New NNRTI Approved

On January 18th, the FDA approved etravirine, Tibotec's second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), for adults with drug-resistant HIV. Formerly known as TMC125 and now marketed as Intelence, etravirine works against HIV that has developed resistance to other drugs in the class.
   
First-generation NNRTIs, efavirenz (Sustiva), nevirapine (Viramune), and delavirdine (Rescriptor), are limited by their low genetic barrier to resistance: a single mutation can make an individual's HIV resistant to the all three drugs. Newer NNRTIs, including the recently approved etravirine and the drug candidate rilpivirine (TMC278), were designed to sidestep the mutations that make HIV resistant to older NNRTIs-meaning that people with NNRTI-resistant HIV may once again be able to benefit from this drug class. 
   
Advanced clinical trials also showed etravirine to be well tolerated, without the troubling mental side effects associated with efavirenz or the liver toxicities experienced by some individuals taking nevirapine at higher CD4 cell counts. 
   
The new NNRTI hit pharmacy shelves in January and came with a wholesale price tag of $21.80 per day. 

Updated Treatment Guidelines

In response to reports that people who begin HIV treatment early tend to live longer, healthier lives, the U.S.  Department of Health and Human Services (DHHS) has updated its Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, now recommending that therapy begin when the CD4 cell count drops below 350 cells/mm3-a significant change from the previous guidelines, which advised starting treatment at 200 cells/mm3.
   
The updated guidelines, issued December 1st, also recommend that treatment-naive individuals first receive the now-effective HIV resistance testing, which can identify upfront the most effective antiretroviral regimen for each individual.  (Otherwise, physicians must prescribe regimens through trial and error, which may increase resistance to other antiretrovirals.) A tropism assay is advised for those considering the CCR5 antagonist maraviroc (Selzentry), and HLA-B*5701 testing for abacavir hypersensitivity is recommended before starting a regimen containing Ziagen.  For treatment-experienced individuals, the updated guidelines offer information about new antiretrovirals in two novel classes: the CCR5 antagonist maraviroc and the integrase inhibitor raltegravir (Isentress), both approved in 2007.The complete updated DHHS guidelines are available for download at www.aidsinfo.nih.gov.