Should we now adopt the HIV-RNA < 50 copy endpoint for clinical trials of antiretroviral-experienced as well as naive patients?
In the TORO, RESIST and POWER trials, the HIV-RNA < 50 copy endpoint showed the strongest durability over time, whereas HIV-RNA reductions of more than 1 log10 or below 400 copies/ml were less sustained during 48 weeks of treatment. Clinical trials of new antiretroviral drugs in highly experienced patients also show high rates of HIV-RNA suppression below 50 copies/ml. HIV-RNA suppression below 50 copies/ml should now become the standard efficacy endpoint across trials of both naive and experienced patients.
Hill
Andrew
A
Department of Pharmacology, University of Liverpool, UK.
Miralles
Diego
D
Vangeneugden
Tony
T
Lefebvre
Eric
E
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D016896:Treatment Outcome; D019562:Viral Load
D019380:Anti-HIV Agents; D012367:RNA, Viral