For the next few days at least- and hopefully longer- I will be in a New York groove. No, I won't be in the City, but following the Yankees playoff drive. Game 1: CC is a horse, Jeter is a stud, A Rod has chased away his ghosts, and the Yankees lead the series 1-0.
In HIV land, you might have seen this story from the fine folks across the hall in the aidsmeds.com cubicles about the early closure of a phase III trial of apricitabine (ATC). Apricitabine is an NRTI, like AZT or tenofovir- that was being tested in people whose HIV had developed resistance to 3TC or FTC.
Avexa, the company developing apriciabine, released a cryptic (a-vexing?) press release saying that the study, meant to be 48 weeks, was being closed early in order to 'offer key insight into ATC's role in the overall HIV treatment landscape, and discussions with regulatory authorities may clarify the ATC approval path. Secondly, this will allow for a mature enough data point to enable potential partners the ability to make a definitive decision on licensing of ATC'
I have no insider scuttlebutt on this story, but it doesn't sound good. The development of this drug has been slow and meandering. The studies done to date have shown some efficacy, but nothing really special.
The Avexa press release, while not really telling us anything, suggests to me that this drug is dead in the water. Typically when companies have positive news they share it. This is even more true of smaller companies, who are dependent on investors.
The need for such a drug is questionable as well. On one hand, many (most?) people's HIV will develop resistance to FTC or 3TC. These drugs are part of most HIV regimens and a single point mutation- called M184V- is enough to greatly reduce the virus' susceptibility to the drugs. However, some research- including a study presented at the recent ICAAC conference, shows that people seem to do just fine clinically if they keep taking these drugs after that resistance mutation emerges.
The bigger picture question for me is the need for NRTIs. NRTIs- the first class of HIV drugs developed and still the 'backbone' of the vast majority of HAART regimens- don't match up favorably when compared to the rest of the anti-HIV armementarium. They are relatively weak and toxic and their place in the 'HIV treatment landscape' is largely an accident of history- that is it has more to do with when the drugs were developed than any strong research.
This should not be read as 'stop taking your NRTIs.' While I have doubts about this entire class of drugs, there simply aren't enough data yet to adequately understand the role they play, or more accurately should play in HIV treatment.
As we wait for more data- Go Yankees!
After I hit save word came down the proverbial wire that the FDA has voted to approve Selzentry (maraviroc) for people taking HIV drugs for the first time. Stay tuned for more info.
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