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CROI 2013: Must NRTIs be included in new regimen after failing a PI-containing regimen?

Karen Tashima from Brown University presented results today in a late breaker session on the outcomes of patients receiving NRTI-free antiretroviral regimens. The subjects were either treatment experienced and/or had virologic failure and were randomized to a new regimen with (ADD) or without (OMIT) NRTI in addition to a personalized regimen with 3-4 ARV with at least 2 active drugs from (raltegravir [RAL], darunavir/ ritonavir [DRVr], telapavir/r [TPVr], etravirine [ETR], maraviroc [MVC], enfuvitide [ENF]). All subjects had resistance testing and tropisms before determining the regimen.

Inclusion criteria included having a viral load >1000 copies and tested negative for chronic hepatitis B. The 2 most common regimes chosen were RAL-DRV/r-ETR (56%), or RAL-DRN/r-MVC (14%). The primary outcome was regimen failure or discontinuation at week 48, a safety endpoint was time to discontinuation of NRTI due to severe symptoms or abnormal laboratory values. A treatment difference of <15% was determined to be non-inferior.
The results demonstrated that the NRTI-free arm (OMIT) was non-inferior to adding NRTI (ADD) at week 48. Similar outcomes were noted in the OMIT and ADD arms for regimen failure (30%, 26%), virologic failure (25%, 25%) and discontinuation (8%, 6%), respectively. CD4 and viral load responses were also similar for both groups.

The benefits of the study included reduced pill burden and reduced cost. The investigators suggested that NRTI regimens be considered for treatment experienced patients and those experiencing virologic failure. During the Q&A that followed, Dr. Andrew Zolopa, from Stanford University, thanked Dr Tashima, calling the results of this study a “game changer."

Tashima K, Smeaton L, Andrade A, Eron J, Fichtenbaum C, Gandhi R, Johnson V, Klingman K, Hollabaugh K, Haubrich R, and A5241 Study Team. Omitting NRTI from ARV regimens is not inferior to adding NRTI in treatment experienced HIV+ subjects failing a protease inhibitor regimen: The ACTG OPTIONS Study. Presented March 6, 2013 at the 20th CROI, Atlanta, GA. Oral Abstract #153LB.

Source: Reporting from Atlanta for PRN News: Susan Weiss, NP, and Anita Radix MD, MPH