Effects of active treatment discontinuation in patients with a CD4+ T-cell nadir greater than 350 cells/mm3: 48-Week Treatment Interruption in Early Starters Netherlands study (TRIESTAN)
OBJECTIVE: To evaluate the safety and efficacy of discontinuing highly active antiretroviral therapy (HAART) in HIV-1-positive patients who initiated HAART at a CD4 T-cell count >350 cells/mm. METHODS: Eligible patients were identified from the Dutch AIDS Therapy Evaluation, The Netherlands (ATHENA) national observational cohort. Interruption or continuation of HAART was offered to all. RESULTS: Of 71 patients enrolled, 46 (64%) interrupted HAART (STOP group) and 25 (36%) continued HAART (control group). The median CD4 T-cell nadirs at the start of HAART were 469 (interquartile range [IQR]: 430-720) cells/mm and 510 (IQR: 440-637) cells/mm, respectively. At week 48, the median plasma HIV RNA level in the STOP group had stabilized at approximately pre-HAART values (4.55 log10, IQR: 4.2-4.9 copies/mL), but the CD4 T-cell count still exceeded the pre-HAART count (563 cells/mm, IQR: 450-710 cells/mm). Only 5 patients (11%) had reinitiated HAART after 48 weeks, all for personal reasons. No Centers for Disease Control and Prevention category events or death occurred after interruption. In 6 (13%) of 46 patients, mild symptoms of acute retroviral rebound syndrome (ARVS) were identified. No improvement was observed in mental or physical health scores. In 37% of patients, nonnucleoside reverse transcriptase inhibitor drug concentrations were still detectable 1 week after stopping. CONCLUSIONS: Although HAART can safely be interrupted in patients with a high CD4 T-cell nadir, no improvement in quality of life was established. Patients can experience ARVS, the risk for development of resistance after treatment interruption is realistic, and there is a potential hazard of HIV transmission to sexual partners. We would not actively advise stopping treatment in patients who started treatment too early according to current guidelines.
|Keywords||Acute retroviral rebound syndrome, Highly active antiretroviral therapy, Plasma drug levels, Quality of life, Treatment interruption|
|Persistent URL||dx.doi.org/10.1097/QAI.0b013e31802f83bc, hdl.handle.net/1765/37031|
|Journal||J A I D S|
Pogány, K, Vanvalkengoed, I.G, Prins, J.M, Nieuwkerk, P.T, van der Ende, I.E, Kauffmann, R.H, … Brinkman, K. (2007). Effects of active treatment discontinuation in patients with a CD4+ T-cell nadir greater than 350 cells/mm3: 48-Week Treatment Interruption in Early Starters Netherlands study (TRIESTAN). J A I D S, 44(4), 395–400. doi:10.1097/QAI.0b013e31802f83bc