atc?, page-2

Nice find DB
I have copied a little more for those who may be interested:

"The NRTI pipeline is disturbingly dry. BMS-986001 is a Phase II thymidine analogue, like AZT and d4T, being developed as an alternative to AZT for treatment naïve patients. GS-7340 is a Phase II tenofovir pro-drug, so it has cross-resistance with tenofovir and will have the same interactions. The most promising candidate, which also happens to be closest to the goal line, is apricitabine (ATC) in Phase III by Avexa.

ATC has been found to have no cross resistance with other NRTIs, no resistance development up to 144 weeks, be very well tolerated and be used in combination with all other available ARV drugs, with the exception of 3TC and FTC as no two cytidine analogues should be used together. ATC is active against the M184V and L74V mutations and TAMs and no resistance has developed in patients on treatment for up to at least 144 weeks. It has a safety profile at least as good as that of FTC and 3TC, and demonstrated no evidence of mitochondrial, bone marrow, pancreatic, hepatic and renal toxicities. The FDA has approved a registration study of 300 patients whose options for effective HAART treatment are limited by drug resistance and/or tolerability with the primary endpoint of a reduction in viral load at day 14 on functional ATC monotherapy. On day 14 the background regimen will be changed to two new active ARVs, all patients will continue on ATC and safety, durability and resistance evaluated.

Where are big pharma and the ACTG? Big pharma is licensing fewer, earlier stage ARV candidates and concentrating exclusively on once daily combination drugs for treatment naïve patients or PrEP and market share among well-suppressed treatment experienced patients. Drug resistant and treatment-experienced patients are a growing market segment. ATC is in late stage clinical development for treatment experienced patients, currently dosed twice daily and not easily incorporated into once daily combination drugs. While once daily combination medications are no doubt extremely successful in treatment naïve patients, they are much less so for treatment-experienced patients who require a more individual approach to construct an effective, tolerable and durable regimen. The current domination of once daily combination drugs for HIV does not benefit a significant and growing segment of the patient population. ATC is the most promising and advanced NRTI candidate and the completion of its clinical development should be prioritized for federally facilitation via an HIV clinical trials network.