Treatment research reached a fever pitch in the final months of last year. The first oral entry inhibitor, Selzentry, was approved by the Food and Drug Administration, as was Isentress, the first drug to emerge in the new integrase inhibitor class. And just days into this year, Intelence, a second-generation nonnucleoside, received the FDA's nod.
But in recent months news of advancements, like those milestones, has quieted, and a close look at the development pipeline shows that the immediate future is going to be uneventful indeed.
Although there are 149 different compounds being studied, none will reach the market this year. In fact, while there are 27 experimental medications in clinical trials, none are in Phase III human trials'the final stage of research before FDA approval is sought'and only seven are in full Phase II efficacy studies.
The upside is that, although there will be no new anti-HIV drugs approved in the foreseeable future, the medications that are the farthest along in development offer significant benefits over existing medications by attacking the virus in new ways, being more potent than similar drugs, producing fewer side effects, or being taken less frequently. The obvious downside is that most are still years away.
DRUGS IN HUMAN STUDIESEntry Inhibitors:
HGS004 (CCR5 blocker antibody), Phase I/II, Human Genome Sciences
INCB9471 (CCR5 blocker), Phase II, Incyte
PF232798 (CCR5 blocker), Phase I, Pfizer
PRO140 (CCR5 blocker antibody), Phase I/II, Progenics
Suc-HSA (gp120 blocker), Phase I, Sanquin
TAK220 (CCR5 blocker), Phase I, Tobira (licensed from Takeda)
TAK652 (CCR5 blocker), Phase I, Tobira (licensed from Takeda)
TNX355 (CD4 blocker antibody), Phase II, Tanox and Biogen
Vicriviroc (CCR5 blocker), Phase II, Schering-Plough
Integrase Inhibitors:
Elvitegravir (GS9137) , Phase II, Gilead Sciences
GSK364735, Phase I, GlaxoSmithKline/Shionogi
Nonnucleoside Reverse Transcriptase Inhibitors:
70h (GW678248), Phase I, GlaxoSmithKline
BILR 355/r BS, Phase I/II, Boehringer Ingelheim
Rilpivirine (TMC278), Phase II, Tibotec
UK435061, Phase I/II, Pfizer
Nucleoside Reverse Transcriptase Inhibitors:
Amdoxovir, Phase II, RFS Pharma
Apricitabine (AVX754), Phase I/II, Avexa
DOT (dioxolane thymidine), Phase I, University of Georgia
Elvucitabine (ACH126), Phase I/II, Achillion
Fosalvudine (alovudine prodrug), Phase I/II, Heidelberg Pharmaceuticals
Racivir, Phase I/II, Pharmasset
Protease Inhibitors:
PPL100, Phase I, Merck
SPI452, Phase I, Sequoia Pharmaceuticals
Other Classes:
Bevirimat (PA457) (maturation inhibitor), Phase II, Panacos
BI201 (anti-tat antibody), Phase I, BioInvent
KP1461 (viral decay accelerator), Phase I/II, Koronis
PA1050040 (gag processing inhibitor), Phase 1, Panacos
