control of HIV. And does so with a pretty simple pill. And one that is pretty easy to take. So there are many who are exploring how this may help out with current treatment concerns.



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