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Commonly Transmitted HIV-1 Drug Resistance Mutations in Reverse Transcriptase and Protease in Antiretroviral Treatment-Naïve Patients do not Affect Response to Tenofovir Disoproxil Fumarate- or Tenofovir Alafenamide-Containing Regimens.

Background.
The presence of transmitted drug-resistance mutations (TDRM) in antiretroviral (ARV) treatment-naïve patients can adversely affect the outcome of ARV therapy.


Methods.
Resistance testing was conducted in 6704 ARV-naïve subjects predominantly from the U.S. and Europe in 9 Gilead clinical studies from 2000 to 2013.


Results.
The presence of TDRM increased during this period (5.2% to 11.4%), primarily driven by non-nucleoside RT inhibitor resistance mutations (NNRTI; 0.3% to 7.1%), particularly K103N/S (0.3% to 5.3%). NRTI mutations were found in 3.1% of patients. Only 1 patient had K65R (0.01%) and 7 patients had M184V/I (0.1%) despite high use of tenofovir disoproxil fumarate (TDF), emtricitabine, and lamivudine and potential transmission of resistance to these drugs. One or more thymidine analog mutations (TAMs) were present in 2.7% of patients with 0.07% harboring T215Y/F and 2.7% harboring T215 revertant mutations (T215rev). Patients with the combination of M41L+L210W+T215rev showed full HIV RNA suppression while receiving a TDF- or tenofovir alafenamide (TAF)-containing regimen.


Conclusions.
There was an overall increase of TDRMs among patients enrolling in clinical trials from 2000 through 2013 driven primarily by an increase in NNRTI-R. However, the presence of common TDRMs, including TAMs/T215rev, showed no impact on response to TDF- or TAF-containing regimens.